An editorial from Andrew Pollack of NY Times' "Prescriptions" blog. He points out that is drug companies aren't always up front when it comes to the cost of new drugs or price increases for older ones. He includes Merck and Vertex's new drugs for Hepatitis C as examples. Not a very exciting or particularly incisive read, but he does make a good point not always obvious to people outside the business of drug development.
May 31, 2011, 4:09 pm
The Hidden Price of Drugs
By ANDREW POLLACK
Pharmaceutical companies are happy to tout the benefits of their newest drugs. But sometimes they seem far less willing to let the public know the price of the product.
The latest example occurred on Tuesday morning when Optimer Pharmaceuticals announced that its new drug to treat diarrhea caused by the bacterium Clostridium difficile would cost $2,800, about twice as much as the existing approved drug.
On Friday, Optimer announced in a press release that the Food and Drug Administration had approved its drug, called Dificid. But the company kept the price out of the press release, saying it would not reveal it until its conference call with securities analysts Tuesday morning.
Whatever the reason for the tactic, it had the result of keeping discussions about what many would consider eye-popping prices out of initial articles about the drug’s approval.
Vertex Pharmaceuticals did this as well after the recent approval of its hepatitis C drug, Incivek. The press release contained a lot of information about how generous the company was going to be in helping customers with their insurance co-payments. But it did not include how much the drug would actually cost — $49,000.
In that case, however, the call with analysts in which the price was unveiled came only about two hours after the approval was announced.
It could be pointed out that analyst calls are also a more supportive environment for a company. Analysts often applaud “premium’’ pricing because it means higher sales for a drug, whereas patients and insurers would have the opposite view.
Merck did put the $1,100-a-week price of its new hepatitis C drug, Victrelis, in its press release. But the price was mentioned in a single short sentence at the very bottom of a press release that was more than 250 lines long.
Dr. Jeffrey H. Albrecht, a gastroenterologist at Hennepin County Medical Center and a professor of medicine at the University of Minnesota, said he was frustrated trying to find documented information, outside of news reports, on the price of the new hepatitis C drugs.
“When you take a step back,’’ he said in an e-mail, “it is really remarkable that patients and physicians often don’t know how much treatments or tests cost.’’
Actually, Merck, Vertex and Optimer did more to make their prices public than some companies, which never reveal their prices. And some companies say they do not want to reveal the price until they actually begin marketing the drug, which in some cases can be weeks or even months after the regulatory approval.
A spokeswoman for Vertex said that price was complicated since patients did not usually pay the listed wholesale price. An analyst call, therefore, was a better way to reveal the information.
“We wanted to get the information out quickly but also avoid confusion about an important and complicated topic,’’ she said.
A spokesman for Optimer said it was not customary to put prices in press releases, and that telling the price to analysts allowed the company put the information in context.
On the call Tuesday morning, Optimer’s chief executive, Pedro Lichtinger argued that the $2,800 price for a 10-day course of treatment with Dificid was in line with prices for some other new antibiotics.
He said Dificid would be cost-effective because it might cut down on hospital stays and other costs associated with treating C. difficile. In clinical trials, Dificid was superior to the only other approved drug, Vancocin, in providing a “sustained clinical response,’’ he said.
Vancocin, an oral form of the antibiotic vancomycin sold by ViroPharma, costs $1,000 to $1,500 for a 10- to 14-day course of treatment at the lowest dose, Mr. Lichtinger said. But some patients get higher doses or longer treatments, multiplying the cost.
ViroPharma has been steadily raising the price of Vancocin and has taken legal action to try to delay approval of generic versions of the drug. Still, many hospitals get around the price of Vancocin by using the intravenous form of vancomycin, which is generic, in a manner that lets patients take it orally.
Tuesday, May 31, 2011
Thursday, May 26, 2011
Achillion Pharmaceuticals ACH-2684 HCV Pan-Genotype HCV Protease inhibitors goes into the clinic...
Achillion Pharmaceuticals announces first-in-human trials of it's own ACH-2684 HCV protease inhibitor. This is a phase 1 trial designed to study the safety, tolerability, pharmacokinetic profile and antiviral activity of the drug in up to 78 healthy volunteers and up to 40 HCV-infected, genotype 1 & 3 patients. ACH-2684 is said to be active against all six genotypes and offers once-daily dosing
First-in-Human Trial Will Evaluate Safety of Pan-Genotypic Protease Inhibitor in Both Healthy Subjects and Genotype 1 or 3 HCV-Infected Patients
NEW HAVEN, Conn., May 25, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has begun dosing in a Phase 1 clinical trial of ACH-2684, a novel pan-genotypic protease inhibitor being developed for the treatment of chronic hepatitis C virus (HCV) infection.
The Phase 1 clinical study is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2684. The trial consists of three segments including assessment of single ascending oral doses in healthy volunteers, a 14 day multiple ascending doses segment in healthy volunteers, and evaluation of 3 days of oral ascending repeat doses in subjects with either genotype 1 or genotype 3 hepatitis C infection. The trial will take place in the United States and is designed to enroll up to 78 healthy volunteers and up to 40 HCV-infected patients.
"This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-2684 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "It will also provide Achillion with important preliminary efficacy data against HCV genotypes 1 and 3, and help us to select doses for subsequent clinical development."
"We are very excited to take ACH-2684 into the clinic and advance what we hope will be a unique pan-genotypic, once-daily protease inhibitor," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "Furthermore, we expect to shortly launch the 12-week segment of the Phase 2 trial of our lead ACH-1625 protease inhibitor, as well as a Phase 1 trial of our ACH-2928 NS5A inhibitor. We believe we remain poised to deliver a trio of important HCV clinical milestones near the end of this year, namely, 12-week EVR results on ACH-1625 and human proof-of-concept data on both ACH-2684 and ACH-2928. These are all important components in our ultimate strategy of becoming a leader in the development of HCV combination therapies involving our protease and NS5A inhibitors."
About ACH-2684
ACH-2684 is a pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-2684 is a macro-cyclic, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-2684 demonstrated pico-molar potency, excellent pharmacokinetic properties and safety profile at high drug exposures. ACH-2684 also exhibits rapid and extensive partitioning to the liver, as well as high liver/plasma ratios in preclinical studies. ACH-2684 has shown pico-molar potency against NS3 protease that is specific to HCV. It is active against the 6 known genotypes of HCV and exhibits equipotent activity against HCV genotypes 1a and 1b at an IC50 of approximately 100 picomolar. The drug candidate was discovered internally and is being advanced by Achillion.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of ACH-2684, which may not be duplicated in clinical studies and Achillion's expectations regarding timing and duration of clinical trials and reporting of results from clinical trials of ACH-1625, ACH-2684 and ACH-2928. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion's ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (646) 229-5178
christin.miller@ogilvypr.com
First-in-Human Trial Will Evaluate Safety of Pan-Genotypic Protease Inhibitor in Both Healthy Subjects and Genotype 1 or 3 HCV-Infected Patients
NEW HAVEN, Conn., May 25, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has begun dosing in a Phase 1 clinical trial of ACH-2684, a novel pan-genotypic protease inhibitor being developed for the treatment of chronic hepatitis C virus (HCV) infection.
The Phase 1 clinical study is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2684. The trial consists of three segments including assessment of single ascending oral doses in healthy volunteers, a 14 day multiple ascending doses segment in healthy volunteers, and evaluation of 3 days of oral ascending repeat doses in subjects with either genotype 1 or genotype 3 hepatitis C infection. The trial will take place in the United States and is designed to enroll up to 78 healthy volunteers and up to 40 HCV-infected patients.
"This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-2684 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "It will also provide Achillion with important preliminary efficacy data against HCV genotypes 1 and 3, and help us to select doses for subsequent clinical development."
"We are very excited to take ACH-2684 into the clinic and advance what we hope will be a unique pan-genotypic, once-daily protease inhibitor," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "Furthermore, we expect to shortly launch the 12-week segment of the Phase 2 trial of our lead ACH-1625 protease inhibitor, as well as a Phase 1 trial of our ACH-2928 NS5A inhibitor. We believe we remain poised to deliver a trio of important HCV clinical milestones near the end of this year, namely, 12-week EVR results on ACH-1625 and human proof-of-concept data on both ACH-2684 and ACH-2928. These are all important components in our ultimate strategy of becoming a leader in the development of HCV combination therapies involving our protease and NS5A inhibitors."
About ACH-2684
ACH-2684 is a pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-2684 is a macro-cyclic, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-2684 demonstrated pico-molar potency, excellent pharmacokinetic properties and safety profile at high drug exposures. ACH-2684 also exhibits rapid and extensive partitioning to the liver, as well as high liver/plasma ratios in preclinical studies. ACH-2684 has shown pico-molar potency against NS3 protease that is specific to HCV. It is active against the 6 known genotypes of HCV and exhibits equipotent activity against HCV genotypes 1a and 1b at an IC50 of approximately 100 picomolar. The drug candidate was discovered internally and is being advanced by Achillion.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of ACH-2684, which may not be duplicated in clinical studies and Achillion's expectations regarding timing and duration of clinical trials and reporting of results from clinical trials of ACH-1625, ACH-2684 and ACH-2928. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion's ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (646) 229-5178
christin.miller@ogilvypr.com
Fair Pricing Coalition puts Merck and Vertex on notice....
Drug pricing is tricky business, to be sure. The drug developer, payors, public policy experts and the patients themselves struggle for equitable outcomes. Variables such as struggling economies, rising healthcare costs and disparate abilities to cover costs all make the pricing policy even more arduous. There are no shortage of arguments to support all sides of the pricing equation. Here,the Fair Pricing Coalition, an ad hoc group of activists who advocate with the pharmaceutical industry regarding the price of HIV and hepatitis drugs, raises their collective concern regarding the price tags of Victrelis and Incivek.
May 25, 2011
Fair Pricing Coalition Says Vertex’s Incivek Price 'Outrageous'
The Fair Pricing Coalition is again sounding the alarm regarding the price of newly approved treatments for hepatitis C, this time questioning the cost of Vertex’s protease inhibitor Incivek (telaprevir). The advocacy group is concerned that Incivek’s price tag of $49,200 per 12-week course will adversely affect the ability of people with HCV to access the drug, while also setting an excessively unreasonable future price point for the many hepatitis C virus (HCV) drugs in the pipeline.
“Merck’s Victrelis costs $48,400 for 48 weeks of treatment,” said FPC member Lynda Dee in a statement from the organization. “Now Vertex has set a price approximately four times greater than Victrelis for 12 weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!”
According to FDA labeling for Incivek, approved May 23, the drug should be taken for 12 weeks with either 24 or 48 weeks of pegylated interferon and ribavirin, depending on a patient’s response to the regimen. The wholesale price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is about $30,000. The $49,200 WAC price for 12 weeks of Incivek, the FPC wrote, “will more than double the already exorbitant 48 week price” of hepatitis C treatment.
“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current U.S. health care crisis,” Dee said.
“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis and Incivek.
“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”
Other costs need to be considered as well, the FPC states. According to a paper presented at the annual conference of the American Association for the Study of Liver Diseases (AASLD), the costs of treating the side effects of HCV protease inhibitors such as Victrelis are expected to be 30 percent higher than for existing treatments. And many of those with hepatitis C suffer from other illnesses. Some have diabetes or bleeding disorders; others are coinfected with HIV. All of these add completely new sets of medical expenses.
“We were very disappointed by the cost set by Merck for Victrelis earlier this month. Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” Dee said. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.
“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP). Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”
May 25, 2011
Fair Pricing Coalition Says Vertex’s Incivek Price 'Outrageous'
The Fair Pricing Coalition is again sounding the alarm regarding the price of newly approved treatments for hepatitis C, this time questioning the cost of Vertex’s protease inhibitor Incivek (telaprevir). The advocacy group is concerned that Incivek’s price tag of $49,200 per 12-week course will adversely affect the ability of people with HCV to access the drug, while also setting an excessively unreasonable future price point for the many hepatitis C virus (HCV) drugs in the pipeline.
“Merck’s Victrelis costs $48,400 for 48 weeks of treatment,” said FPC member Lynda Dee in a statement from the organization. “Now Vertex has set a price approximately four times greater than Victrelis for 12 weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!”
According to FDA labeling for Incivek, approved May 23, the drug should be taken for 12 weeks with either 24 or 48 weeks of pegylated interferon and ribavirin, depending on a patient’s response to the regimen. The wholesale price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is about $30,000. The $49,200 WAC price for 12 weeks of Incivek, the FPC wrote, “will more than double the already exorbitant 48 week price” of hepatitis C treatment.
“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current U.S. health care crisis,” Dee said.
“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis and Incivek.
“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”
Other costs need to be considered as well, the FPC states. According to a paper presented at the annual conference of the American Association for the Study of Liver Diseases (AASLD), the costs of treating the side effects of HCV protease inhibitors such as Victrelis are expected to be 30 percent higher than for existing treatments. And many of those with hepatitis C suffer from other illnesses. Some have diabetes or bleeding disorders; others are coinfected with HIV. All of these add completely new sets of medical expenses.
“We were very disappointed by the cost set by Merck for Victrelis earlier this month. Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” Dee said. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.
“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP). Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”
Tuesday, May 24, 2011
Pill burden and HCV Direct Acting Antivirals....
While Victrelis and Incivek are major game changing drugs in the treatment of Hepatitis C, it’s critical to remember that adherence to the entire regimen, not just the protease inhibitor, is essential to achieving and SVR and avoiding resistance.
NEW YORK, NY — This past Friday, the U.S. Food and Drug Administration (FDA) approved the first of a new generation of chronic hepatitis C drugs, known as protease inhibitors. The drug, VICTRELIS® (boceprevir), from Merck & Co., has been shown to increase the rate of sustained viral response and shorten treatment times when used in combination with the current standard of care, ribavirin and pegylated alpha interferon, in the treatment of chronic hepatitis C. Vertex Pharmaceuticals is seeking approval to market a similar drug, INCIVEK® (telaprevir).
The addition of protease inhibitors to the current standard of care puts a new and significantly greater treatment burden on the patient. Under most treatment regimens, pegylated alpha-interferon is injected once a week, and ribavirin is taken twice a day, for a total of five or six pills when prescribed in generic form. VICTRELIS is taken three times a day, for a total of 12 pills. INCIVEK is also taken three times a day, for a total of 6 pills. A treatment cycle lasting 48 weeks could mean that the patient is responsible for taking over 5,700 pills on schedule for the entire regimen. If the patient does not adhere to the prescribed regimen, the risk of treatment failure or relapse is increased (Reddy KR, Shiffman ML, Morgan TR, et al. Clin Gastroenterol Hepatol. 2007;5:124-129). Furthermore, because of the direct antiviral mechanism of protease inhibitors, missed doses of a protease inhibitor could lead to viral resistance (Weiss, et al. Aliment Pharmacol Ther 2009; 30:14-27).
Kadmon Pharmaceuticals' proprietary RIBASPHERE® RIBAPAK® (ribavirin, USP) is the only ribavirin available in a daily, two-pill compliance package designed to enhance therapy adherence. With RIBASPHERE RIBAPAK, the patient takes only two pills each day -- one in the morning and one at night -- reducing the total ribavirin pill burden by up to 66 percent over a 48 week course of treatment. RIBASPHERE RIBAPAK packaging is clearly marked for seven days of AM and PM dosing, and the completion of a compliance pack reminds the patient to administer their accompanying weekly interferon therapy. Kadmon is also offering patients a daily therapy diary to help keep track of their treatment schedule.
"Maintaining treatment adherence under the burden of a triple therapy combination will require significantly greater vigilance from the patient," said Bruce R. Bacon, M.D., professor of internal medicine at the Saint Louis University School of Medicine, and a clinical investigator for VICTRELIS. "With only one chance at success with this therapeutic approach, RIBASPHERE RIBAPAK represents an invaluable insurance policy for a treatment combination which could transform the enormous public health risks of hepatitis C."
NEW YORK, NY — This past Friday, the U.S. Food and Drug Administration (FDA) approved the first of a new generation of chronic hepatitis C drugs, known as protease inhibitors. The drug, VICTRELIS® (boceprevir), from Merck & Co., has been shown to increase the rate of sustained viral response and shorten treatment times when used in combination with the current standard of care, ribavirin and pegylated alpha interferon, in the treatment of chronic hepatitis C. Vertex Pharmaceuticals is seeking approval to market a similar drug, INCIVEK® (telaprevir).
The addition of protease inhibitors to the current standard of care puts a new and significantly greater treatment burden on the patient. Under most treatment regimens, pegylated alpha-interferon is injected once a week, and ribavirin is taken twice a day, for a total of five or six pills when prescribed in generic form. VICTRELIS is taken three times a day, for a total of 12 pills. INCIVEK is also taken three times a day, for a total of 6 pills. A treatment cycle lasting 48 weeks could mean that the patient is responsible for taking over 5,700 pills on schedule for the entire regimen. If the patient does not adhere to the prescribed regimen, the risk of treatment failure or relapse is increased (Reddy KR, Shiffman ML, Morgan TR, et al. Clin Gastroenterol Hepatol. 2007;5:124-129). Furthermore, because of the direct antiviral mechanism of protease inhibitors, missed doses of a protease inhibitor could lead to viral resistance (Weiss, et al. Aliment Pharmacol Ther 2009; 30:14-27).
Kadmon Pharmaceuticals' proprietary RIBASPHERE® RIBAPAK® (ribavirin, USP) is the only ribavirin available in a daily, two-pill compliance package designed to enhance therapy adherence. With RIBASPHERE RIBAPAK, the patient takes only two pills each day -- one in the morning and one at night -- reducing the total ribavirin pill burden by up to 66 percent over a 48 week course of treatment. RIBASPHERE RIBAPAK packaging is clearly marked for seven days of AM and PM dosing, and the completion of a compliance pack reminds the patient to administer their accompanying weekly interferon therapy. Kadmon is also offering patients a daily therapy diary to help keep track of their treatment schedule.
"Maintaining treatment adherence under the burden of a triple therapy combination will require significantly greater vigilance from the patient," said Bruce R. Bacon, M.D., professor of internal medicine at the Saint Louis University School of Medicine, and a clinical investigator for VICTRELIS. "With only one chance at success with this therapeutic approach, RIBASPHERE RIBAPAK represents an invaluable insurance policy for a treatment combination which could transform the enormous public health risks of hepatitis C."
Monday, May 23, 2011
Vertex's Incivek approved by the FDA....
The second protease inhibitor for HCV was just approved by the FDA, Vertex's Incivek. Should be in pharmacies by the end of the week. Looks like they are offering a pretty aggressive patient assistance program as well.
FDA clears Vertex's hepatitis C drug Incivek
By MARLEY SEAMAN
AP Health Writer
Published: Monday, May. 23, 2011 - 7:17 am
Last Modified: Monday, May. 23, 2011 - 9:18 am
NEW YORK -- The Food and Drug Administration approved Vertex Pharmaceuticals Inc.'s hepatitis C drug Incivek Monday, making it the second new treatment to be approved in the last two weeks.
Incivek is a highly-anticipated pill that is expected to have annual sales in the billions. It is approved for patients who have some liver damage from hepatitis C who either have not been treated, or were not cured by other drugs. Patients on Incivek take two pills three times per day. The Cambridge, Mass., company has already started promoting the drug in advance of approval, and it said Incivek will be available in pharmacies later this week.
The company says a 12-week course of treatment will cost $49,200, compared to $30,000 for standard therapies.
Hepatitis C is an infectious disease that is spread through the blood, including by sharing needles or having sex with an infected person. Vertex said about 4 million people in the U.S. have the disease, and many people do not know they are infected. Hepatitis C can cause liver damage, cirrhosis, liver failure or cancer. Incivek and Merck & Co.'s Victrelis, which was approved earlier this month, are the first new breakthrough treatments for the liver disease to be approved in 20 years.
In clinical trials, patients were treated with a combination of Incivek and standard therapies for 12 weeks. They continued on the standard treatments for another 36 weeks, but many of them were cured within 24 weeks. Vertex said about 79 percent of previously untreated patients were cured after treatment with Incivek. The drug was also much more effective in patients who had relapsed, had some response but not a cure, or had no response to other drugs.
Both Incivek and Victrelis block an enzyme that helps the virus reproduce. Incivek is seen as the more effective of the two drugs and is expected to have greater sales. Victrelis is a pill taken three times per day.
The most common side effects of Incivek are fatigue, itching, nausea, diarrhea, vomiting, taste changes, and anal or rectal problems. More serious side effects include rash, anemia, low red blood cell count, and birth defects in pregnant women. The side effects of standard treatments - including the IV drug pegylated interferon and the pill ribavirin - can include months of side effects, but less than half of patients are cured.
Vertex owns the North American marketing rights to Incivek, also known as telaprevir, and is seeking marketing approval in other countries through partnerships, including an agreement with Johnson & Johnson. The company said it has a 115-person sales team to support the drug, and will give Incivek for free to people with no health insurance and annual household income of less than $100,000. It will also cover some co-pay or co-insurance costs.
Shares of Vertex rose 20 cents to $55.20 in midday trading.
Read more: http://www.sacbee.com/2011/05/23/3647497/fda-clears-vertexs-hepatitis-c.html#ixzz1NCDkkUY5
FDA clears Vertex's hepatitis C drug Incivek
By MARLEY SEAMAN
AP Health Writer
Published: Monday, May. 23, 2011 - 7:17 am
Last Modified: Monday, May. 23, 2011 - 9:18 am
NEW YORK -- The Food and Drug Administration approved Vertex Pharmaceuticals Inc.'s hepatitis C drug Incivek Monday, making it the second new treatment to be approved in the last two weeks.
Incivek is a highly-anticipated pill that is expected to have annual sales in the billions. It is approved for patients who have some liver damage from hepatitis C who either have not been treated, or were not cured by other drugs. Patients on Incivek take two pills three times per day. The Cambridge, Mass., company has already started promoting the drug in advance of approval, and it said Incivek will be available in pharmacies later this week.
The company says a 12-week course of treatment will cost $49,200, compared to $30,000 for standard therapies.
Hepatitis C is an infectious disease that is spread through the blood, including by sharing needles or having sex with an infected person. Vertex said about 4 million people in the U.S. have the disease, and many people do not know they are infected. Hepatitis C can cause liver damage, cirrhosis, liver failure or cancer. Incivek and Merck & Co.'s Victrelis, which was approved earlier this month, are the first new breakthrough treatments for the liver disease to be approved in 20 years.
In clinical trials, patients were treated with a combination of Incivek and standard therapies for 12 weeks. They continued on the standard treatments for another 36 weeks, but many of them were cured within 24 weeks. Vertex said about 79 percent of previously untreated patients were cured after treatment with Incivek. The drug was also much more effective in patients who had relapsed, had some response but not a cure, or had no response to other drugs.
Both Incivek and Victrelis block an enzyme that helps the virus reproduce. Incivek is seen as the more effective of the two drugs and is expected to have greater sales. Victrelis is a pill taken three times per day.
The most common side effects of Incivek are fatigue, itching, nausea, diarrhea, vomiting, taste changes, and anal or rectal problems. More serious side effects include rash, anemia, low red blood cell count, and birth defects in pregnant women. The side effects of standard treatments - including the IV drug pegylated interferon and the pill ribavirin - can include months of side effects, but less than half of patients are cured.
Vertex owns the North American marketing rights to Incivek, also known as telaprevir, and is seeking marketing approval in other countries through partnerships, including an agreement with Johnson & Johnson. The company said it has a 115-person sales team to support the drug, and will give Incivek for free to people with no health insurance and annual household income of less than $100,000. It will also cover some co-pay or co-insurance costs.
Shares of Vertex rose 20 cents to $55.20 in midday trading.
Read more: http://www.sacbee.com/2011/05/23/3647497/fda-clears-vertexs-hepatitis-c.html#ixzz1NCDkkUY5
Friday, May 20, 2011
FDA Approves Tibotec's New HIV Treatment, Edurant
FDA Approves Tibotec's New HIV Treatment, Edurant
5/20/2011
SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).
Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.
"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.
Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.
The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.
Edurant does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Edurant is manufactured by Raritan, N.J.-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.
For more information:
FDA: HIV and AIDS Activities
http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm
FDA: Antiretroviral drugs used in the treatment of HIV infection
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm
CDC: HIV/AIDS
http://www.cdc.gov/hiv/default.htm
HHS: AIDS News and Resources
http://www.aids.gov/
AIDS Information
http://www.aidsinfo.nih.gov/
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries:Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
5/20/2011
SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).
Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.
"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.
Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.
The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.
Edurant does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Edurant is manufactured by Raritan, N.J.-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.
For more information:
FDA: HIV and AIDS Activities
http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm
FDA: Antiretroviral drugs used in the treatment of HIV infection
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm
CDC: HIV/AIDS
http://www.cdc.gov/hiv/default.htm
HHS: AIDS News and Resources
http://www.aids.gov/
AIDS Information
http://www.aidsinfo.nih.gov/
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries:Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Medivir Announces Positive 48-week Interim Data from TMC435 Hepatitis C Phase 2b ASPIRE Study in Treatment-Experienced Genotype-1 Patients...
I need to add 'SVR4' to my list of HCV Direct Acting Antiviral terminology... 'SVR4' is SVR 4 weeks post end of treatment date. Glad to get that squared away. This press release covers the majority of results of the phase IIb trial (ASPIRE) with the HCV protease inhibitor TMC435 looking at those who were previous non-responders to previous Peg-inf + P/R therapy - Relapsers, Partial Responders and Null-Responders to be specific. SVR4 in the TMC435 150mg + P/R was achieved in 88%, 77% and 57% oof those respective populations vs 50%, 11% and 23% in the placebo + P/R ar, again, respectively. No relevant differences between the 12, 24 and 48 week arms. Serious AEs were reported in 6.1% subjects in the placebo and vs 8.3% of the subjects treated with TMC435 with no substantial differences seen between the TMC435 dose groups. AEs leading to treatment discontinuation were reported in 4.5% of the placebo subjects and in 8.8% of the TMC435 treated subjects. The relative lack of AE's compared to the first generation of HCV PIs and the once a day dosing make TMC435 one to keep our eyes on.
HUDDINGE, Sweden, May 20, 2011 /PRNewswire/ --
- All TMC435 Patient Subgroups Achieved Substantially Higher SVR4 Rates (Undetectable Virus 4 Weeks After End of Treatment) Compared to pegylated-interferon and ribavirin Alone
- TMC435 was Safe and Well Tolerated at All Doses and Treatment Durations
Medivir AB (OMX: MVIR), the emerging research-based specialty
pharmaceutical company focused on infectious diseases, today announced results from the ASPIRE phase 2b study that evaluates the addition of once daily TMC435 to pegylated interferon and ribavirin in patients with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon (PegIFN) and ribavirin (RBV) was unsuccessful either because they relapsed, had a partial response or had a null response.
Bertil Samuelsson, CSO of Medivir, commented, "We are delighted with the encouraging efficacy and safety results shown by TMC435-based triple therapy over pegylated-interferon and ribavirin, in this 48-Week interim analysis of the ASPIRE study in treatment experienced genotype-1 hepatitis C patients. This patient group is known to be the most difficult one to treat, where in particular prior null and partial responder groups respond very poorly upon retreatment with PegIFN/RBV alone. With several global phase 3 clinical trials ongoing in hepatitis C patients we are expecting the momentum to continue with regards to the development of TMC435."
ASPIRE (C206) - Design and Week-48 Interim Analysis
TMC435, a potent, once-daily, oral hepatitis C virus protease inhibitor is being developed by Tibotec jointly with Medivir. The randomized, placebo-controlled, double-blind ASPIRE study evaluates the effect of TMC435 in combination with pegylated-interferon and ribavirin in 462 patients infected with genotype-1 hepatitis C virus who have failed prior treatment with PegIFN/RBV. The study includes patients that have relapsed, achieved partial response, or achieved no response (null responders) to SoC treatment and where 62 percent (287/462) of patients overall had advanced liver disease, periportal or septal fibrosis or cirrhosis (scarring of the liver) upon study entry (Metavir score F2-F4).
Patients were equally randomized to 1 of 7 different treatment arms: 6 TMC435 treatment arms and one placebo arm. TMC435 was administered once daily at a dose of either 100 mg or 150 mg given for either 12, 24, or 48 weeks in combination with PegIFN/RBV. PegIFN/RBV treatment was continued in all patients until the study completion at week 48. This interim analysis was performed when all patients had completed 48 weeks of treatment or discontinued earlier. The analysis was done based on the intent-to-treat, ITT, population which included all randomized subjects who took at least one dose of the study medication. SVR4, Sustained Virologic Response 4 weeks after planned end of treatment data, was available for 94% and 84% of TMC435 and placebo patients respectively.
ASPIRE Results - Efficacy
In this Week 48 interim analysis, all subgroups of treatment-experienced patients who failed previous peginterferon and ribavirin treatment, achieved substantially higher virologic response rates following treatment with TMC435-containing regimen at all doses and durations, compared with pegylated-interferon and ribavirin.
There was no relevant difference in virological response between the TMC435 150 mg dose groups who received TMC435-based triple therapy of 12 weeks, 24 weeks or 48 weeks. At end of treatment (EoT) 92%, 83% and 71% of relapser patients, partial responder patients and null responder patients taking TMC435 150 mg once daily and placebo, respectively, achieved undetectable HCV RNA levels compared to 70%, 17% and 25% in the placebo PegIFN/RBV groups respectively. At week 4 after cessation of treatment (SVR4) 88%, 77% and 57% of prior relapser patients, partial responder patients and null responder patients taking TMC435 150 mg once daily and placebo, respectively, achieved undetectable HCV RNA levels, compared to 50%, 11% and 23% in the placebo groups, respectively.
Virological Response Rates in TMC435 Dose Groups (150 mg q.d.) vs
Placebo
TMC435 TMC435 TMC435 All TMC435 Placebo
% (n/N) 12PR48 24PR48 48PR48 PR48 PR48
N=66 N=68 N=65 N=199 N=66
Prior EoT 92 (24/26) 93 (25/27) 92 (24/26) 92 (73/79) 70 (19/27)
Relapser
SVR4 84 (21/25) 93 (25/27) 85 (22/26) 87 (68/78) 50 (12/24)
Prior EoT 78 (18/23) 83 (20/24) 86 (19/22) 83 (57/69) 17 (4/23)
Partial
Responder SVR4 64 (14/22) 86 (18/21) 82 (18/22) 77 (50/65) 11 (2/18)
Prior Null EoT 65 (11/17) 71 (12/17) 77 (13/17) 71 (36/51) 25 (4/16)
Responder
SVR4 56 (9/16) 60 (9/15) 56 (9/16) 57 (27/47) 23 (3/13)
q.d.: once daily; PR: pegIFNalpha-2A and ribavirin; EoT: End of Treatment,
SVR4: patients with undetectable HCV RNA (<25 IU/mL Undetectable) at EOT and 4 weeks after planned EoT. Prior Relapser: undetectable HCV RNA at EoT and detectable within 24 weeks of follow-up
Partial Responders: more than 2 log reduction in HCV RNA at W12 but not achieving undetectable at EoT
Prior Null Responders: less than 2 log reduction in HCV RNA at W12
Results - Safety and Tolerability
TMC435 was generally safe and well tolerated and overall incidence of adverse events (AEs) was similar across treatment groups. Most of the AEs were grade 1 or 2 in severity. Serious AEs (SAEs) were reported in 6.1% subjects in the placebo and in 8.3% of the subjects treated with TMC435 with no substantial differences seen between the TMC435 dose groups. AEs leading to treatment discontinuation were reported in 4.5% of the placebo subjects and in 8.8% of the TMC435 treated subjects. Patients in the TMC435 ASPIRE treatment groups had overall longer treatment duration than patients in the placebo group due to a higher frequency of early discontinuation in the placebo group caused by treatment failures (i.e. reaching viral stopping rules). The most common AEs during the treatment period were headache, fatigue, pruritus and influenza-like illness.
Incidence was similar across treatment groups and the level of AEs and frequency were consistent with prior phase 2b PILLAR study of TMC435.
In the safety analyses, special attention was given to the following AEs of interest: hepatobiliary AEs, pruritus, rash, anemia and cardiac events. Most AEs of interest were grade 1 or 2 in severity and infrequently led to treatment discontinuation. For each category of AEs of interest the incidence was similar with TMC435 and PegIFN/RBV.
Mild and reversible increases in bilirubin (total, direct and indirect) were observed in TMC435 dose groups with no differences between 100 mg and 150 mg. There were no meaningful differences between treatment groups for any of the other laboratory parameters. There were no clinically significant findings on vital signs, nor were there any relevant changes in electrocardiogram (ECG) parameters, including QTc. Mean alanine aminotransferase (ALT) levels decreased in all treatment groups.
About TMC435 in other clinical studies
TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Tibotec Pharmaceuticals and, to treat chronic hepatitis C virus infections.
Three global clinical phase 3 response guided studies were recently initiated by Tibotec:
- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients
- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients
- TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment
In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011. Phase 3 programs for TMC435 are also ongoing in Japan.
For additional information for these studies, please see http://www.clinicaltrials.gov
Conference call for analysts and investors:
There will be a conference call today, May 20 2011, for investors and analysts at 08.00 (EDT) / 13.00 (GMT) / 14.00 (CET) to discuss the data. To dial-in to the conference call please use the following numbers:
Participant Telephone Numbers: +1-718-354-1359 USA
+46(0)8-5051-3785 Sweden
+44(0)20-7136-2053 UK
Participant code 1156834
Soundbyte Replay Access Number: +44(0)20-7111-1244 UK
+1-347-366-9565 USA
+46(0)8-5051-3897 Sweden
Replay Access Code: 1156834#
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is TMC435, a protease inhibitor which has recently entered phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals.
Medivir is also marketing its first product, the unique cold sore product Xerese(TM)/Xerclear(R) which has recently been launched on the US market. Xerese(TM)/Xerclear(R), which is also approved in Europe, is partnered with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia and with Meda AB in North America, Canada and Mexico. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: http://www.medivir.com.
For more information about Medivir, please contact:
Medivir (http://www.medivir.com):
Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292
Bertil Samuelsson, CSO Research & Development +46-8-54683100
M:Communications:
Mary-Jane Elliott / Amber Bielecka / Katja Toon +44(0)20-7920-2330
Medivir@mcomgroup.com
USA: Roland Tomforde +1-212-232-2356
SOURCE Medivir AB
HUDDINGE, Sweden, May 20, 2011 /PRNewswire/ --
- All TMC435 Patient Subgroups Achieved Substantially Higher SVR4 Rates (Undetectable Virus 4 Weeks After End of Treatment) Compared to pegylated-interferon and ribavirin Alone
- TMC435 was Safe and Well Tolerated at All Doses and Treatment Durations
Medivir AB (OMX: MVIR), the emerging research-based specialty
pharmaceutical company focused on infectious diseases, today announced results from the ASPIRE phase 2b study that evaluates the addition of once daily TMC435 to pegylated interferon and ribavirin in patients with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon (PegIFN) and ribavirin (RBV) was unsuccessful either because they relapsed, had a partial response or had a null response.
Bertil Samuelsson, CSO of Medivir, commented, "We are delighted with the encouraging efficacy and safety results shown by TMC435-based triple therapy over pegylated-interferon and ribavirin, in this 48-Week interim analysis of the ASPIRE study in treatment experienced genotype-1 hepatitis C patients. This patient group is known to be the most difficult one to treat, where in particular prior null and partial responder groups respond very poorly upon retreatment with PegIFN/RBV alone. With several global phase 3 clinical trials ongoing in hepatitis C patients we are expecting the momentum to continue with regards to the development of TMC435."
ASPIRE (C206) - Design and Week-48 Interim Analysis
TMC435, a potent, once-daily, oral hepatitis C virus protease inhibitor is being developed by Tibotec jointly with Medivir. The randomized, placebo-controlled, double-blind ASPIRE study evaluates the effect of TMC435 in combination with pegylated-interferon and ribavirin in 462 patients infected with genotype-1 hepatitis C virus who have failed prior treatment with PegIFN/RBV. The study includes patients that have relapsed, achieved partial response, or achieved no response (null responders) to SoC treatment and where 62 percent (287/462) of patients overall had advanced liver disease, periportal or septal fibrosis or cirrhosis (scarring of the liver) upon study entry (Metavir score F2-F4).
Patients were equally randomized to 1 of 7 different treatment arms: 6 TMC435 treatment arms and one placebo arm. TMC435 was administered once daily at a dose of either 100 mg or 150 mg given for either 12, 24, or 48 weeks in combination with PegIFN/RBV. PegIFN/RBV treatment was continued in all patients until the study completion at week 48. This interim analysis was performed when all patients had completed 48 weeks of treatment or discontinued earlier. The analysis was done based on the intent-to-treat, ITT, population which included all randomized subjects who took at least one dose of the study medication. SVR4, Sustained Virologic Response 4 weeks after planned end of treatment data, was available for 94% and 84% of TMC435 and placebo patients respectively.
ASPIRE Results - Efficacy
In this Week 48 interim analysis, all subgroups of treatment-experienced patients who failed previous peginterferon and ribavirin treatment, achieved substantially higher virologic response rates following treatment with TMC435-containing regimen at all doses and durations, compared with pegylated-interferon and ribavirin.
There was no relevant difference in virological response between the TMC435 150 mg dose groups who received TMC435-based triple therapy of 12 weeks, 24 weeks or 48 weeks. At end of treatment (EoT) 92%, 83% and 71% of relapser patients, partial responder patients and null responder patients taking TMC435 150 mg once daily and placebo, respectively, achieved undetectable HCV RNA levels compared to 70%, 17% and 25% in the placebo PegIFN/RBV groups respectively. At week 4 after cessation of treatment (SVR4) 88%, 77% and 57% of prior relapser patients, partial responder patients and null responder patients taking TMC435 150 mg once daily and placebo, respectively, achieved undetectable HCV RNA levels, compared to 50%, 11% and 23% in the placebo groups, respectively.
Virological Response Rates in TMC435 Dose Groups (150 mg q.d.) vs
Placebo
TMC435 TMC435 TMC435 All TMC435 Placebo
% (n/N) 12PR48 24PR48 48PR48 PR48 PR48
N=66 N=68 N=65 N=199 N=66
Prior EoT 92 (24/26) 93 (25/27) 92 (24/26) 92 (73/79) 70 (19/27)
Relapser
SVR4 84 (21/25) 93 (25/27) 85 (22/26) 87 (68/78) 50 (12/24)
Prior EoT 78 (18/23) 83 (20/24) 86 (19/22) 83 (57/69) 17 (4/23)
Partial
Responder SVR4 64 (14/22) 86 (18/21) 82 (18/22) 77 (50/65) 11 (2/18)
Prior Null EoT 65 (11/17) 71 (12/17) 77 (13/17) 71 (36/51) 25 (4/16)
Responder
SVR4 56 (9/16) 60 (9/15) 56 (9/16) 57 (27/47) 23 (3/13)
q.d.: once daily; PR: pegIFNalpha-2A and ribavirin; EoT: End of Treatment,
SVR4: patients with undetectable HCV RNA (<25 IU/mL Undetectable) at EOT and 4 weeks after planned EoT. Prior Relapser: undetectable HCV RNA at EoT and detectable within 24 weeks of follow-up
Partial Responders: more than 2 log reduction in HCV RNA at W12 but not achieving undetectable at EoT
Prior Null Responders: less than 2 log reduction in HCV RNA at W12
Results - Safety and Tolerability
TMC435 was generally safe and well tolerated and overall incidence of adverse events (AEs) was similar across treatment groups. Most of the AEs were grade 1 or 2 in severity. Serious AEs (SAEs) were reported in 6.1% subjects in the placebo and in 8.3% of the subjects treated with TMC435 with no substantial differences seen between the TMC435 dose groups. AEs leading to treatment discontinuation were reported in 4.5% of the placebo subjects and in 8.8% of the TMC435 treated subjects. Patients in the TMC435 ASPIRE treatment groups had overall longer treatment duration than patients in the placebo group due to a higher frequency of early discontinuation in the placebo group caused by treatment failures (i.e. reaching viral stopping rules). The most common AEs during the treatment period were headache, fatigue, pruritus and influenza-like illness.
Incidence was similar across treatment groups and the level of AEs and frequency were consistent with prior phase 2b PILLAR study of TMC435.
In the safety analyses, special attention was given to the following AEs of interest: hepatobiliary AEs, pruritus, rash, anemia and cardiac events. Most AEs of interest were grade 1 or 2 in severity and infrequently led to treatment discontinuation. For each category of AEs of interest the incidence was similar with TMC435 and PegIFN/RBV.
Mild and reversible increases in bilirubin (total, direct and indirect) were observed in TMC435 dose groups with no differences between 100 mg and 150 mg. There were no meaningful differences between treatment groups for any of the other laboratory parameters. There were no clinically significant findings on vital signs, nor were there any relevant changes in electrocardiogram (ECG) parameters, including QTc. Mean alanine aminotransferase (ALT) levels decreased in all treatment groups.
About TMC435 in other clinical studies
TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Tibotec Pharmaceuticals and, to treat chronic hepatitis C virus infections.
Three global clinical phase 3 response guided studies were recently initiated by Tibotec:
- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients
- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients
- TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment
In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011. Phase 3 programs for TMC435 are also ongoing in Japan.
For additional information for these studies, please see http://www.clinicaltrials.gov
Conference call for analysts and investors:
There will be a conference call today, May 20 2011, for investors and analysts at 08.00 (EDT) / 13.00 (GMT) / 14.00 (CET) to discuss the data. To dial-in to the conference call please use the following numbers:
Participant Telephone Numbers: +1-718-354-1359 USA
+46(0)8-5051-3785 Sweden
+44(0)20-7136-2053 UK
Participant code 1156834
Soundbyte Replay Access Number: +44(0)20-7111-1244 UK
+1-347-366-9565 USA
+46(0)8-5051-3897 Sweden
Replay Access Code: 1156834#
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is TMC435, a protease inhibitor which has recently entered phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals.
Medivir is also marketing its first product, the unique cold sore product Xerese(TM)/Xerclear(R) which has recently been launched on the US market. Xerese(TM)/Xerclear(R), which is also approved in Europe, is partnered with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia and with Meda AB in North America, Canada and Mexico. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: http://www.medivir.com.
For more information about Medivir, please contact:
Medivir (http://www.medivir.com):
Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292
Bertil Samuelsson, CSO Research & Development +46-8-54683100
M:Communications:
Mary-Jane Elliott / Amber Bielecka / Katja Toon +44(0)20-7920-2330
Medivir@mcomgroup.com
USA: Roland Tomforde +1-212-232-2356
SOURCE Medivir AB
Merck's Hepatitis C Drug Victrelis Gets Positive Opinion From European Regulator
(RTTNews) - Healthcare giant Merck & Co. Inc. (MRK: News ) Friday stated that a committee of European Medicines Agency has issued a positive opinion, recommending approval of its investigational hepatitis C drug victrelis in combination with current standard therapy.
Victrelis, also known as boceprevir, is a direct acting antiviral agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
Victrelis is being investigated in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
New Jersey-based Merck said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP adopted the positive opinion on victrelis under an accelerated assessment, which was introduced by the EU in November 2005 to help speed up access to new medicines of major public-health interest.
The CHMP's recommendation for victrelis was based on efficacy and safety results from two large Phase III clinical studies conducted in EU and the U.S. These studies evaluated about 1,500 adult patients with chronic HCV genotype 1 infection.
The company has published the final results of the studies in the New England Journal of Medicine on March 31.
The European Commission will review CHMP's positive opinion and will grant marketing authorization with unified labeling that is valid in the 27 EU member countries as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Victrelis is currently available in the U.S. following its approval by the U.S. FDA on May 13.
MRK closed Thursday's trading at $37.38, down $0.30, on a volume of 11.36 million shares.
Victrelis, also known as boceprevir, is a direct acting antiviral agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
Victrelis is being investigated in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
New Jersey-based Merck said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP adopted the positive opinion on victrelis under an accelerated assessment, which was introduced by the EU in November 2005 to help speed up access to new medicines of major public-health interest.
The CHMP's recommendation for victrelis was based on efficacy and safety results from two large Phase III clinical studies conducted in EU and the U.S. These studies evaluated about 1,500 adult patients with chronic HCV genotype 1 infection.
The company has published the final results of the studies in the New England Journal of Medicine on March 31.
The European Commission will review CHMP's positive opinion and will grant marketing authorization with unified labeling that is valid in the 27 EU member countries as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Victrelis is currently available in the U.S. following its approval by the U.S. FDA on May 13.
MRK closed Thursday's trading at $37.38, down $0.30, on a volume of 11.36 million shares.
Tuesday, May 17, 2011
Former archenemies Merck and Roche form a Hepatitis C alliance....
Even the most casual of observers of Pharma industries machinations would have to agree that it's been a rough five days for Vertex. Their main competitor, Merck, gets first mover advantage, a best-case label, AND effectively buys loyalty in a marketing alliance with it's former archenemy, Roche. Roche gets peace of mind that Merck won't drop it's drawers on Peg-Intron and Boceprevir bundling to gain formulary access, leaving it's cash cow Pegasys out of harms way and potential for even greater sales. Vertex has to partner with Pegasys regardless of the alliance because Pegasys was the only interferon used in Telaprevir's Phase III pivotal trials. I'm not right about a whole bunch of things, more than I'd like to admit, but I've never been wrong regarding Merck as a marketing juggernaut. Genius move that may give Boceprevir greater strength against Telaprevir's sure-to-come broadsides on efficacy and dosing schedule.
Merck Girds For Hep C Battle With Roche Deal
Adam Feuerstein
05/17/11 - 12:40 PM EDT
WHITEHOUSE STATION, N.J. (TheStreet) -- Merck(MRK) gained an unlikely ally in the hyper-competitive battle to market a new crop of hepatitis C drugs.
Roche said Tuesday that it will promote in the U.S. Merck's newly approved drug Victrelis in combination with its own hepatitis C drug Pegasys under a broader marketing and research alliance signed between the two drug giants.
What makes this partnership unusual is that Roche and Merck have been long-time hepatitis C treatment competitors. The new arrangement aligns the interests of two pharmaceutical marketing powerhouses, which for Merck is especially helpful as it strikes out to compete against Vertex Pharmaceuticals(VRTX) and its new hepatitis C drug.
Roche's Pegasys, or weekly interferon injection, has about 80% market share to Merck's own long-acting interferon injection, Peg-Intron, which has about 20% market share.
Under this new agreement, Roche will be promoting the use of Merck's Victrelis in combination with Pegasys as a new, triple-combination therapy against hepatitis C. Victrelis was approved in the U.S. last Friday, making it the first in a new class of direct-acting antiviral agents against hepatitis C.
Vertex is expecting to receive similar U.S. approval on or before May 23 for its drug, Incivek. The launch of two new and similar hepatitis C drugs promises to ignite one of the fiercest drug marketing battles in years.
The Merck-Roche deal is not exclusive, which means that Roche, at some point, could agree to a similar deal with Vertex to promote Incivek. Vertex, however, may not necessarily need Roche's direct help because Incivek is already closely tied to Pegasys. Incivek's pivotal clinical trials used Roche's Pegasys as the long-acting interferon backbone, whereas Merck tested Victrelis in combination with its own Peg-Intron.
Still, bringing Roche on board to promote Victrelis is a coup for Merck because it adds a new and experienced sales force that will be able to educate doctors about how to best use Victrelis. One of the issues weighing on Merck is the complex and often confusing dosing schedules required with Victrelis as compared to a much simpler dosing schedule for Vertex's Incivek.
Victrelis and Incivek have never been compared in a head-to-head study but the Vertex drug is also widely viewed as more effective -- able to cure upwards of 80% of newly treated patients compared to an approximate 60% cure rate for Merck's drug.
Merck and Roche did not disclose financial terms of the deal but a Merck spokesman said that Merck retains 100% of the Victrelis economics even with the Roche marketing deal in place. Presumably, that means Roche will not receive a royalty on Victrelis sales but will gain as more doctors choose to use its Pegasys with either Victrelis or Incivek. Roche may have also been worried that Merck was planning to tempt doctors with a discounted bundle of Peg-Intron with Victrelis that could have hurt Pegasys market share.
Under terms of the agreement, Merck and Roche will also cooperate on new studies that will seek to combine Victrelis with Roche's experimental hepatitis C drugs. This new research alliance can include experimental drugs that Roche licensed from other companies, including one from Pharmasset(VRUS), according to a Roche spokeswoman.
--Written by Adam Feuerstein in Boston.
Merck Girds For Hep C Battle With Roche Deal
Adam Feuerstein
05/17/11 - 12:40 PM EDT
WHITEHOUSE STATION, N.J. (TheStreet) -- Merck(MRK) gained an unlikely ally in the hyper-competitive battle to market a new crop of hepatitis C drugs.
Roche said Tuesday that it will promote in the U.S. Merck's newly approved drug Victrelis in combination with its own hepatitis C drug Pegasys under a broader marketing and research alliance signed between the two drug giants.
What makes this partnership unusual is that Roche and Merck have been long-time hepatitis C treatment competitors. The new arrangement aligns the interests of two pharmaceutical marketing powerhouses, which for Merck is especially helpful as it strikes out to compete against Vertex Pharmaceuticals(VRTX) and its new hepatitis C drug.
Roche's Pegasys, or weekly interferon injection, has about 80% market share to Merck's own long-acting interferon injection, Peg-Intron, which has about 20% market share.
Under this new agreement, Roche will be promoting the use of Merck's Victrelis in combination with Pegasys as a new, triple-combination therapy against hepatitis C. Victrelis was approved in the U.S. last Friday, making it the first in a new class of direct-acting antiviral agents against hepatitis C.
Vertex is expecting to receive similar U.S. approval on or before May 23 for its drug, Incivek. The launch of two new and similar hepatitis C drugs promises to ignite one of the fiercest drug marketing battles in years.
The Merck-Roche deal is not exclusive, which means that Roche, at some point, could agree to a similar deal with Vertex to promote Incivek. Vertex, however, may not necessarily need Roche's direct help because Incivek is already closely tied to Pegasys. Incivek's pivotal clinical trials used Roche's Pegasys as the long-acting interferon backbone, whereas Merck tested Victrelis in combination with its own Peg-Intron.
Still, bringing Roche on board to promote Victrelis is a coup for Merck because it adds a new and experienced sales force that will be able to educate doctors about how to best use Victrelis. One of the issues weighing on Merck is the complex and often confusing dosing schedules required with Victrelis as compared to a much simpler dosing schedule for Vertex's Incivek.
Victrelis and Incivek have never been compared in a head-to-head study but the Vertex drug is also widely viewed as more effective -- able to cure upwards of 80% of newly treated patients compared to an approximate 60% cure rate for Merck's drug.
Merck and Roche did not disclose financial terms of the deal but a Merck spokesman said that Merck retains 100% of the Victrelis economics even with the Roche marketing deal in place. Presumably, that means Roche will not receive a royalty on Victrelis sales but will gain as more doctors choose to use its Pegasys with either Victrelis or Incivek. Roche may have also been worried that Merck was planning to tempt doctors with a discounted bundle of Peg-Intron with Victrelis that could have hurt Pegasys market share.
Under terms of the agreement, Merck and Roche will also cooperate on new studies that will seek to combine Victrelis with Roche's experimental hepatitis C drugs. This new research alliance can include experimental drugs that Roche licensed from other companies, including one from Pharmasset(VRUS), according to a Roche spokeswoman.
--Written by Adam Feuerstein in Boston.
Monday, May 16, 2011
TheStreet's Adam Feuerstein runs the numbers on the approval of Boceprevir....
It's always interesting to see what TheStreet.com's Adam Feuerstein has to say about anything related to the Direct Acting Antivirals, coming from a business perspective. I think he's dead on here. The only thing I'd add in regards to both Telaprevir and Boceprevir is that Boceprevir's studies of drug interactions isn't very robust and needs to be better characterized. Telaprevir's is sure to be VERY detailed, Telaprevir being a pretty potent inhibitor of CYP 450 and Vertex doing the due diligence to do drug interaction studies with common medications.
Merck Strikes First in Hep C Drug Battle
Adam Feuerstein
05/16/11 - 08:33 AM EDT
WHITEHOUSE STATION, NJ (TheStreet) -- The U.S. approval Friday of Merck's(MRK) hepatitis C drug Victrelis was expected. More surprising was the drug's "best case" label that will help Merck better compete in the new hepatitis C treatment market.
The U.S. Food and Drug Administration approved Victrelis with a broad label that basically gives Merck what it wanted, which is to leave decisions about how best to use the hepatitis C drug in the hands of physicians. The downside for Merck to this broad discretion on Victrelis' label is that doctors may have too many complicated dosing options.
Vertex Pharmaceuticals(VRTX) could exploit any confusion caused by Victrelis' label. Vertex's hepatitis C drug Incivek is expected to receive U.S. approval later this month with a more straightforward and easy-to-understand dosing schedule. Vertex's Incivek is also more potent, curing a greater percentage of hepatitis C patients compared to Merck's Victrelis, at least according to the respective clinical trials run by both companies.
The stakes are high in the new hepatitis C treatment market. Approximately 3.2 million Americans are infected with the viral disease that attacks and progressively destroys the liver. Most people infected with hepatitis C don't know they have the disease and aren't diagnosed until liver damage occurs, which can take years.
The old gold-standard treatment regimen for hepatitis C -- 48 weekly injection of interferon and daily doses of oral ribavirin -- cured about 40% of patients. Adding Victrelis to that regimen will shorten treatment duration for some and improve cure rates to more than 60%. Likewise, Vertex's Incivek will also shorten treatment and boost cure rates to as high as 80%.
The looming marketing battle between Merck and Vertex is worth billions of dollars in new hepatitis C drug sales.
For now, at least, Merck has the market to itself -- the prize for being first to approval. Victrelis will cost $1,100 per week, which means patients and insurers will pay between $26,000 and $48,000 for Victrelis, depending on the length of treatment. This price doesn't include the cost of interferon and ribavirin, which adds another $25,000 to $35,000, again, depending on duration of treatment.
Figuring out how much Victrelis will cost is complicated because the drug's label includes four different treatment suggestions ranging from 26 weeks to 44 weeks. Doctors must first start patients on a four-week lead in of interferon and ribavirin before adding Victrelis. The course of Victrelis should be 28, 36, or 44 weeks long depending on how patients respond at various time points.
The Victrelis label is complex, but Merck is happy because the FDA could have been more restrictive. Merck didn't study Victrelis in so-called "null responders" -- the hardest-to-treat hepatitis C patients -- yet FDA didn't exclude them from the Victrelis label. The FDA also went relatively easy on safety warnings about Victrelis causing anemia -- the drug's most worrisome side effect.
Investors have fairly low expectations for Victrelis so it remains to be seen whether the better-than-expected label helps Merck compete better against Vertex. At this point, Vertex's Incivek is expected to garner about 70% of the new hepatitis C treatment market, according to many analyst forecasts.
Vertex is expecting U.S. approval of Incivek on May 23 with a label that will likely include just two relatively straightforward treatment options of 24 or 48 weeks. Both regimens include the same 12-week course of Incivek, the only difference is the length of interferon and ribavirin use.
Vertex studied Incivek in the hardest-to-treat null responder patients and cured about 30% of them compared to 3% cured with interferon and ribavirin alone. For the best-responding patients, cure rates approach 80% with a relatively short six months of treatment. While Victrelis causes anemia, Vertex's Incivek causes rash, sometimes severe.
Once Incivek is approved, the hepatitis C marketing battle between Merck and Vertex can begin.
Merck Strikes First in Hep C Drug Battle
Adam Feuerstein
05/16/11 - 08:33 AM EDT
WHITEHOUSE STATION, NJ (TheStreet) -- The U.S. approval Friday of Merck's(MRK) hepatitis C drug Victrelis was expected. More surprising was the drug's "best case" label that will help Merck better compete in the new hepatitis C treatment market.
The U.S. Food and Drug Administration approved Victrelis with a broad label that basically gives Merck what it wanted, which is to leave decisions about how best to use the hepatitis C drug in the hands of physicians. The downside for Merck to this broad discretion on Victrelis' label is that doctors may have too many complicated dosing options.
Vertex Pharmaceuticals(VRTX) could exploit any confusion caused by Victrelis' label. Vertex's hepatitis C drug Incivek is expected to receive U.S. approval later this month with a more straightforward and easy-to-understand dosing schedule. Vertex's Incivek is also more potent, curing a greater percentage of hepatitis C patients compared to Merck's Victrelis, at least according to the respective clinical trials run by both companies.
The stakes are high in the new hepatitis C treatment market. Approximately 3.2 million Americans are infected with the viral disease that attacks and progressively destroys the liver. Most people infected with hepatitis C don't know they have the disease and aren't diagnosed until liver damage occurs, which can take years.
The old gold-standard treatment regimen for hepatitis C -- 48 weekly injection of interferon and daily doses of oral ribavirin -- cured about 40% of patients. Adding Victrelis to that regimen will shorten treatment duration for some and improve cure rates to more than 60%. Likewise, Vertex's Incivek will also shorten treatment and boost cure rates to as high as 80%.
The looming marketing battle between Merck and Vertex is worth billions of dollars in new hepatitis C drug sales.
For now, at least, Merck has the market to itself -- the prize for being first to approval. Victrelis will cost $1,100 per week, which means patients and insurers will pay between $26,000 and $48,000 for Victrelis, depending on the length of treatment. This price doesn't include the cost of interferon and ribavirin, which adds another $25,000 to $35,000, again, depending on duration of treatment.
Figuring out how much Victrelis will cost is complicated because the drug's label includes four different treatment suggestions ranging from 26 weeks to 44 weeks. Doctors must first start patients on a four-week lead in of interferon and ribavirin before adding Victrelis. The course of Victrelis should be 28, 36, or 44 weeks long depending on how patients respond at various time points.
The Victrelis label is complex, but Merck is happy because the FDA could have been more restrictive. Merck didn't study Victrelis in so-called "null responders" -- the hardest-to-treat hepatitis C patients -- yet FDA didn't exclude them from the Victrelis label. The FDA also went relatively easy on safety warnings about Victrelis causing anemia -- the drug's most worrisome side effect.
Investors have fairly low expectations for Victrelis so it remains to be seen whether the better-than-expected label helps Merck compete better against Vertex. At this point, Vertex's Incivek is expected to garner about 70% of the new hepatitis C treatment market, according to many analyst forecasts.
Vertex is expecting U.S. approval of Incivek on May 23 with a label that will likely include just two relatively straightforward treatment options of 24 or 48 weeks. Both regimens include the same 12-week course of Incivek, the only difference is the length of interferon and ribavirin use.
Vertex studied Incivek in the hardest-to-treat null responder patients and cured about 30% of them compared to 3% cured with interferon and ribavirin alone. For the best-responding patients, cure rates approach 80% with a relatively short six months of treatment. While Victrelis causes anemia, Vertex's Incivek causes rash, sometimes severe.
Once Incivek is approved, the hepatitis C marketing battle between Merck and Vertex can begin.
Sunday, May 15, 2011
Early H.I.V. Therapy Sharply Curbs Transmission....
I don't talk too much about HIV on Viral Matters, but the article originally appearing in the New York Times on May 12, happens to be a finding so incredibly important that NOT spreading the word would be a great disservice, even to the 3 people that read this blog ;). The data from this trial was so strong and deemed so important that the trial ended early, instead of it’s intended 2015 completion date. So what’s the big deal? Well, the authors have found that those who had HIV AND on antiretroviral therapy were 96% less likely to pass on the infection if they were taking antiretroviral drugs. That’s a big deal, so much so that it’s likely to change world policy on the treatment of HIV. The finding is bedeviled by the age-old problem we denizens of the globe have always faced since the dawn of antiretroviral therapy… it’s expensive and not everyone has access to the drugs they need in order to stop the spread, especially those in 3rd world countries. Hope springs eternal, however – great findings in medicine to advance ourselves against a global problem often find funding in the strangest places. Let’s hope the same is true for this.
Early H.I.V. Therapy Sharply Curbs Transmission
By DONALD G. McNEIL Jr.
People infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate, according to preliminary results from a large clinical trial released Thursday.
Patients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs — a finding that is so overwhelming that it is likely to change the way American AIDS doctors treat patients and what treatment policies are adopted by the World Health Organization and other countries, said Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, which paid for the trial.
The data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.
There have been previous studies, notably among drug abusers in San Francisco and Vancouver, British Columbia, that concluded that starting patients on drugs immediately would stop them from infecting others.
Those studies led Unaids, the United Nations AIDS-fighting agency, to adopt “test and treat” as its goal last year; the policy encourages doctors to start people on treatment as soon as they test positive for H.I.V. However, this is the first evidence from a randomized clinical trial, the gold standard in medical research.
AIDS prevention specialists not connected to the trial were enthusiastic.
“These results are phenomenal,” said Thomas J. Coates, director of the global health program at the University of California, Los Angeles, and the founder of the Center for AIDS Prevention Studies in San Francisco. “It was a tough study to do, and I’m thrilled it came out this way.”
Dr. Julio Montaner, an AIDS specialist at the University of British Columbia whose work among Vancouver heroin addicts helped lead to the Unaids policy, called the result of 96 percent protection “as good as it gets.”
“This is consistent with what we’ve been saying and doing in British Columbia for close to a decade,” he said. “How much more evidence do we need before we implement what we know works?”
The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.
In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.
In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.
On Thursday, Dr. Fauci and Dr. Myron Cohen, an AIDS specialist from the University of North Carolina at Chapel Hill and the study’s director, announced that the data collected since the study began in 2005 had been “unblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.
The results carry moral implications for doctors in the United States. Although medical associations like the Infectious Diseases Society of America advocate starting patients on AIDS drugs early, the decision is made by the doctor and patient. Some patients fear the reported side effects of AIDS drugs and want to delay taking the drugs until they get obviously sick or until their CD4 counts fall, and some doctors go along with that, Dr. Fauci said, especially as long as their patients’ CD4 counts remain above 350.
But that means the patient may infect others during the delay. Of the 27 people in the study who became infected while their partners were not yet taking the drugs, 17 had partners whose CD4 counts were still above 350.
Asked if it could now be considered immoral for a doctor to accede to a patient’s request to delay starting drugs, Dr. Fauci said: “I’m not going to go there. I’m not going to say it’s immoral. But there is more and more data showing the advantages of starting as early as you can.”
Dr. Coates of U.C.L.A. said he hoped that treatment delays would fade away because the newest antiretroviral drugs had few side effects.
Although the evidence suggests that it would be good public health policy to lower infection rates by starting everyone on drugs as soon as they are infected, that is impossible in much of the world. For lack of money, clinics in Africa are turning away patients who are not just infected but close to death. And in some American states where money provided by the Ryan White Care Act has run out, poor uninsured people are on waiting lists.
Although the trial was relatively large, there are some limitations on interpreting the data.
More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.
“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.
Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.
Early H.I.V. Therapy Sharply Curbs Transmission
By DONALD G. McNEIL Jr.
People infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate, according to preliminary results from a large clinical trial released Thursday.
Patients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs — a finding that is so overwhelming that it is likely to change the way American AIDS doctors treat patients and what treatment policies are adopted by the World Health Organization and other countries, said Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, which paid for the trial.
The data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.
There have been previous studies, notably among drug abusers in San Francisco and Vancouver, British Columbia, that concluded that starting patients on drugs immediately would stop them from infecting others.
Those studies led Unaids, the United Nations AIDS-fighting agency, to adopt “test and treat” as its goal last year; the policy encourages doctors to start people on treatment as soon as they test positive for H.I.V. However, this is the first evidence from a randomized clinical trial, the gold standard in medical research.
AIDS prevention specialists not connected to the trial were enthusiastic.
“These results are phenomenal,” said Thomas J. Coates, director of the global health program at the University of California, Los Angeles, and the founder of the Center for AIDS Prevention Studies in San Francisco. “It was a tough study to do, and I’m thrilled it came out this way.”
Dr. Julio Montaner, an AIDS specialist at the University of British Columbia whose work among Vancouver heroin addicts helped lead to the Unaids policy, called the result of 96 percent protection “as good as it gets.”
“This is consistent with what we’ve been saying and doing in British Columbia for close to a decade,” he said. “How much more evidence do we need before we implement what we know works?”
The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.
In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.
In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.
On Thursday, Dr. Fauci and Dr. Myron Cohen, an AIDS specialist from the University of North Carolina at Chapel Hill and the study’s director, announced that the data collected since the study began in 2005 had been “unblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.
The results carry moral implications for doctors in the United States. Although medical associations like the Infectious Diseases Society of America advocate starting patients on AIDS drugs early, the decision is made by the doctor and patient. Some patients fear the reported side effects of AIDS drugs and want to delay taking the drugs until they get obviously sick or until their CD4 counts fall, and some doctors go along with that, Dr. Fauci said, especially as long as their patients’ CD4 counts remain above 350.
But that means the patient may infect others during the delay. Of the 27 people in the study who became infected while their partners were not yet taking the drugs, 17 had partners whose CD4 counts were still above 350.
Asked if it could now be considered immoral for a doctor to accede to a patient’s request to delay starting drugs, Dr. Fauci said: “I’m not going to go there. I’m not going to say it’s immoral. But there is more and more data showing the advantages of starting as early as you can.”
Dr. Coates of U.C.L.A. said he hoped that treatment delays would fade away because the newest antiretroviral drugs had few side effects.
Although the evidence suggests that it would be good public health policy to lower infection rates by starting everyone on drugs as soon as they are infected, that is impossible in much of the world. For lack of money, clinics in Africa are turning away patients who are not just infected but close to death. And in some American states where money provided by the Ryan White Care Act has run out, poor uninsured people are on waiting lists.
Although the trial was relatively large, there are some limitations on interpreting the data.
More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.
“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.
Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.
Friday, May 13, 2011
Boceprevir labeling highlights...
View approved label for Boceprevir here: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf
Boceprevir gets FDA approval, first to market in the battle against HCV...
A historic moment for both Merck and HCV genotype 1 infected patients as the FDA approves Boceprevir for the treatment of chronic genotype 1 hepatitis C. Boceprevir is the first of the Direct Acting Antivirals (DAAs) specifically targeting HCV to make it to market and represents the largest shift in how this disease is treated since ribavirin was found to have synergistic activity with interferon in the '90's. The first generation of DAAs are far from perfect, but no doubt they will add tremendous leverage in curing patients of the HCV virus. With great achievements comes great responsibility however – physicians and the patients they treat have to be thoroughly fluent in managing AE’s and compliance.
FDA Approves Merck's VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS" (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR)1, and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
VICTRELIS is the first in a new class of medicines approved to treat chronic hepatitis C
VICTRELIS is the first in a new class of medicines known as hepatitis C virus (HCV) protease inhibitors approved for use in combination with peginterferon alfa and ribavirin, which is the current standard therapy, for the treatment of chronic hepatitis C.
This is an exciting day for physicians and patients because VICTRELIS is the first major advancement for the treatment of chronic hepatitis C approved in a decade, said Bruce Bacon, M.D., professor of internal medicine, Saint Louis University School of Medicine, and a clinical investigator for VICTRELIS. Compared to current standard therapy, VICTRELIS can significantly increase a patient s chance of achieving undetectable levels of the virus, thereby obtaining an SVR. For many patients, VICTRELIS may allow for a shorter total duration of treatment.
Merck is deeply committed to innovation in bringing forward new medicines that significantly address unmet medical needs, and VICTRELIS is a shining example of our commitment being realized," said Kenneth C. Frazier, president and chief executive officer, Merck. "We look forward to building on our legacy in the fight against infectious diseases, and to being a part of this exciting new era in the treatment of chronic hepatitis C."
Merck will begin shipping VICTRELIS to pharmacies within a week so that patients will have access to this new medication as soon as possible. In addition, the company is expanding its support of public awareness and education programs for chronic hepatitis C. Resources include coupons to help eligible patients with their medication cost, reimbursement support to help patients understand their insurance coverage for VICTRELIS, and 24/7 nurse phone support.
Separately, Merck will also add VICTRELIS to its patient assistance program through which eligible patients may be able to receive product free of charge.
Current standard therapy for HCV works to strengthen the body s natural immune response to the virus, but only about 40 percent of patients with chronic HCV genotype 1 infection are able to achieve SVR. VICTRELIS is a Direct Acting Antiviral (DAA) agent that interferes with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
The FDA approval of VICTRELIS is based on the efficacy and safety results from two large Phase III clinical studies that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection. Both studies included two treatment arms with VICTRELIS: a response-guided therapy (RGT) arm, in which patients with undetectable virus (HCV-RNA) at treatment week 8 were eligible for a shorter duration of therapy, as well as a 48-week treatment arm. All patients receiving VICTRELIS in these studies were first treated with peginterferon alfa-2b and ribavirin (P/R) in a 4-week lead-in phase, followed by the addition of VICTRELIS after week 4. The studies also included a control arm in which patients received 48 weeks of treatment with P/R alone. Historical null responders were not enrolled.
Adding VICTRELIS to P/R achieved a significant increase in SVR rates compared to P/R alone
Primary results from the two pivotal studies:
Treatment-failure patients: the addition of VICTRELIS to P/R resulted in nearly a three-fold increase in SVR rates to 59 percent (96/162) for the RGT arm and 66 percent (106/161) for the 48-week treatment arm, compared to 23 percent (18/80) for control. Relapse rates were 14 percent (16/111) for the RGT arm and 12 percent (14/121) for the 48-week treatment arm, compared to 28 percent (7/25) for control.
Treatment-naïve patients: the addition of VICTRELIS to P/R resulted in a significant increase (1.7 fold) in SVR rates to 63 percent (232/368) for the RGT arm and 66 percent (242/366) for the 48-week treatment arm, compared to 38 percent (138/363) for control. Relapse rates were 9 percent (24/257) for the RGT arm and 9 percent (24/265) for the 48-week treatment arm, compared to 22 percent (39/176) for control.
In a separate, pre-specified cohort of 159 Black treatment-naïve patients, the addition of VICTRELIS to P/R resulted in a significant increase in SVR to 42 percent (22/52) for the RGT arm and 53 percent (29/55) for the 48-week treatment arm, compared to 23 percent (12/52) for control. Relapse rates were 12 percent (3/25) for the RGT arm and 17 percent (6/35) for the 48-week treatment arm, compared to 14 percent (2/14) for control.
Many patients receiving VICTRELIS in combination therapy were early responders at treatment week 8
Secondary analyses from the two pivotal studies were as follows:
Treatment-failure patients: 46 percent (74/162) of patients in the RGT arm and 52 percent (84/161) of patients in the 48-week treatment arm receiving VICTRELIS had undetectable virus (HCV-RNA) at treatment week 8 and were considered early responders, compared to 9 percent (7/80) for control. The SVR rate for these early responders was 88 percent (65/74) in the RGT arm and 88 percent (74/84) in the 48-week treatment arm, compared to 100 percent (7/7) for control. Early responders in the RGT arm were eligible to stop all treatment at week 36.
Treatment-naïve patients: 57 percent (208/368) of patients in the RGT arm and 56 percent (204/366) of patients in the 48-week treatment arm receiving VICTRELIS had undetectable virus (HCV-RNA) at treatment week 8 and were considered early responders, compared to 17 percent (60/363) for control. The SVR rate for these early responders was 88 percent (184/208) in the RGT arm and 90 percent (184/204) in the 48-week treatment arm, compared to 85 percent (51/60) for control. Early responders in the RGT arm were eligible to stop all treatment at week 28.
SVR achieved with VICTRELIS in combination therapy in late responders
Treatment-failure patients: Patients who had detectable virus (HCV-RNA) at treatment week 8, but undetectable virus (HCV-RNA) at treatment week 12, and completed at least 36 weeks of treatment, were considered late responders. The SVR rate for these late responders was 79 percent (27/34) in the RGT arm and 72 percent (29/40) in the 48-week treatment arm. Late responders in the RGT arm stopped VICTRELIS at week 36 and continued P/R alone for an additional 12 weeks (48 weeks total).
Treatment-naïve patients: Patients who had detectable virus (HCV-RNA) at treatment week 8, but undetectable virus (HCV-RNA) at treatment week 24, and completed at least 28 weeks of treatment, were considered late responders. The SVR rate for these late responders was 66 percent (45/68) in the RGT arm and 75 percent (55/73) in the 48-week treatment arm. Late responders in the RGT arm stopped VICTRELIS at week 28 and continued P/R alone for an additional 20 weeks (48 weeks total).
VICTRELIS in combination therapy increased SVR rates in specific patient populations
The addition of VICTRELIS to P/R in treatment-failure patients with less than a 1 log decline in virus (HCV-RNA) during the 4-week lead-in resulted in an increase in SVR rates to 33 percent (15/46) for the RGT arm and 34 percent (15/44) for the 48-week treatment arm, compared to 0 percent (0/12) for control.
In treatment-failure patients with cirrhosis at baseline, 77 percent (17/22) achieved SVR with the addition of 44 weeks of VICTRELIS to P/R, compared to 35 percent (6/17) for those who received RGT.
In treatment-naïve patients with cirrhosis at baseline, 42 percent (10/24) achieved SVR with the addition of 44 weeks of VICTRELIS to P/R, compared to 31 percent (5/16) for those who received RGT.
Safety and tolerability profile of VICTRELIS in 2,095 patients in Phase II and III studies
Serious adverse events were reported in 11 percent of patients receiving VICTRELIS in combination with P/R, compared to 8 percent of patients receiving P/R alone.
During the entire course of treatment, the proportion of patients who discontinued treatment due to adverse reactions was 13 percent for patients receiving VICTRELIS in combination with P/R, compared to 12 percent for patients receiving P/R alone. Events resulting in discontinuation were similar to those seen in previous studies with P/R alone.
Adverse reactions that led to dose modifications of any drug (primarily P/R) occurred in 39 percent of patients receiving the combination of VICTRELIS with P/R compared to 24 percent of patients receiving P/R alone.
The most common reason for dose reduction was anemia, which occurred more frequently in patients receiving the combination of VICTRELIS with P/R than in patients receiving P/R alone.
The proportion of patients who experienced anemia was higher in patients receiving VICTRELIS in combination with P/R than in those treated with P/R alone. With management of anemia, the average additional decrease of hemoglobin was approximately 1 g/dL. Dose modifications (generally of P/R) due to anemia occurred more often in patients treated with VICTRELIS in combination with P/R (26 percent), compared to those treated with P/R alone (13 percent). Treatment discontinuations due to anemia were similar for patients receiving VICTRELIS in combination with P/R
(1 percent) compared to those treated with P/R alone (1 percent).
Erythropoietin (EPO) with or without ribavirin dose reduction for management of anemia was allowed at the discretion of the investigator per the study protocol.
In pivotal clinical studies, the 4-week lead-in provided important clinical insights
Interferon-responsiveness (equal to or greater than a 1 log decline in virus (HCV-RNA) at treatment week 4) was predictive of SVR. Patients receiving VICTRELIS who demonstrated interferon-responsiveness at treatment week 4 achieved higher SVR rates than those with poor interferon-responsiveness (less than a 1 log decline in virus (HCV-RNA) at treatment week 4). During the four-week lead-in period with P/R in the treatment arms containing VICTRELIS, 2 percent (28/1263) of patients experienced adverse reactions leading to discontinuation of treatment.
Background on the pivotal Phase III studies for VICTRELIS
The HCV RESPOND-2 study (treatment-failure patients) and the HCV SPRINT-2 study (treatment-naïve patients) each evaluated two treatment strategies with VICTRELIS added to P/R to assess the ability of VICTRELIS to improve SVR rates and potentially shorten overall treatment duration, compared to the use of P/R alone for 48 weeks, which is the current standard duration of therapy.
In both studies, all patients receiving VICTRELIS were treated with a 4-week lead-in of peginterferon alfa-2b (1.5 mcg/kg/week) and an investigational dose of ribavirin (600-1,400 mg/day), followed by the addition of VICTRELIS (800 mg three times a day) after week 4.
In each study, patients were randomized to three groups:
Response-guided therapy (RGT), in which patients with undetectable virus (HCV-RNA) at treatment week 8 were considered early responders and were eligible for a shorter duration of therapy. Treatment-naïve patients with undetectable HCV-RNA during weeks 8 through 24 were eligible to stop all treatment at week 28. Treatment-failure patients with undetectable HCV-RNA at treatment weeks 8 and 12 were eligible to stop all treatment at week 36.
48 weeks of treatment, in which patients received a 4-week lead-in with P/R followed by 44 weeks of VICTRELIS in combination with P/R.
Control, in which patients received P/R for 48 weeks.
In the HCV RESPOND-2 study, all patients with detectable virus (HCV-RNA) at treatment week 12 were discontinued from treatment. In the HCV SPRINT-2 study, all patients with detectable virus (HCV-RNA) at treatment week 24 were discontinued from treatment.
The HCV RESPOND-2 study was conducted at U.S. and international sites, and included 403 adult patients who had failed prior treatment, including patients who relapsed or were partial responders to prior treatment with standard therapy. Historical null responders were not enrolled. Patients were randomized in a 1:2:2 ratio and stratified based on response to their previous qualifying regimen (relapsers vs. partial responders) and by HCV genotype (1a or 1b).
The HCV SPRINT-2 study was conducted at U.S. and international sites in 1,097 adult patients who were new to treatment. Patients were randomized in a 1:1:1 ratio within two separate cohorts (938 non-Black patients and 159 Black patients) and were stratified by HCV genotype (1a or 1b) and by HCV-RNA viral load (less than or equal to 400,000 IU/mL vs. greater than 400,000 IU/mL). Black patients with chronic HCV historically have been shown to be harder to treat successfully.
Final results of the HCV RESPOND-2 and HCV SPRINT-2 studies were published in the New England Journal of Medicine on March 31, 2011.
Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin. VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients that were treated with VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously untreated patients that were treated with VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.
Dosing and administration
VICTRELIS must be administered in combination with peginterferon alfa and ribavirin. Therapy is initiated with peginterferon alfa and ribavirin for 4 weeks. Beginning in treatment week 5, VICTRELIS is added at a dose of 800 mg (four 200 mg capsules) orally three times daily (every 7-9 hours) with food (a meal or light snack). Based on the patient's virus (HCV-RNA) levels at treatment weeks 8, 12 and 24, dosing is adjusted using the following response-guided therapy guidelines.
Treatment-naive patients: Patients who are undetectable at treatment weeks 8 and 24 complete all therapy at treatment week 28. Patients who are detectable at treatment week 8, but undetectable at treatment week 24, complete VICTRELIS at treatment week 36 and continue on peginterferon alfa and ribavirin alone until treatment week 48.
Treatment-failure patients: Patients (previous partial responders or relapsers) who are undetectable at treatment weeks 8 and 24 complete all therapy at treatment week 36. Patients who are detectable at treatment week 8, but undetectable at treatment week 24, complete VICTRELIS at treatment week 36 and continue on peginterferon alfa and ribavirin alone until treatment week 48. Response-guided therapy was not studied in treatment-failure patients who had less than a 2 log decrease in virus (HCV-RNA) at treatment week 12 of prior treatment (null responders). If treated, these patients should receive 4 weeks of peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS in combination with peginterferon alfa and ribavirin.
Patients with compensated cirrhosis should receive 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS in combination with peginterferon alfa and ribavirin.
Patients who have HCV-RNA results greater than or equal to 100 IU/mL at treatment week 12 discontinue the three-medicine regimen. Patients who have confirmed detectable HCV-RNA at treatment week 24 discontinue the three-medicine regimen.
The wholesale acquisition cost (WAC) of VICTRELIS per week is $1,100.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
Forward-Looking Statement
This news release includes forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck s ability to accurately predict future market conditions; dependence on the effectiveness of Merck s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck s 2010 Annual Report on Form 10-K and the company s other filings with the Securities and Exchange Commission (SEC) available at the SEC s Internet site (www.sec.gov).
The Prescribing Information and Medication Guide are available at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf.
____________________________
1 SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient s 12-week post-treatment assessment was utilized.
VICTRELIS" is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio® and Adcirca® are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Merck
Media:
Pamela Eisele, 908-423-5042
Robert Consalvo, 908-423-6595
or
Investors:
Alex Kelly, 908-423-5185
Carol Ferguson, 908-423-4465
Source: Merck
FDA Approves Merck's VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS" (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR)1, and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
VICTRELIS is the first in a new class of medicines approved to treat chronic hepatitis C
VICTRELIS is the first in a new class of medicines known as hepatitis C virus (HCV) protease inhibitors approved for use in combination with peginterferon alfa and ribavirin, which is the current standard therapy, for the treatment of chronic hepatitis C.
This is an exciting day for physicians and patients because VICTRELIS is the first major advancement for the treatment of chronic hepatitis C approved in a decade, said Bruce Bacon, M.D., professor of internal medicine, Saint Louis University School of Medicine, and a clinical investigator for VICTRELIS. Compared to current standard therapy, VICTRELIS can significantly increase a patient s chance of achieving undetectable levels of the virus, thereby obtaining an SVR. For many patients, VICTRELIS may allow for a shorter total duration of treatment.
Merck is deeply committed to innovation in bringing forward new medicines that significantly address unmet medical needs, and VICTRELIS is a shining example of our commitment being realized," said Kenneth C. Frazier, president and chief executive officer, Merck. "We look forward to building on our legacy in the fight against infectious diseases, and to being a part of this exciting new era in the treatment of chronic hepatitis C."
Merck will begin shipping VICTRELIS to pharmacies within a week so that patients will have access to this new medication as soon as possible. In addition, the company is expanding its support of public awareness and education programs for chronic hepatitis C. Resources include coupons to help eligible patients with their medication cost, reimbursement support to help patients understand their insurance coverage for VICTRELIS, and 24/7 nurse phone support.
Separately, Merck will also add VICTRELIS to its patient assistance program through which eligible patients may be able to receive product free of charge.
Current standard therapy for HCV works to strengthen the body s natural immune response to the virus, but only about 40 percent of patients with chronic HCV genotype 1 infection are able to achieve SVR. VICTRELIS is a Direct Acting Antiviral (DAA) agent that interferes with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
The FDA approval of VICTRELIS is based on the efficacy and safety results from two large Phase III clinical studies that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection. Both studies included two treatment arms with VICTRELIS: a response-guided therapy (RGT) arm, in which patients with undetectable virus (HCV-RNA) at treatment week 8 were eligible for a shorter duration of therapy, as well as a 48-week treatment arm. All patients receiving VICTRELIS in these studies were first treated with peginterferon alfa-2b and ribavirin (P/R) in a 4-week lead-in phase, followed by the addition of VICTRELIS after week 4. The studies also included a control arm in which patients received 48 weeks of treatment with P/R alone. Historical null responders were not enrolled.
Adding VICTRELIS to P/R achieved a significant increase in SVR rates compared to P/R alone
Primary results from the two pivotal studies:
Treatment-failure patients: the addition of VICTRELIS to P/R resulted in nearly a three-fold increase in SVR rates to 59 percent (96/162) for the RGT arm and 66 percent (106/161) for the 48-week treatment arm, compared to 23 percent (18/80) for control. Relapse rates were 14 percent (16/111) for the RGT arm and 12 percent (14/121) for the 48-week treatment arm, compared to 28 percent (7/25) for control.
Treatment-naïve patients: the addition of VICTRELIS to P/R resulted in a significant increase (1.7 fold) in SVR rates to 63 percent (232/368) for the RGT arm and 66 percent (242/366) for the 48-week treatment arm, compared to 38 percent (138/363) for control. Relapse rates were 9 percent (24/257) for the RGT arm and 9 percent (24/265) for the 48-week treatment arm, compared to 22 percent (39/176) for control.
In a separate, pre-specified cohort of 159 Black treatment-naïve patients, the addition of VICTRELIS to P/R resulted in a significant increase in SVR to 42 percent (22/52) for the RGT arm and 53 percent (29/55) for the 48-week treatment arm, compared to 23 percent (12/52) for control. Relapse rates were 12 percent (3/25) for the RGT arm and 17 percent (6/35) for the 48-week treatment arm, compared to 14 percent (2/14) for control.
Many patients receiving VICTRELIS in combination therapy were early responders at treatment week 8
Secondary analyses from the two pivotal studies were as follows:
Treatment-failure patients: 46 percent (74/162) of patients in the RGT arm and 52 percent (84/161) of patients in the 48-week treatment arm receiving VICTRELIS had undetectable virus (HCV-RNA) at treatment week 8 and were considered early responders, compared to 9 percent (7/80) for control. The SVR rate for these early responders was 88 percent (65/74) in the RGT arm and 88 percent (74/84) in the 48-week treatment arm, compared to 100 percent (7/7) for control. Early responders in the RGT arm were eligible to stop all treatment at week 36.
Treatment-naïve patients: 57 percent (208/368) of patients in the RGT arm and 56 percent (204/366) of patients in the 48-week treatment arm receiving VICTRELIS had undetectable virus (HCV-RNA) at treatment week 8 and were considered early responders, compared to 17 percent (60/363) for control. The SVR rate for these early responders was 88 percent (184/208) in the RGT arm and 90 percent (184/204) in the 48-week treatment arm, compared to 85 percent (51/60) for control. Early responders in the RGT arm were eligible to stop all treatment at week 28.
SVR achieved with VICTRELIS in combination therapy in late responders
Treatment-failure patients: Patients who had detectable virus (HCV-RNA) at treatment week 8, but undetectable virus (HCV-RNA) at treatment week 12, and completed at least 36 weeks of treatment, were considered late responders. The SVR rate for these late responders was 79 percent (27/34) in the RGT arm and 72 percent (29/40) in the 48-week treatment arm. Late responders in the RGT arm stopped VICTRELIS at week 36 and continued P/R alone for an additional 12 weeks (48 weeks total).
Treatment-naïve patients: Patients who had detectable virus (HCV-RNA) at treatment week 8, but undetectable virus (HCV-RNA) at treatment week 24, and completed at least 28 weeks of treatment, were considered late responders. The SVR rate for these late responders was 66 percent (45/68) in the RGT arm and 75 percent (55/73) in the 48-week treatment arm. Late responders in the RGT arm stopped VICTRELIS at week 28 and continued P/R alone for an additional 20 weeks (48 weeks total).
VICTRELIS in combination therapy increased SVR rates in specific patient populations
The addition of VICTRELIS to P/R in treatment-failure patients with less than a 1 log decline in virus (HCV-RNA) during the 4-week lead-in resulted in an increase in SVR rates to 33 percent (15/46) for the RGT arm and 34 percent (15/44) for the 48-week treatment arm, compared to 0 percent (0/12) for control.
In treatment-failure patients with cirrhosis at baseline, 77 percent (17/22) achieved SVR with the addition of 44 weeks of VICTRELIS to P/R, compared to 35 percent (6/17) for those who received RGT.
In treatment-naïve patients with cirrhosis at baseline, 42 percent (10/24) achieved SVR with the addition of 44 weeks of VICTRELIS to P/R, compared to 31 percent (5/16) for those who received RGT.
Safety and tolerability profile of VICTRELIS in 2,095 patients in Phase II and III studies
Serious adverse events were reported in 11 percent of patients receiving VICTRELIS in combination with P/R, compared to 8 percent of patients receiving P/R alone.
During the entire course of treatment, the proportion of patients who discontinued treatment due to adverse reactions was 13 percent for patients receiving VICTRELIS in combination with P/R, compared to 12 percent for patients receiving P/R alone. Events resulting in discontinuation were similar to those seen in previous studies with P/R alone.
Adverse reactions that led to dose modifications of any drug (primarily P/R) occurred in 39 percent of patients receiving the combination of VICTRELIS with P/R compared to 24 percent of patients receiving P/R alone.
The most common reason for dose reduction was anemia, which occurred more frequently in patients receiving the combination of VICTRELIS with P/R than in patients receiving P/R alone.
The proportion of patients who experienced anemia was higher in patients receiving VICTRELIS in combination with P/R than in those treated with P/R alone. With management of anemia, the average additional decrease of hemoglobin was approximately 1 g/dL. Dose modifications (generally of P/R) due to anemia occurred more often in patients treated with VICTRELIS in combination with P/R (26 percent), compared to those treated with P/R alone (13 percent). Treatment discontinuations due to anemia were similar for patients receiving VICTRELIS in combination with P/R
(1 percent) compared to those treated with P/R alone (1 percent).
Erythropoietin (EPO) with or without ribavirin dose reduction for management of anemia was allowed at the discretion of the investigator per the study protocol.
In pivotal clinical studies, the 4-week lead-in provided important clinical insights
Interferon-responsiveness (equal to or greater than a 1 log decline in virus (HCV-RNA) at treatment week 4) was predictive of SVR. Patients receiving VICTRELIS who demonstrated interferon-responsiveness at treatment week 4 achieved higher SVR rates than those with poor interferon-responsiveness (less than a 1 log decline in virus (HCV-RNA) at treatment week 4). During the four-week lead-in period with P/R in the treatment arms containing VICTRELIS, 2 percent (28/1263) of patients experienced adverse reactions leading to discontinuation of treatment.
Background on the pivotal Phase III studies for VICTRELIS
The HCV RESPOND-2 study (treatment-failure patients) and the HCV SPRINT-2 study (treatment-naïve patients) each evaluated two treatment strategies with VICTRELIS added to P/R to assess the ability of VICTRELIS to improve SVR rates and potentially shorten overall treatment duration, compared to the use of P/R alone for 48 weeks, which is the current standard duration of therapy.
In both studies, all patients receiving VICTRELIS were treated with a 4-week lead-in of peginterferon alfa-2b (1.5 mcg/kg/week) and an investigational dose of ribavirin (600-1,400 mg/day), followed by the addition of VICTRELIS (800 mg three times a day) after week 4.
In each study, patients were randomized to three groups:
Response-guided therapy (RGT), in which patients with undetectable virus (HCV-RNA) at treatment week 8 were considered early responders and were eligible for a shorter duration of therapy. Treatment-naïve patients with undetectable HCV-RNA during weeks 8 through 24 were eligible to stop all treatment at week 28. Treatment-failure patients with undetectable HCV-RNA at treatment weeks 8 and 12 were eligible to stop all treatment at week 36.
48 weeks of treatment, in which patients received a 4-week lead-in with P/R followed by 44 weeks of VICTRELIS in combination with P/R.
Control, in which patients received P/R for 48 weeks.
In the HCV RESPOND-2 study, all patients with detectable virus (HCV-RNA) at treatment week 12 were discontinued from treatment. In the HCV SPRINT-2 study, all patients with detectable virus (HCV-RNA) at treatment week 24 were discontinued from treatment.
The HCV RESPOND-2 study was conducted at U.S. and international sites, and included 403 adult patients who had failed prior treatment, including patients who relapsed or were partial responders to prior treatment with standard therapy. Historical null responders were not enrolled. Patients were randomized in a 1:2:2 ratio and stratified based on response to their previous qualifying regimen (relapsers vs. partial responders) and by HCV genotype (1a or 1b).
The HCV SPRINT-2 study was conducted at U.S. and international sites in 1,097 adult patients who were new to treatment. Patients were randomized in a 1:1:1 ratio within two separate cohorts (938 non-Black patients and 159 Black patients) and were stratified by HCV genotype (1a or 1b) and by HCV-RNA viral load (less than or equal to 400,000 IU/mL vs. greater than 400,000 IU/mL). Black patients with chronic HCV historically have been shown to be harder to treat successfully.
Final results of the HCV RESPOND-2 and HCV SPRINT-2 studies were published in the New England Journal of Medicine on March 31, 2011.
Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin. VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients that were treated with VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously untreated patients that were treated with VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.
Dosing and administration
VICTRELIS must be administered in combination with peginterferon alfa and ribavirin. Therapy is initiated with peginterferon alfa and ribavirin for 4 weeks. Beginning in treatment week 5, VICTRELIS is added at a dose of 800 mg (four 200 mg capsules) orally three times daily (every 7-9 hours) with food (a meal or light snack). Based on the patient's virus (HCV-RNA) levels at treatment weeks 8, 12 and 24, dosing is adjusted using the following response-guided therapy guidelines.
Treatment-naive patients: Patients who are undetectable at treatment weeks 8 and 24 complete all therapy at treatment week 28. Patients who are detectable at treatment week 8, but undetectable at treatment week 24, complete VICTRELIS at treatment week 36 and continue on peginterferon alfa and ribavirin alone until treatment week 48.
Treatment-failure patients: Patients (previous partial responders or relapsers) who are undetectable at treatment weeks 8 and 24 complete all therapy at treatment week 36. Patients who are detectable at treatment week 8, but undetectable at treatment week 24, complete VICTRELIS at treatment week 36 and continue on peginterferon alfa and ribavirin alone until treatment week 48. Response-guided therapy was not studied in treatment-failure patients who had less than a 2 log decrease in virus (HCV-RNA) at treatment week 12 of prior treatment (null responders). If treated, these patients should receive 4 weeks of peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS in combination with peginterferon alfa and ribavirin.
Patients with compensated cirrhosis should receive 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS in combination with peginterferon alfa and ribavirin.
Patients who have HCV-RNA results greater than or equal to 100 IU/mL at treatment week 12 discontinue the three-medicine regimen. Patients who have confirmed detectable HCV-RNA at treatment week 24 discontinue the three-medicine regimen.
The wholesale acquisition cost (WAC) of VICTRELIS per week is $1,100.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
Forward-Looking Statement
This news release includes forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck s ability to accurately predict future market conditions; dependence on the effectiveness of Merck s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck s 2010 Annual Report on Form 10-K and the company s other filings with the Securities and Exchange Commission (SEC) available at the SEC s Internet site (www.sec.gov).
The Prescribing Information and Medication Guide are available at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf.
____________________________
1 SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient s 12-week post-treatment assessment was utilized.
VICTRELIS" is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio® and Adcirca® are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Merck
Media:
Pamela Eisele, 908-423-5042
Robert Consalvo, 908-423-6595
or
Investors:
Alex Kelly, 908-423-5185
Carol Ferguson, 908-423-4465
Source: Merck
Tuesday, May 10, 2011
Merck launches "Hope Against Hepatitis C" initiative....
FYI, I'm too jaded for appropriate commentary, hopefully something truly good will come from this alliance of drug developers/marketers and the CDC.
Merck Announces Hope Against Hepatitis C Initiative to Support Public Awareness, Education and Research in the Fight Against Hepatitis C Virus
May 09, 2011 08:33 AM Eastern Daylight Time
WHITEHOUSE STATION, N.J.--(EON: Enhanced Online News)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the launch of Hope Against Hepatitis C, a company initiative to increase awareness, prevention and diagnosis of hepatitis C virus (HCV) infection. Through the Hope Against Hepatitis C program, Merck will support a wide range of public education and patient support programs, as well as research efforts to help improve care for people living with chronic HCV infection.
“We also are committed to partnering with the scientific community to advance the field, and to improving access to chronic hepatitis C care.”
Chronic HCV is a serious infection of the liver and many of those infected do not know that they have the virus – approximately 60 to 80 percent of people infected with chronic HCV do not have symptoms. As a result, people who are undiagnosed may continue to unknowingly spread the virus to others. Chronic HCV infection can damage the liver over time and may lead to cirrhosis, end-stage liver disease and liver cancer.
"Winning the battle against viral hepatitis C requires improved public awareness and education to ensure that those at risk speak to their physicians about getting tested," said Patrick Bergstedt, senior vice president and general manager, Infectious Diseases, Global Human Health, Merck. "Merck is committed to supporting these efforts, which are critical to managing this serious public health issue.”
The Hope Against Hepatitis C initiative will encompass a variety of public-private partnerships, educational programs and collaborative research efforts aimed at supporting the hepatitis C community.
Key initiatives of the program include Merck's participation in the CDC Foundation's Viral Hepatitis Action Coalition. As a member of the Coalition, Merck is providing support for key research and programs led by the Division of Viral Hepatitis at the Centers for Disease Control and Prevention (CDC) through grants to the CDC Foundation. Specifically, Merck is providing support for CDC's Birth-cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) project. This two-year study will evaluate a birth-cohort-based approach of routine one-time screening for HCV infection of all persons born 1945-1965 to increase the proportion of people who are aware of their HCV status. Merck also is providing full funding through the CDC Foundation for a fellowship in CDC's Division of Viral Hepatitis to evaluate HCV testing practices and partial support for CDC's National Hepatitis Education Campaign targeted to health care providers, the general community, as well as populations at risk.
Merck is sponsoring the expansion of the American Liver Foundation's (ALF) Treatment Choices Initiative for individuals who have or are at high risk of chronic HCV infection. This initiative encompasses community-based education programs to inform participants about the liver, liver disease, specifically chronic HCV infection, and disease management strategies. The programs provide perspectives from healthcare providers, as well as individuals who are infected with chronic HCV. Program speakers and participants discuss available information and local resources.
Merck also has launched a new consumer education website, www.AllAboutHepC.com, to help inform patients about the risks associated with chronic HCV infection and to address common questions about the disease. The site is designed to provide content and resources in a user-friendly format that empowers patients to take action and start a conversation with their healthcare professionals. Among the useful features of the site is a risk factor questionnaire that patients can use to assess their risk for infection with chronic HCV. The site offers information on how chronic HCV can lead to serious health problems and helpful tips for patients to use in talking to a physician about chronic HCV infection. A list of questions is available for print-out so that users can take it to their doctor’s office for consultation.
"Merck's commitment in HCV spans three decades and extends beyond drug discovery and development," Bergstedt said. "We also are committed to partnering with the scientific community to advance the field, and to improving access to chronic hepatitis C care.”
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Contacts
Merck
Media:
Pamela Eisele, 908-423-5042
Robert Consalvo, 908-423-6595
or
Investors:
Alex Kelly, 908-423-5185
Carol Ferguson, 908-423-4465
Merck Announces Hope Against Hepatitis C Initiative to Support Public Awareness, Education and Research in the Fight Against Hepatitis C Virus
May 09, 2011 08:33 AM Eastern Daylight Time
WHITEHOUSE STATION, N.J.--(EON: Enhanced Online News)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the launch of Hope Against Hepatitis C, a company initiative to increase awareness, prevention and diagnosis of hepatitis C virus (HCV) infection. Through the Hope Against Hepatitis C program, Merck will support a wide range of public education and patient support programs, as well as research efforts to help improve care for people living with chronic HCV infection.
“We also are committed to partnering with the scientific community to advance the field, and to improving access to chronic hepatitis C care.”
Chronic HCV is a serious infection of the liver and many of those infected do not know that they have the virus – approximately 60 to 80 percent of people infected with chronic HCV do not have symptoms. As a result, people who are undiagnosed may continue to unknowingly spread the virus to others. Chronic HCV infection can damage the liver over time and may lead to cirrhosis, end-stage liver disease and liver cancer.
"Winning the battle against viral hepatitis C requires improved public awareness and education to ensure that those at risk speak to their physicians about getting tested," said Patrick Bergstedt, senior vice president and general manager, Infectious Diseases, Global Human Health, Merck. "Merck is committed to supporting these efforts, which are critical to managing this serious public health issue.”
The Hope Against Hepatitis C initiative will encompass a variety of public-private partnerships, educational programs and collaborative research efforts aimed at supporting the hepatitis C community.
Key initiatives of the program include Merck's participation in the CDC Foundation's Viral Hepatitis Action Coalition. As a member of the Coalition, Merck is providing support for key research and programs led by the Division of Viral Hepatitis at the Centers for Disease Control and Prevention (CDC) through grants to the CDC Foundation. Specifically, Merck is providing support for CDC's Birth-cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) project. This two-year study will evaluate a birth-cohort-based approach of routine one-time screening for HCV infection of all persons born 1945-1965 to increase the proportion of people who are aware of their HCV status. Merck also is providing full funding through the CDC Foundation for a fellowship in CDC's Division of Viral Hepatitis to evaluate HCV testing practices and partial support for CDC's National Hepatitis Education Campaign targeted to health care providers, the general community, as well as populations at risk.
Merck is sponsoring the expansion of the American Liver Foundation's (ALF) Treatment Choices Initiative for individuals who have or are at high risk of chronic HCV infection. This initiative encompasses community-based education programs to inform participants about the liver, liver disease, specifically chronic HCV infection, and disease management strategies. The programs provide perspectives from healthcare providers, as well as individuals who are infected with chronic HCV. Program speakers and participants discuss available information and local resources.
Merck also has launched a new consumer education website, www.AllAboutHepC.com, to help inform patients about the risks associated with chronic HCV infection and to address common questions about the disease. The site is designed to provide content and resources in a user-friendly format that empowers patients to take action and start a conversation with their healthcare professionals. Among the useful features of the site is a risk factor questionnaire that patients can use to assess their risk for infection with chronic HCV. The site offers information on how chronic HCV can lead to serious health problems and helpful tips for patients to use in talking to a physician about chronic HCV infection. A list of questions is available for print-out so that users can take it to their doctor’s office for consultation.
"Merck's commitment in HCV spans three decades and extends beyond drug discovery and development," Bergstedt said. "We also are committed to partnering with the scientific community to advance the field, and to improving access to chronic hepatitis C care.”
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Contacts
Merck
Media:
Pamela Eisele, 908-423-5042
Robert Consalvo, 908-423-6595
or
Investors:
Alex Kelly, 908-423-5185
Carol Ferguson, 908-423-4465
Aethlon Medical requests FDA meeting to expand Hemopurifier® indications to include HCV...
Pretty compelling idea using Aethlon Medical's Hemopurifier® therapeutic filtration system as adjunct therapy to HCV therapy to improve outcomes in special populations. Essentially, the filtration system is used to lower HCV viral load in combination with standard-of-care therapy and possibly DAAs to improve SVR rates. This would especially be useful in patients where ribavirin would be risky or contraindicated (post-transplant, hemodialysis). Depending on the FDA response, I hope the potential trials turn out to be as compelling in reality as they appear to be on paper.
Aethlon Medical Discloses FDA Meeting Request and Proposed Expansion of U.S. Treatment Indications to Include Hepatitis C Virus (HCV)
SAN DIEGO, May 9, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD) announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.
"Since submitting our IDE, we have expanded our collection of human safety data, which has also provided insight that our Hemopurifier® can have a substantial effect in reducing viral load in HCV-infected patients even in the absence of antiviral drugs," stated Jim Joyce, Chairman and CEO of Aethlon Medical. "These results combined with the emergence of a remarkable clinical validation for therapeutic filtration in HCV care provide a compelling basis for an FDA meeting to discuss and advance a potential clinical strategy to treat HCV-infected individuals in the United States."
The meeting with the FDA will provide a collaborative opportunity for Aethlon management to interact directly with Agency officials and to obtain guidance and input on advancing both its HCV and Medical Countermeasure indications in the U.S. Aethlon anticipates a meeting with FDA officials will likely occur in mid-summer.
The Company believes a significant and enduring opportunity exists for the Hemopurifier® as an adjunct to improve the benefit of current, forthcoming and future iterations of standard-of-care drug therapy (SOC) by accelerating viral load depletion in the first few days of HCV-SOC. The clinical validation for therapeutic filtration of HCV has been established by the VRAD system developed and marketed by Asahi Kasei Kuraray Medical in Japan. The early administration of VRAD in combination with HCV-SOC achieved 71.4% sustained virologic response rates (SVR) in HCV patients who previously failed HCV-SOC. These results were achieved through a once daily administration of VRAD for three consecutive days at the outset of SOC therapy. The average viral load reduction during each treatment period, which averaged 3 1/4 hours in duration, was 26.1%. In comparison, the Aethlon Hemopurifier® has demonstrated average viral load reductions of 64% during similar treatment timeframes in the absence of any drug therapy benefit. Aethlon is now actively advancing an adjunct study to demonstrate the ability of the Hemopurifier® to accelerate early viral load depletion in patients who initiate HCV-SOC. The study is being conducted at the Medanta Medicity Institute in Delhi, India.
The Hemopurifier® is also uniquely suited to treat HCV-infected End-stage renal disease (ESRD) patients, whose condition limits their ability to be treated with HCV-SOC. The incidence of HCV infection in ESRD patients is approximately 100-1000 times higher than that in the general population. Recent studies have clearly shown that HCV-infected ESRD patients on maintenance dialysis are at increased risk of liver-related mortality. A significant proportion develops chronic hepatitis, cirrhosis, and even hepatocellular carcinoma. Overall, chronic HCV patients on hemodialysis bear an increased risk of liver-related morbidity and mortality, either during dialysis or after renal transplantation. Interferon (IFN) therapy is modestly effective for the treatment of HCV infection in ESRD patients but is not recommended after renal transplantation due to the risk of acute graft rejection. Ribavirin is considered contraindicated for the treatment of ESRD patients with chronic hepatitis C because of the risk of life-threatening hemolytic anemia. A major advantage in treating HCV-infected ESRD patients with the Hemopurifier® is that the device adds no drug toxicity or interaction concerns and can be included in series with a patient's dialysis cartridge, thus adding no treatment burden beyond the patient's pre-established dialysis treatment schedule.
Aethlon further disclosed that it will begin discussions with the FDA on the regulatory requirements to obtain an Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats that emerge naturally or are released by man as an agent of bioterrorism. The Project BioShield Act of 2004 permits the FDA Commissioner to authorize the use of an unapproved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The EUA authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological and nuclear agents that may be used to attack the American people or the U.S. armed forces. The FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.
Aethlon believes the Hemopurifier®, which is the sole antiviral strategy to address drug and vaccine resistant viral pathogens, is well positioned to meet the U.S. government's urgent need for innovative new medical countermeasures that can be deployed during national health emergencies.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the FDA's willingness to meet with company officials to discuss re-initiation of an Investigational Device Exemption (IDE) study, or the FDA's willingness to meet with company officials to discuss Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Executive Officer
858.459.7800 x 300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
SOURCE Aethlon Medical, Inc.
Back to top
RELATED LINKS
http://www.aethlonmedical.com
Aethlon Medical Discloses FDA Meeting Request and Proposed Expansion of U.S. Treatment Indications to Include Hepatitis C Virus (HCV)
SAN DIEGO, May 9, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD) announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.
"Since submitting our IDE, we have expanded our collection of human safety data, which has also provided insight that our Hemopurifier® can have a substantial effect in reducing viral load in HCV-infected patients even in the absence of antiviral drugs," stated Jim Joyce, Chairman and CEO of Aethlon Medical. "These results combined with the emergence of a remarkable clinical validation for therapeutic filtration in HCV care provide a compelling basis for an FDA meeting to discuss and advance a potential clinical strategy to treat HCV-infected individuals in the United States."
The meeting with the FDA will provide a collaborative opportunity for Aethlon management to interact directly with Agency officials and to obtain guidance and input on advancing both its HCV and Medical Countermeasure indications in the U.S. Aethlon anticipates a meeting with FDA officials will likely occur in mid-summer.
The Company believes a significant and enduring opportunity exists for the Hemopurifier® as an adjunct to improve the benefit of current, forthcoming and future iterations of standard-of-care drug therapy (SOC) by accelerating viral load depletion in the first few days of HCV-SOC. The clinical validation for therapeutic filtration of HCV has been established by the VRAD system developed and marketed by Asahi Kasei Kuraray Medical in Japan. The early administration of VRAD in combination with HCV-SOC achieved 71.4% sustained virologic response rates (SVR) in HCV patients who previously failed HCV-SOC. These results were achieved through a once daily administration of VRAD for three consecutive days at the outset of SOC therapy. The average viral load reduction during each treatment period, which averaged 3 1/4 hours in duration, was 26.1%. In comparison, the Aethlon Hemopurifier® has demonstrated average viral load reductions of 64% during similar treatment timeframes in the absence of any drug therapy benefit. Aethlon is now actively advancing an adjunct study to demonstrate the ability of the Hemopurifier® to accelerate early viral load depletion in patients who initiate HCV-SOC. The study is being conducted at the Medanta Medicity Institute in Delhi, India.
The Hemopurifier® is also uniquely suited to treat HCV-infected End-stage renal disease (ESRD) patients, whose condition limits their ability to be treated with HCV-SOC. The incidence of HCV infection in ESRD patients is approximately 100-1000 times higher than that in the general population. Recent studies have clearly shown that HCV-infected ESRD patients on maintenance dialysis are at increased risk of liver-related mortality. A significant proportion develops chronic hepatitis, cirrhosis, and even hepatocellular carcinoma. Overall, chronic HCV patients on hemodialysis bear an increased risk of liver-related morbidity and mortality, either during dialysis or after renal transplantation. Interferon (IFN) therapy is modestly effective for the treatment of HCV infection in ESRD patients but is not recommended after renal transplantation due to the risk of acute graft rejection. Ribavirin is considered contraindicated for the treatment of ESRD patients with chronic hepatitis C because of the risk of life-threatening hemolytic anemia. A major advantage in treating HCV-infected ESRD patients with the Hemopurifier® is that the device adds no drug toxicity or interaction concerns and can be included in series with a patient's dialysis cartridge, thus adding no treatment burden beyond the patient's pre-established dialysis treatment schedule.
Aethlon further disclosed that it will begin discussions with the FDA on the regulatory requirements to obtain an Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats that emerge naturally or are released by man as an agent of bioterrorism. The Project BioShield Act of 2004 permits the FDA Commissioner to authorize the use of an unapproved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The EUA authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological and nuclear agents that may be used to attack the American people or the U.S. armed forces. The FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.
Aethlon believes the Hemopurifier®, which is the sole antiviral strategy to address drug and vaccine resistant viral pathogens, is well positioned to meet the U.S. government's urgent need for innovative new medical countermeasures that can be deployed during national health emergencies.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the FDA's willingness to meet with company officials to discuss re-initiation of an Investigational Device Exemption (IDE) study, or the FDA's willingness to meet with company officials to discuss Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Executive Officer
858.459.7800 x 300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
SOURCE Aethlon Medical, Inc.
Back to top
RELATED LINKS
http://www.aethlonmedical.com
Subscribe to:
Posts (Atom)
Posts
