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.
Tuesday, May 17, 2011
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
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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.
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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.
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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.
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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.
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