FDA backs Vertex hepatitis drug efficacy, shares jump
Tue, Apr 26 2011
By Lisa Richwine
WASHINGTON (Reuters) - A hepatitis C drug from Vertex Pharmaceuticals Inc cured more patients than previously reported, U.S. health reviewers said, boosting the approval chances for a pill expected to transform treatment of the liver-destroying disease that afflicts millions.
Vertex shares rose 12 percent to their highest level in a decade after comments from Food and Drug Administration staff on Tuesday that analysts said favored the medicine's approval.
Shares of Merck, whose rival hepatitis C treatment also faces an FDA panel's review this week, rose 2.2 percent.
Both medicines are expected to reap more than $1 billion in sales if approved after demonstrating an ability to cure far more patients than current standard drugs, in some cases in half the time.
Vertex's telaprevir eliminated the hepatitis C virus in 79 percent of newly treated patients, FDA reviewers said. That was higher than the 75 percent Vertex reported earlier because the FDA used a different cure rate calculation.
Analysts said the higher effectiveness, plus few FDA safety concerns, meant an advisory panel would likely recommend approval of the drug on Thursday.
"We now expect telaprevir to get a relatively clean recommendation (and hence approval) with no significant exclusions, restrictions, warnings or caveats," Sanford Bernstein analyst Geoffrey Porges said in a research note.
Current therapies require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate, with only about a 40 percent success rate. Both of the new medicines work by blocking a protein called protease that the virus needs to replicate.
WAITING FOR TREATMENT
Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new anti-virals, which still must be taken in combination with the older drugs ribavirin and interferon.
Hepatitis C is a bloodborne liver disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. It is spread mainly through reuse of needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. About 3.2 million Americans and 170 million people worldwide have the disease.
Analysts widely expect the Vertex pill to dominate the market with its greater effectiveness. Telaprevir's 79 percent success rate compares with up to 66 percent for Merck's drug, boceprevir, in previously untreated patients. It also had a higher cure rate than the Merck drug in patients who had failed to be helped by prior therapy.
"Overall, the FDA review team's independent analyses confirmed the applicant's primary efficacy findings," FDA staff said in a summary prepared for the advisory panel of outside experts.
The FDA reviewers said they would ask the panel to discuss rashes and anemia seen in clinical trials of telaprevir. Those issues were known and analysts do not expect them to derail the drug's approval.
An FDA panel will review the Merck drug on Wednesday. In documents released on Monday, agency reviewers said Merck's drug appeared effective but highlighted anemia and other safety issues for panel discussion.
The FDA usually approves medicines that win advisory panel backing. An approval decision for either drug could come as early as May.
(Additional reporting by Toni Clarke and Bill Berkrot, editing by Michele Gershberg, Gerald E. McCormick, Derek Caney and Bernard Orr)
Friday, April 29, 2011
Wednesday, April 27, 2011
FDA advisory board gives Boceprevir the green light, FDA final decision will be in mid-May...
FDA Panel Backs Experimental Merck Hepatitis Drug
WASHINGTON April 27, 2011 (AP)
Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.
A Food and Drug Administration panel of experts voted unanimously, 18-0, in favor of Merck's boceprevir tablet as an effective treatment for hepatitis C, which affects an estimated 3.2 million Americans.
The agency is not required to follow the group's recommendation, though it usually does. A final decision is expected mid-May.
On Thursday the panel will review a similar drug from Vertex Pharmaceuticals. Both of the new drugs block the enzyme that helps the hepatitis virus reproduce.
Panelists said the drug is largely safe, but noted side effects including anemia and lower blood cell counts.
WASHINGTON April 27, 2011 (AP)
Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.
A Food and Drug Administration panel of experts voted unanimously, 18-0, in favor of Merck's boceprevir tablet as an effective treatment for hepatitis C, which affects an estimated 3.2 million Americans.
The agency is not required to follow the group's recommendation, though it usually does. A final decision is expected mid-May.
On Thursday the panel will review a similar drug from Vertex Pharmaceuticals. Both of the new drugs block the enzyme that helps the hepatitis virus reproduce.
Panelists said the drug is largely safe, but noted side effects including anemia and lower blood cell counts.
Tuesday, April 26, 2011
New drug targets raise hopes for hepatitis C cure
Article appearing in the online "news" section of the journal Nature, discussing how the best in HCV treatment - and prevention of resistance - may be yet to come with drugs currently in the development pipeline. Companies mentioned are Pharmasset, BMS and iTherX.
New drug targets raise hopes for hepatitis C cure
As the first targeted therapies edge towards regulatory approval, attention turns to the next drugs in line.
Heidi Ledford
A cocktail of tailored drugs will be needed to defeat the hepatitis C virus.
This week, a panel of advisers to the US Food and Drug Administration (FDA) will decide whether the regulator should approve the first therapies tailored to target the hepatitis C virus (HCV). The drugs, called protease inhibitors, are expected to win approval, but observers say that they are only the beginning of a revolution in HCV treatment.
The most exciting developments for patients, they say, may still be in the drug-development pipeline. Researchers are working on drugs that target many aspects of the virus's biology. Used in combination, these might thwart HCV's ability to evolve resistance.
About 3% of the world's population is infected with HCV, an RNA virus that can cause chronic liver disease. Current therapy — a year-long regimen of the antiviral compounds interferon-alpha and ribavirin — cures only about half of cases. Side effects of this treatment can be severe: interferon-alpha can cause flu-like symptoms, fatigue, anaemia and depression.
On 27 and 28 April, the FDA's Antiviral Drugs Advisory Committee will meet to discuss the first anti-HCV drugs to target HCV proteins. Both these drugs — boceprevir, made by pharmaceutical giant Merck, headquartered in Whitehouse Station, New Jersey, and telaprevir from Vertex Pharmaceuticals, based in Cambridge, Massachusetts — target a protein called the NS3-4A protease, which is required to make essential viral proteins.
Each drug, when combined with standard therapy, boosts the cure rate to about 75%.
"I am very excited," says Michael Houghton, a virologist at the University of Alberta in Edmonton, who was a member of the team that discovered the virus in 1989. "These drugs are great news for HCV patients."
The long road to a blockbuster
Nevertheless, these drugs are only the beginning. "These first-generation protease inhibitors will enjoy their day in the sun for maybe two or three years," says Raymond Chung, head of hepatology at the Massachusetts General Hospital in Boston. "But I don't see them having staying power once we have many more of these targeted drugs getting into the game."
The hope is to eventually use several drugs in combination, avoiding the need for interferon-alpha while staving off drug resistance. Houghton estimates, based on mathematical models and clinical studies, that it will take a cocktail of three targeted therapies to prevent drug resistance.
There are about 60 compounds in preclinical and clinical development as companies jostle to grab a slice of a multi-billion-dollar market.
In 2010, researchers at Bristol-Myers-Squibb's lab in Wallingford, Connecticut, reported their discovery of an HCV protein called NS5A that is essential for the assembly of infectious viral particles and the amplification of viral RNA1. In early clinical trials of an NS5A inhibitor, the level of HCV RNA in the blood dropped almost 2,000-fold after only one day of treatment. This drug is now in phase 2 clinical trials.
Combining the NS5A inhibitor with a protease inhibitor wiped out the virus in four of 11 patients whose infections had not responded to standard therapy. The virus remained undetectable for at least 24 weeks.
These latest results, presented at the International Liver Congress annual meeting in Berlin on 1 April, are exciting because they suggest that interferon may eventually be dispensable, says Chung. He anticipates a flurry of such combination studies in the next few years.
Access denied
Another approach is to stop HCV spreading inside patients by targeting its ability to enter cells. "To contain the virus in a subset of cells rather than allowing it to spread would be a huge boost for containing liver damage," says Michael Gale, a virologist at the University of Washington in Seattle.
In a study published in Nature Medicine on 24 April, a team led by virologist Thomas Baumert of the University of Strasbourg, France, reports that HCV relies on a cellular receptor protein, the epidermal growth factor receptor (EGFR), to enter human cells2. EGFR inhibitors are already on the market as cancer therapies and Baumert's team plans to begin clinical trials of the EGFR inhibitor erlotinib in HCV patients by the end of the year.
Another drug that blocks entry, ITX-5061, is being developed by iTherX, a pharmaceutical company based in San Diego, California, and is in phase 2 clinical trials.
Chung, meanwhile, believes that drugs called nucleoside polymerase inhibitors, which prevent the virus from copying its genome, will be a key ingredient of any future HCV drug cocktail. These compounds set a high barrier for the virus, he notes, and early tests suggest that resistance to them is rare.
Pharmasset, a pharmaceutical firm in Princeton, New Jersey, has several such drugs in development. One called RG7128 is in phase 2 clinical trials and is being developed by Pharmasset together with the Swiss drug giant Roche, based in Basel.
"We used to live in a monochromatic world," says Chung. "Now we realize there are several roads to the same destination."
References
1.Gao, M. et al. Nature 465, 96-100 (2010).
2.Lupberger, J. et al. Nature Med. doi:10.1038/nm.2341 (2011).
New drug targets raise hopes for hepatitis C cure
As the first targeted therapies edge towards regulatory approval, attention turns to the next drugs in line.
Heidi Ledford
A cocktail of tailored drugs will be needed to defeat the hepatitis C virus.
This week, a panel of advisers to the US Food and Drug Administration (FDA) will decide whether the regulator should approve the first therapies tailored to target the hepatitis C virus (HCV). The drugs, called protease inhibitors, are expected to win approval, but observers say that they are only the beginning of a revolution in HCV treatment.
The most exciting developments for patients, they say, may still be in the drug-development pipeline. Researchers are working on drugs that target many aspects of the virus's biology. Used in combination, these might thwart HCV's ability to evolve resistance.
About 3% of the world's population is infected with HCV, an RNA virus that can cause chronic liver disease. Current therapy — a year-long regimen of the antiviral compounds interferon-alpha and ribavirin — cures only about half of cases. Side effects of this treatment can be severe: interferon-alpha can cause flu-like symptoms, fatigue, anaemia and depression.
On 27 and 28 April, the FDA's Antiviral Drugs Advisory Committee will meet to discuss the first anti-HCV drugs to target HCV proteins. Both these drugs — boceprevir, made by pharmaceutical giant Merck, headquartered in Whitehouse Station, New Jersey, and telaprevir from Vertex Pharmaceuticals, based in Cambridge, Massachusetts — target a protein called the NS3-4A protease, which is required to make essential viral proteins.
Each drug, when combined with standard therapy, boosts the cure rate to about 75%.
"I am very excited," says Michael Houghton, a virologist at the University of Alberta in Edmonton, who was a member of the team that discovered the virus in 1989. "These drugs are great news for HCV patients."
The long road to a blockbuster
Nevertheless, these drugs are only the beginning. "These first-generation protease inhibitors will enjoy their day in the sun for maybe two or three years," says Raymond Chung, head of hepatology at the Massachusetts General Hospital in Boston. "But I don't see them having staying power once we have many more of these targeted drugs getting into the game."
The hope is to eventually use several drugs in combination, avoiding the need for interferon-alpha while staving off drug resistance. Houghton estimates, based on mathematical models and clinical studies, that it will take a cocktail of three targeted therapies to prevent drug resistance.
There are about 60 compounds in preclinical and clinical development as companies jostle to grab a slice of a multi-billion-dollar market.
In 2010, researchers at Bristol-Myers-Squibb's lab in Wallingford, Connecticut, reported their discovery of an HCV protein called NS5A that is essential for the assembly of infectious viral particles and the amplification of viral RNA1. In early clinical trials of an NS5A inhibitor, the level of HCV RNA in the blood dropped almost 2,000-fold after only one day of treatment. This drug is now in phase 2 clinical trials.
Combining the NS5A inhibitor with a protease inhibitor wiped out the virus in four of 11 patients whose infections had not responded to standard therapy. The virus remained undetectable for at least 24 weeks.
These latest results, presented at the International Liver Congress annual meeting in Berlin on 1 April, are exciting because they suggest that interferon may eventually be dispensable, says Chung. He anticipates a flurry of such combination studies in the next few years.
Access denied
Another approach is to stop HCV spreading inside patients by targeting its ability to enter cells. "To contain the virus in a subset of cells rather than allowing it to spread would be a huge boost for containing liver damage," says Michael Gale, a virologist at the University of Washington in Seattle.
In a study published in Nature Medicine on 24 April, a team led by virologist Thomas Baumert of the University of Strasbourg, France, reports that HCV relies on a cellular receptor protein, the epidermal growth factor receptor (EGFR), to enter human cells2. EGFR inhibitors are already on the market as cancer therapies and Baumert's team plans to begin clinical trials of the EGFR inhibitor erlotinib in HCV patients by the end of the year.
Another drug that blocks entry, ITX-5061, is being developed by iTherX, a pharmaceutical company based in San Diego, California, and is in phase 2 clinical trials.
Chung, meanwhile, believes that drugs called nucleoside polymerase inhibitors, which prevent the virus from copying its genome, will be a key ingredient of any future HCV drug cocktail. These compounds set a high barrier for the virus, he notes, and early tests suggest that resistance to them is rare.
Pharmasset, a pharmaceutical firm in Princeton, New Jersey, has several such drugs in development. One called RG7128 is in phase 2 clinical trials and is being developed by Pharmasset together with the Swiss drug giant Roche, based in Basel.
"We used to live in a monochromatic world," says Chung. "Now we realize there are several roads to the same destination."
References
1.Gao, M. et al. Nature 465, 96-100 (2010).
2.Lupberger, J. et al. Nature Med. doi:10.1038/nm.2341 (2011).
Boehringer Ingelheim enrolls first patient in Phase 3 trial for BI 201335
Good news for BI as the first patient is enrolled in their phase 3 trials looking at HCV protease inhibitior BI 201335 in combinations with peg and riba. VERY nice to see that they will be looking at this compound in the HIV/HCV co-infected patient, an area that the first generation of protease inhibitors, Telaprevir and Boceprevir may be lacking in due to drug interaction and tolerability issues
Boehringer Ingelheim Announces Enrollment of First Patient in Phase 3 Trial for Lead Hepatitis C Compound
Development program has been granted FDA Fast Track designation
RIDGEFIELD, Conn., April 26, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that enrollment has commenced at North American sites in its pivotal Phase 3 clinical trial program for BI 201335, the Company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase 3 trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naive and -experienced patients with chronic genotype-1 HCV, the most challenging HCV genotype to treat.(1) Results from the Phase 3 studies are expected in the first half of 2013.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development program for BI 201335. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.(2)
"We are pleased to have begun enrolling patients at North American trial sites as we continue development of BI 201335," said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to initiating additional trials later this year in more patient populations, including HCV-HIV coinfected patients, as we continue to advance our HCV portfolio."
BI 201335 U.S. Phase 3 Trials
There are currently three Phase 3 trials enrolling patients around the world that together seek to enroll approximately 1,875 patients. Two of the three trials have U.S. trial sites that together plan to enroll approximately 495 patients.
In the U.S., Study 1220.47 will enroll approximately 370 treatment-naive genotype-1 HCV patients at 95 trial sites. This study will also include additional sites in Canada, Taiwan and Korea. Study 1220.7 will enroll approximately 125 treatment-experienced genotype-1 HCV patients who have failed at least 12 weeks of prior treatment with SOC at 40 trial sites in the U.S. This study also includes additional trial sites around the world. In treatment-naive patients (Study 1220.47), BI 201335 will be dosed once-daily at either 120 mg or 240 mg for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated interferon and ribavirin, the current HCV SOC. In treatment-experienced patients (Study 1220.7) BI 201335 will be dosed once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 48 weeks for prior partial and null responder patients. Patients with prior relapse will be dosed with BI 201335 once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 24 or 48 weeks total duration. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure.(3)
For more information about clinical trials involving BI 201335, please visit www.clinicaltrials.gov.
About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant.(1,4) The number of individuals chronically infected with HCV globally has been estimated at 170 million, with three to four million new infections occurring each year.(5) Only about 20-45 percent of patients clear the virus in the acute phase.(5) Of the remaining chronically infected patients, 20 percent will develop cirrhosis within a mean of 20 years.(1) The mortality rate after cirrhosis has developed is two to five percent per year.(6) End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.(1)
About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research program for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV. The company has a well established research center in Laval, Canada, dedicated to virology research since the early 1990's, and is committed to developing new therapies for virologic diseases with a high unmet medical need.
Boehringer Ingelheim in Hepatitis C Virus (HCV)
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim's own research and development, which has completed clinical trials through Phase 2b (SILEN-C studies). This Phase 2 program supports the investigation of BI 201335 in Phase 3 trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase 1 clinical trials. Phase 2 trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.
References:
National Digestive Disease Information Clearing House (NDDICH), NIH. Chronic Hepatitis C: Current Disease Management. http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm.
U.S. Food and Drug Administration (FDA). Fast Track Designation Request Performance. http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122932.htm.
American Association for the Study of Liver Disease Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology, April 2009. http://www.natap.org/2009/HCV/aasld.pdf.
Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for the Public. http://www.cdc.gov/hepatitis/C/cFAQ.htm.
World Health Organization (WHO): Europe. Hepatitis: Hepatitis C. http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/facts-and-figures/hepatitis-c.
Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009. http://cid.oxfordjournals.org/content/48/3/313.full.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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RELATED LINKS
http://us.boehringer-ingelheim.com
Boehringer Ingelheim Announces Enrollment of First Patient in Phase 3 Trial for Lead Hepatitis C Compound
Development program has been granted FDA Fast Track designation
RIDGEFIELD, Conn., April 26, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that enrollment has commenced at North American sites in its pivotal Phase 3 clinical trial program for BI 201335, the Company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase 3 trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naive and -experienced patients with chronic genotype-1 HCV, the most challenging HCV genotype to treat.(1) Results from the Phase 3 studies are expected in the first half of 2013.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development program for BI 201335. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.(2)
"We are pleased to have begun enrolling patients at North American trial sites as we continue development of BI 201335," said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to initiating additional trials later this year in more patient populations, including HCV-HIV coinfected patients, as we continue to advance our HCV portfolio."
BI 201335 U.S. Phase 3 Trials
There are currently three Phase 3 trials enrolling patients around the world that together seek to enroll approximately 1,875 patients. Two of the three trials have U.S. trial sites that together plan to enroll approximately 495 patients.
In the U.S., Study 1220.47 will enroll approximately 370 treatment-naive genotype-1 HCV patients at 95 trial sites. This study will also include additional sites in Canada, Taiwan and Korea. Study 1220.7 will enroll approximately 125 treatment-experienced genotype-1 HCV patients who have failed at least 12 weeks of prior treatment with SOC at 40 trial sites in the U.S. This study also includes additional trial sites around the world. In treatment-naive patients (Study 1220.47), BI 201335 will be dosed once-daily at either 120 mg or 240 mg for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated interferon and ribavirin, the current HCV SOC. In treatment-experienced patients (Study 1220.7) BI 201335 will be dosed once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 48 weeks for prior partial and null responder patients. Patients with prior relapse will be dosed with BI 201335 once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 24 or 48 weeks total duration. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure.(3)
For more information about clinical trials involving BI 201335, please visit www.clinicaltrials.gov.
About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant.(1,4) The number of individuals chronically infected with HCV globally has been estimated at 170 million, with three to four million new infections occurring each year.(5) Only about 20-45 percent of patients clear the virus in the acute phase.(5) Of the remaining chronically infected patients, 20 percent will develop cirrhosis within a mean of 20 years.(1) The mortality rate after cirrhosis has developed is two to five percent per year.(6) End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.(1)
About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research program for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV. The company has a well established research center in Laval, Canada, dedicated to virology research since the early 1990's, and is committed to developing new therapies for virologic diseases with a high unmet medical need.
Boehringer Ingelheim in Hepatitis C Virus (HCV)
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim's own research and development, which has completed clinical trials through Phase 2b (SILEN-C studies). This Phase 2 program supports the investigation of BI 201335 in Phase 3 trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase 1 clinical trials. Phase 2 trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.
References:
National Digestive Disease Information Clearing House (NDDICH), NIH. Chronic Hepatitis C: Current Disease Management. http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm.
U.S. Food and Drug Administration (FDA). Fast Track Designation Request Performance. http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122932.htm.
American Association for the Study of Liver Disease Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology, April 2009. http://www.natap.org/2009/HCV/aasld.pdf.
Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for the Public. http://www.cdc.gov/hepatitis/C/cFAQ.htm.
World Health Organization (WHO): Europe. Hepatitis: Hepatitis C. http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/facts-and-figures/hepatitis-c.
Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009. http://cid.oxfordjournals.org/content/48/3/313.full.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Back to top
RELATED LINKS
http://us.boehringer-ingelheim.com
Monday, April 25, 2011
Boceprevir Wins Favorable FDA Staff Review
MedPage Today covers FDA review of Boceprevir. Aside from the issues regarding Merck's definition of 'null responder', the predictive value of viral kinetics and the hemotologic issues with the drug, the only formal voting issue, however, is whether "the available data support approval" of boceprevir for treating HCV genotype 1 in combination with peginterferon and ribavirin.
Boceprevir Wins Favorable FDA Staff Review
By John Gever, Senior Editor, MedPage Today
Published: April 25, 2011
WASHINGTON -- The FDA's professional staff believes the investigational hepatitis C drug boceprevir (Victrelis) is effective and reasonably safe, according to a briefing document made public in advance of a Wednesday advisory committee meeting.
But before the agency approves the drug, it wants the panel's views on certain marketing claims that the drug's manufacturer, Merck, is proposing to make. These include the drug's efficacy in patients with "null" responses to the standard regimen of pegylated interferon and ribavirin as well as the benefits of so-called response-guided therapy.
The Antiviral Drugs Advisory Committee will also be asked to review risks of anemia and other hematologic abnormalities associated with boceprevir.
The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during a two-day meeting this week. The other is telaprevir -- no brand name has been proposed as yet -- which will have its day on Thursday.
The two drugs would be the first HCV protease inhibitors to reach the market. They have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
These data suggest that adding one of the drugs to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates.
For example, among treatment-naive patients in one of the boceprevir trials, 40% of a control group receiving the conventional regimen had a sustained response versus about 70% of patients with the protease inhibitor added.
A separate trial in patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round, whereas approximately 60% did with the addition of boceprevir.
In the briefing paper prepared for Wednesday's panel meeting, the FDA staff reviewers could find little to fault in these data.
But they did question Merck's arguments in favor of "response-guided therapy," particularly in African-American patients and raised concerns about the drug's hematologic side effects.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on viral responses after eight and 24 weeks.
In particular, Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the FDA staff reviewers pointed to data in one of the trials indicating a slightly lower sustained-response rate in previous treatment failures receiving the response-guided therapy compared with fixed-duration treatment (59% versus 66%).
They also noted that black participants in a study of treatment-naive patients also had a lower sustained-response rate with response-guided therapy (42% versus 53%).
"The 11% numerical difference ... is of some concern and will be an issue for discussion," the briefing paper said.
Another issue is whether a proposed indication for patients who completely failed previous peginterferon-ribavirin therapy is justified, considering that such patients were excluded from trials of previously treated patients.
Merck is arguing that its major trial in treatment-naive patients included null responders, identified as those with negligible responses during the lead-in with standard therapy, and the drug's efficacy in this population can be gauged from those results.
However, the FDA reviewers indicated that responses at week four do not perfectly predict who will ultimately respond. The lack of a trial designed expressly to test the drug in null responders "raises questions about using [standard therapy] lead-in responses as a surrogate," they wrote in the briefing document.
About a quarter of the briefing document was devoted to boceprevir's adverse hematologic effects, primarily anemia but also including neutropenia and thrombocytopenia.
In the drug's two main phase III trials, half the patients taking the drug had nadir hemoglobin values of 10 g/dL or below and more than 40% required erythropoietin therapy -- with both rates about twice those seen in the control groups.
The other hematologic effects were far less common, but still a potential concern, according the briefing document.
Counting all cases, the incidence of neutropenia was about the same with or without boceprevir, but the drug was associated with a greater rate of serious cases. Eight of 1,057 patients taking the drug discontinued the study because of neutropenia compared with none in the control groups.
Similarly, severe thrombocytopenia was seen in 15 boceprevir-treated patients compared with three control patients.
The FDA plans to ask the advisory panel to comment on these adverse events, as well as to discuss postmarketing studies that Merck should conduct if the product is approved.
The only formal voting issue, however, is whether "the available data support approval" of boceprevir for treating HCV genotype 1 in combination with peginterferon and ribavirin.
Boceprevir Wins Favorable FDA Staff Review
By John Gever, Senior Editor, MedPage Today
Published: April 25, 2011
WASHINGTON -- The FDA's professional staff believes the investigational hepatitis C drug boceprevir (Victrelis) is effective and reasonably safe, according to a briefing document made public in advance of a Wednesday advisory committee meeting.
But before the agency approves the drug, it wants the panel's views on certain marketing claims that the drug's manufacturer, Merck, is proposing to make. These include the drug's efficacy in patients with "null" responses to the standard regimen of pegylated interferon and ribavirin as well as the benefits of so-called response-guided therapy.
The Antiviral Drugs Advisory Committee will also be asked to review risks of anemia and other hematologic abnormalities associated with boceprevir.
The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during a two-day meeting this week. The other is telaprevir -- no brand name has been proposed as yet -- which will have its day on Thursday.
The two drugs would be the first HCV protease inhibitors to reach the market. They have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
These data suggest that adding one of the drugs to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates.
For example, among treatment-naive patients in one of the boceprevir trials, 40% of a control group receiving the conventional regimen had a sustained response versus about 70% of patients with the protease inhibitor added.
A separate trial in patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round, whereas approximately 60% did with the addition of boceprevir.
In the briefing paper prepared for Wednesday's panel meeting, the FDA staff reviewers could find little to fault in these data.
But they did question Merck's arguments in favor of "response-guided therapy," particularly in African-American patients and raised concerns about the drug's hematologic side effects.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on viral responses after eight and 24 weeks.
In particular, Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the FDA staff reviewers pointed to data in one of the trials indicating a slightly lower sustained-response rate in previous treatment failures receiving the response-guided therapy compared with fixed-duration treatment (59% versus 66%).
They also noted that black participants in a study of treatment-naive patients also had a lower sustained-response rate with response-guided therapy (42% versus 53%).
"The 11% numerical difference ... is of some concern and will be an issue for discussion," the briefing paper said.
Another issue is whether a proposed indication for patients who completely failed previous peginterferon-ribavirin therapy is justified, considering that such patients were excluded from trials of previously treated patients.
Merck is arguing that its major trial in treatment-naive patients included null responders, identified as those with negligible responses during the lead-in with standard therapy, and the drug's efficacy in this population can be gauged from those results.
However, the FDA reviewers indicated that responses at week four do not perfectly predict who will ultimately respond. The lack of a trial designed expressly to test the drug in null responders "raises questions about using [standard therapy] lead-in responses as a surrogate," they wrote in the briefing document.
About a quarter of the briefing document was devoted to boceprevir's adverse hematologic effects, primarily anemia but also including neutropenia and thrombocytopenia.
In the drug's two main phase III trials, half the patients taking the drug had nadir hemoglobin values of 10 g/dL or below and more than 40% required erythropoietin therapy -- with both rates about twice those seen in the control groups.
The other hematologic effects were far less common, but still a potential concern, according the briefing document.
Counting all cases, the incidence of neutropenia was about the same with or without boceprevir, but the drug was associated with a greater rate of serious cases. Eight of 1,057 patients taking the drug discontinued the study because of neutropenia compared with none in the control groups.
Similarly, severe thrombocytopenia was seen in 15 boceprevir-treated patients compared with three control patients.
The FDA plans to ask the advisory panel to comment on these adverse events, as well as to discuss postmarketing studies that Merck should conduct if the product is approved.
The only formal voting issue, however, is whether "the available data support approval" of boceprevir for treating HCV genotype 1 in combination with peginterferon and ribavirin.
Sunday, April 24, 2011
Boston Globe article on Vertex's challenges in becoming a full-fledged commercial entity...
Good article by Boston Globe's Robert Weisman on the catalysts and challenges of Vertex Pharmaceuticals becoming a full fledged commercial pharmaceutical company with the pending launch of Telaprevir. Clearly the largest challenge to the successful launch of Telaprevir (aside from Vertex's shuffling of leadership positions late in the game) is the formidable marketing prowess of Merck behind Boceprevir coupled with the company's long-running experience in the Hepatitis C marketplace. This battle will be a compelling one to watch as both companies almost simultaneously launch ground-breaking drugs that will forver change the way Hepatitis C is treated. The Merck/Vertex battle is almost certainly destined to shape the playbooks of drug marketing/manufacturing mavens and become a case study of choice in business schools around the globe.
Rearranging the Corporate DNA
On the verge of its first blockbuster drug, can Vertex transform itself into a money-making enterprise?
By Robert Weisman
Globe Staff / April 24, 2011
CAMBRIDGE — This week, a Food and Drug Administration advisory panel in Silver Spring, Md., is scheduled to make a recommendation critical to the future of Vertex Pharmaceuticals Inc. The advisers will rule on whether the FDA should approve the first drug developed solely by the biotechnology company in its 22 years of existence.
Approval for telaprevir — a drug aimed at curing hepatitis C — would hasten Vertex’s transition from a research and development company that invested some $4 billion in drug discovery over the past two decades to an integrated research and commercial organization. It also would become, for the first time, a company that consistently makes money.
“Vertex’s plan has always been to be a fully capable company, and that’s still the plan,’’ said Joshua Boger, who founded the biotech company in 1989 and retired two years ago. “This is the fulfillment of that aspiration.’’
In a warren of former industrial buildings in Cambridgeport that make up the Vertex corporate campus, the company’s transition is well underway. Chief executive Matthew Emmens, the biotechnology veteran tapped in 2009 to create a sales and marketing force, has hired more than 200 people for Vertex’s fledgling commercial team.
Overall, the company now has about 1,800 employees, 25 percent more than at the start of last year. That includes about 1,200 in the Boston area and 175 field representatives preparing to promote telaprevir — which will be given a more consumer-friendly brand name — if it wins final FDA approval in May.
Vertex is still hiring and currently has 150 job openings. In February, it unveiled plans to add 500 more employees and build a new headquarters in the Fan Pier waterfront development area in South Boston. That move, which includes $60 million in incentives from the state, is contingent on approval of telaprevir. Vertex also is moving forward with clinical trials of a drug to treat cystic fibrosis.
“It’s just a golden era right now for this company,’’ said Emmens, 59, former chief executive of British drug maker Shire PLC, who worked with Boger years ago at pharmaceutical giant Merck & Co. in New Jersey. “Some of the best researchers in the world are here, and we’re building a commercial presence. You’ve got millions of patients waiting for a drug that can save their life.’’
Vertex’s market value has climbed to $9.8 billion, second only to Weston-based Biogen Idec Inc. among Massachusetts biotechnology companies, largely on investor anticipation of its new drug that, if approved, would enter a market projected at $3.3 billion a year starting in 2012.
But it might not have that market to itself. The day before the FDA advisory committee takes up telaprevir on Thursday, it will consider a competing hepatitis C virus treatment from Merck. Both are protease inhibitors, a class of drugs that act to prevent viral infections. They target a US population that includes hundreds of thousands of patients treated unsuccessfully by current drugs and tens of thousands “warehoused’’ by doctors — patients infected with hepatitis C but not yet experiencing symptoms — until the Vertex and Merck drugs are available.
“We’re expecting it to be a very big market initially,’’ said biotechnology analyst Howard Liang, managing director at health care investment bank Leerink Swann in Boston, who projects the new hepatitis C treatments will generate $2.2 billion in revenue for Vertex and $1 billion for Merck in 2012, and even more the following year. “Both drugs are a very significant advance over existing therapies.’’
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Joshua Boger, founder of Vertex.
A look at the history of
Vertex Pharmaceuticals
* On the long, hard road
to a breakthrough
* Can Vertex transform into
a money-making enterprise?
* Biotech ‘gunslingers’
aim for breakthroughs
* Now comes the hard part:
marketing an unknown
Hepatitis C is believed to kill about 10,000 people a year worldwide, many of whom develop cancer or scarring of the liver. But the virus can be carried for decades before patients become sick, and millions of people are thought to have the virus and not know it. The virus has become an epidemic among baby boomers infected decades ago through injecting drugs or blood transfusions. It may be carried by as many as 3 million people in the United States and 100 million worldwide.
Patients are currently treated with a combination of two drugs: pegylated interferon and ribaviran. Vertex’s telaprevir or Merck’s drug, known as boceprevir, would be added to that “cocktail,’’ boosting its potency and acting directly against the virus in a bid to cure many patients. The drugs are expected to be priced at between $35,000 and $40,000 per patient, Leerink Swann estimates, and taken in combination with the current drugs, they promise to shorten the duration of treatment for large numbers of patients.
Telaprevir, in particular, aims to cut the treatment time in half, from 12 to six months, for about 60 percent of patients with the most serious form of the virus, Leerink’s Liang said. “Our opinion is, telaprevir looks to be a more potent drug,’’ he said. “The cure rate is a little higher, and it’s more likely the duration of treatment will be reduced.’’
But Merck would have some advantages in marketing boceprevir, which it says it would sell under the name Victrelis. Among them, it is likely to market the drug together with its own brands of pegylated interferon and ribaviran, both already on the market. “We would take a franchise approach to this,’’ said Mark Timney, president of Merck’s US Human Health business. “We have a long history and deep scientific and commercial knowledge in treatment of the hepatitis C virus.’’
For Vertex, the challenge would be not only developing the superior product, but selling it to doctors, such as gastroenterologists and hepatologists, with a new sales force. Boger, a scientist, turned over the Vertex management reins to Emmens, an organizational specialist, specifically to build up the commercial side of the business.
“What we did here is we actually had the R&D people interview the people we brought in on the commercial side,’’ Emmens said. “That was one of my ideas, simply because I thought I didn’t want to have an adverse reaction . . . let’s put it that way.’’
If it succeeds, Vertex will become a more prominent player in the Boston area life sciences scene, especially following the recent acquisition of Genzyme Corp. — long the largest biotech in the state — by French drug giant Sanofi-Aventis SA.
“Nature will take its course,’’ Boger said. “As we become a larger company and we shift from a company that consumes capital to a company that creates capital, our footprint will grow.’’
Robert Weisman can be reached at weisman@globe.com.
Rearranging the Corporate DNA
On the verge of its first blockbuster drug, can Vertex transform itself into a money-making enterprise?
By Robert Weisman
Globe Staff / April 24, 2011
CAMBRIDGE — This week, a Food and Drug Administration advisory panel in Silver Spring, Md., is scheduled to make a recommendation critical to the future of Vertex Pharmaceuticals Inc. The advisers will rule on whether the FDA should approve the first drug developed solely by the biotechnology company in its 22 years of existence.
Approval for telaprevir — a drug aimed at curing hepatitis C — would hasten Vertex’s transition from a research and development company that invested some $4 billion in drug discovery over the past two decades to an integrated research and commercial organization. It also would become, for the first time, a company that consistently makes money.
“Vertex’s plan has always been to be a fully capable company, and that’s still the plan,’’ said Joshua Boger, who founded the biotech company in 1989 and retired two years ago. “This is the fulfillment of that aspiration.’’
In a warren of former industrial buildings in Cambridgeport that make up the Vertex corporate campus, the company’s transition is well underway. Chief executive Matthew Emmens, the biotechnology veteran tapped in 2009 to create a sales and marketing force, has hired more than 200 people for Vertex’s fledgling commercial team.
Overall, the company now has about 1,800 employees, 25 percent more than at the start of last year. That includes about 1,200 in the Boston area and 175 field representatives preparing to promote telaprevir — which will be given a more consumer-friendly brand name — if it wins final FDA approval in May.
Vertex is still hiring and currently has 150 job openings. In February, it unveiled plans to add 500 more employees and build a new headquarters in the Fan Pier waterfront development area in South Boston. That move, which includes $60 million in incentives from the state, is contingent on approval of telaprevir. Vertex also is moving forward with clinical trials of a drug to treat cystic fibrosis.
“It’s just a golden era right now for this company,’’ said Emmens, 59, former chief executive of British drug maker Shire PLC, who worked with Boger years ago at pharmaceutical giant Merck & Co. in New Jersey. “Some of the best researchers in the world are here, and we’re building a commercial presence. You’ve got millions of patients waiting for a drug that can save their life.’’
Vertex’s market value has climbed to $9.8 billion, second only to Weston-based Biogen Idec Inc. among Massachusetts biotechnology companies, largely on investor anticipation of its new drug that, if approved, would enter a market projected at $3.3 billion a year starting in 2012.
But it might not have that market to itself. The day before the FDA advisory committee takes up telaprevir on Thursday, it will consider a competing hepatitis C virus treatment from Merck. Both are protease inhibitors, a class of drugs that act to prevent viral infections. They target a US population that includes hundreds of thousands of patients treated unsuccessfully by current drugs and tens of thousands “warehoused’’ by doctors — patients infected with hepatitis C but not yet experiencing symptoms — until the Vertex and Merck drugs are available.
“We’re expecting it to be a very big market initially,’’ said biotechnology analyst Howard Liang, managing director at health care investment bank Leerink Swann in Boston, who projects the new hepatitis C treatments will generate $2.2 billion in revenue for Vertex and $1 billion for Merck in 2012, and even more the following year. “Both drugs are a very significant advance over existing therapies.’’
* Tweet
*
* Yahoo! Buzz ShareThis
Related
Photos
Joshua Boger, founder of Vertex.
A look at the history of
Vertex Pharmaceuticals
* On the long, hard road
to a breakthrough
* Can Vertex transform into
a money-making enterprise?
* Biotech ‘gunslingers’
aim for breakthroughs
* Now comes the hard part:
marketing an unknown
Hepatitis C is believed to kill about 10,000 people a year worldwide, many of whom develop cancer or scarring of the liver. But the virus can be carried for decades before patients become sick, and millions of people are thought to have the virus and not know it. The virus has become an epidemic among baby boomers infected decades ago through injecting drugs or blood transfusions. It may be carried by as many as 3 million people in the United States and 100 million worldwide.
Patients are currently treated with a combination of two drugs: pegylated interferon and ribaviran. Vertex’s telaprevir or Merck’s drug, known as boceprevir, would be added to that “cocktail,’’ boosting its potency and acting directly against the virus in a bid to cure many patients. The drugs are expected to be priced at between $35,000 and $40,000 per patient, Leerink Swann estimates, and taken in combination with the current drugs, they promise to shorten the duration of treatment for large numbers of patients.
Telaprevir, in particular, aims to cut the treatment time in half, from 12 to six months, for about 60 percent of patients with the most serious form of the virus, Leerink’s Liang said. “Our opinion is, telaprevir looks to be a more potent drug,’’ he said. “The cure rate is a little higher, and it’s more likely the duration of treatment will be reduced.’’
But Merck would have some advantages in marketing boceprevir, which it says it would sell under the name Victrelis. Among them, it is likely to market the drug together with its own brands of pegylated interferon and ribaviran, both already on the market. “We would take a franchise approach to this,’’ said Mark Timney, president of Merck’s US Human Health business. “We have a long history and deep scientific and commercial knowledge in treatment of the hepatitis C virus.’’
For Vertex, the challenge would be not only developing the superior product, but selling it to doctors, such as gastroenterologists and hepatologists, with a new sales force. Boger, a scientist, turned over the Vertex management reins to Emmens, an organizational specialist, specifically to build up the commercial side of the business.
“What we did here is we actually had the R&D people interview the people we brought in on the commercial side,’’ Emmens said. “That was one of my ideas, simply because I thought I didn’t want to have an adverse reaction . . . let’s put it that way.’’
If it succeeds, Vertex will become a more prominent player in the Boston area life sciences scene, especially following the recent acquisition of Genzyme Corp. — long the largest biotech in the state — by French drug giant Sanofi-Aventis SA.
“Nature will take its course,’’ Boger said. “As we become a larger company and we shift from a company that consumes capital to a company that creates capital, our footprint will grow.’’
Robert Weisman can be reached at weisman@globe.com.
Tuesday, April 19, 2011
Quest Diagnostics jumps in to the IL28B testing arena with the launch of AccuType...
Quest Diagnostics has launched their own IL28B test called AccuType to compete with LabCorp's IL28B assay. As discussed before, I've talked with several physicians who felt that the assay is helpful, but may not be clinically relevant enough to make the decision to treat or not to treat, despite the data to back the assay. They've had enough T/T's succeed in achieving SVR and enough C/C's fail therapy to know that the IL28B polymorphism is an important factor in achieving an SVR, but certainly not the only one. In the words of one physician, "RVR trumps all". I've also talked with several who buy into the importance of the assay in making treatment decisions. I reckon the market will decide for us.
AccuType® IL28B test now available to physicians and for clinical trials research
MADISON, N.J., April 18, 2011 /PRNewswire/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the availability of its AccuType® IL28B test for aiding in the prediction of patient response to peginterferon alpha-based therapy for hepatitis C virus (HCV) infection. Quest Diagnostics is now offering the test to physicians and other healthcare providers in the U.S. and to pharmaceutical companies for use in clinical trials research.
The test was developed through a global non-exclusive license agreement under which Schering Corporation, a Merck affiliate, licensed certain patent rights claiming Interleukin (IL) 28B genetic markers to Quest Diagnostics. These genetic markers have been shown to provide an indicator of potential response to peginterferon alpha-based therapy for HCV. Additional terms were not disclosed.
"Our AccuType IL28B test will give physicians greater insights for treating individual patients infected with the most common form of HCV using standard antiviral therapies," said Rick L. Pesano, M.D., Ph.D., medical director, infectious diseases, Quest Diagnostics. "AccuType IL28B testing will also help physicians consider alternative therapies, which in the future may include HCV protease inhibitors."
Combination interferon-ribavirin therapy administered over several months is considered standard of care in treating HCV, although experimental HCV protease inhibitors are now under priority review by the U.S. Food and Drug Administration.(1),(2) Side effects, such as fatigue, depression and nausea, affect the majority of patients, and an estimated 10% to 14% of people discontinue therapy.(3),(4) Moreover, as many as one in two patients fail to eradicate the virus, as indicated by blood tests, after a full course of therapy.(5)
A certain polymorphism of the IL28B gene found in individuals infected with the most common type of HCV, HCV genotype 1, aids in identifying those patients who are twice as likely to eliminate the HCV virus on a sustained basis when treated with pegylated interferon-ribavirin combination therapies.(6) Other factors, including age and gender, may affect treatment response.
HCV infection is the most common chronic blood borne infection in the United States, chronically infecting approximately 3.2 million people. Left untreated, chronic HCV can lead to liver cancer or liver cirrhosis requiring liver transplantation. Chronic HCV infection accounts for an estimated 8,000 to 10,000 deaths each year in the United States.(7)
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.
Quest Diagnostics' broad hepatitis C and B virus testing menu includes hepatic function tests to help determine HCV exposure and identify abnormal liver function; Heptimax® viral RNA quantitative testing to monitor viral load during therapy; and HCV genotyping to aid in predicting treatment duration and success. Quest Diagnostics also offers tests, such as HepaScore™, to help physicians identify and stage liver fibrosis.
Additional company information is available at www.QuestDiagnostics.com.
Quest, Quest Diagnostics, the associated logo, Nichols Institute and all associated Quest Diagnostics marks are the registered trademarks of Quest Diagnostics. All third party marks — ®' and ™' — are the property of their respective owners. © 2000-2011 Quest Diagnostics Incorporated. All rights reserved.
(1) Merck press release, 1/6/11; Vertex Pharmaceuticals press release; 1/20/11.
(2) HCSP Fact Sheet, Hepatitis C Support Project (HCSP);2008;ver 3.
(3) Lancet 2001; 358:958-965.
(4) N Engl J Med 2002; 347:975-982.
(5) HCSP Fact Sheet, Hepatitis C Support Project (HCSP),ver 3, 12/08.
(6) "Nature, 2009;10.1038;1-3.
(7) Hepatitis C FAQs for Health Professionals, U.S. Centers for Disease Control and Prevention Source, updated 12/17/10.
Quest Diagnostics Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900
SOURCE Quest Diagnostics Incorporated
Back to top
RELATED LINKS
http://www.questdiagnostics.com
AccuType® IL28B test now available to physicians and for clinical trials research
MADISON, N.J., April 18, 2011 /PRNewswire/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the availability of its AccuType® IL28B test for aiding in the prediction of patient response to peginterferon alpha-based therapy for hepatitis C virus (HCV) infection. Quest Diagnostics is now offering the test to physicians and other healthcare providers in the U.S. and to pharmaceutical companies for use in clinical trials research.
The test was developed through a global non-exclusive license agreement under which Schering Corporation, a Merck affiliate, licensed certain patent rights claiming Interleukin (IL) 28B genetic markers to Quest Diagnostics. These genetic markers have been shown to provide an indicator of potential response to peginterferon alpha-based therapy for HCV. Additional terms were not disclosed.
"Our AccuType IL28B test will give physicians greater insights for treating individual patients infected with the most common form of HCV using standard antiviral therapies," said Rick L. Pesano, M.D., Ph.D., medical director, infectious diseases, Quest Diagnostics. "AccuType IL28B testing will also help physicians consider alternative therapies, which in the future may include HCV protease inhibitors."
Combination interferon-ribavirin therapy administered over several months is considered standard of care in treating HCV, although experimental HCV protease inhibitors are now under priority review by the U.S. Food and Drug Administration.(1),(2) Side effects, such as fatigue, depression and nausea, affect the majority of patients, and an estimated 10% to 14% of people discontinue therapy.(3),(4) Moreover, as many as one in two patients fail to eradicate the virus, as indicated by blood tests, after a full course of therapy.(5)
A certain polymorphism of the IL28B gene found in individuals infected with the most common type of HCV, HCV genotype 1, aids in identifying those patients who are twice as likely to eliminate the HCV virus on a sustained basis when treated with pegylated interferon-ribavirin combination therapies.(6) Other factors, including age and gender, may affect treatment response.
HCV infection is the most common chronic blood borne infection in the United States, chronically infecting approximately 3.2 million people. Left untreated, chronic HCV can lead to liver cancer or liver cirrhosis requiring liver transplantation. Chronic HCV infection accounts for an estimated 8,000 to 10,000 deaths each year in the United States.(7)
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.
Quest Diagnostics' broad hepatitis C and B virus testing menu includes hepatic function tests to help determine HCV exposure and identify abnormal liver function; Heptimax® viral RNA quantitative testing to monitor viral load during therapy; and HCV genotyping to aid in predicting treatment duration and success. Quest Diagnostics also offers tests, such as HepaScore™, to help physicians identify and stage liver fibrosis.
Additional company information is available at www.QuestDiagnostics.com.
Quest, Quest Diagnostics, the associated logo, Nichols Institute and all associated Quest Diagnostics marks are the registered trademarks of Quest Diagnostics. All third party marks — ®' and ™' — are the property of their respective owners. © 2000-2011 Quest Diagnostics Incorporated. All rights reserved.
(1) Merck press release, 1/6/11; Vertex Pharmaceuticals press release; 1/20/11.
(2) HCSP Fact Sheet, Hepatitis C Support Project (HCSP);2008;ver 3.
(3) Lancet 2001; 358:958-965.
(4) N Engl J Med 2002; 347:975-982.
(5) HCSP Fact Sheet, Hepatitis C Support Project (HCSP),ver 3, 12/08.
(6) "Nature, 2009;10.1038;1-3.
(7) Hepatitis C FAQs for Health Professionals, U.S. Centers for Disease Control and Prevention Source, updated 12/17/10.
Quest Diagnostics Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900
SOURCE Quest Diagnostics Incorporated
Back to top
RELATED LINKS
http://www.questdiagnostics.com
Friday, April 15, 2011
Modeling data shows that Telaprevir increases second-phase HCV decline...
Predictive models make me nervous, especially those with the word "new" in front of them because I always think of the one person who might take this study as gospel and actually treat accordingly. But this data, (published online in the journal Hepatology) using a new predictive model, does offer a plausible hypothesis - that the steep decline in the second phase viral clearance is responsible for the shortened duration of therapy with Telaprevir and, assuming high compliance and no resistance, HCV viral particles could be cleared in as little as seven weeks. Compelling, because we've heard of patients who had truncated durations of therapy with Telaprevir + Peg & Riba and still clear virus. Interesting, but again, only a model.
Telaprevir Increases Second-Phase Hepatitis C Decline
Predictive model indicates virus particles could be cleared in seven weeks assuming high compliance
Analysis of the kinetics of telaprevir treatment for hepatitis C virus shows a rapid second-phase viral decline, which may allow for shorter duration of treatment, according to a study published online March 7 in Hepatology.
FRIDAY, April 8 (HealthDay News) -- Analysis of the kinetics of telaprevir treatment for hepatitis C virus (HCV) shows a rapid second-phase viral decline, which may allow for shorter duration of treatment, according to a study published online March 7 in Hepatology.
Jeremie Guedj, Ph.D., and Alan S. Perelson, Ph.D., from the Los Alamos National Laboratory in New Mexico, examined second-phase HCV viral decline during treatment with telaprevir. Two aspects of telaprevir treatment were investigated: the effect of varying regimens of telaprevir monotherapy in 28 participants, and the comparison of telaprevir monotherapy in eight patients with telaprevir plus interferon therapy in eight patients. Using a new viral kinetic model, and assuming that drug resistance can be avoided, the treatment time needed to eliminate all virus and infected cells was estimated.
The investigators found that the second-phase viral decline was associated with the effectiveness of treatment, and was approximately four times more rapid with telaprevir than interferon-based therapies. In the predictive model, assuming 95 percent of the patients are fully compliant, the last virus particle could be eliminated within seven weeks, and the clearance of remaining infections in the hepatocytes by no more than 10 weeks. This time would be extended if doses were missed.
"Using a new viral kinetic model that allowed for an improved description of the changes in antiviral treatment effectiveness, the second phase of viral decay was found to be very rapid compared with second phases observed in patients treated with interferon alone, with no differences according to the treatment regimen," the authors write.
Telaprevir Increases Second-Phase Hepatitis C Decline
Predictive model indicates virus particles could be cleared in seven weeks assuming high compliance
Analysis of the kinetics of telaprevir treatment for hepatitis C virus shows a rapid second-phase viral decline, which may allow for shorter duration of treatment, according to a study published online March 7 in Hepatology.
FRIDAY, April 8 (HealthDay News) -- Analysis of the kinetics of telaprevir treatment for hepatitis C virus (HCV) shows a rapid second-phase viral decline, which may allow for shorter duration of treatment, according to a study published online March 7 in Hepatology.
Jeremie Guedj, Ph.D., and Alan S. Perelson, Ph.D., from the Los Alamos National Laboratory in New Mexico, examined second-phase HCV viral decline during treatment with telaprevir. Two aspects of telaprevir treatment were investigated: the effect of varying regimens of telaprevir monotherapy in 28 participants, and the comparison of telaprevir monotherapy in eight patients with telaprevir plus interferon therapy in eight patients. Using a new viral kinetic model, and assuming that drug resistance can be avoided, the treatment time needed to eliminate all virus and infected cells was estimated.
The investigators found that the second-phase viral decline was associated with the effectiveness of treatment, and was approximately four times more rapid with telaprevir than interferon-based therapies. In the predictive model, assuming 95 percent of the patients are fully compliant, the last virus particle could be eliminated within seven weeks, and the clearance of remaining infections in the hepatocytes by no more than 10 weeks. This time would be extended if doses were missed.
"Using a new viral kinetic model that allowed for an improved description of the changes in antiviral treatment effectiveness, the second phase of viral decay was found to be very rapid compared with second phases observed in patients treated with interferon alone, with no differences according to the treatment regimen," the authors write.
Tuesday, April 12, 2011
Medco database analysis says patients on antidepressants more likely to be adherent to HCV treatment...
Interesting study from the Medco folks, published in the American Journal of Managed Care and presented recently at the 2011 International Conference on Viral Hepatitis. Medco used de-personalized data from their drug claims database to look at 3,607 patients newly Rx'd Peg-interferon and ribavirin for treatment of HCV. They evaluated adherence using a ratio called the 'medication possession ratio' or MPR, which measures the percent of time that HCV patients had medication available for their use. Patients with a MPR that was equal or greater than 80% were considered adherent. The study found that among patients with HCV who were both on HCV therapy and using an antidepressant, 68.5 percent were adherent. Grant it, database studies - like any study - comes with it's own inherent biases and it's hard to gather what other extraneous variables might have had impact on adherence, such as support groups, family support system, physician or mid-level check-ins, etc. Still, pretty impactful and compelling data that makes sense - if you feel better, one can assume that you'd feel more compelled to take one's medication.
BALTIMORE, April 11, 2011 /PRNewswire/ -- Adherence to interferon, an important medication used to treat Hepatitis C, is critical to successfully clearing the virus that causes the disease. A new observational analysis by Medco Health Solutions, Inc. (NYSE: MHS) finds that when Hepatitis C patients are also being treated for depression -- a frequent side effect of interferon use -- they are more likely to remain on their interferon therapy. The analysis is being presented today at the International Conference on Viral Hepatitis 2011.
According to the study, approximately 40 percent of Hepatitis C patients on interferon and ribavirin -- an antiviral medication used in combination with interferon -- were not adherent to their medication regimen. This puts patients at risk for progression of their disease due to their inability to eliminate the virus. The research found that the patients also using an antidepressant had the highest rates of adherence to their Hepatitis C treatment. Among patients with Hepatitis C who were using an antidepressant, 68.5 percent were adherent to their interferon therapy. For patients being treated for both Hepatitis C and HIV, 77.3 percent taking antidepressants were properly complying with their interferon therapy. Overall, 46 percent of patients with Hepatitis C were on an antidepressant.
"A common side-effect of interferon is depression, but little research has been done looking at the impact of treating depression on a patient's adherence with their Hepatitis C medications," said Mary Cassler RPh, Director of Clinical Innovation in Medco's Advanced Clinical Science and Research Group, who conducted the analysis. "These findings point to the need to proactively screen patients on interferon for depression and make sure that those who show signs of depression receive the proper interventions."
The usual course of interferon therapy for patients with Hepatitis C lasts either 24 or 48 weeks depending on the genotype of the virus, which influences the duration of treatment. Patients who discontinue use of the medication before treatment is completed, or those who do not take their medication as prescribed, frequently need to be retreated. Patients who fail to completely eliminate the virus have a higher risk of developing liver cancer. According to a study published in the American Journal of Managed Care, therapy can cost more than $40,000 per patient.
"Depression, whether interferon-induced or a separate co-morbid condition, can sabotage efforts to effectively treat Hepatitis C," said Dr. David Muzina, National Practice Leader, Medco Neuroscience Therapeutic Resource Center®. "All health care professionals, including pharmacists, need to know how to detect depression and work together to support safe, effective and affordable treatments."
Details
The analysis reviewed de-identified prescription drug claims from Medco's database and identified 3,607 patients who were newly prescribed interferon and ribavirin to treat Hepatitis C. Among the Hepatitis C patients who were identified, only 1,657 were being treated for depression. For the 109 patients who were also co-infected with HIV, 66 were on an antidepressant.
Adherence was evaluated by using the medication possession ratio (MPR) which measures the percent of time that patients have medication available for their use. Patients whose MPR was 80 percent or greater were considered adherent.
Added Richard Faris, PhD, RPh, National Practice Leader of the Accredo Rare and Specialty Pharmacy Therapeutic Resource Center: "These findings are important because they help in identifying patients experiencing depression while being treated in the home, and enable intervention to drive better outcomes for the patient and reduced costs for the payer."
About Medco
Medco Health Solutions, Inc. (NYSE: MHS) is pioneering the world's most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter™ for approximately 65 million members.
With more than 20,000 employees worldwide dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2010 revenues of nearly $66 billion, Medco ranks 35th on the Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies.
For more information, go to http://www.medcohealth.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
SOURCE Medco Health Solutions, Inc.
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RELATED LINKS
http://www.medcohealth.com
BALTIMORE, April 11, 2011 /PRNewswire/ -- Adherence to interferon, an important medication used to treat Hepatitis C, is critical to successfully clearing the virus that causes the disease. A new observational analysis by Medco Health Solutions, Inc. (NYSE: MHS) finds that when Hepatitis C patients are also being treated for depression -- a frequent side effect of interferon use -- they are more likely to remain on their interferon therapy. The analysis is being presented today at the International Conference on Viral Hepatitis 2011.
According to the study, approximately 40 percent of Hepatitis C patients on interferon and ribavirin -- an antiviral medication used in combination with interferon -- were not adherent to their medication regimen. This puts patients at risk for progression of their disease due to their inability to eliminate the virus. The research found that the patients also using an antidepressant had the highest rates of adherence to their Hepatitis C treatment. Among patients with Hepatitis C who were using an antidepressant, 68.5 percent were adherent to their interferon therapy. For patients being treated for both Hepatitis C and HIV, 77.3 percent taking antidepressants were properly complying with their interferon therapy. Overall, 46 percent of patients with Hepatitis C were on an antidepressant.
"A common side-effect of interferon is depression, but little research has been done looking at the impact of treating depression on a patient's adherence with their Hepatitis C medications," said Mary Cassler RPh, Director of Clinical Innovation in Medco's Advanced Clinical Science and Research Group, who conducted the analysis. "These findings point to the need to proactively screen patients on interferon for depression and make sure that those who show signs of depression receive the proper interventions."
The usual course of interferon therapy for patients with Hepatitis C lasts either 24 or 48 weeks depending on the genotype of the virus, which influences the duration of treatment. Patients who discontinue use of the medication before treatment is completed, or those who do not take their medication as prescribed, frequently need to be retreated. Patients who fail to completely eliminate the virus have a higher risk of developing liver cancer. According to a study published in the American Journal of Managed Care, therapy can cost more than $40,000 per patient.
"Depression, whether interferon-induced or a separate co-morbid condition, can sabotage efforts to effectively treat Hepatitis C," said Dr. David Muzina, National Practice Leader, Medco Neuroscience Therapeutic Resource Center®. "All health care professionals, including pharmacists, need to know how to detect depression and work together to support safe, effective and affordable treatments."
Details
The analysis reviewed de-identified prescription drug claims from Medco's database and identified 3,607 patients who were newly prescribed interferon and ribavirin to treat Hepatitis C. Among the Hepatitis C patients who were identified, only 1,657 were being treated for depression. For the 109 patients who were also co-infected with HIV, 66 were on an antidepressant.
Adherence was evaluated by using the medication possession ratio (MPR) which measures the percent of time that patients have medication available for their use. Patients whose MPR was 80 percent or greater were considered adherent.
Added Richard Faris, PhD, RPh, National Practice Leader of the Accredo Rare and Specialty Pharmacy Therapeutic Resource Center: "These findings are important because they help in identifying patients experiencing depression while being treated in the home, and enable intervention to drive better outcomes for the patient and reduced costs for the payer."
About Medco
Medco Health Solutions, Inc. (NYSE: MHS) is pioneering the world's most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter™ for approximately 65 million members.
With more than 20,000 employees worldwide dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2010 revenues of nearly $66 billion, Medco ranks 35th on the Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies.
For more information, go to http://www.medcohealth.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
SOURCE Medco Health Solutions, Inc.
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RELATED LINKS
http://www.medcohealth.com
Medivir to buy BioPhausia to "create a platform" for the launch of TMC435....
Medivir to buy BioPhausia for 62 million euros
World News | April 12, 2011
Medivir is to acquire fellow Swedish firm BioPhausia in a deal that will "create a platform" for the launch of its promising hepatitis C treatment.
Under the terms of the deal, Medivir is offering a mixture of cash and new shares, thus valuing BioPhausia at around 565 million Swedish kroner (62 million euros) or 1.65 crowns per share. The offer represents a 44% premium over the average price of BioPhausia shares over the last 30 days and the latter's board has unanimously recommended the offer.
The Huddinge-headquartered group says that BioPhausia will provide it with "complementary competencies in regulatory affairs, logistics, distribution, marketing, sales and quality assurance", plus a local presence in Sweden, Denmark and Finland. It also brings quite healthy revenues; turnover in 2010 came in at 506 million kroner, compared to Medivir's 62 million kroner.
Seeking sustainable profits
Ron Long, Medivir's chief executive, said the acquisition brings the firm closer to "achieving its goal of becoming a sustainably profitable, research-based specialty pharmaceutical company". He added that the BioPhausia team will "significantly advance our commercial capabilities as we prepare to realize full value from TMC435".
The latter is a once-daily, protease inhibitor for hepatitis C, which is partnered with Johnson & Johnson affiliate Tibotec and has recently reported positive interim data in three Phase IIb studies. It has moved to Phase III and Medivir has retained full commercial rights to TMC435 in the Nordic region.
Links
www.medivir.se
www.biophausia.se
World News | April 12, 2011
Medivir is to acquire fellow Swedish firm BioPhausia in a deal that will "create a platform" for the launch of its promising hepatitis C treatment.
Under the terms of the deal, Medivir is offering a mixture of cash and new shares, thus valuing BioPhausia at around 565 million Swedish kroner (62 million euros) or 1.65 crowns per share. The offer represents a 44% premium over the average price of BioPhausia shares over the last 30 days and the latter's board has unanimously recommended the offer.
The Huddinge-headquartered group says that BioPhausia will provide it with "complementary competencies in regulatory affairs, logistics, distribution, marketing, sales and quality assurance", plus a local presence in Sweden, Denmark and Finland. It also brings quite healthy revenues; turnover in 2010 came in at 506 million kroner, compared to Medivir's 62 million kroner.
Seeking sustainable profits
Ron Long, Medivir's chief executive, said the acquisition brings the firm closer to "achieving its goal of becoming a sustainably profitable, research-based specialty pharmaceutical company". He added that the BioPhausia team will "significantly advance our commercial capabilities as we prepare to realize full value from TMC435".
The latter is a once-daily, protease inhibitor for hepatitis C, which is partnered with Johnson & Johnson affiliate Tibotec and has recently reported positive interim data in three Phase IIb studies. It has moved to Phase III and Medivir has retained full commercial rights to TMC435 in the Nordic region.
Links
www.medivir.se
www.biophausia.se
Saturday, April 9, 2011
Catch Viral Matters on the Twitters and the LinkedIns...
Like George Dubya, we love the Internets.
Viral Matters tweets on a semi-regular basis, always at least semi-responsibly... http://twitter.com/viralmatters
Viral Matters is also on the LinkedIns at http://www.linkedin.com/groups?mostPopular=&gid=3207213
Thanks!
Chris Barnes
Viral Matters tweets on a semi-regular basis, always at least semi-responsibly... http://twitter.com/viralmatters
Viral Matters is also on the LinkedIns at http://www.linkedin.com/groups?mostPopular=&gid=3207213
Thanks!
Chris Barnes
The Street's Adam Feuerstein takes a look at pharma stock picks post-EASL....
Nice scorecard from The Street's Adam Feuerstein on how the HCV drug development marketplace looks post-EASL. I think folks are a little to bullish on Pharmasset's all-oral combo. To the company's credit, no one has shown this sort of efficacy without the help of ribavirin and peg, but 14 days is long way from SVR. It will be interesting to see how this all sorts out.
Biotech Stock Mailbag: Hep C Stock Winners
Adam Feuerstein
04/08/11 - 07:00 AM EDT
BOSTON (TheStreet) -- Trying to make sense of the rapidly changing field of hepatitis C drug research kicks off this week's Biotech Stock Mailbag.
Evan R. emails, "It looks like Pharmasset(VRUS) was the big winner at the hepatitis C conference. What's your take on hepatitis C stocks now?"
I could easily devote this entire Mailbag to hepatitis C because so much of the data presented at the just-wrapped European Association for the Study of the Liver (EASL) meeting has the potential to radically improve the way hepatitis C is treated. It's never a great time to be a Hep C patient, obviously, but the prospect for better, faster and more well-tolerated cures coming relatively soon should be a real source of hope and optimism.
Investors have a tougher challenge trying to pick a winning stock or two (or three of four) from among the many that are racing to bring these new Hep C drugs to market.
Case in point: The buzz at this week's EASL meeting was about new, all-oral multi-drug combinations for Hep C treatment that won't likely be ready for approval or sale for four or five years. The Hep C treatment landscape is evolving quickly and investors are jumping so far ahead that the looming April/May advisory panels and approval decision dates for new drugs from Vertex Pharmaceuticals(VRTX) and Merck(MRK) seem like old news already.
It sounds incredibly weird to even conjure this thought, but from Wall Street's what-have-you-done-for-me-lately perspective, Vertex's telaprevir and Merck's boceprevir look a bit old in the tooth even before the two drugs are approved!
Pharmasset was the belle of the EASL ball after presenting early data (in a relatively small number of patients) demonstrating that two oral drugs -- PSI 7977 and PSI 938 -- could render the Hep C virus undetectable with no obvious signs of resistance or relapse. This still-experimental regimen is remarkable for the absence of interferon or ribavirin -- the former injected, the latter oral -- which make up the current standard of care for Hep C treatment.
A typical Hep C patient today is treated with interferon and ribavirin for one year, enduring side effects that include flu-like symptoms for a 40% to 50% chance of being cured.
By this spring or early summer, the addition of 12 weeks of treatment with Vertex's telaprevir to a shortened, six-month course of interferon and ribavirin will boost cure rates to 75% to 80%. Telaprevir+interferon+ribavirin will be the new standard of care for Hep C. [Merck's boceprevir plus standard of care should be in the mix, too.]
Look ahead a few more years. Pharmasset is dangling the prospect of an even simpler Hep C regimen: Two pills, taken once a day for six months providing odds of a cure as good as, perhaps even better, than what's achieved with the triple-drug telaprevir regimen.
As an encore of sorts, Pharmasset also wowed the EASL crowd with strong antiviral response data from studies combining PSI7977 with interferon and ribavirin. PSI7977 may be four or so years away from the market, but it's already looking like the next Hep C treatment standard bearer.
Little wonder Pharmasset shares continue to surge even after EASL ended. The stock closed Wednesday at $98.68 but was off 2% to $96 in mid-day trading Thursday. Still, remember Pharmasset shares were worth $50 one month ago.
Vertex emerged from EASL under more pressure to make the most of telaprevir commercially before competition arrives on the scene. Telaprevir is a major advance in Hep C treatment and the drug should pass easily through an April 28 FDA advisory panel and receive agency approval on or before May 23. As effective as the drug is for treatment-naive Hep C patients, the drug will have an even more beneficial effect for the hundreds of thousands of patients with Hep C virus that wasn't cured by the current standard of care.
Vertex's dilemma is that investors know this story well and have baked much of telaprevir's potential into the company's valuation already. What concerns investors today and perhaps even more post-EASL is that the slope of the expected telaprevir revenue tail may be steeper than previously appreciated. Investors are also raising questions about what Vertex is doing to sustain its Hep C franchise in 2015 and beyond when new drugs are expected to enter the market.
Looming largest in Vertex's rear-view mirror are Johnson & Johnson's(JNJ) TMC435 and perhaps Bristol-Myer Squibb's(BMY) BMS 052. [Worth noting, too, that Bristol-Myers and Pharmasset are already testing combinations of their respective Hep C drugs.]
Vertex is working on new combination therapies, too, but so far, the efforts haven't yielded much. A two-drug regimen of telaprevir plus VX-222 was shelved, leaving Vertex experimenting with a "quad" regimen of telaprevir, VX-222 plus standard of care.
VX-222 was highly touted as Vertex's next-generation Hep C drug candidate when it was picked up through the 2009 acquisition of privately held Virochem. Today, VX-222 isn't looking so hot, which means Vertex needs to license or buy something else if the company wants to stay in the Hep C game long term.
Roche is in desperate shape because Pegasys, the market-leading interferon, is going away. Roche bought InterMune's(ITMN) Hep C drug and licensed a first-generation drug from Pharmasset but neither of these compounds are working out as hoped.
Gilead Sciences(GILD) continues to make slow but steady progress. A late-starter to Hep C drug development, Gilead came out of EASL with progressively better data on multiple drug regimens although its programs are still early stage and lag the competition.
The smaller Hep C drug players -- Achillion Pharmaceuticals(ACHN), Inhibitex(INHX), Idenix Pharmaceuticals(IDIX) and Anadys(ANDS) -- emerge from EASL under more pressure to find partners or acquirers. Hep C is rapidly evolving into a market similar to HIV where winners have multiple drugs to play with and losers are the single-drug companies sitting alone on the sidelines. Roche, J&J, Merck and Vertex should all be motivated to make deals in the coming year.
Biotech Stock Mailbag: Hep C Stock Winners
Adam Feuerstein
04/08/11 - 07:00 AM EDT
BOSTON (TheStreet) -- Trying to make sense of the rapidly changing field of hepatitis C drug research kicks off this week's Biotech Stock Mailbag.
Evan R. emails, "It looks like Pharmasset(VRUS) was the big winner at the hepatitis C conference. What's your take on hepatitis C stocks now?"
I could easily devote this entire Mailbag to hepatitis C because so much of the data presented at the just-wrapped European Association for the Study of the Liver (EASL) meeting has the potential to radically improve the way hepatitis C is treated. It's never a great time to be a Hep C patient, obviously, but the prospect for better, faster and more well-tolerated cures coming relatively soon should be a real source of hope and optimism.
Investors have a tougher challenge trying to pick a winning stock or two (or three of four) from among the many that are racing to bring these new Hep C drugs to market.
Case in point: The buzz at this week's EASL meeting was about new, all-oral multi-drug combinations for Hep C treatment that won't likely be ready for approval or sale for four or five years. The Hep C treatment landscape is evolving quickly and investors are jumping so far ahead that the looming April/May advisory panels and approval decision dates for new drugs from Vertex Pharmaceuticals(VRTX) and Merck(MRK) seem like old news already.
It sounds incredibly weird to even conjure this thought, but from Wall Street's what-have-you-done-for-me-lately perspective, Vertex's telaprevir and Merck's boceprevir look a bit old in the tooth even before the two drugs are approved!
Pharmasset was the belle of the EASL ball after presenting early data (in a relatively small number of patients) demonstrating that two oral drugs -- PSI 7977 and PSI 938 -- could render the Hep C virus undetectable with no obvious signs of resistance or relapse. This still-experimental regimen is remarkable for the absence of interferon or ribavirin -- the former injected, the latter oral -- which make up the current standard of care for Hep C treatment.
A typical Hep C patient today is treated with interferon and ribavirin for one year, enduring side effects that include flu-like symptoms for a 40% to 50% chance of being cured.
By this spring or early summer, the addition of 12 weeks of treatment with Vertex's telaprevir to a shortened, six-month course of interferon and ribavirin will boost cure rates to 75% to 80%. Telaprevir+interferon+ribavirin will be the new standard of care for Hep C. [Merck's boceprevir plus standard of care should be in the mix, too.]
Look ahead a few more years. Pharmasset is dangling the prospect of an even simpler Hep C regimen: Two pills, taken once a day for six months providing odds of a cure as good as, perhaps even better, than what's achieved with the triple-drug telaprevir regimen.
As an encore of sorts, Pharmasset also wowed the EASL crowd with strong antiviral response data from studies combining PSI7977 with interferon and ribavirin. PSI7977 may be four or so years away from the market, but it's already looking like the next Hep C treatment standard bearer.
Little wonder Pharmasset shares continue to surge even after EASL ended. The stock closed Wednesday at $98.68 but was off 2% to $96 in mid-day trading Thursday. Still, remember Pharmasset shares were worth $50 one month ago.
Vertex emerged from EASL under more pressure to make the most of telaprevir commercially before competition arrives on the scene. Telaprevir is a major advance in Hep C treatment and the drug should pass easily through an April 28 FDA advisory panel and receive agency approval on or before May 23. As effective as the drug is for treatment-naive Hep C patients, the drug will have an even more beneficial effect for the hundreds of thousands of patients with Hep C virus that wasn't cured by the current standard of care.
Vertex's dilemma is that investors know this story well and have baked much of telaprevir's potential into the company's valuation already. What concerns investors today and perhaps even more post-EASL is that the slope of the expected telaprevir revenue tail may be steeper than previously appreciated. Investors are also raising questions about what Vertex is doing to sustain its Hep C franchise in 2015 and beyond when new drugs are expected to enter the market.
Looming largest in Vertex's rear-view mirror are Johnson & Johnson's(JNJ) TMC435 and perhaps Bristol-Myer Squibb's(BMY) BMS 052. [Worth noting, too, that Bristol-Myers and Pharmasset are already testing combinations of their respective Hep C drugs.]
Vertex is working on new combination therapies, too, but so far, the efforts haven't yielded much. A two-drug regimen of telaprevir plus VX-222 was shelved, leaving Vertex experimenting with a "quad" regimen of telaprevir, VX-222 plus standard of care.
VX-222 was highly touted as Vertex's next-generation Hep C drug candidate when it was picked up through the 2009 acquisition of privately held Virochem. Today, VX-222 isn't looking so hot, which means Vertex needs to license or buy something else if the company wants to stay in the Hep C game long term.
Roche is in desperate shape because Pegasys, the market-leading interferon, is going away. Roche bought InterMune's(ITMN) Hep C drug and licensed a first-generation drug from Pharmasset but neither of these compounds are working out as hoped.
Gilead Sciences(GILD) continues to make slow but steady progress. A late-starter to Hep C drug development, Gilead came out of EASL with progressively better data on multiple drug regimens although its programs are still early stage and lag the competition.
The smaller Hep C drug players -- Achillion Pharmaceuticals(ACHN), Inhibitex(INHX), Idenix Pharmaceuticals(IDIX) and Anadys(ANDS) -- emerge from EASL under more pressure to find partners or acquirers. Hep C is rapidly evolving into a market similar to HIV where winners have multiple drugs to play with and losers are the single-drug companies sitting alone on the sidelines. Roche, J&J, Merck and Vertex should all be motivated to make deals in the coming year.
Wednesday, April 6, 2011
Telaprevir, Boceprevir pricing in Europe....
Given the rather large sum of 22,000 euros or $31,271 to treat a patient with HCV in France (under the current expanded access conditions), some experts predict most European countries to restrict the drugs to patients who have failed previous therapy. With a short 2-3 year window of time, Both Vertex and Merck are anxious to recoup their costs and make a profit before the next generation of drugs hit the market. In an economic sense, this is as good a reason as any for commercial for-profit enterprises to charge a premium on their product, especially in an environment of limited competition. All this can lead one to speculate on how much the drugs will cost here in the States and, ultimately, who will have access.
Bloomberg. New hepatitis C drugs from Merck & Co. and Johnson & Johnson (JNJ) are being sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say may limit access after the medicines are approved throughout Europe.
J&J and Vertex Pharmaceuticals Inc. (VRTX)'s telaprevir costs 22,000 euros under a French program for seriously ill patients for whom there is no other effective treatment on the market, according to patient association SOS Hepatites. Merck & Co. said its boceprevir costs 30,000 euros under the same program.
The price may drop once the drugs are approved for the broader market, Merck and J&J executives said. Still, the French model shows the new drugs may triple the cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely to delay use or restrict which patients are allowed access, said Antonio Craxi, director of gastroenterology and internal medicine at the University of Palermo.
"It may be that we can't use it at all until the price comes down," Mark Thursz, professor of hepatology at Imperial College London, said in an interview at a conference in Berlin over the weekend. "It's not the best economic environment to launch an expensive new drug."
The U.K.'s National Institute for Health and Clinical Excellence may restrict the new drugs to patients who have tried existing treatments without success, Thursz said. The agency may also require genetic tests to determine whether patients are likely to respond to the medicines, he said at the meeting of the European Association for the Study of the Liver.
Italy and Spain also may delay or restrict use, Craxi said. Italy spends about 350 million euros a year on existing hepatitis C treatments, he said. "If you triple the cost, that would be more than 1 billion euros," he said.
Under Review
The new drugs are being reviewed by regulators at the European Medicines Agency. Both are scheduled for U.S. Food and Drug Administration hearings at the end of this month.
In France, telaprevir and boceprevir received special temporary authorization in December, under a program designed for seriously ill patients for whom there is no other effective treatment on the market, according to French pharmaceutical regulator AFSSAPS. This allowed the drugs to bypass the usual approval procedures, the regulator said.
About 500 patients are being treated in France now, said Michel Bonjour, spokesman for SOS Hepatites. The new drugs are prescribed together with the current standard therapy of interferon and generic ribavirin, and the total cost of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per patient, Bonjour said in an interview. The cost is covered in full by France's national health insurance program.
'Cost Effective'
"It's not a good indication of price elsewhere," Patrick Bergstedt, senior vice president for vaccines and infectious diseases at Whitehouse Station, New Jersey-based Merck, said in an interview.
The very sick patients in the French program get 44 weeks of treatment with boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he said. There's a "high likelihood" the eventual commercial price for a course of treatment will be less than the 30,000 euros Merck charges under the French program, he said.
"It's black and white that these drugs are cost- effective," Bergstedt said. "The challenge will be how do you stratify treatment, and how do you use these drugs responsibly to ensure the patients with the greatest need are treated first."
12-Week Treatment
Vertex, based in Cambridge, Massachusetts, referred questions to partner J&J, which will market telaprevir in Europe. J&J hasn't decided on a final price, said Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New Brunswick, New Jersey-based company's Tibotec Therapeutics unit.
Patients take telaprevir for 12 weeks together with standard treatment, then continue on the older standard drugs for a total of six months to a year of therapy.
Both new hepatitis C drugs are protease inhibitors crafted from the same technologies that led to discoveries in HIV research. Used in addition to existing therapies, they boost the chance of a cure from half of patients to between two-thirds and three-quarters of those treated, studies have shown.
In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates Howard Liang, a Boston-based analyst at Leerink Swann & Co.
"A cure saves a lot of money down the road," Liang said in an interview. "It's a shock to physicians, but I think it can be justified because it's a cure."
Next Generation
Hepatitis C, spread through contact with infected blood, is a virus that often lingers as a chronic condition, causing nausea and exhaustion as it destroys the liver over the course of years or decades. About 170 million people are infected, according to the World Health Organization.
Meanwhile, the next generation of drugs with even higher cure rates and fewer side effects is likely to reach the market within three years, Liang said.
Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH, Gilead Sciences Inc. (GILD) and Bristol- Myers Squibb Co. are among a dozen companies aiming for drug cocktails to replace the existing interferon combination.
Looming competition leaves Merck, Vertex and J&J without much time to recoup their investment, said Charles Gore, president of the Geneva-based patient advocacy group World Hepatitis Alliance.
"There is no easy answer to this," Gore said in an interview. "We've got to have a way to give people access but incentivize the drug companies to research in this area."
To contact the reporters on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net; Carol Matlack in Paris at cmatlack@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net;
Bloomberg. New hepatitis C drugs from Merck & Co. and Johnson & Johnson (JNJ) are being sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say may limit access after the medicines are approved throughout Europe.
J&J and Vertex Pharmaceuticals Inc. (VRTX)'s telaprevir costs 22,000 euros under a French program for seriously ill patients for whom there is no other effective treatment on the market, according to patient association SOS Hepatites. Merck & Co. said its boceprevir costs 30,000 euros under the same program.
The price may drop once the drugs are approved for the broader market, Merck and J&J executives said. Still, the French model shows the new drugs may triple the cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely to delay use or restrict which patients are allowed access, said Antonio Craxi, director of gastroenterology and internal medicine at the University of Palermo.
"It may be that we can't use it at all until the price comes down," Mark Thursz, professor of hepatology at Imperial College London, said in an interview at a conference in Berlin over the weekend. "It's not the best economic environment to launch an expensive new drug."
The U.K.'s National Institute for Health and Clinical Excellence may restrict the new drugs to patients who have tried existing treatments without success, Thursz said. The agency may also require genetic tests to determine whether patients are likely to respond to the medicines, he said at the meeting of the European Association for the Study of the Liver.
Italy and Spain also may delay or restrict use, Craxi said. Italy spends about 350 million euros a year on existing hepatitis C treatments, he said. "If you triple the cost, that would be more than 1 billion euros," he said.
Under Review
The new drugs are being reviewed by regulators at the European Medicines Agency. Both are scheduled for U.S. Food and Drug Administration hearings at the end of this month.
In France, telaprevir and boceprevir received special temporary authorization in December, under a program designed for seriously ill patients for whom there is no other effective treatment on the market, according to French pharmaceutical regulator AFSSAPS. This allowed the drugs to bypass the usual approval procedures, the regulator said.
About 500 patients are being treated in France now, said Michel Bonjour, spokesman for SOS Hepatites. The new drugs are prescribed together with the current standard therapy of interferon and generic ribavirin, and the total cost of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per patient, Bonjour said in an interview. The cost is covered in full by France's national health insurance program.
'Cost Effective'
"It's not a good indication of price elsewhere," Patrick Bergstedt, senior vice president for vaccines and infectious diseases at Whitehouse Station, New Jersey-based Merck, said in an interview.
The very sick patients in the French program get 44 weeks of treatment with boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he said. There's a "high likelihood" the eventual commercial price for a course of treatment will be less than the 30,000 euros Merck charges under the French program, he said.
"It's black and white that these drugs are cost- effective," Bergstedt said. "The challenge will be how do you stratify treatment, and how do you use these drugs responsibly to ensure the patients with the greatest need are treated first."
12-Week Treatment
Vertex, based in Cambridge, Massachusetts, referred questions to partner J&J, which will market telaprevir in Europe. J&J hasn't decided on a final price, said Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New Brunswick, New Jersey-based company's Tibotec Therapeutics unit.
Patients take telaprevir for 12 weeks together with standard treatment, then continue on the older standard drugs for a total of six months to a year of therapy.
Both new hepatitis C drugs are protease inhibitors crafted from the same technologies that led to discoveries in HIV research. Used in addition to existing therapies, they boost the chance of a cure from half of patients to between two-thirds and three-quarters of those treated, studies have shown.
In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates Howard Liang, a Boston-based analyst at Leerink Swann & Co.
"A cure saves a lot of money down the road," Liang said in an interview. "It's a shock to physicians, but I think it can be justified because it's a cure."
Next Generation
Hepatitis C, spread through contact with infected blood, is a virus that often lingers as a chronic condition, causing nausea and exhaustion as it destroys the liver over the course of years or decades. About 170 million people are infected, according to the World Health Organization.
Meanwhile, the next generation of drugs with even higher cure rates and fewer side effects is likely to reach the market within three years, Liang said.
Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH, Gilead Sciences Inc. (GILD) and Bristol- Myers Squibb Co. are among a dozen companies aiming for drug cocktails to replace the existing interferon combination.
Looming competition leaves Merck, Vertex and J&J without much time to recoup their investment, said Charles Gore, president of the Geneva-based patient advocacy group World Hepatitis Alliance.
"There is no easy answer to this," Gore said in an interview. "We've got to have a way to give people access but incentivize the drug companies to research in this area."
To contact the reporters on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net; Carol Matlack in Paris at cmatlack@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net;
Sunday, April 3, 2011
PEG-Interferon Lambda shows higher RVR, less side-effects than Pegasys...
BMS is becoming a Hepatitis C antiviral powerhouse, showing some impressive data on their interferon-free NS5A inhibitor BMS-790052 and protease NS3 inhibitor BMS-650032 combo. They also are developing PEG-Interferon Lambda as part of their recent acquisition of ZymoGenetics. PEG-lambda achieved statistically significant (p<0.05) higher rates of cEVR (primary study endpoint) versus PEG-Interferon alfa at all doses [lambda 240 µg: 56.3% (n=103), lambda 180 µg: 55.9% (n=102), lambda 120 µg: 55.0% (n=100) vs. alfa: 37.9% (n=103)]. The two highest doses (240 µg and 180 µg) of PEG-lambda also displayed greater rates of RVR: 16.5% and 14.7% respectively vs 5.8% for PEG-alfa. In addition, there were fewer flu-like, musculoskeletal symptoms and cytopenia, as well as fewer interferon and ribavirin dose reductions for anemia in the PEG-Interferon lambda arms up to 12 weeks. However, rates of serious adverse events, depression and other common adverse events (incidence ≥10%) were similar across treatment arms up to week 12, which is a bit surprising. From my standpoint, any interferon that is even incrementally more efficacious and tolerable than what we currently have AND causes fewer dose reductions of the all-important ribavirin, would be a welcome alternative. - Chris
Written by TradersHuddle Staff
Saturday, 02 April 2011 11:33
PRINCETON, N.J.-( Business Wire )-
Bristol-Myers Squibb Company (NYSE: BMY) today announced results from the Phase IIb EMERGE clinical trial, in which treatment with the investigational compound PEG-Interferon lambda and ribavirin achieved higher rates of rapid virologic response (RVR) in genotypes 1, 2, 3, and 4, and complete early virologic response (cEVR) in genotypes 1 and 4 than the standard regimen of PEG-Interferon alfa and ribavirin in treatment-naïve patients chronically infected with hepatitis C (HCV). In this study, there were fewer flu-like and musculoskeletal symptoms and cytopenia, as well as fewer interferon and ribavirin dose reductions for anemia in the PEG-Interferon lambda arms up to 12 weeks. Rates of serious adverse events, depression and other common adverse events (incidence ≥10%) were similar across treatment arms up to week 12.
The EMERGE study findings were presented in a late-breaker oral session at the International Liver Congress (ILC), the 46th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany.
“There is a significant unmet medical need for more therapies that can benefit more hepatitis C patients. This is especially true for patients with HCV genotypes 1 and 4, who generally have lower response rates to treatment with PEG-Interferon alfa and ribavirin than patients with other genotypes,” said Stefan Zeuzem, MD, chief of the department of medicine and professor of medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany. “The EMERGE study results demonstrate that PEG-Interferon lambda may have the potential to help address this unmet need, and support further studies of this new type of investigational interferon.”
PEG-Interferon lambda is the first investigational type III interferon. Interferon lambda mediates antiviral activity through a receptor that is distinct from that used by interferon alfa and is present on fewer cell types within the tissues of the body. This restricted distribution of the interferon lambda receptor offers the potential for more targeted delivery of interferon therapy.
Study Results
Viral Response: HCV Genotypes 1 and 4
In this study, HCV genotype 1 and 4 patients treated with PEG-Interferon lambda achieved statistically significant (p<0.05) higher rates of cEVR (primary study endpoint) versus PEG-Interferon alfa at all doses [lambda 240 µg: 56.3% (n=103), lambda 180 µg: 55.9% (n=102), lambda 120 µg: 55.0% (n=100) vs. alfa: 37.9% (n=103)]. These statistically significant (p<0.05) higher viral response rates were seen as early as four weeks of treatment, with greater rates of RVR at the two higher doses of PEG-Interferon lambda (lambda 240 µg: 16.5%, lambda 180 µg: 14.7%, lambda 120µg: 6.0% vs. alfa: 5.8%). Viral Response: HCV Genotypes 2 and 3 In patients with HCV genotypes 2 and 3, treatment with all doses of PEG-Interferon lambda achieved cEVR rates similar to PEG-Interferon alfa [lambda 240 µg: 83.3% (n=30), lambda 180 µg: 96.6% (n=29), lambda 120 µg: 90% (n=30), and alfa: 86.2%, (n=29)]. Statistically significant (p<0.05) higher rates of RVR were achieved at the two higher doses of PEG-Interferon lambda (lambda 240 µg: 66.7%, lambda 180 µg: 75.9%, lambda 120 µg: 43.3% vs. alfa: 31%). Safety In this study, rates of adverse events commonly associated with interferon treatment were lower with PEG-Interferon lambda than with PEG-Interferon alfa. These adverse events included flu-like symptoms (lambda 240 µg: 9.7%; lambda 180 µg: 9.9%; lambda 120 µg: 12.5%; alfa: 42.9%), musculoskeletal symptoms (lambda 240 µg: 14.2%; lambda 180 µg: 14.5%; lambda 120 µg: 18.0%; alfa: 46.6%), neutropenia < 750/mm³ (lambda 240 µg: 0.0%; lambda 180 µg: 0.8%; lambda 120 µg: 0.0%; alfa: 15.2%), anemia with hemoglobin < 10 g/dL (lambda 240 µg: 12.9%; lambda 180 µg: 15.4%; lambda 120 µg: 20.5%; alfa: 43.9%.) and thrombocytopenia < 50K/mm³ (lambda 240 µg: 0.0%; lambda 180 µg: 0.0%; lambda 120 µg: 0.0%; alfa: 14.4%). The proportion of patients that required interferon dose reductions were: lambda 240 µg: 12.7%; lambda 180 µg: 3.8%; lambda 120 µg: 0.8%; alfa: 18.8%, and the proportion of patients that withheld and/or reduced ribavirin were: lambda 240 µg: 11.2%; lambda 180 µg: 4.6%; lambda 120 µg: 10.2%; alfa: 20.3%. The proportion of patients who required ribavirin dose reductions for anemia were: lambda 240 µg: 0.7%; lambda 180 µg: 1.5%; lambda 120 µg: 2.3%; alfa: 12.8%. Rates of serious adverse events, depression and other common adverse events (≥10%) were similar across treatment arms. Higher rates of elevated liver enzymes [AST or ALT >5x the upper limit of normal (ULN)] were seen in the highest-dose PEG-Interferon lambda treatment arm compared with PEG-Interferon alfa (lambda 240 µg: 17.4%; lambda 180 µg: 2.3%; lambda 120 µg: 0.8%; alfa: 7.6%), and direct bilirubin was also elevated (>1.2 mg/dL) in the highest-dose PEG-Interferon lambda treatment arm compared with PEG-Interferon alfa (lambda 240 µg: 7.6%; lambda 180 µg: 3.9%; lambda 120 µg: 0.8%; alfa: 0.8%); all resolved spontaneously without sequelae or following interferon dose modification and/or discontinuation.
About the EMERGE Phase IIb Study
The EMERGE study is a two-part, randomized, controlled, multicenter, phase II study of PEG-Interferon lambda in 526 treatment-naïve patients with chronic hepatitis C genotype 1, 2, 3 or 4. Part one of EMERGE was a Phase IIa study, and results were previously presented at The American Association for the Study of Liver Diseases (AASLD) 2010 Liver Meeting. Part two of EMERGE is an ongoing, blinded Phase IIb study designed to evaluate the safety, efficacy, and pharmacokinetics of PEG-Interferon lambda vs. PEG-Interferon alfa, both in combination with ribavirin. The 526 patients were randomized into four dose groups: PEG-Interferon lambda 240 µg (n=134), PEG-Interferon lambda 180 µg (n=131), PEG-Interferon lambda 120 µg (n=128) and PEG-Interferon alfa 180 µg (n=133).
The study will continue for 48 weeks in genotype 1 and 4 patients and 24 weeks in genotype 2 and 3 patients. The primary endpoint of the study is the proportion of patients who achieve complete early virologic response (cEVR).
About PEG-Interferon lambda
PEG-Interferon lambda is the first investigational type III interferon in Phase IIb development for the treatment of hepatitis C. Native human interferon lambda proteins are generated by the immune system in response to viral infection, and signal through a different receptor than native human interferon alfa proteins. Lambda receptors are present on fewer cell types within the human body than alfa receptors. This restricted distribution of the interferon lambda receptor offers the potential for more targeted delivery of interferon therapy.
About Hepatitis C1
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with blood. An estimated 170 million people worldwide are infected with hepatitis C. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, 20 percent will progress to liver cancer. Although there is no vaccine to prevent hepatitis C, it is a curable disease.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will move from exploratory development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2010, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
______________________
* Rapid virologic response (RVR): undetectable viral load (HCV RNA <25 IU/mL) at week 4
† Complete early virologic response (cEVR): undetectable viral load at week 12
References
1 World Health Organization. Hepatitis C. Available at: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html. Accessed March 9, 2011.
Bristol-Myers Squibb CompanyMedia:Cristi Barnett, 609-252-6028cristi.barnett@bms.comorInvestors:John Elicker, 609-252-4611john.elicker@bms.com
Written by TradersHuddle Staff
Saturday, 02 April 2011 11:33
PRINCETON, N.J.-( Business Wire )-
Bristol-Myers Squibb Company (NYSE: BMY) today announced results from the Phase IIb EMERGE clinical trial, in which treatment with the investigational compound PEG-Interferon lambda and ribavirin achieved higher rates of rapid virologic response (RVR) in genotypes 1, 2, 3, and 4, and complete early virologic response (cEVR) in genotypes 1 and 4 than the standard regimen of PEG-Interferon alfa and ribavirin in treatment-naïve patients chronically infected with hepatitis C (HCV). In this study, there were fewer flu-like and musculoskeletal symptoms and cytopenia, as well as fewer interferon and ribavirin dose reductions for anemia in the PEG-Interferon lambda arms up to 12 weeks. Rates of serious adverse events, depression and other common adverse events (incidence ≥10%) were similar across treatment arms up to week 12.
The EMERGE study findings were presented in a late-breaker oral session at the International Liver Congress (ILC), the 46th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany.
“There is a significant unmet medical need for more therapies that can benefit more hepatitis C patients. This is especially true for patients with HCV genotypes 1 and 4, who generally have lower response rates to treatment with PEG-Interferon alfa and ribavirin than patients with other genotypes,” said Stefan Zeuzem, MD, chief of the department of medicine and professor of medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany. “The EMERGE study results demonstrate that PEG-Interferon lambda may have the potential to help address this unmet need, and support further studies of this new type of investigational interferon.”
PEG-Interferon lambda is the first investigational type III interferon. Interferon lambda mediates antiviral activity through a receptor that is distinct from that used by interferon alfa and is present on fewer cell types within the tissues of the body. This restricted distribution of the interferon lambda receptor offers the potential for more targeted delivery of interferon therapy.
Study Results
Viral Response: HCV Genotypes 1 and 4
In this study, HCV genotype 1 and 4 patients treated with PEG-Interferon lambda achieved statistically significant (p<0.05) higher rates of cEVR (primary study endpoint) versus PEG-Interferon alfa at all doses [lambda 240 µg: 56.3% (n=103), lambda 180 µg: 55.9% (n=102), lambda 120 µg: 55.0% (n=100) vs. alfa: 37.9% (n=103)]. These statistically significant (p<0.05) higher viral response rates were seen as early as four weeks of treatment, with greater rates of RVR at the two higher doses of PEG-Interferon lambda (lambda 240 µg: 16.5%, lambda 180 µg: 14.7%, lambda 120µg: 6.0% vs. alfa: 5.8%). Viral Response: HCV Genotypes 2 and 3 In patients with HCV genotypes 2 and 3, treatment with all doses of PEG-Interferon lambda achieved cEVR rates similar to PEG-Interferon alfa [lambda 240 µg: 83.3% (n=30), lambda 180 µg: 96.6% (n=29), lambda 120 µg: 90% (n=30), and alfa: 86.2%, (n=29)]. Statistically significant (p<0.05) higher rates of RVR were achieved at the two higher doses of PEG-Interferon lambda (lambda 240 µg: 66.7%, lambda 180 µg: 75.9%, lambda 120 µg: 43.3% vs. alfa: 31%). Safety In this study, rates of adverse events commonly associated with interferon treatment were lower with PEG-Interferon lambda than with PEG-Interferon alfa. These adverse events included flu-like symptoms (lambda 240 µg: 9.7%; lambda 180 µg: 9.9%; lambda 120 µg: 12.5%; alfa: 42.9%), musculoskeletal symptoms (lambda 240 µg: 14.2%; lambda 180 µg: 14.5%; lambda 120 µg: 18.0%; alfa: 46.6%), neutropenia < 750/mm³ (lambda 240 µg: 0.0%; lambda 180 µg: 0.8%; lambda 120 µg: 0.0%; alfa: 15.2%), anemia with hemoglobin < 10 g/dL (lambda 240 µg: 12.9%; lambda 180 µg: 15.4%; lambda 120 µg: 20.5%; alfa: 43.9%.) and thrombocytopenia < 50K/mm³ (lambda 240 µg: 0.0%; lambda 180 µg: 0.0%; lambda 120 µg: 0.0%; alfa: 14.4%). The proportion of patients that required interferon dose reductions were: lambda 240 µg: 12.7%; lambda 180 µg: 3.8%; lambda 120 µg: 0.8%; alfa: 18.8%, and the proportion of patients that withheld and/or reduced ribavirin were: lambda 240 µg: 11.2%; lambda 180 µg: 4.6%; lambda 120 µg: 10.2%; alfa: 20.3%. The proportion of patients who required ribavirin dose reductions for anemia were: lambda 240 µg: 0.7%; lambda 180 µg: 1.5%; lambda 120 µg: 2.3%; alfa: 12.8%. Rates of serious adverse events, depression and other common adverse events (≥10%) were similar across treatment arms. Higher rates of elevated liver enzymes [AST or ALT >5x the upper limit of normal (ULN)] were seen in the highest-dose PEG-Interferon lambda treatment arm compared with PEG-Interferon alfa (lambda 240 µg: 17.4%; lambda 180 µg: 2.3%; lambda 120 µg: 0.8%; alfa: 7.6%), and direct bilirubin was also elevated (>1.2 mg/dL) in the highest-dose PEG-Interferon lambda treatment arm compared with PEG-Interferon alfa (lambda 240 µg: 7.6%; lambda 180 µg: 3.9%; lambda 120 µg: 0.8%; alfa: 0.8%); all resolved spontaneously without sequelae or following interferon dose modification and/or discontinuation.
About the EMERGE Phase IIb Study
The EMERGE study is a two-part, randomized, controlled, multicenter, phase II study of PEG-Interferon lambda in 526 treatment-naïve patients with chronic hepatitis C genotype 1, 2, 3 or 4. Part one of EMERGE was a Phase IIa study, and results were previously presented at The American Association for the Study of Liver Diseases (AASLD) 2010 Liver Meeting. Part two of EMERGE is an ongoing, blinded Phase IIb study designed to evaluate the safety, efficacy, and pharmacokinetics of PEG-Interferon lambda vs. PEG-Interferon alfa, both in combination with ribavirin. The 526 patients were randomized into four dose groups: PEG-Interferon lambda 240 µg (n=134), PEG-Interferon lambda 180 µg (n=131), PEG-Interferon lambda 120 µg (n=128) and PEG-Interferon alfa 180 µg (n=133).
The study will continue for 48 weeks in genotype 1 and 4 patients and 24 weeks in genotype 2 and 3 patients. The primary endpoint of the study is the proportion of patients who achieve complete early virologic response (cEVR).
About PEG-Interferon lambda
PEG-Interferon lambda is the first investigational type III interferon in Phase IIb development for the treatment of hepatitis C. Native human interferon lambda proteins are generated by the immune system in response to viral infection, and signal through a different receptor than native human interferon alfa proteins. Lambda receptors are present on fewer cell types within the human body than alfa receptors. This restricted distribution of the interferon lambda receptor offers the potential for more targeted delivery of interferon therapy.
About Hepatitis C1
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with blood. An estimated 170 million people worldwide are infected with hepatitis C. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, 20 percent will progress to liver cancer. Although there is no vaccine to prevent hepatitis C, it is a curable disease.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will move from exploratory development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2010, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
______________________
* Rapid virologic response (RVR): undetectable viral load (HCV RNA <25 IU/mL) at week 4
† Complete early virologic response (cEVR): undetectable viral load at week 12
References
1 World Health Organization. Hepatitis C. Available at: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html. Accessed March 9, 2011.
Bristol-Myers Squibb CompanyMedia:Cristi Barnett, 609-252-6028cristi.barnett@bms.comorInvestors:John Elicker, 609-252-4611john.elicker@bms.com
Bristol Myers Squibb's BMS-790052 and BMS-650032 combo opens up new possibilites at EASL...
Wow. And I said it couldn't be done, that the possibilities were remote at best for an interferon-free DAA combination to cure HCV. Well, I'll gladly step up and dig in to my slice of Humble Pie, because this really is terrific news that quite possibly will open up a brand new treatment paradigm that sheds the side effect-laden burden of interferon, at least in some patients. BMS unleashed their Phase II data at EASL on the combination of their NS5A inhibitor BMS-790052 protease NS3 inhibitor BMS-650032 in patients that had been previously treated with the current standard of care therapy, peglyated-interferon plus ribavirin for 48 weeks. Out of the 11 patients who took took the drug combo without the inteferon component, five cleared virus at the end of treatment, and four of those remained undetectable 24 weeks after 24 weeks. In a similar patient population that received the drug combo plus peg and riba, 9 out 10 patients were cured. That's some potency right there. From a business perspective, it looks like the company is being extremely proactive in looking at partners to help fill the void between the pending launch of the first generation of DAA agents and BMS-790052 + BMS-650032. Pharmasset, which just announced positive two week data on their own interferon-free two drug combo PSI-938 and PSI-7977, might be looking mighty sexy to BMS at this point.
Bristol-Myers Squibb Co. (BMY)’s cocktail of two experimental drugs cured four hepatitis C patients in the first success for a therapy that excludes often-toxic existing drugs.
The combination had a higher rate of success when paired with the current standard treatment in the 21-person trial, curing nine of 10 patients, researchers said today at the Berlin meeting of the European Association for the Study of the Liver. The study points to the next generation of drugs for the evasive virus, said Mark Thursz, a professor of hepatology at Imperial College London and vice-secretary of EASL.
Bristol-Myers, based in New York, is among about a dozen companies trying to make better drug combinations that either include interferon, a decades-old shot that causes flu-like symptoms and only works in half of patients, or that replace interferon entirely. At stake is leadership in a market that Jefferies International Ltd. estimates may total $15 billion a year by 2019.
“This is perhaps one of the most exciting developments this year,” Thursz said in an interview. “For some patients who are not going to tolerate interferon, this is the light at the end of the tunnel.”
Bristol-Myers plans to begin the last trials required for regulatory approval this year, Douglas Manion, the drugmaker’s head of neuroscience and virology research, said in an interview.
Toughest-to-Treat
Today’s trial studied the Bristol-Myers drugs, BMS-790052 and BMS-650032, in patients for whom existing therapies hadn’t been successful, “the toughest-to-treat population,” Manion said.
Ten patients got the two drugs together with interferon and generic ribavirin. All showed no sign of the virus 12 weeks after the treatment was over. One patient had signs of virus at 24 weeks and was again virus-free in another follow-up test 35 days later.
Of 11 patients who took the Bristol-Myers combination alone, five had cleared the virus from their bodies at the end of treatment. Four remained virus-free after 24 weeks.
Patients may start treatment earlier if they aren’t faced with the toxic side effects of traditional hepatitis C drugs, said Howard Liang, a Boston-based analyst for Leerink Swann & Co., in an interview.
“If you have an interferon-free regimen, the market expands fairly dramatically,” Liang said.
Side Effects
Side effects of the existing interferon regimen are often severe enough to force patients to take time off work, said Charles Gore, president of the Geneva-based patient advocacy group World Hepatitis Alliance.
Roche Holding AG (ROG) of Basel, Switzerland, sells a version of interferon under the brand name Pegasys, while Merck & Co. of Whitehouse Station, New Jersey markets a form called PegIntron.
Merck, Vertex Pharmaceuticals Inc. (VRTX) and Johnson & Johnson are expected to bring the first new hepatitis C drugs in a decade to the market this year. About 90 percent of patients who responded quickly to treatment with Johnson & Johnson (JNJ) and Vertex’s telaprevir were cured, Cambridge, Massachusetts-based Vertex said in two studies last year. Three-quarters of all patients were cured. Patients who responded quickly to Merck’s boceprevir showed similarly high cure rates in studies last year, with about two-thirds of all patients being cured.
The Vertex and Merck trials included people who hadn’t yet been treated, an easier-to-cure group than those in today’s smaller study. By comparison, about 30 percent of those who hadn’t responded to previous treatment were cured after trying telaprevir plus standard therapy, researchers said.
Seeking Partners
Merck is seeking partnerships to gain its own hepatitis C drug combinations, Patrick Bergstedt, general manager of the infectious diseases franchise, said in an interview.
“We’re behind the others,” Bergstedt said. “We need to partner to fill the gap.”
Bristol-Myers expects an “element of consolidation” as companies use acquisitions, partnerships and research and development collaborations to gain their own hepatitis C drug combinations, Manion said. After signing a development deal with Princeton, New Jersey-based Pharmasset Inc. (VRUS) in January, Bristol- Myers is “talking to pretty much every company out there,” he said.
“This is like trying to redesign a car as you’re rolling down the road at 100 miles per hour, because the data are coming so fast,” he said. “What an exciting time.”
To contact the reporter on this story: Naomi Kresge in Frankfurt at nkresge@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Bristol-Myers Squibb Co. (BMY)’s cocktail of two experimental drugs cured four hepatitis C patients in the first success for a therapy that excludes often-toxic existing drugs.
The combination had a higher rate of success when paired with the current standard treatment in the 21-person trial, curing nine of 10 patients, researchers said today at the Berlin meeting of the European Association for the Study of the Liver. The study points to the next generation of drugs for the evasive virus, said Mark Thursz, a professor of hepatology at Imperial College London and vice-secretary of EASL.
Bristol-Myers, based in New York, is among about a dozen companies trying to make better drug combinations that either include interferon, a decades-old shot that causes flu-like symptoms and only works in half of patients, or that replace interferon entirely. At stake is leadership in a market that Jefferies International Ltd. estimates may total $15 billion a year by 2019.
“This is perhaps one of the most exciting developments this year,” Thursz said in an interview. “For some patients who are not going to tolerate interferon, this is the light at the end of the tunnel.”
Bristol-Myers plans to begin the last trials required for regulatory approval this year, Douglas Manion, the drugmaker’s head of neuroscience and virology research, said in an interview.
Toughest-to-Treat
Today’s trial studied the Bristol-Myers drugs, BMS-790052 and BMS-650032, in patients for whom existing therapies hadn’t been successful, “the toughest-to-treat population,” Manion said.
Ten patients got the two drugs together with interferon and generic ribavirin. All showed no sign of the virus 12 weeks after the treatment was over. One patient had signs of virus at 24 weeks and was again virus-free in another follow-up test 35 days later.
Of 11 patients who took the Bristol-Myers combination alone, five had cleared the virus from their bodies at the end of treatment. Four remained virus-free after 24 weeks.
Patients may start treatment earlier if they aren’t faced with the toxic side effects of traditional hepatitis C drugs, said Howard Liang, a Boston-based analyst for Leerink Swann & Co., in an interview.
“If you have an interferon-free regimen, the market expands fairly dramatically,” Liang said.
Side Effects
Side effects of the existing interferon regimen are often severe enough to force patients to take time off work, said Charles Gore, president of the Geneva-based patient advocacy group World Hepatitis Alliance.
Roche Holding AG (ROG) of Basel, Switzerland, sells a version of interferon under the brand name Pegasys, while Merck & Co. of Whitehouse Station, New Jersey markets a form called PegIntron.
Merck, Vertex Pharmaceuticals Inc. (VRTX) and Johnson & Johnson are expected to bring the first new hepatitis C drugs in a decade to the market this year. About 90 percent of patients who responded quickly to treatment with Johnson & Johnson (JNJ) and Vertex’s telaprevir were cured, Cambridge, Massachusetts-based Vertex said in two studies last year. Three-quarters of all patients were cured. Patients who responded quickly to Merck’s boceprevir showed similarly high cure rates in studies last year, with about two-thirds of all patients being cured.
The Vertex and Merck trials included people who hadn’t yet been treated, an easier-to-cure group than those in today’s smaller study. By comparison, about 30 percent of those who hadn’t responded to previous treatment were cured after trying telaprevir plus standard therapy, researchers said.
Seeking Partners
Merck is seeking partnerships to gain its own hepatitis C drug combinations, Patrick Bergstedt, general manager of the infectious diseases franchise, said in an interview.
“We’re behind the others,” Bergstedt said. “We need to partner to fill the gap.”
Bristol-Myers expects an “element of consolidation” as companies use acquisitions, partnerships and research and development collaborations to gain their own hepatitis C drug combinations, Manion said. After signing a development deal with Princeton, New Jersey-based Pharmasset Inc. (VRUS) in January, Bristol- Myers is “talking to pretty much every company out there,” he said.
“This is like trying to redesign a car as you’re rolling down the road at 100 miles per hour, because the data are coming so fast,” he said. “What an exciting time.”
To contact the reporter on this story: Naomi Kresge in Frankfurt at nkresge@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Friday, April 1, 2011
Medivr/Tibotec QD HCV PI TMC435 Interim 24 week data from Phase 2b ASPIRE trial presented at EASL...
This is by far the cockiest press release I've read thus far that's associated with EASL, and I've had an eyeful. But the Medivir/Tibotec partnership has good reason to be at least somewhat arrogant. If they can keep these numbers looking as good 6 months post-treatment, then TMC435 will be the next gen DAA poised to usurp what looks to be Telaprevir’s throne. TMC435 looks to have extraordinary efficacy and tolerability in combination with PEG and Ribavirin at 24 weeks, boasting as much as 93.3% week 24 HCV RNA < 25 IU/mL in prior NULL responders in the 48 weeks TMC435 + Peg + RBV for 48 weeks arm (yes, NULL responders!) . Take a look at the tables here: http://www.prnewswire.com/news-releases/medivir-week-24-interim-results-from-tmc435-hepatitis-c-phase-2b-aspire-study-presented-at-easl-119040924.html
HUDDINGE, Sweden, April 1, 2011 /PRNewswire-FirstCall/ --
- Results Show Potent Antiviral Efficacy of Once Daily 150 mg TMC435 in Hepatitis C Patients Who Have Failed Earlier Treatment, Especially in Prior Null Responders, and Excellent Safety and Tolerability
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces that their partner, Tibotec has presented the results of a planned Week 24 interim analysis of the phase 2b ASPIRE study for TMC435 in treatment experienced hepatitis C patients in a late-breaker session at the 46th Annual meeting of the European Association for the Study of the Liver (EASL), Berlin, Germany.
Treatment experienced patients are known to be the most difficult to treat hepatitis C patient group.
TMC435 is a potent, once-daily, oral hepatitis C virus protease inhibitor which recently entered clinical phase 3 studies. The study enrolled patients chronically infected with genotype-1 hepatitis C virus (HCV) that had previously failed treatment with standard of care therapy (peginterferon and ribavarin). TMC435 is being jointly developed by Medivir and its partner Tibotec.
In this Week 24 interim analysis, treatment-experienced patients who failed peginterferon and ribavarin treatment achieved significantly greater virologic response rates following treatment with TMC435-containing regimen at all doses, compared with placebo. Results demonstrated that the TMC435 150 mg dose group showed the highest response, particularly in prior null responders. In this 150 mg dose group, HCV RNA levels were undetectable at week 24 for between 82% and 91% of the patients. Results also showed that there was no statistically relevant difference in safety and tolerability between the TMC435 and placebo treated groups.
Ron Long, CEO of Medivir, commented: "We are delighted that these strong results are to be presented at such a prestigious scientific conference as EASL. TMC435 continues to demonstrate why Medivir are so confident that hepatitis C treatment can be significantly changed by a more convenient, once daily protease inhibitor especially for treatment experienced patients. These data and the recent start of phase 3 clinical studies for TMC435, represent an exciting stage in Medivir's development as a significant player in the infectious disease market."
The ASPIRE study evaluates the effect of TMC435 in combination with standard of care (SoC) in 462 patients infected with the difficult to treat genotype-1 hepatitis C virus who had undergone and failed prior treatment with (SoC). The study includes patients that have relapsed, achieved partial response, or achieved no response (null responders) to treatment with standard of care. TMC435 was administered once daily at a dose of either 100 mg or 150mg given for either 12, 24, or 48 weeks in combination with standard of care. Standard of care treatment was continued until the study completion at week 48.
As well as the late-breaker ASPIRE data presented, a further three presentations will be made at EASL on TMC435. These include:
Oral presentation: Impact of IL28b genotype and pretreatment serum IP-10 in treatment-naive genotype-1 HCV patients treated with TMC435 in combination with peginterferona-2a and ribavirin in PILLAR study, J. Aerssens, which found that during 24 weeks of treatment, IL28B genotype and serum IP-10 were predictive of response in patients receiving standard of care (peginterferon and ribavirin) but had limited predictive value in patients treated with both TMC435 and peginterferon and ribavirin, therefore suggesting that TMC435, a potent, once daily oral protease inhibitor, may overcome the negative consequences of unfavourable host genotype encountered with pegIFN/RBV.
Poster presentation No.472: Pharmacokinetics of TMC435 in subjects with moderate hepatic impairment, V. Sekar, which found that no TMC435 dose adjustment was necessary for patients with moderate liver impairment.
Poster presentation No.1221: Treatment outcome and resistance analysis in HCV genotype 1 patients previously exposed to TMC435 monotherapy and re-treated with TMC435 in combination with pegifna-2a/ribavirin, O. Lenz, which found that viral variants in patients who had received TMC435 as a monotherapy were no longer detected over time and successful treatment after prior exposure to TMC435 with emergence of resistance variants was possible in 3/5 patients who had failed interferon-based therapy.
About TMC435 in other clinical studies
TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections.
Three clinical phase 3 response guided studies were recently initiated:
- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients
- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients
- TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment
In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.
A phase 3 program for TMC435 has also recently been launched in Japan.
For additional information for these studies, please see http://www.clinicaltrials.gov
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is TMC435, a protease inhibitor which has recently entered phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals.
Medivir is also marketing its first product, the unique cold sore product Xerese(TM)/Xerclear(R) which has recently been launched on the US market. Xerese(TM)/Xerclear(R), which is also approved in Europe, is partnered with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia and with Meda AB in North America, Canada and Mexico. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: http://www.medivir.com.
For more information about Medivir, please contact:
Medivir (http://www.medivir.com):
Rein Piir, CFO & VP Investor Relations
Mobile: +46-708-537-292
Bertil Samuelsson, CFO Mobile: +46(70)576-13-50
M:Communications:
Mary-Jane Elliott / Amber Bielecka / Katja Toon
Medivir@mcomgroup.com
+44(0)20-7920 2330
USA: Roland Tomforde
+1-212-232-2356
Read the full press release with tables
HUDDINGE, Sweden, April 1, 2011 /PRNewswire-FirstCall/ --
- Results Show Potent Antiviral Efficacy of Once Daily 150 mg TMC435 in Hepatitis C Patients Who Have Failed Earlier Treatment, Especially in Prior Null Responders, and Excellent Safety and Tolerability
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces that their partner, Tibotec has presented the results of a planned Week 24 interim analysis of the phase 2b ASPIRE study for TMC435 in treatment experienced hepatitis C patients in a late-breaker session at the 46th Annual meeting of the European Association for the Study of the Liver (EASL), Berlin, Germany.
Treatment experienced patients are known to be the most difficult to treat hepatitis C patient group.
TMC435 is a potent, once-daily, oral hepatitis C virus protease inhibitor which recently entered clinical phase 3 studies. The study enrolled patients chronically infected with genotype-1 hepatitis C virus (HCV) that had previously failed treatment with standard of care therapy (peginterferon and ribavarin). TMC435 is being jointly developed by Medivir and its partner Tibotec.
In this Week 24 interim analysis, treatment-experienced patients who failed peginterferon and ribavarin treatment achieved significantly greater virologic response rates following treatment with TMC435-containing regimen at all doses, compared with placebo. Results demonstrated that the TMC435 150 mg dose group showed the highest response, particularly in prior null responders. In this 150 mg dose group, HCV RNA levels were undetectable at week 24 for between 82% and 91% of the patients. Results also showed that there was no statistically relevant difference in safety and tolerability between the TMC435 and placebo treated groups.
Ron Long, CEO of Medivir, commented: "We are delighted that these strong results are to be presented at such a prestigious scientific conference as EASL. TMC435 continues to demonstrate why Medivir are so confident that hepatitis C treatment can be significantly changed by a more convenient, once daily protease inhibitor especially for treatment experienced patients. These data and the recent start of phase 3 clinical studies for TMC435, represent an exciting stage in Medivir's development as a significant player in the infectious disease market."
The ASPIRE study evaluates the effect of TMC435 in combination with standard of care (SoC) in 462 patients infected with the difficult to treat genotype-1 hepatitis C virus who had undergone and failed prior treatment with (SoC). The study includes patients that have relapsed, achieved partial response, or achieved no response (null responders) to treatment with standard of care. TMC435 was administered once daily at a dose of either 100 mg or 150mg given for either 12, 24, or 48 weeks in combination with standard of care. Standard of care treatment was continued until the study completion at week 48.
As well as the late-breaker ASPIRE data presented, a further three presentations will be made at EASL on TMC435. These include:
Oral presentation: Impact of IL28b genotype and pretreatment serum IP-10 in treatment-naive genotype-1 HCV patients treated with TMC435 in combination with peginterferona-2a and ribavirin in PILLAR study, J. Aerssens, which found that during 24 weeks of treatment, IL28B genotype and serum IP-10 were predictive of response in patients receiving standard of care (peginterferon and ribavirin) but had limited predictive value in patients treated with both TMC435 and peginterferon and ribavirin, therefore suggesting that TMC435, a potent, once daily oral protease inhibitor, may overcome the negative consequences of unfavourable host genotype encountered with pegIFN/RBV.
Poster presentation No.472: Pharmacokinetics of TMC435 in subjects with moderate hepatic impairment, V. Sekar, which found that no TMC435 dose adjustment was necessary for patients with moderate liver impairment.
Poster presentation No.1221: Treatment outcome and resistance analysis in HCV genotype 1 patients previously exposed to TMC435 monotherapy and re-treated with TMC435 in combination with pegifna-2a/ribavirin, O. Lenz, which found that viral variants in patients who had received TMC435 as a monotherapy were no longer detected over time and successful treatment after prior exposure to TMC435 with emergence of resistance variants was possible in 3/5 patients who had failed interferon-based therapy.
About TMC435 in other clinical studies
TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections.
Three clinical phase 3 response guided studies were recently initiated:
- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients
- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients
- TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment
In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.
A phase 3 program for TMC435 has also recently been launched in Japan.
For additional information for these studies, please see http://www.clinicaltrials.gov
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is TMC435, a protease inhibitor which has recently entered phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals.
Medivir is also marketing its first product, the unique cold sore product Xerese(TM)/Xerclear(R) which has recently been launched on the US market. Xerese(TM)/Xerclear(R), which is also approved in Europe, is partnered with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia and with Meda AB in North America, Canada and Mexico. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: http://www.medivir.com.
For more information about Medivir, please contact:
Medivir (http://www.medivir.com):
Rein Piir, CFO & VP Investor Relations
Mobile: +46-708-537-292
Bertil Samuelsson, CFO Mobile: +46(70)576-13-50
M:Communications:
Mary-Jane Elliott / Amber Bielecka / Katja Toon
Medivir@mcomgroup.com
+44(0)20-7920 2330
USA: Roland Tomforde
+1-212-232-2356
Read the full press release with tables
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