(Wall Street reacts to better-than-expected sales of Telaprevir, which only begs the question... how'd Merck do with Victrelis? Merck, being infinitely more diversified, has less to lose than Vertex but in the competitive world of zero sum games, I can't help but be curious.)
Vertex Smashes Wall Street Sales Expectations In Hepatitis C Drug Debut
Luke Timmerman 7/28/11
Vertex Pharmaceuticals is off to a running start in the marketplace with its brand new hepatitis C drug.
The Cambridge, MA-based company (NASDAQ: VRTX) said today that it generated $74.5 million in sales of telaprevir (Incivek) in the quarter that ended June 30. That’s an especially big number as far as new pharmaceutical rollouts go—Wall Street analysts were only expecting about $31 million, according to TheStreet.com. It also should be noted that Vertex’s performance came in just six weeks of work, since the drug was first cleared for sale by the FDA on May 23.
Vertex’s sales number is the most important figure in today’s earnings report, since this product has been hotly anticipated for years. The product has shown in clinical trials that when it is added to a couple standard treatments, it can double the cure rate to about 80 percent of patients, while cutting the course of treatment in half, to about six months. Vertex’s drug, along with a competitor from Merck, has created new demand for treatment among the estimated 3 million Americans with hepatitis C infections.
Many are lining up to get treatment for the first time for this chronic liver damaging disease, since the cure rate is so much higher, and the Vertex drug enables patients to shorten the time they must endure the flu-like side effects of the standard drugs.
Shares of Vertex climbed $1.52, or about 3 percent, to $49.50 in after-hours trading following the earnings report. Vertex will host a conference call and webcast today at 5 pm ET/2 pm PT to discuss the second quarter, and take analysts’ questions.
Thursday, July 28, 2011
Tuesday, July 26, 2011
Interim Data from Phase 2 Study of Combination Regimen Including VX-222 and INCIVEK™ Suggest Potential to Treat Genotype 1 Hepatitis C in as few as 12 Weeks and No More Than 24 Weeks
(Interim analysis of this 30 patient Phase II trial today designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with Vertex's polymerase inhibitor VX-222 (400 mg or 100 mg), and Telaprevir plus Peg/ Riba in genotype1 treatment naive subjects. Results showed that 50 percent of people (15/30) in the study who received VX-222 (400 mg) in combination with INCIVEK, pegylated-interferon and ribavirin were eligible to stop all treatment at week 12, and 93 percent (14/15) had SVR12. Patients from the VX-222 (400 mg) treatment arm who were not eligible to stop all treatment at week 12 received an additional 12 weeks of pegylated-interferon and ribavirin alone for 24 total weeks of treatment. The hepatitis C virus was undetectable in 100 percent (13/13) of these patients at the end of 24 weeks. In this study, VX-222, Telaprevir and ribavirin were given twice daily (BID). Interim safety results from the four-drug treatment arms showed that mild gastrointestinal symptoms and mild fatigue were the most frequently reported adverse events. Side effects consistent with the known safety profile of INCIVEK combination treatment also were observed. Leaves one to wonder what sort of results we'd see with Telaprevir in combination with the recently purchased nucleoside analogs from Aliso Pharmaceuticals)
BusinessWire · Jul. 26, 2011 | Last Updated: Jul. 26, 2011 7:30 AM ET
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222 (400 mg or 100 mg), its lead polymerase inhibitor in development, in combination with INCIVEK™ (telaprevir) tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. This is an interim analysis from patients in the four-drug treatment arms and was conducted after these patients completed their assigned treatment. Results showed that 50 percent of people (15/30) in the study who received VX-222 (400 mg) in combination with INCIVEK, pegylated-interferon and ribavirin were eligible to stop all treatment at week 12, and 93 percent (14/15) of these patients had undetectable hepatitis C virus 12 weeks after treatment ended (sustained viral response 12, or SVR12). Patients from the VX-222 (400 mg) treatment arm who were not eligible to stop all treatment at week 12 received an additional 12 weeks of pegylated-interferon and ribavirin alone for 24 total weeks of treatment. The hepatitis C virus was undetectable in 100 percent (13/13) of these patients at the end of 24 weeks. In this study, VX-222, INCIVEK and ribavirin were given twice daily (BID). Interim safety results from the four-drug treatment arms showed that mild gastrointestinal symptoms and mild fatigue were the most frequently reported adverse events. Side effects consistent with the known safety profile of INCIVEK combination treatment also were observed.
“The results from this study are the first to show the potential for a combination of multiple direct-acting antiviral medicines to help people with hepatitis C clear the virus with as few as 12 and no more than 24 weeks of treatment,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. “We look forward to additional data from this study, including data from the ongoing all-oral treatment arms, which will guide our future development plans with the goal of further improving treatment.”
ZENITH is an ongoing Phase 2 study that initially enrolled 106 people with genotype 1 chronic hepatitis C and began with four treatment arms designed to evaluate multiple response-guided treatment regimens with VX-222, Vertex’s lead polymerase inhibitor in development, in combination with INCIVEK, Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin), three medicines approved to treat hepatitis C. In this study, VX-222, INCIVEK and ribavirin were given twice daily. The primary endpoint of the study is safety and tolerability. The secondary endpoint is on-treatment antiviral activity and the proportion of people in each treatment arm who achieve a sustained viral response. Additional results from this study will be submitted for presentation at an upcoming medical meeting.
Arms A (n=18) and B (n=29) were designed to evaluate all-oral, two-drug combination regimens of VX-222 (400 mg or 100 mg) and INCIVEK (1,125 mg). Data presented in March at The International Liver Congress™ 2011, the 46th annual meeting of the European Association for the Study of the Liver (EASL), in Berlin, Germany, showed significant initial antiviral activity in people who were treated with VX-222 (400 mg) and INCIVEK. However, these treatment arms were discontinued due to a pre-defined stopping rule related to viral breakthrough. Arms C (n=29) and D (n=30) are ongoing and are designed to evaluate four-drug combination regimens of VX-222 (400 mg or 100 mg), INCIVEK (1,125 mg), pegylated-interferon and ribavirin.
Data announced today are from the four-drug treatment arms (Arms C and D). In these two arms, patients were assigned to take all four medicines for the first 12 weeks of treatment. People who had undetectable hepatitis C virus levels in the blood (HCV RNA) at weeks two and eight of treatment were eligible to stop all treatment at week 12. In this study, the amount of hepatitis C virus in the blood was measured by the Roche COBAS® Taqman HCV test (<10 IU/mL undetectable). People who did not meet these criteria were assigned to receive 24 total weeks of treatment: 12 weeks of the four-drug combination regimen followed by 12 weeks of pegylated-interferon and ribavirin alone. This interim analysis includes SVR12 results for the people who were eligible for and completed 12 total weeks of treatment and end-of-treatment results for the people who were assigned to and completed 24 total weeks of treatment.
ZENITH: Interim Analysis
SVR12 in people who
were eligible for and
completed 12 total
weeks of treatment
Undetectable hepatitis C
virus in people who were
assigned to and
completed 24 weeks of
treatment
Undetectable
hepatitis C virus at
week 24 for all
patients (intent-to-
treat analysis)
VX-222 (400 mg), INCIVEK,
pegylated-interferon and ribavirin*
(n=30)
93%
(14/15)+
100%
(13/13)
90%
(27/30)
VX-222 (100 mg), INCIVEK,
pegylated-interferon and ribavirin**
(n=29)
82%
(9/11) ++
93%
(13/14)^
83%
(24/29)
SVR12: undetectable hepatitis C virus 12 weeks after treatment ended.
*50 percent (15/30) had undetectable hepatitis C virus at weeks 2 and 8 and were eligible to stop all treatment at week 12. Two people in the VX-222 (400 mg) treatment arm discontinued treatment before week 12 and did not achieve SVR12.
**38 percent (11/29) had undetectable hepatitis C virus at weeks 2 and 8 and were eligible to stop all treatment at week 12. Four people in the VX-222 (100 mg) treatment arm discontinued treatment before week 12 and two of them achieved SVR12.
+One person in the 12-week VX-222 (400 mg) treatment arm relapsed.
++Two people in the 12-week VX-222 (100 mg) treatment arm relapsed.
^24-week end-of-treatment data are not available for one patient.
Two additional treatment arms (E and F) were added to the study to evaluate a three-drug, all-oral, interferon-free regimen of VX-222 (400 mg), INCIVEK and ribavirin. Enrollment in these treatment arms is expected to be complete by the end of the third quarter of 2011. Arm E will evaluate people with genotype 1b chronic hepatitis C and Arm F will evaluate people with genotype 1a chronic hepatitis C. Vertex expects to report data from the all-oral treatment arms in the first half of 2012.
Interim Safety and Tolerability Results from the Four-drug Treatment Arms
The most frequent adverse events observed in the four-drug treatment arms were fatigue, nausea, diarrhea, anemia, pruritis (itchiness) and rash. The majority of events were mild or moderate. Mild diarrhea occurred more frequently in the VX-222 (400 mg) treatment arm. The majority of people in the study did not use medication to control diarrhea. There were no treatment discontinuations due to diarrhea. Six patients discontinued treatment due to adverse events; three each from the 400 mg and 100 mg treatment arms. Two people from each arm discontinued treatment before week 12 and one person in each arm discontinued treatment between weeks 12 and 24 while they were receiving pegylated-interferon and ribavirin alone.
About INCIVEK and VX-222
INCIVEK (in-SEE-veck) is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. In May 2011, INCIVEK was approved by the U.S. Food and Drug Administration (FDA) for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK is approved for people who are new to treatment, and for people who were treated previously but who did not achieve a SVR, or viral cure (relapsers, partial responders and null responders).
VX-222 is an oral medicine in development that is a non-nucleoside inhibitor of the HCV NS5B polymerase. VX-222 is currently being evaluated in combination with INCIVEK, pegylated-interferon and ribavirin in a Phase 2 study. Vertex has worldwide commercial rights for VX-222.
Vertex developed telaprevir in collaboration with Tibotec Vicro-Virology BVBA, one of the Janssen Pharmaceutical companies of Johnson & Johnson, and Mitsubishi Tanabe Pharma. Vertex is commercializing telaprevir in North America, where it is known as INCIVEK. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In July 2011, Janssen announced that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for INCIVO (telaprevir). Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
INCIVEK™ is a trademark of Vertex Pharmaceuticals Incorporated.
PEGASYS®, COPEGUS® and Roche COBAS® Taqman HCV test are registered trademarks of Hoffmann-La Roche.
Indication
INCIVEKTM (telaprevir) tablets is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.
It is not known if INCIVEK is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Tell your healthcare provider about any side effect that bothers you or doesn’t go away.
Please see full Prescribing Information for INCIVEK, including the Medication Guide, available at www.INCIVEK.com.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Chronic hepatitis C is the leading cause of liver cancer and liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually. 11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding (i) the potential for a combination of multiple direct-acting antiviral medicines to treat genotype 1 hepatitis C in as few as 12 weeks and no more than 24 weeks; (ii) additional results from the study being submitted for presentation at an upcoming medical meeting; (iii) additional data from this study, including data from the ongoing all-oral treatment arms, guiding our future development plans with the goal of further improving treatment; (iv) the design of Arm E and Arm F of the study and the expectation that enrollment in these arms will be completed by the end of the third quarter of 2011; and (v) the expectation that Vertex will report data from the all-oral treatment arms in the first half of 2012. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the interim data presented in this press release may not be predictive of the final outcomes from this clinical trial; the outcomes from additional arms in this clinical trial and/or from any future clinical trials of telaprevir/VX-222 may not be favorable; future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir/VX-222-based therapy and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex's website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
(VRTX - GEN)
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed March 21, 2011.
2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed March 21, 2011.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
12 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
Contacts
Vertex Pharmaceuticals Incorporated
Media:
Dawn Kalmar, 617-444-6992
or
Amy Pasqua, 617-444-6992
or
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
or
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Matthew Osborne, 617-444-6057
or
Patient Inquiries: 1-855-837-3894
BusinessWire · Jul. 26, 2011 | Last Updated: Jul. 26, 2011 7:30 AM ET
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222 (400 mg or 100 mg), its lead polymerase inhibitor in development, in combination with INCIVEK™ (telaprevir) tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. This is an interim analysis from patients in the four-drug treatment arms and was conducted after these patients completed their assigned treatment. Results showed that 50 percent of people (15/30) in the study who received VX-222 (400 mg) in combination with INCIVEK, pegylated-interferon and ribavirin were eligible to stop all treatment at week 12, and 93 percent (14/15) of these patients had undetectable hepatitis C virus 12 weeks after treatment ended (sustained viral response 12, or SVR12). Patients from the VX-222 (400 mg) treatment arm who were not eligible to stop all treatment at week 12 received an additional 12 weeks of pegylated-interferon and ribavirin alone for 24 total weeks of treatment. The hepatitis C virus was undetectable in 100 percent (13/13) of these patients at the end of 24 weeks. In this study, VX-222, INCIVEK and ribavirin were given twice daily (BID). Interim safety results from the four-drug treatment arms showed that mild gastrointestinal symptoms and mild fatigue were the most frequently reported adverse events. Side effects consistent with the known safety profile of INCIVEK combination treatment also were observed.
“The results from this study are the first to show the potential for a combination of multiple direct-acting antiviral medicines to help people with hepatitis C clear the virus with as few as 12 and no more than 24 weeks of treatment,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. “We look forward to additional data from this study, including data from the ongoing all-oral treatment arms, which will guide our future development plans with the goal of further improving treatment.”
ZENITH is an ongoing Phase 2 study that initially enrolled 106 people with genotype 1 chronic hepatitis C and began with four treatment arms designed to evaluate multiple response-guided treatment regimens with VX-222, Vertex’s lead polymerase inhibitor in development, in combination with INCIVEK, Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin), three medicines approved to treat hepatitis C. In this study, VX-222, INCIVEK and ribavirin were given twice daily. The primary endpoint of the study is safety and tolerability. The secondary endpoint is on-treatment antiviral activity and the proportion of people in each treatment arm who achieve a sustained viral response. Additional results from this study will be submitted for presentation at an upcoming medical meeting.
Arms A (n=18) and B (n=29) were designed to evaluate all-oral, two-drug combination regimens of VX-222 (400 mg or 100 mg) and INCIVEK (1,125 mg). Data presented in March at The International Liver Congress™ 2011, the 46th annual meeting of the European Association for the Study of the Liver (EASL), in Berlin, Germany, showed significant initial antiviral activity in people who were treated with VX-222 (400 mg) and INCIVEK. However, these treatment arms were discontinued due to a pre-defined stopping rule related to viral breakthrough. Arms C (n=29) and D (n=30) are ongoing and are designed to evaluate four-drug combination regimens of VX-222 (400 mg or 100 mg), INCIVEK (1,125 mg), pegylated-interferon and ribavirin.
Data announced today are from the four-drug treatment arms (Arms C and D). In these two arms, patients were assigned to take all four medicines for the first 12 weeks of treatment. People who had undetectable hepatitis C virus levels in the blood (HCV RNA) at weeks two and eight of treatment were eligible to stop all treatment at week 12. In this study, the amount of hepatitis C virus in the blood was measured by the Roche COBAS® Taqman HCV test (<10 IU/mL undetectable). People who did not meet these criteria were assigned to receive 24 total weeks of treatment: 12 weeks of the four-drug combination regimen followed by 12 weeks of pegylated-interferon and ribavirin alone. This interim analysis includes SVR12 results for the people who were eligible for and completed 12 total weeks of treatment and end-of-treatment results for the people who were assigned to and completed 24 total weeks of treatment.
ZENITH: Interim Analysis
SVR12 in people who
were eligible for and
completed 12 total
weeks of treatment
Undetectable hepatitis C
virus in people who were
assigned to and
completed 24 weeks of
treatment
Undetectable
hepatitis C virus at
week 24 for all
patients (intent-to-
treat analysis)
VX-222 (400 mg), INCIVEK,
pegylated-interferon and ribavirin*
(n=30)
93%
(14/15)+
100%
(13/13)
90%
(27/30)
VX-222 (100 mg), INCIVEK,
pegylated-interferon and ribavirin**
(n=29)
82%
(9/11) ++
93%
(13/14)^
83%
(24/29)
SVR12: undetectable hepatitis C virus 12 weeks after treatment ended.
*50 percent (15/30) had undetectable hepatitis C virus at weeks 2 and 8 and were eligible to stop all treatment at week 12. Two people in the VX-222 (400 mg) treatment arm discontinued treatment before week 12 and did not achieve SVR12.
**38 percent (11/29) had undetectable hepatitis C virus at weeks 2 and 8 and were eligible to stop all treatment at week 12. Four people in the VX-222 (100 mg) treatment arm discontinued treatment before week 12 and two of them achieved SVR12.
+One person in the 12-week VX-222 (400 mg) treatment arm relapsed.
++Two people in the 12-week VX-222 (100 mg) treatment arm relapsed.
^24-week end-of-treatment data are not available for one patient.
Two additional treatment arms (E and F) were added to the study to evaluate a three-drug, all-oral, interferon-free regimen of VX-222 (400 mg), INCIVEK and ribavirin. Enrollment in these treatment arms is expected to be complete by the end of the third quarter of 2011. Arm E will evaluate people with genotype 1b chronic hepatitis C and Arm F will evaluate people with genotype 1a chronic hepatitis C. Vertex expects to report data from the all-oral treatment arms in the first half of 2012.
Interim Safety and Tolerability Results from the Four-drug Treatment Arms
The most frequent adverse events observed in the four-drug treatment arms were fatigue, nausea, diarrhea, anemia, pruritis (itchiness) and rash. The majority of events were mild or moderate. Mild diarrhea occurred more frequently in the VX-222 (400 mg) treatment arm. The majority of people in the study did not use medication to control diarrhea. There were no treatment discontinuations due to diarrhea. Six patients discontinued treatment due to adverse events; three each from the 400 mg and 100 mg treatment arms. Two people from each arm discontinued treatment before week 12 and one person in each arm discontinued treatment between weeks 12 and 24 while they were receiving pegylated-interferon and ribavirin alone.
About INCIVEK and VX-222
INCIVEK (in-SEE-veck) is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. In May 2011, INCIVEK was approved by the U.S. Food and Drug Administration (FDA) for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK is approved for people who are new to treatment, and for people who were treated previously but who did not achieve a SVR, or viral cure (relapsers, partial responders and null responders).
VX-222 is an oral medicine in development that is a non-nucleoside inhibitor of the HCV NS5B polymerase. VX-222 is currently being evaluated in combination with INCIVEK, pegylated-interferon and ribavirin in a Phase 2 study. Vertex has worldwide commercial rights for VX-222.
Vertex developed telaprevir in collaboration with Tibotec Vicro-Virology BVBA, one of the Janssen Pharmaceutical companies of Johnson & Johnson, and Mitsubishi Tanabe Pharma. Vertex is commercializing telaprevir in North America, where it is known as INCIVEK. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In July 2011, Janssen announced that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for INCIVO (telaprevir). Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
INCIVEK™ is a trademark of Vertex Pharmaceuticals Incorporated.
PEGASYS®, COPEGUS® and Roche COBAS® Taqman HCV test are registered trademarks of Hoffmann-La Roche.
Indication
INCIVEKTM (telaprevir) tablets is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.
It is not known if INCIVEK is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Tell your healthcare provider about any side effect that bothers you or doesn’t go away.
Please see full Prescribing Information for INCIVEK, including the Medication Guide, available at www.INCIVEK.com.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Chronic hepatitis C is the leading cause of liver cancer and liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually. 11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding (i) the potential for a combination of multiple direct-acting antiviral medicines to treat genotype 1 hepatitis C in as few as 12 weeks and no more than 24 weeks; (ii) additional results from the study being submitted for presentation at an upcoming medical meeting; (iii) additional data from this study, including data from the ongoing all-oral treatment arms, guiding our future development plans with the goal of further improving treatment; (iv) the design of Arm E and Arm F of the study and the expectation that enrollment in these arms will be completed by the end of the third quarter of 2011; and (v) the expectation that Vertex will report data from the all-oral treatment arms in the first half of 2012. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the interim data presented in this press release may not be predictive of the final outcomes from this clinical trial; the outcomes from additional arms in this clinical trial and/or from any future clinical trials of telaprevir/VX-222 may not be favorable; future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir/VX-222-based therapy and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex's website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
(VRTX - GEN)
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed March 21, 2011.
2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed March 21, 2011.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
12 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
Contacts
Vertex Pharmaceuticals Incorporated
Media:
Dawn Kalmar, 617-444-6992
or
Amy Pasqua, 617-444-6992
or
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
or
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Matthew Osborne, 617-444-6057
or
Patient Inquiries: 1-855-837-3894
Monday, July 25, 2011
NanoViricides announces anti-HIV therapy could lead to functional cure...
NanoViricide press release on a successful HIV animal study comparing it's lead anti-HIV candidate that achieved efficacy similar to three-drug HAART therapy, apparently with less opportunity for drug toxicity. Nanoviricides utilizes new technology to 'mimic cellular structures to which the virus binds, specifically attacking and dismantling them'. The CEO claims that this could lead to a 'functional cure', which isn't complete eradication of the virus, but 'would allow an infected person to continue normal life even after discontinuation of therapy, maintaining undetectable viral load until a recurrence.'
NanoViricides announces anti-HIV therapy could lead to functional cure
Mon 10:53 am by Deborah Sterescu
NanoViricides announces anti-HIV therapy could lead to functional cure
NanoViricides (OTCBB:NNVC) reported Monday that its lead anti-HIV candidate achieved an efficacy level equivalent to a highly active anti-retroviral triple (HAART) drug cocktail in a recent animal study.
Treatment with the drug reduced HIV levels and protected human immune T-cells to the same extent as treatment with the cocktail did in a study of mice, said the company. The three drug-combination used for comparison is one of the current therapies recommended for patients with HIV.
NanoViricides, which uses special purpose nanomaterials to design viral therapies, also said that no evidence of drug toxicity was observed during the study, and that the investigational drug will now undergo further optimization.
The latest study verifies the company's previous results, which found that nanoviricides had a significant therapeutic effect, equal or superior to the same three-drug cocktail in a mouse study.
The company's nanoviricide therapy works to mimick cellular structures to which the virus binds, specifically attacking and dismantling them. By working differently than many combination therapies, the drug developer believes that the nanoviral treatment, or HIVCide, could compliment current standard-of-care, possibly achieving a "functional cure" of HIV/AIDS, NanoViricides said.
Although a functional cure is not a complete cure, it would allow an infected person to continue normal life even after discontinuation of therapy, maintaining undetectable viral load until a recurrence.
"Creating an adjunct drug that acts by a novel mechanism complementing the current HAART therapy is becoming extremely important," said CEO, Eugene Seymour.
"The HIV virus mutates constantly resulting in failure of HAART therapy regimens. In some countries, it has now mutated to such an extent that in up to 40% of patients the standard HAART therapy has become ineffective."
The company's nanoviricide class of drugs are being developed against a number of viral diseases, including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, oral and genital Herpes, viral Hepatitis C, and Ebola virus, among others.
A recent study of anti-flu treatment FluCide showed that the drug was better than oseltamivir, or Tamiflu, with a 1,000-fold greater viral load reduction than the standard flu therapy, after optimization.
"The results of the current study have provided important insight to guide the next cycle of chemical optimization. We clearly know now that we are on the right path," said president Anil R. Diwan
NanoViricides announces anti-HIV therapy could lead to functional cure
Mon 10:53 am by Deborah Sterescu
NanoViricides announces anti-HIV therapy could lead to functional cure
NanoViricides (OTCBB:NNVC) reported Monday that its lead anti-HIV candidate achieved an efficacy level equivalent to a highly active anti-retroviral triple (HAART) drug cocktail in a recent animal study.
Treatment with the drug reduced HIV levels and protected human immune T-cells to the same extent as treatment with the cocktail did in a study of mice, said the company. The three drug-combination used for comparison is one of the current therapies recommended for patients with HIV.
NanoViricides, which uses special purpose nanomaterials to design viral therapies, also said that no evidence of drug toxicity was observed during the study, and that the investigational drug will now undergo further optimization.
The latest study verifies the company's previous results, which found that nanoviricides had a significant therapeutic effect, equal or superior to the same three-drug cocktail in a mouse study.
The company's nanoviricide therapy works to mimick cellular structures to which the virus binds, specifically attacking and dismantling them. By working differently than many combination therapies, the drug developer believes that the nanoviral treatment, or HIVCide, could compliment current standard-of-care, possibly achieving a "functional cure" of HIV/AIDS, NanoViricides said.
Although a functional cure is not a complete cure, it would allow an infected person to continue normal life even after discontinuation of therapy, maintaining undetectable viral load until a recurrence.
"Creating an adjunct drug that acts by a novel mechanism complementing the current HAART therapy is becoming extremely important," said CEO, Eugene Seymour.
"The HIV virus mutates constantly resulting in failure of HAART therapy regimens. In some countries, it has now mutated to such an extent that in up to 40% of patients the standard HAART therapy has become ineffective."
The company's nanoviricide class of drugs are being developed against a number of viral diseases, including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, oral and genital Herpes, viral Hepatitis C, and Ebola virus, among others.
A recent study of anti-flu treatment FluCide showed that the drug was better than oseltamivir, or Tamiflu, with a 1,000-fold greater viral load reduction than the standard flu therapy, after optimization.
"The results of the current study have provided important insight to guide the next cycle of chemical optimization. We clearly know now that we are on the right path," said president Anil R. Diwan
Friday, July 22, 2011
Genotype 1b HCV Patients Fare Better on Boceprevir
(Article from Medscape on IAS presentation culling data from the SPRINT-2 and RESPOND-2 trails that find that genotype 1a patients have a lower barrier to resistance than genotype 1b. This was also found to be true for Telaprevir as well)
Genotype 1b HCV Patients Fare Better on Boceprevir
Emma Hitt, PhD
July 22, 2011 (Rome, Italy) — Boceprevir/peginterferon plus ribavirin is associated with a small but consistently higher sustained viral response (SVR) rate and a lower rate of development of boceprevir-related resistance-associated variants (RAVs) in patients infected with hepatitis C virus (HCV) genotype 1b subtype than in those infected with genotype 1a subtype, according to new data from the SPRINT-2 and RESPOND-2 phase 3 trials.
Daria Hazuda, PhD, vice president of virus and cell biology at Merck Research Laboratories, in Whitehouse Station, New Jersey, presented the findings in a late-breaking oral session here at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.
"It was important to do this study in order to better understand the development of resistance with boceprevir," Dr. Hazuda told Medscape Medical News. "Additional analyses of our clinical studies with boceprevir are ongoing. A 3.5-year long-term follow-up study is underway to evaluate the persistence of resistance-associated variants over time," she added.
Dr. Daria Hazuda
In the SPRINT-2 and RESPOND-2 clinical trials, Dr. Hazuda and colleagues compared the SVR to boceprevir in combination with pegylated-interferon alfa-2b plus ribavirin and the associated presence or absence of RAVs between patients with HCV genotype 1a and those with genotype 1b.
The rate of SVR among those receiving boceprevir in the 2 trials was higher in patients with genotype 1b than in those with genotype 1a (66%–73% vs 59%–64%). The number of patients with RAVs detected was higher in genotype 1a patients than in genotype 1b patients in SPRINT-2 (58% vs 48%) and in RESPOND-2 (48% vs 41%).
The researchers also found that the RAVs V36M and R155K were more common in genotype 1a patients, whereas T54A/S, A156S, and V170A were more common in genotype 1b patients.
RAVs were more common in patients with a poor interferon response (defined as a decline in viral load of less than 1 log at week 4) than in those with a good interferon response (a decline in viral load of 1 log or more at week 4) (68% vs 31%). Overall, baseline samples showed a low rate of RAVs, and most patients with RAVs still achieved SVR.
"Understanding which mutations develop and how long they persist may help us assess the potential for retreatment with first-generation protease inhibitors and, importantly, facilitate the development of next-generation protease inhibitors that can work effectively against resistant mutants," Dr. Hazuda explained.
According to Dr. Hazuda, the resistance variants observed with boceprevir are similar, if not identical, to those observed with telaprevir. "Although we do not know if retreatment will be possible, there should be no difference between these 2 first-generation protease inhibitors," she said.
Dr. Hazuda added that it is still not known how long these resistant variants last, or whether the viral population has been altered in a way to make it less likely that patients will respond to retreatment with another first-generation protease inhibitor.
"These are valuable phase 3 trial data, which emphasize the fact that the main determinant of the SVR is not the preexistence of RAVs at baseline but the response to interferon and ribavirin," said independent commentator Jean-Michel Pawlotsky, MD, professor of medicine at the University of Paris-Est, director of the Department of Virology at the Henri Mondor University Hospital in Créteil, France, and director of the Department of Molecular Virology and Immunology at the Mondor Institute of Biomedical Research.
"Patients and doctors should not be afraid of resistance to protease inhibitors," he told Medscape Medical News. "Hepatitis remains theoretically curable in 100% of cases, and new drugs will allow patients who failed on triple-combination therapy the opportunity for treatment in the future," he added.
The study was funded Merck and Co. Dr. Hazuda is an employee of Merck. Dr. Pawlotsky reports acting as a consultant to Vertex, Jannsen, Merck, and Roche.
6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention: Abstract WELBX04. Presented July 20, 2011.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
Genotype 1b HCV Patients Fare Better on Boceprevir
Emma Hitt, PhD
July 22, 2011 (Rome, Italy) — Boceprevir/peginterferon plus ribavirin is associated with a small but consistently higher sustained viral response (SVR) rate and a lower rate of development of boceprevir-related resistance-associated variants (RAVs) in patients infected with hepatitis C virus (HCV) genotype 1b subtype than in those infected with genotype 1a subtype, according to new data from the SPRINT-2 and RESPOND-2 phase 3 trials.
Daria Hazuda, PhD, vice president of virus and cell biology at Merck Research Laboratories, in Whitehouse Station, New Jersey, presented the findings in a late-breaking oral session here at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.
"It was important to do this study in order to better understand the development of resistance with boceprevir," Dr. Hazuda told Medscape Medical News. "Additional analyses of our clinical studies with boceprevir are ongoing. A 3.5-year long-term follow-up study is underway to evaluate the persistence of resistance-associated variants over time," she added.
Dr. Daria Hazuda
In the SPRINT-2 and RESPOND-2 clinical trials, Dr. Hazuda and colleagues compared the SVR to boceprevir in combination with pegylated-interferon alfa-2b plus ribavirin and the associated presence or absence of RAVs between patients with HCV genotype 1a and those with genotype 1b.
The rate of SVR among those receiving boceprevir in the 2 trials was higher in patients with genotype 1b than in those with genotype 1a (66%–73% vs 59%–64%). The number of patients with RAVs detected was higher in genotype 1a patients than in genotype 1b patients in SPRINT-2 (58% vs 48%) and in RESPOND-2 (48% vs 41%).
The researchers also found that the RAVs V36M and R155K were more common in genotype 1a patients, whereas T54A/S, A156S, and V170A were more common in genotype 1b patients.
RAVs were more common in patients with a poor interferon response (defined as a decline in viral load of less than 1 log at week 4) than in those with a good interferon response (a decline in viral load of 1 log or more at week 4) (68% vs 31%). Overall, baseline samples showed a low rate of RAVs, and most patients with RAVs still achieved SVR.
"Understanding which mutations develop and how long they persist may help us assess the potential for retreatment with first-generation protease inhibitors and, importantly, facilitate the development of next-generation protease inhibitors that can work effectively against resistant mutants," Dr. Hazuda explained.
According to Dr. Hazuda, the resistance variants observed with boceprevir are similar, if not identical, to those observed with telaprevir. "Although we do not know if retreatment will be possible, there should be no difference between these 2 first-generation protease inhibitors," she said.
Dr. Hazuda added that it is still not known how long these resistant variants last, or whether the viral population has been altered in a way to make it less likely that patients will respond to retreatment with another first-generation protease inhibitor.
"These are valuable phase 3 trial data, which emphasize the fact that the main determinant of the SVR is not the preexistence of RAVs at baseline but the response to interferon and ribavirin," said independent commentator Jean-Michel Pawlotsky, MD, professor of medicine at the University of Paris-Est, director of the Department of Virology at the Henri Mondor University Hospital in Créteil, France, and director of the Department of Molecular Virology and Immunology at the Mondor Institute of Biomedical Research.
"Patients and doctors should not be afraid of resistance to protease inhibitors," he told Medscape Medical News. "Hepatitis remains theoretically curable in 100% of cases, and new drugs will allow patients who failed on triple-combination therapy the opportunity for treatment in the future," he added.
The study was funded Merck and Co. Dr. Hazuda is an employee of Merck. Dr. Pawlotsky reports acting as a consultant to Vertex, Jannsen, Merck, and Roche.
6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention: Abstract WELBX04. Presented July 20, 2011.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
Sexual transmission of HCV virus more prevalent than previously thought....
(From the LA Times 'Booster Shots' blog, July 21, 2011. This type of thing isn't usually fare for the purposes of this group but I think it is significant in a couple of different ways - first, sexual transmission of the HCV virus is still inefficient, but it happens more than we previously though. Second, this opens up the possibility that transmission of fit drug resistant variants of the virus may be possible which is of major concern, especially in the HIV/HCV co-infected population where the progression of the disease is much more rapid. Currently, there is no sequential therapy for HCV and not likely to be until late 2013. - Chris)
By Thomas H. Maugh II, Los Angeles Times/For the Booster Shots blog
July 21, 2011, 11:12 a.m.
The hepatitis C virus, normally thought to be transmitted exclusively through blood — such as by sharing of needles among intravenous drug abusers — can also be transmitted through sexual activity, principally through anal sex among gay men, a growing body of evidence suggests. The most recent evidence was reported Thursday by New York City researchers who documented an outbreak of the virus, commonly known as HCV, among gay men.
Hepatitis C, which can cause severe liver disease and even death if left untreated, affects an estimated 3.2 million Americans. Many infected people show no symptoms, but others have severe disease that can require liver transplants. The infection can be cured in most people with a combination of the drugs pegylated interferon alpha and ribavirin, plus a recently approved drug called Incivek, but treatment is most successful when started early in the course of the disease.
Dr. Daniel Fierer, an infectious diseases expert at the Mount Sinai School of Medicine, and his colleagues first observed two cases of HCV that they believed to be caused by sexual transmission in late 2005. They requested referrals of similar patients. The team reported Thursday in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report that they found a total of 74 cases. All the men reported having receptive anal sex and none had any other risk factors for HCV, such as intravenous drug abuse. When the team compared the infected men to other gay men who were not infected with the virus, they found that those who became infected were 23 times more likely to have had unprotected gay sex and 29 times more likely to have had anal sex while using crystal methamphetamine. Moreover, genetic analysis showed that there were five separate clusters of the virus, indicating that the virus was getting transmitted through groups of interconnected men.
"While hepatitis C is not sexually transmitted among stable heterosexual couples, this is clearly not the case among HIV-infected [men having sex with men] in New York City," Fierer said in a statement. Such men, "and to some extent their healthcare providers, are generally not aware that having unprotected receptive sex can result in HCV infection .... Our study suggests that HIV-infected [gay men] should take steps to protect themselves and others by using condoms and by avoiding crystal methamphetamine."
By Thomas H. Maugh II, Los Angeles Times/For the Booster Shots blog
July 21, 2011, 11:12 a.m.
The hepatitis C virus, normally thought to be transmitted exclusively through blood — such as by sharing of needles among intravenous drug abusers — can also be transmitted through sexual activity, principally through anal sex among gay men, a growing body of evidence suggests. The most recent evidence was reported Thursday by New York City researchers who documented an outbreak of the virus, commonly known as HCV, among gay men.
Hepatitis C, which can cause severe liver disease and even death if left untreated, affects an estimated 3.2 million Americans. Many infected people show no symptoms, but others have severe disease that can require liver transplants. The infection can be cured in most people with a combination of the drugs pegylated interferon alpha and ribavirin, plus a recently approved drug called Incivek, but treatment is most successful when started early in the course of the disease.
Dr. Daniel Fierer, an infectious diseases expert at the Mount Sinai School of Medicine, and his colleagues first observed two cases of HCV that they believed to be caused by sexual transmission in late 2005. They requested referrals of similar patients. The team reported Thursday in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report that they found a total of 74 cases. All the men reported having receptive anal sex and none had any other risk factors for HCV, such as intravenous drug abuse. When the team compared the infected men to other gay men who were not infected with the virus, they found that those who became infected were 23 times more likely to have had unprotected gay sex and 29 times more likely to have had anal sex while using crystal methamphetamine. Moreover, genetic analysis showed that there were five separate clusters of the virus, indicating that the virus was getting transmitted through groups of interconnected men.
"While hepatitis C is not sexually transmitted among stable heterosexual couples, this is clearly not the case among HIV-infected [men having sex with men] in New York City," Fierer said in a statement. Such men, "and to some extent their healthcare providers, are generally not aware that having unprotected receptive sex can result in HCV infection .... Our study suggests that HIV-infected [gay men] should take steps to protect themselves and others by using condoms and by avoiding crystal methamphetamine."
Wednesday, July 20, 2011
Merck and Roche sign global agreement to promote Victrelis...
WHITEHOUSE STATION, N.J., Jul 20, 2011 (BUSINESS WIRE) -- Merck /quotes/zigman/574389/quotes/nls/mrk MRK -0.56% , known as MSD outside the United States and Canada, announced today that it has signed a new non-exclusive agreement with Roche (six:RO)(six:ROG)(otcqx:RHHBY), through the companies' respective subsidiaries, for the global promotion, upon appropriate marketing approvals, of VICTRELIS(TM) (boceprevir) as part of a triple combination therapy regimen with peginterferon alfa and ribavirin (peg/riba).
"Reaching physicians with important information about the use of VICTRELIS in combination with peg/riba is essential as we enter this new era in the field of chronic hepatitis C," said Adam H. Schechter, executive vice president and president, Global Human Health, Merck. "We're pleased to work with Roche to help physicians help patients with chronic hepatitis C around the world."
Under the terms of the agreement, Roche and Merck will work together in global markets, including Europe, Asia and Latin America, to educate physicians and patients about hepatitis C virus (HCV). The companies previously announced an agreement to promote VICTRELIS in the United States and collaborate to explore new treatment regimens for patients with chronic HCV.
"Improving treatment outcomes for more patients with chronic hepatitis C is our ultimate goal," said Pascal Soriot, Roche Pharmaceuticals Division, chief operating officer. "Through this extended collaboration and the education of health care professionals, Roche and Merck aim to ensure that appropriate patients can benefit from triple combination therapy."
VICTRELIS in the United States
In the United States, VICTRELIS is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
-- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
-- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
-- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR)(1) , and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
VICTRELIS was approved by the U.S. Food and Drug Administration on May 13 and is available to all U.S. pharmacies nationwide, including specialty pharmacies.
On July 18, Merck announced that the European Commission (EC) approved VICTRELIS for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Important U.S. safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least six months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS. VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio(R) (sildenafil) or Adcirca(R) (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously treated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com .
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf .
____________________ (1) SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient's 12-week post-treatment assessment was utilized.
VICTRELIS(TM) is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio(R) and Adcirca(R) are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
SOURCE: Merck
"Reaching physicians with important information about the use of VICTRELIS in combination with peg/riba is essential as we enter this new era in the field of chronic hepatitis C," said Adam H. Schechter, executive vice president and president, Global Human Health, Merck. "We're pleased to work with Roche to help physicians help patients with chronic hepatitis C around the world."
Under the terms of the agreement, Roche and Merck will work together in global markets, including Europe, Asia and Latin America, to educate physicians and patients about hepatitis C virus (HCV). The companies previously announced an agreement to promote VICTRELIS in the United States and collaborate to explore new treatment regimens for patients with chronic HCV.
"Improving treatment outcomes for more patients with chronic hepatitis C is our ultimate goal," said Pascal Soriot, Roche Pharmaceuticals Division, chief operating officer. "Through this extended collaboration and the education of health care professionals, Roche and Merck aim to ensure that appropriate patients can benefit from triple combination therapy."
VICTRELIS in the United States
In the United States, VICTRELIS is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
-- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
-- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
-- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR)(1) , and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
VICTRELIS was approved by the U.S. Food and Drug Administration on May 13 and is available to all U.S. pharmacies nationwide, including specialty pharmacies.
On July 18, Merck announced that the European Commission (EC) approved VICTRELIS for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Important U.S. safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least six months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS. VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio(R) (sildenafil) or Adcirca(R) (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously treated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com .
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf .
____________________ (1) SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient's 12-week post-treatment assessment was utilized.
VICTRELIS(TM) is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio(R) and Adcirca(R) are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
SOURCE: Merck
Tuesday, July 19, 2011
InPharm article on Telaprevir vs Boceprevir in the battle for market share....
Pretty fair-balanced article on Merck vs Vertex in the battle for market share here in the states. The author left out a large disadvantage of both drugs... the propensity for drug interactions. As for the high cost of Telaprevir, one could also make the argument that Vertex needs to make back it's investment in the drug in a hurry... the the first of the second generation of Direct Acting Antivirals with potential for greater efficacy and less side effects are due sometime in 2013, giving Telaprevir and Boceprevir relatively a short window of opportunity.
Hepatitis C rivals go head to head
By amcconag
Created 19/07/2011 - 14:28
Summary:
Launched within days of each other in the US, J&J and Vertex’s Incivek and Merck’s Victrelis will battle for market share
The field of hepatitis C treatment has two new groundbreaking medicines to treat the condition.
Merck’s Victrelis (boceprevir) and Johnson & Johnson/Vertex’s Incivek (telaprevir) were both launched in the US in May, and Victrelis has now been given the green light in Europe.
The drugs have much in common; both are oral protease inhibitors, and promise to significantly improve treatment when added to the current standard treatments for the disease. An estimated 270-300 million people world have the disease.
Both drugs are expected to reach blockbuster status, but which will win out in the battle for market share? Many analysts are predicting Vertex and J&J’s Incivek will prevail because it has shown a higher cure rate, and a simpler and faster simpler dosing regimen.
But Vertex, which has never launched a drug before, will have to overcome the might of Merck and its new US marketing partner Roche.
Victrelis versus Incivek
Current hepatitis C treatments produce only limited success in treating patients with the disease. The current standard treatments are peginterferon alfa and ribavirin taken for 48 weeks, but less than 50% of patients respond to this therapy.
The two new protease inhibitors promise to help more patients, and to lower the viral load of the disease down to an undetectable level, considered a cure for the disease.
Both Incivek and Victrelis are licensed in the US to treat hepatitis C genotype 1 infection with compensated liver disease, including cirrhosis, in combination with peginterferon alfa and ribavirin. The new drugs can be given to patients who have been previously untreated or who have failed previous interferon and ribavirin therapy.
Victrelis had a 66% sustained viralogic response (SVR) - as close to a cure as possible - in late-stage studies, but Incivek produced a significantly higher rate of 79 per cent. Incivek has a further advantage - patients who respond well to the drug can stop treatment at just 24 weeks rather than the nearly year-long 48 weeks of the current drug regimen. Safety data suggests Incivek is generally well-tolerated, but about half of patients developed a skin rash or itching, while a small number developed the severe Stevens-Johnson Syndrome.
Merck’s Victrelis has a few factors in its favour - is likely to cost less (depending on the duration of treatment) and has had no cases of the Stevens-Johnson Syndrome. However Merck’s drug has a more complicated dosing regimen, which is expected to count against it.
The marketing battle
Merck has shown its determination to win the US marketing battle by signing a co-marketing deal with Roche. This means Vertex will have to compete with two of the biggest and most experienced salesforces in the sector. Vertex has a sales team of 115, a fraction of the numbers Merck and Roche will be able to muster. But Vertex’s chief executive Matthew Emmens believes the company can hold its own against its bigger competitors, thanks to the already high level of awareness among their target audience, and the advantages of its drug.
Vertex’s belief in the superiority of its product is reflected in its price, which is $49,200 for a 12-week course. This cost is much higher than Victrelis, and is equivalent to the price of a whole 48 week treatment with Merck’s drug. Vertex justifies the high price on the promise of a shorter treatment period, but patient advocacy groups have already criticised the high costs patients and insurance systems will have to pay.
European approvals
The FDA made a speedy decision on Victrelis and Incivek, fast-tracking the drugs because of their groundbreaking status. The drugs have been given similar priority status in Europe, and Victrelis has just gained final EU approval. Vertex says it hopes for a European approval, where its partner Johnson & Johnson holds the marketing rights, by the end of the year.
Liver experts are already familiar with what Victrelis and Incivek will offer, and are looking further ahead to continued progress. Researchers are now looking to combine molecules or produce a single agent to simplify treatment and do away with interferon, which produces flu-like symptoms and other side effects. There is also a need for drugs to treat a wider spectrum of virus genotypes, and to address viral resistance to drug treatment.
Hepatitis C rivals go head to head
By amcconag
Created 19/07/2011 - 14:28
Summary:
Launched within days of each other in the US, J&J and Vertex’s Incivek and Merck’s Victrelis will battle for market share
The field of hepatitis C treatment has two new groundbreaking medicines to treat the condition.
Merck’s Victrelis (boceprevir) and Johnson & Johnson/Vertex’s Incivek (telaprevir) were both launched in the US in May, and Victrelis has now been given the green light in Europe.
The drugs have much in common; both are oral protease inhibitors, and promise to significantly improve treatment when added to the current standard treatments for the disease. An estimated 270-300 million people world have the disease.
Both drugs are expected to reach blockbuster status, but which will win out in the battle for market share? Many analysts are predicting Vertex and J&J’s Incivek will prevail because it has shown a higher cure rate, and a simpler and faster simpler dosing regimen.
But Vertex, which has never launched a drug before, will have to overcome the might of Merck and its new US marketing partner Roche.
Victrelis versus Incivek
Current hepatitis C treatments produce only limited success in treating patients with the disease. The current standard treatments are peginterferon alfa and ribavirin taken for 48 weeks, but less than 50% of patients respond to this therapy.
The two new protease inhibitors promise to help more patients, and to lower the viral load of the disease down to an undetectable level, considered a cure for the disease.
Both Incivek and Victrelis are licensed in the US to treat hepatitis C genotype 1 infection with compensated liver disease, including cirrhosis, in combination with peginterferon alfa and ribavirin. The new drugs can be given to patients who have been previously untreated or who have failed previous interferon and ribavirin therapy.
Victrelis had a 66% sustained viralogic response (SVR) - as close to a cure as possible - in late-stage studies, but Incivek produced a significantly higher rate of 79 per cent. Incivek has a further advantage - patients who respond well to the drug can stop treatment at just 24 weeks rather than the nearly year-long 48 weeks of the current drug regimen. Safety data suggests Incivek is generally well-tolerated, but about half of patients developed a skin rash or itching, while a small number developed the severe Stevens-Johnson Syndrome.
Merck’s Victrelis has a few factors in its favour - is likely to cost less (depending on the duration of treatment) and has had no cases of the Stevens-Johnson Syndrome. However Merck’s drug has a more complicated dosing regimen, which is expected to count against it.
The marketing battle
Merck has shown its determination to win the US marketing battle by signing a co-marketing deal with Roche. This means Vertex will have to compete with two of the biggest and most experienced salesforces in the sector. Vertex has a sales team of 115, a fraction of the numbers Merck and Roche will be able to muster. But Vertex’s chief executive Matthew Emmens believes the company can hold its own against its bigger competitors, thanks to the already high level of awareness among their target audience, and the advantages of its drug.
Vertex’s belief in the superiority of its product is reflected in its price, which is $49,200 for a 12-week course. This cost is much higher than Victrelis, and is equivalent to the price of a whole 48 week treatment with Merck’s drug. Vertex justifies the high price on the promise of a shorter treatment period, but patient advocacy groups have already criticised the high costs patients and insurance systems will have to pay.
European approvals
The FDA made a speedy decision on Victrelis and Incivek, fast-tracking the drugs because of their groundbreaking status. The drugs have been given similar priority status in Europe, and Victrelis has just gained final EU approval. Vertex says it hopes for a European approval, where its partner Johnson & Johnson holds the marketing rights, by the end of the year.
Liver experts are already familiar with what Victrelis and Incivek will offer, and are looking further ahead to continued progress. Researchers are now looking to combine molecules or produce a single agent to simplify treatment and do away with interferon, which produces flu-like symptoms and other side effects. There is also a need for drugs to treat a wider spectrum of virus genotypes, and to address viral resistance to drug treatment.
Monday, July 18, 2011
The EU approves Boceprevir for treatment of chronic HCV....
The European Commission approved Boceprevir for treatment of chronic HCV. It will be interesting to see how socialized medicine within the members of the EU provides access to the DAAs for HCV, given their dizzying costs coupled with the economic crisis of some of the more notable member nations.
WHITEHOUSE STATION, N.J., Jul 18, 2011 (BUSINESS WIRE) -- Merck /quotes/zigman/574389/quotes/nls/mrk MRK -1.22% , known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved VICTRELIS(TM)(boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects an estimated 4 million people in Europe.
The European Commission's Decision grants a single marketing authorisation that is valid in the 27 countries that are members of the European Union (EU), as well as unified labeling applicable to the European Economic Area members, Iceland, Liechtenstein and Norway.
"The EU approval of VICTRELIS for chronic hepatitis C genotype 1 is very exciting, because we now have a new option for patients with the hardest to treat form of the disease. With VICTRELIS, patients who have failed previous therapy or are new to treatment can significantly improve their chances of clearing the virus from their bodies compared to current standard therapy," said Rafael Esteban, M.D., head of the internal medicine and liver unit of the Hospital Universitario Val d'Hebron, Barcelona, Spain. "For some patients new to treatment, VICTRELIS also may allow for a shorter total duration of therapy."
VICTRELIS is the first in a new class of medicines known as HCV protease inhibitors. It is a Direct Acting Antiviral (DAA) agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease). Current standard therapy for HCV works to strengthen the body's natural immune response to the virus, but a majority of patients with chronic hepatitis C genotype 1 are not able to achieve a sustained virologic response (SVR).(1)
"VICTRELIS is the first major advancement for the treatment of chronic hepatitis C approved in the EU in a decade, and represents an important step forward for people living with this serious disease and the physicians who treat them," said Bruno Strigini, president, Europe/Canada, Merck. "Recognizing the high unmet need in this area, Merck will work closely with local authorities across the EU to make VICTRELIS available to patients as quickly as possible."
The marketing authorization for VICTRELIS in combination with current standard therapy is based on the efficacy and safety results from two large pivotal Phase III clinical studies conducted at European and North American sites that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection who were previously untreated or who had failed prior therapy. Both studies included two treatment arms with VICTRELIS: a response-guided therapy (RGT) arm, in which patients with undetectable virus (HCV-RNA) at treatment week 8 were eligible for a shorter duration of therapy, as well as a 48-week treatment arm. All patients receiving VICTRELIS in these studies were first treated with peginterferon alfa-2b and ribavirin (P/R) in a 4-week lead-in phase, followed by the addition of VICTRELIS after week 4. The studies also included a control arm in which patients received 48 weeks of treatment with P/R alone. Final results of the HCV SPRINT-2 (treatment-naive) study and the HCV RESPOND-2 (treatment-failure) study were published in the New England Journal of Medicine on March 31, 2011.
VICTRELIS in the United States
VICTRELIS was approved by the U.S. Food and Drug Administration on May 13 and is available to all U.S. pharmacies nationwide, including specialty pharmacies.
VICTRELIS is indicated in the U.S. for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
-- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
-- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
-- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
-- Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
Important U.S. safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio(R) (sildenafil) or Adcirca(R) (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously treated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com .
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf .
(1)SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient's 12-week post-treatment assessment was utilized.
VICTRELIS(TM) is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio(R) and Adcirca(R) are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
SOURCE: Merck
Merck
Media:
Pamela Eisele, 908-423-5042
Lainie Keller, 908-423-4187
or
Investors:
Alex Kelly, 908-423-5185
Carol Ferguson, 908-423-4465
WHITEHOUSE STATION, N.J., Jul 18, 2011 (BUSINESS WIRE) -- Merck /quotes/zigman/574389/quotes/nls/mrk MRK -1.22% , known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved VICTRELIS(TM)(boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects an estimated 4 million people in Europe.
The European Commission's Decision grants a single marketing authorisation that is valid in the 27 countries that are members of the European Union (EU), as well as unified labeling applicable to the European Economic Area members, Iceland, Liechtenstein and Norway.
"The EU approval of VICTRELIS for chronic hepatitis C genotype 1 is very exciting, because we now have a new option for patients with the hardest to treat form of the disease. With VICTRELIS, patients who have failed previous therapy or are new to treatment can significantly improve their chances of clearing the virus from their bodies compared to current standard therapy," said Rafael Esteban, M.D., head of the internal medicine and liver unit of the Hospital Universitario Val d'Hebron, Barcelona, Spain. "For some patients new to treatment, VICTRELIS also may allow for a shorter total duration of therapy."
VICTRELIS is the first in a new class of medicines known as HCV protease inhibitors. It is a Direct Acting Antiviral (DAA) agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease). Current standard therapy for HCV works to strengthen the body's natural immune response to the virus, but a majority of patients with chronic hepatitis C genotype 1 are not able to achieve a sustained virologic response (SVR).(1)
"VICTRELIS is the first major advancement for the treatment of chronic hepatitis C approved in the EU in a decade, and represents an important step forward for people living with this serious disease and the physicians who treat them," said Bruno Strigini, president, Europe/Canada, Merck. "Recognizing the high unmet need in this area, Merck will work closely with local authorities across the EU to make VICTRELIS available to patients as quickly as possible."
The marketing authorization for VICTRELIS in combination with current standard therapy is based on the efficacy and safety results from two large pivotal Phase III clinical studies conducted at European and North American sites that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection who were previously untreated or who had failed prior therapy. Both studies included two treatment arms with VICTRELIS: a response-guided therapy (RGT) arm, in which patients with undetectable virus (HCV-RNA) at treatment week 8 were eligible for a shorter duration of therapy, as well as a 48-week treatment arm. All patients receiving VICTRELIS in these studies were first treated with peginterferon alfa-2b and ribavirin (P/R) in a 4-week lead-in phase, followed by the addition of VICTRELIS after week 4. The studies also included a control arm in which patients received 48 weeks of treatment with P/R alone. Final results of the HCV SPRINT-2 (treatment-naive) study and the HCV RESPOND-2 (treatment-failure) study were published in the New England Journal of Medicine on March 31, 2011.
VICTRELIS in the United States
VICTRELIS was approved by the U.S. Food and Drug Administration on May 13 and is available to all U.S. pharmacies nationwide, including specialty pharmacies.
VICTRELIS is indicated in the U.S. for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
-- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
-- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
-- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
-- Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
Important U.S. safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio(R) (sildenafil) or Adcirca(R) (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously treated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com .
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf .
(1)SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient's 12-week post-treatment assessment was utilized.
VICTRELIS(TM) is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio(R) and Adcirca(R) are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
SOURCE: Merck
Merck
Media:
Pamela Eisele, 908-423-5042
Lainie Keller, 908-423-4187
or
Investors:
Alex Kelly, 908-423-5185
Carol Ferguson, 908-423-4465
Wednesday, July 13, 2011
Gilead first company to share AIDS and HBV drugs with Medicines Patent Pool...
Gilead is the first to share it's HIV and HBV drugs with the international Medicines Patents Pool according to the NY Times on Monday July 12. The concept of the patent pool is to create an international independent agency that would hold patents on antiviral and antiretroviral drugs and sub-license them to low-cost manufacturers for little or no royalties as long as those manufacturers only supply the drugs to an agreed-upon list of poor countries. Great idea and hats off to Gilead!
Company Agrees to Share AIDS and Hepatitis Drugs With Patent Pool
By DONALD G. McNEIL Jr.
In the first agreement between a pharmaceutical company and the new international Medicines Patent Pool, Gilead Sciences announced Tuesday that it would license four of its AIDS and hepatitis B drugs to the pool.
The move is particularly important because it includes tenofovir and emtricitabine, which have emerged as important components of AIDS therapy and new prophylaxis regimens, like vaginal microbicides for women and once-a-day pills protecting gay men. Many poor countries now have only older drugs, some of which have harsh side effects.
Health advocates have long championed the idea of a pool: an independent agency that would hold patents on drugs and sub-license them to low-cost manufacturers for low or no royalties on the condition that they supply only poor countries. (In Uganda, above, cost cutting has set back anti-AIDS programs.)
The pool was created last year, but drugmakers resisted it, wanting to control quality and protect rights to future profits from middle-income countries. Until this week, the only participant was the National Institutes of Health, which turned over a partial patent on an obscure AIDS drug.
“This is a great achievement,” said James P. Love, a campaigner for lower drug prices who first proposed a pool in 2002. “The other drug companies didn’t want Gilead to sign anything, and this will put pressure on them.”
The pool must negotiate which countries can get which drugs, and Mr. Love said he will watch that carefully. Gilead may benefit, he noted, because it may now get modest royalties from sales in countries where it never bothered to take out patents.
Company Agrees to Share AIDS and Hepatitis Drugs With Patent Pool
By DONALD G. McNEIL Jr.
In the first agreement between a pharmaceutical company and the new international Medicines Patent Pool, Gilead Sciences announced Tuesday that it would license four of its AIDS and hepatitis B drugs to the pool.
The move is particularly important because it includes tenofovir and emtricitabine, which have emerged as important components of AIDS therapy and new prophylaxis regimens, like vaginal microbicides for women and once-a-day pills protecting gay men. Many poor countries now have only older drugs, some of which have harsh side effects.
Health advocates have long championed the idea of a pool: an independent agency that would hold patents on drugs and sub-license them to low-cost manufacturers for low or no royalties on the condition that they supply only poor countries. (In Uganda, above, cost cutting has set back anti-AIDS programs.)
The pool was created last year, but drugmakers resisted it, wanting to control quality and protect rights to future profits from middle-income countries. Until this week, the only participant was the National Institutes of Health, which turned over a partial patent on an obscure AIDS drug.
“This is a great achievement,” said James P. Love, a campaigner for lower drug prices who first proposed a pool in 2002. “The other drug companies didn’t want Gilead to sign anything, and this will put pressure on them.”
The pool must negotiate which countries can get which drugs, and Mr. Love said he will watch that carefully. Gilead may benefit, he noted, because it may now get modest royalties from sales in countries where it never bothered to take out patents.
Monday, July 11, 2011
Achillion Pharmaceuticals launches Phase 1 study of it's NS5A inhibitor, ACH-2928
ACH-2928 is Achillion's pan-genotypic NS5A inhibitor, said to have favorable PK for once daily dosing and synergistic with Achillion's portfolio of developmental direct-acting HCV agents.
New Haven drug developer Achillion Pharmaceuticals has launched Phase 1 trials of another treatment for chronic hepatitis just two weeks after starting the next phase of clinical trials on a companion treatment.
Achillion said Monday it has begun trial dosing of ACH-2928, a small-molecule drug for treating the hepatitis C virus.
The U.S. trial involves 48 healthy volunteers 20 patients infected with hepatitis C.
On June 23, Achillion opened Phase 2 of its clinical trial in the U.S. and Europe on 60 patients to test the efficacy and tolerability of its other drug compound, ACH-1625, as an effective treatment for chronic hepatitis.
The bioscience firm has begun dosing 60 patients in the U.S. and Europe for 12 weeks in the second segment of its trial of ACH-1625 for the treatment of hepatitis C virus. Results will be announced in the fourth quarter.
New Haven drug developer Achillion Pharmaceuticals has launched Phase 1 trials of another treatment for chronic hepatitis just two weeks after starting the next phase of clinical trials on a companion treatment.
Achillion said Monday it has begun trial dosing of ACH-2928, a small-molecule drug for treating the hepatitis C virus.
The U.S. trial involves 48 healthy volunteers 20 patients infected with hepatitis C.
On June 23, Achillion opened Phase 2 of its clinical trial in the U.S. and Europe on 60 patients to test the efficacy and tolerability of its other drug compound, ACH-1625, as an effective treatment for chronic hepatitis.
The bioscience firm has begun dosing 60 patients in the U.S. and Europe for 12 weeks in the second segment of its trial of ACH-1625 for the treatment of hepatitis C virus. Results will be announced in the fourth quarter.
Sunday, July 10, 2011
The Motley Fool on the J&J/Pharmasset partnership....
J&J's Been Busy
http://www.fool.com/investing/general/2011/07/07/jjs-been-busy.aspx
Brian Orelli
July 7, 2011
When it comes to virus inhibition, Johnson & Johnson (NYSE: JNJ ) has been getting around. Last week, the health-care giant signed a partnership with Gilead Sciences (Nasdaq: GILD ) to combine their HIV drugs. And yesterday, Johnson & Johnson announced it was hooking up with a different partner, Pharmasset (Nasdaq: VRUS ) , to create a hepatitis C drug combo.
The duo plan to run a phase 2 trial combining the companies' experimental drug candidates: PSI-7977 from Pharmasset and TMC435 from Johnson & Johnson. They'll start in patients that have already failed a round of treatment, but if the drugs show success, the companies will surely move into treatment-naive patients.
The press release didn't mention any financial details. Maybe they're waiting to see if they're compatible before putting a name on their relationship.
Like the HIV market, the future of hepatitis C treatment is a cocktail that's hopefully capable of curing everyone. Incivek and Victrelis from Vertex Pharmaceuticals (Nasdaq: VRTX ) and Merck (NYSE: MRK ) , respectively, are combined with older medications to help boost the cure rate from around half of the treated patients to as much as 79%.
But that still leaves room for improvement. And the older medications -- Merck's PegIntron and Roche's Pegasys -- have to be injected and have unpleasant side effects. Going to an all-oral regimen is the ultimate goal.
Hepatitis C drugmakers with limited compounds are scrambling to partner up to avoid being left behind. Pharmasset has a similar deal combining PSI-7977 with a drug from Bristol-Myers Squibb (NYSE: BMY ) . Merck and Roche have also hooked up to test their drug candidates.
Gilead has six hepatitis C compounds in clinical trials that it can mix or match to find the right combo on its own, which might explain why Johnson & Johnson didn't hit up its HIV partner for another go around in hepatitis C.
http://www.fool.com/investing/general/2011/07/07/jjs-been-busy.aspx
Brian Orelli
July 7, 2011
When it comes to virus inhibition, Johnson & Johnson (NYSE: JNJ ) has been getting around. Last week, the health-care giant signed a partnership with Gilead Sciences (Nasdaq: GILD ) to combine their HIV drugs. And yesterday, Johnson & Johnson announced it was hooking up with a different partner, Pharmasset (Nasdaq: VRUS ) , to create a hepatitis C drug combo.
The duo plan to run a phase 2 trial combining the companies' experimental drug candidates: PSI-7977 from Pharmasset and TMC435 from Johnson & Johnson. They'll start in patients that have already failed a round of treatment, but if the drugs show success, the companies will surely move into treatment-naive patients.
The press release didn't mention any financial details. Maybe they're waiting to see if they're compatible before putting a name on their relationship.
Like the HIV market, the future of hepatitis C treatment is a cocktail that's hopefully capable of curing everyone. Incivek and Victrelis from Vertex Pharmaceuticals (Nasdaq: VRTX ) and Merck (NYSE: MRK ) , respectively, are combined with older medications to help boost the cure rate from around half of the treated patients to as much as 79%.
But that still leaves room for improvement. And the older medications -- Merck's PegIntron and Roche's Pegasys -- have to be injected and have unpleasant side effects. Going to an all-oral regimen is the ultimate goal.
Hepatitis C drugmakers with limited compounds are scrambling to partner up to avoid being left behind. Pharmasset has a similar deal combining PSI-7977 with a drug from Bristol-Myers Squibb (NYSE: BMY ) . Merck and Roche have also hooked up to test their drug candidates.
Gilead has six hepatitis C compounds in clinical trials that it can mix or match to find the right combo on its own, which might explain why Johnson & Johnson didn't hit up its HIV partner for another go around in hepatitis C.
Noninvasive tests predicted survival in chronic hepatitis C...
(Not exactly on topic for a blog dedicated to drug development for the treatment of Hepatitis C, but I thought this synopsis of this study published in the latest installment of the journal Gastroenterology was compelling. I think FibroTest is a noninvasive marker commercially available only in France (correct me if I'm wrong - I know it was developed there). It appears in this nicely sized study that both FibroTest in combination with liver stiffness evaluation accurately predicted the 5 year survival rate for patients suffering from chronic HCV)
Noninvasive tests predicted survival in chronic hepatitis C
Vergniol J. Gastroenterology. 2011;140:1970-1979.
Noninvasive tests for fibrosis and liver stiffness predicted 5-year survival in patients with chronic hepatitis C, according to researchers from CHU Bordeaux in France.
“The evaluation of liver fibrosis is a key step to manage a chronic liver disease and to assess its prognosis, as complications mainly occur in patients with advanced stages,” the researchers wrote. “Early assessment of the risk of bad prognosis helps the physician to manage patients with cirrhosis and to make decisions about liver transplantation.”
Story continues below↓
The researchers prospectively collected data from a cohort of 1,457 consecutive patients who presented with chronic hepatitis C from April 2003 to February 2009. The patients’ fibrosis and liver stiffness were measured using the FibroTest, the aspartate aminotransferase-to-platelet ratio index and the FIB-4. Some patients also received liver biopsies. During the follow-up period, the researchers analyzed data on death, liver-related death and liver transplantation.
At 5 years, the overall survival was 91.7%, and survival without liver-related death was 94.4%. Among patients diagnosed with severe fibrosis at baseline, the survival was significantly decreased. Although all methods used were able to predict shorter survival, liver stiffness and the FibroTest had higher predictive values. After adjustment for treatment response, patient age and estimates of necroinflammatory grade, the prognostic value of liver stiffness (P<.0001) and FibroTest results (P<.0001) remained.
“In this prospective study, we confirmed the prognostic value of liver stiffness and FibroTest on survival,” the researchers wrote. “This information is of major importance, helping us to sharpen our various tools for the follow-up of our patients.”
Noninvasive tests predicted survival in chronic hepatitis C
Vergniol J. Gastroenterology. 2011;140:1970-1979.
Noninvasive tests for fibrosis and liver stiffness predicted 5-year survival in patients with chronic hepatitis C, according to researchers from CHU Bordeaux in France.
“The evaluation of liver fibrosis is a key step to manage a chronic liver disease and to assess its prognosis, as complications mainly occur in patients with advanced stages,” the researchers wrote. “Early assessment of the risk of bad prognosis helps the physician to manage patients with cirrhosis and to make decisions about liver transplantation.”
Story continues below↓
The researchers prospectively collected data from a cohort of 1,457 consecutive patients who presented with chronic hepatitis C from April 2003 to February 2009. The patients’ fibrosis and liver stiffness were measured using the FibroTest, the aspartate aminotransferase-to-platelet ratio index and the FIB-4. Some patients also received liver biopsies. During the follow-up period, the researchers analyzed data on death, liver-related death and liver transplantation.
At 5 years, the overall survival was 91.7%, and survival without liver-related death was 94.4%. Among patients diagnosed with severe fibrosis at baseline, the survival was significantly decreased. Although all methods used were able to predict shorter survival, liver stiffness and the FibroTest had higher predictive values. After adjustment for treatment response, patient age and estimates of necroinflammatory grade, the prognostic value of liver stiffness (P<.0001) and FibroTest results (P<.0001) remained.
“In this prospective study, we confirmed the prognostic value of liver stiffness and FibroTest on survival,” the researchers wrote. “This information is of major importance, helping us to sharpen our various tools for the follow-up of our patients.”
Thursday, July 7, 2011
Medivir/Tibotec's HCV protease inhibitor TMC435 receives FDA 'Fast-Track' status...
Medivir: TMC435 has Received Fast Track Designation from the FDA and TMC435 will be studied in combination with Pharmasset's PSI-7977 for HCV genotype-1
HUDDINGE, Sweden, Jul 06, 2011 (BUSINESS WIRE) -- Regulatory News:
Medivir AB (sto:MVIRB)(omx:MVIR), is an emerging research-based specialty pharmaceutical company focused on infectious diseases.
Medivir today announced that its investigational protease inhibitor TMC435 has received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435's potential to address unmet medical needs in the treatment of CHC infection compared to currently approved therapies.
TMC435 may offer:
-- High sustained virological response (SVR) rates in genotype-1 HCV-infected patients, including hard-to-treat subgroups
-- Short treatment duration
-- Favorable overall safety and tolerability profile
-- A convenient once-daily (q.d.) dosing regimen
Furthermore, Medivir also confirms the intention to start a proof-of-concept oral, interferon-free phase 2 trial, investigating the combination of TMC435, a once daily NS3/4A protease inhibitor (PI) for the treatment of genotype-1 chronic hepatitis C virus (HCV) infection and Pharmasset's PSI-7977, a once daily nucleotide NS5B polymerase inhibitor. The phase 2 study, which is being managed by Tibotec Pharmaceuticals, will investigate the efficacy and safety of 12 weeks or 24 weeks of TMC435 150 mg q.d. in combination with PSI-7977 400 mg q.d. with or without ribavirin in prior null responders to peginterferon/ribavirin therapy. The primary endpoint of the trial will be sustained virological response at 12 weeks (SVR12).
Bertil Samuelsson, CSO, of Medivir commented, "We are delighted to have received the Fast Track designation for TMC435 from the FDA. This shows that TMC435 with its high safety profile, efficacy, short treatment duration and convenience of once daily dosing is believed to have the potential to provide benefit over current treatments. We believe TMC435 has the potential to become a cornerstone of future direct-acting antiviral combinations for HCV therapy. We are thus very pleased over the clinical collaboration agreement Pharmasset announced today with Tibotec, and the coming start-up of a TMC435 combination trial with Pharmasset's once daily NS5B nucleotide inhibitor PSI-7977. This is one of several ongoing TMC435 combination trials and we expect the momentum to continue with regards to the development of TMC435"
About Fast Track
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and to fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. "Filling an unmet medical need" is defined as providing a therapy where none exists or providing a therapy that may potentially be superior to existing therapy. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:
-- Showing superior effectiveness
-- Avoiding serious side effects of an available treatment
-- Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
-- Decreasing a clinically significant toxicity of an accepted treatment
A drug that receives Fast Track designation is eligible for some or all of the following:
-- More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
-- More frequent written correspondence from the FDA about such things as the design of the proposed clinical trials
-- Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate or substitute endpoint reasonably likely to predict clinical benefit
-- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
-- Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.
In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
About TMC435
TMC435, an investigational CHC protease inhibitor currently in phase 3 clinical development, is a highly potent, selective and safe once-daily (q.d.) drug jointly developed by Tibotec Pharmaceuticals to treat chronic hepatitis C virus infections.
TMC435 is being developed in combination with PegIFN/RBV and in combination with Direct-acting Antiviral (DAA) agents without peginterferon and with or without ribavirin (RBV). In June 2011 the combination study of TMC435 with TMC647055, a non-nucleoside NS5B polymerase inhibitor being developed by Tibotec Pharmaceuticals, was initiated.
Three global clinical phase 3 response guided studies were initiated in early 2011 by Tibotec:
-- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients
-- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients
-- TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment
Phase 3 programs for TMC435 are also ongoing in Japan.
In parallel with 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.
For additional information from these studies, please see www.medivir.com and 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 US Centers for Disease Control ("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 novel protease inhibitor is in phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals. In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialization of TMC435 in the Nordic markets, once approved.
Medivir's first product, the unique cold sore product Xerese(TM)/Xerclear(R) was launched on the US market in February 2011. Xerese(TM)/Xerclear(R), which has been approved in both the US and Europe is partnered with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights in North America, Canada and Mexico have recently been sold to Meda AB. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: www.medivir.com .
This information was brought to you by Cision http://www.cisionwire.com
SOURCE: Medivir
HUDDINGE, Sweden, Jul 06, 2011 (BUSINESS WIRE) -- Regulatory News:
Medivir AB (sto:MVIRB)(omx:MVIR), is an emerging research-based specialty pharmaceutical company focused on infectious diseases.
Medivir today announced that its investigational protease inhibitor TMC435 has received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435's potential to address unmet medical needs in the treatment of CHC infection compared to currently approved therapies.
TMC435 may offer:
-- High sustained virological response (SVR) rates in genotype-1 HCV-infected patients, including hard-to-treat subgroups
-- Short treatment duration
-- Favorable overall safety and tolerability profile
-- A convenient once-daily (q.d.) dosing regimen
Furthermore, Medivir also confirms the intention to start a proof-of-concept oral, interferon-free phase 2 trial, investigating the combination of TMC435, a once daily NS3/4A protease inhibitor (PI) for the treatment of genotype-1 chronic hepatitis C virus (HCV) infection and Pharmasset's PSI-7977, a once daily nucleotide NS5B polymerase inhibitor. The phase 2 study, which is being managed by Tibotec Pharmaceuticals, will investigate the efficacy and safety of 12 weeks or 24 weeks of TMC435 150 mg q.d. in combination with PSI-7977 400 mg q.d. with or without ribavirin in prior null responders to peginterferon/ribavirin therapy. The primary endpoint of the trial will be sustained virological response at 12 weeks (SVR12).
Bertil Samuelsson, CSO, of Medivir commented, "We are delighted to have received the Fast Track designation for TMC435 from the FDA. This shows that TMC435 with its high safety profile, efficacy, short treatment duration and convenience of once daily dosing is believed to have the potential to provide benefit over current treatments. We believe TMC435 has the potential to become a cornerstone of future direct-acting antiviral combinations for HCV therapy. We are thus very pleased over the clinical collaboration agreement Pharmasset announced today with Tibotec, and the coming start-up of a TMC435 combination trial with Pharmasset's once daily NS5B nucleotide inhibitor PSI-7977. This is one of several ongoing TMC435 combination trials and we expect the momentum to continue with regards to the development of TMC435"
About Fast Track
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and to fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. "Filling an unmet medical need" is defined as providing a therapy where none exists or providing a therapy that may potentially be superior to existing therapy. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:
-- Showing superior effectiveness
-- Avoiding serious side effects of an available treatment
-- Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
-- Decreasing a clinically significant toxicity of an accepted treatment
A drug that receives Fast Track designation is eligible for some or all of the following:
-- More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
-- More frequent written correspondence from the FDA about such things as the design of the proposed clinical trials
-- Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate or substitute endpoint reasonably likely to predict clinical benefit
-- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
-- Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.
In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
About TMC435
TMC435, an investigational CHC protease inhibitor currently in phase 3 clinical development, is a highly potent, selective and safe once-daily (q.d.) drug jointly developed by Tibotec Pharmaceuticals to treat chronic hepatitis C virus infections.
TMC435 is being developed in combination with PegIFN/RBV and in combination with Direct-acting Antiviral (DAA) agents without peginterferon and with or without ribavirin (RBV). In June 2011 the combination study of TMC435 with TMC647055, a non-nucleoside NS5B polymerase inhibitor being developed by Tibotec Pharmaceuticals, was initiated.
Three global clinical phase 3 response guided studies were initiated in early 2011 by Tibotec:
-- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients
-- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients
-- TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment
Phase 3 programs for TMC435 are also ongoing in Japan.
In parallel with 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.
For additional information from these studies, please see www.medivir.com and 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 US Centers for Disease Control ("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 novel protease inhibitor is in phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals. In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialization of TMC435 in the Nordic markets, once approved.
Medivir's first product, the unique cold sore product Xerese(TM)/Xerclear(R) was launched on the US market in February 2011. Xerese(TM)/Xerclear(R), which has been approved in both the US and Europe is partnered with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights in North America, Canada and Mexico have recently been sold to Meda AB. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: www.medivir.com .
This information was brought to you by Cision http://www.cisionwire.com
SOURCE: Medivir
Wednesday, July 6, 2011
Join "Viral Matters" HCV drug development discussion group on LinkedIn....
Check out the Viral Matters group on LinkedIn here.
Pharmasset & Tibotec team up HCV drugs in clinical collaborative agreement...
Pharmasset all over the news this week, they definitely seem to be teaming up with the right folks in their development of their nucleotide analog PSI-7977... with their own nuc PSI-938, with BMS's NS5a inhibitor and now with Medivir/Tibotec's TMC435. The HCV DAA development space is definitely heating up!
Pharmasset Enters into a Clinical Collaboration Agreement with Tibotec Pharmaceuticals for a Combination Study in Patients Chronically Infected with Hepatitis C
- Study to evaluate the combination of PSI-7977 and TMC435 with and without ribavirin in prior null responder, genotype 1 HCV patients
PRINCETON, N.J., July 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (NASDAQ: VRUS), announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate in a Phase 2 study the safety and efficacy of PSI-7977, Pharmasset's investigational nucleotide polymerase inhibitor, in combination with TMC435, Tibotec Pharmaceuticals' investigational protease inhibitor, for the treatment of chronic hepatitis C virus (HCV).
This phase 2 proof of concept study will evaluate the potential to achieve sustained virologic response 12 weeks post treatment with an all oral, once-daily, interferon-free treatment regimen in patients infected with genotype 1 HCV. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of 12 and 24 weeks of PSI-7977 in combination with TMC435, with and without ribavirin, in patients chronically infected with HCV genotype 1 who had a prior null response to peginterferon alfa and ribavirin treatment. The study is planned to start in the second half of 2011.
"We are excited to be working with Tibotec to simplify and improve HCV treatment," stated Bill Symonds, PharmD, Pharmasset's Senior Vice President of Clinical Pharmacology and Translational Medicine. "PSI-7977 is now being studied in interferon-free combinations with each of the three leading classes of direct-acting antivirals: Tibotec's protease inhibitor, Bristol-Myers Squibb's NS5a inhibitor, and our own nucleotide, PSI-938. This advances one of our key goals at Pharmasset: to develop our nucleotide analogs as the backbone of interferon-free HCV therapy."
About PSI-7977
PSI-7977 is a prodrug of a uracil nucleotide analog polymerase inhibitor we are developing for the treatment of chronic HCV infection. PSI-7977 has completed a 28 day phase 2a trial in combination with peg-interferon and ribavirin (Peg-IFN/RBV) and is currently being tested in four phase 2b studies: the PROTON trial in combination with peg-IFN/RBV in HCV genotype 1, 2 or 3 patients; the ATOMIC trial with peg-IFN/RBV in HCV genotypes 1,4,5,6; the ELECTRON trial, an interferon sparing /interferon free study in HCV genotypes 1,2 and 3 and a study with Bristol-Myers Squibb's NS5a inhibitor, BMS-790052, as part of an interferon free regimen. Pharmasset also anticipates initiating its own interferon free trial with PSI-7977 and PSI-938, a guanine nucleotide polymerase inhibitor in the third calendar quarter 2011.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in three Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14 days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the purine-pyrimidine combination is anticipated to begin in the third quarter of 2011. Mericitabine (RG7128) continues in two Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
Pharmasset
Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office: +1 (609) 865-0693
Pharmasset Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
SOURCE Pharmasset, Inc.
RELATED LINKS
http://www.pharmasset.com
Pharmasset Enters into a Clinical Collaboration Agreement with Tibotec Pharmaceuticals for a Combination Study in Patients Chronically Infected with Hepatitis C
- Study to evaluate the combination of PSI-7977 and TMC435 with and without ribavirin in prior null responder, genotype 1 HCV patients
PRINCETON, N.J., July 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (NASDAQ: VRUS), announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate in a Phase 2 study the safety and efficacy of PSI-7977, Pharmasset's investigational nucleotide polymerase inhibitor, in combination with TMC435, Tibotec Pharmaceuticals' investigational protease inhibitor, for the treatment of chronic hepatitis C virus (HCV).
This phase 2 proof of concept study will evaluate the potential to achieve sustained virologic response 12 weeks post treatment with an all oral, once-daily, interferon-free treatment regimen in patients infected with genotype 1 HCV. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of 12 and 24 weeks of PSI-7977 in combination with TMC435, with and without ribavirin, in patients chronically infected with HCV genotype 1 who had a prior null response to peginterferon alfa and ribavirin treatment. The study is planned to start in the second half of 2011.
"We are excited to be working with Tibotec to simplify and improve HCV treatment," stated Bill Symonds, PharmD, Pharmasset's Senior Vice President of Clinical Pharmacology and Translational Medicine. "PSI-7977 is now being studied in interferon-free combinations with each of the three leading classes of direct-acting antivirals: Tibotec's protease inhibitor, Bristol-Myers Squibb's NS5a inhibitor, and our own nucleotide, PSI-938. This advances one of our key goals at Pharmasset: to develop our nucleotide analogs as the backbone of interferon-free HCV therapy."
About PSI-7977
PSI-7977 is a prodrug of a uracil nucleotide analog polymerase inhibitor we are developing for the treatment of chronic HCV infection. PSI-7977 has completed a 28 day phase 2a trial in combination with peg-interferon and ribavirin (Peg-IFN/RBV) and is currently being tested in four phase 2b studies: the PROTON trial in combination with peg-IFN/RBV in HCV genotype 1, 2 or 3 patients; the ATOMIC trial with peg-IFN/RBV in HCV genotypes 1,4,5,6; the ELECTRON trial, an interferon sparing /interferon free study in HCV genotypes 1,2 and 3 and a study with Bristol-Myers Squibb's NS5a inhibitor, BMS-790052, as part of an interferon free regimen. Pharmasset also anticipates initiating its own interferon free trial with PSI-7977 and PSI-938, a guanine nucleotide polymerase inhibitor in the third calendar quarter 2011.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in three Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14 days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the purine-pyrimidine combination is anticipated to begin in the third quarter of 2011. Mericitabine (RG7128) continues in two Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
Pharmasset
Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office: +1 (609) 865-0693
Pharmasset Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
SOURCE Pharmasset, Inc.
RELATED LINKS
http://www.pharmasset.com
Tuesday, July 5, 2011
Pharmasset's PSI-7977 deemed having "Blockbuster potential"...
Hold your horses, I think an analyst used this to describe VX-222 at one time...
Associated Press
Pharmasset climbs as analyst raises target
Associated Press, 07.05.11, 12:23 PM EDT
NEW YORK -- Shares of hepatitis C drug developer Pharmasset Inc. rose Tuesday after a Canaccord Genuity analyst raised his price target on the stock.
THE SPARK: Analyst George Farmer assumed coverage of the stock, maintaining a "Buy" rating and raising the price target to $160 per share from $57. He said Pharmasset ( VRUS - news- people )'s hepatitis drug candidate PSI-7977 has "blockbuster potential" and its pipeline is promising, as another hepatitis C treatment has also looked very effective in earlier studies.
THE BIG PICTURE: The Princeton, N.J., company said last month that it will expand a trial of PSI-79777 to see if it is effective for patients who have not responded to other hepatitis C drugs and to see if it can eliminate the virus in eight weeks instead of the normal 12 weeks. The changes indicate the drug is working well in the study. PSI-7977 is years away from reaching the market, as Pharmasset plans to report mid-stage trial results later in 2011 and will have to conduct late-stage trials after that.
SHARE ACTION: Pharmasset stock rose $3.59, or 3.2 percent, to $116.33 in midday trading. Shares have traded between $23.56 and $135.92 over the past year.
Associated Press
Pharmasset climbs as analyst raises target
Associated Press, 07.05.11, 12:23 PM EDT
NEW YORK -- Shares of hepatitis C drug developer Pharmasset Inc. rose Tuesday after a Canaccord Genuity analyst raised his price target on the stock.
THE SPARK: Analyst George Farmer assumed coverage of the stock, maintaining a "Buy" rating and raising the price target to $160 per share from $57. He said Pharmasset ( VRUS - news- people )'s hepatitis drug candidate PSI-7977 has "blockbuster potential" and its pipeline is promising, as another hepatitis C treatment has also looked very effective in earlier studies.
THE BIG PICTURE: The Princeton, N.J., company said last month that it will expand a trial of PSI-79777 to see if it is effective for patients who have not responded to other hepatitis C drugs and to see if it can eliminate the virus in eight weeks instead of the normal 12 weeks. The changes indicate the drug is working well in the study. PSI-7977 is years away from reaching the market, as Pharmasset plans to report mid-stage trial results later in 2011 and will have to conduct late-stage trials after that.
SHARE ACTION: Pharmasset stock rose $3.59, or 3.2 percent, to $116.33 in midday trading. Shares have traded between $23.56 and $135.92 over the past year.
Subscribe to:
Posts (Atom)
Posts
