March 08, 2011 08:00 AM Eastern Time
2011 Meeting of the European Association for the Study of the Liver
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced that data from its Phase 1 clinical trial of IMO-2125, its novel immune modulator for the treatment of chronic hepatitis C virus (HCV) infection, in treatment-naïve genotype 1 HCV patients will be presented at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) being held March 30 – April 3, 2011 in Berlin, Germany. The presentation entitled "IMO-2125 plus ribavirin gives substantial first-dose viral load reductions, cumulative antiviral effect, is well tolerated in naïve genotype 1 HCV patients: a Phase 1 trial,” D. Guyader, et al., will be made in a poster session entitled Viral Hepatitis C: Clinical (new compounds, resistance) on Saturday, April 2, 2011. The full abstract (#1209) can now be accessed through the EASL website http://www.easl.eu/.
About IMO-2125
IMO-2125, a Toll-like Receptor (TLR) 9 agonist, is a novel immune modulator being developed as a component of treatment for chronic hepatitis C virus (HCV) infection. IMO-2125 is designed to stimulate the immune system, causing the body to generate natural interferons and other antiviral cytokines. IMO-2125 has been evaluated in a Phase 1 clinical trial in null-responder HCV patients, defined as those who did not achieve a 2 log10 reduction with prior standard of care treatment, as monotherapy for 4 weeks and in a Phase 1 clinical trial in treatment-naïve HCV patients in combination with ribavirin for 4 weeks.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat chronic hepatitis C virus infection, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. The company's proprietary drug candidates are designed to modulate specific Toll-like Receptors, which are a family of immune system receptors. Idera's pioneering DNA and RNA chemistry expertise enables it to create drug candidates for internal development and generates opportunities for multiple collaborative alliances. For more information, visit http://www.iderapharma.com/.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated by such forward-looking statements; whether results obtained in preclinical and clinical studies such as the studies referred to in this release will be indicative of results obtained in future clinical trials; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaborations will be successful; whether the patents and patent applications owned or licensed by the Company will protect the Company’s technology and prevent others from infringing it; whether Idera's cash resources will be sufficient to fund the Company's operations; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q for the three months ended September 30, 2010, which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.
Contacts
Idera Pharmaceuticals, Inc.
Teri Dahlman, 617-679-5519
tdahlman@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
Source
March 8, 2011
Pharmasset to Challenge Vertex Hepatitis C Treatment, BMO Says
By Naomi Kresge - Mar 8, 2011 9:57 AM ET
Pharmasset Inc. (VRUS)’s experimental hepatitis C therapies may pose a challenge to treatments from Vertex Pharmaceuticals Inc. (VRTX), based on trial results to be released in late March, BMO Capital Markets Corp. analysts said.
Two drugs from Pharmasset showed “impressive” figures as stand-alone medications or combination therapies, while results from a two-drug combination from Vertex weren’t good enough to justify more patient studies, the analysts, led by Jason Zhang in Montreal, wrote in a research report to investors yesterday, citing abstracts of the trials.
The Vertex trial combined its drug telaprevir, due for U.S. regulatory review on May 23, with experimental drug VX-222, Zhang wrote. The Pharmasset trials combined two experimental therapies, PSI-7977 and PSI-938, with standard therapies or with each other. Zhang lowered his recommendation on Vertex’s stock from “outperform” to “market perform,” saying that investors already expect telaprevir to be approved.
“The hepatitis C treatment landscape subsequent to the initial phase of telaprevir dominance is tilting away from Vertex to companies such as Pharmasset that have potent combinations,” Zhang wrote.
Vertex fell as much as 5.1 percent to $47.07 and was down 5 percent in Nasdaq trading as of 9:53 a.m. in New York. That pared the stock’s gain this year to 35 percent, valuing the Cambridge, Massachusetts-based company at $9.64 billion. Princeton, New Jersey-based Pharmasset jumped as much as 7.3 percent to $66.48 and was up 4 percent.
Telaprevir may generate $1.9 billion in revenue in 2012, according to BMO’s estimates.
The trials were summarized in abstracts released yesterday by the European Association for the Study of the Liver. Though published online, the data are under a press embargo until the conference, which starts on March 30 in Berlin.
To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Source
Pharmasset Inc. (VRUS)’s experimental hepatitis C therapies may pose a challenge to treatments from Vertex Pharmaceuticals Inc. (VRTX), based on trial results to be released in late March, BMO Capital Markets Corp. analysts said.
Two drugs from Pharmasset showed “impressive” figures as stand-alone medications or combination therapies, while results from a two-drug combination from Vertex weren’t good enough to justify more patient studies, the analysts, led by Jason Zhang in Montreal, wrote in a research report to investors yesterday, citing abstracts of the trials.
The Vertex trial combined its drug telaprevir, due for U.S. regulatory review on May 23, with experimental drug VX-222, Zhang wrote. The Pharmasset trials combined two experimental therapies, PSI-7977 and PSI-938, with standard therapies or with each other. Zhang lowered his recommendation on Vertex’s stock from “outperform” to “market perform,” saying that investors already expect telaprevir to be approved.
“The hepatitis C treatment landscape subsequent to the initial phase of telaprevir dominance is tilting away from Vertex to companies such as Pharmasset that have potent combinations,” Zhang wrote.
Vertex fell as much as 5.1 percent to $47.07 and was down 5 percent in Nasdaq trading as of 9:53 a.m. in New York. That pared the stock’s gain this year to 35 percent, valuing the Cambridge, Massachusetts-based company at $9.64 billion. Princeton, New Jersey-based Pharmasset jumped as much as 7.3 percent to $66.48 and was up 4 percent.
Telaprevir may generate $1.9 billion in revenue in 2012, according to BMO’s estimates.
The trials were summarized in abstracts released yesterday by the European Association for the Study of the Liver. Though published online, the data are under a press embargo until the conference, which starts on March 30 in Berlin.
To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Source
Gilead Drug Combination Cut Hepatitis Virus in Study, RBC Says
By Kristen Hallam - Mar 8, 2011 7:27 AM ET
Gilead Sciences Inc. (GILD)’s four-drug combination eliminated hepatitis C virus in patients in an early-stage study, RBC Capital Markets LLC analysts said.
The findings support an ongoing mid-stage study of the combination, the analysts, led by Michael Yee in San Francisco, wrote yesterday in a note to investors, citing an abstract of the trial. The analysts said they expect data next year from a mid-stage study by the Foster City, California-based company.
The early-stage study examined a combination of Gilead’s GS-9256 and GS-9190 with two older drugs that are the standard of care, ribavirin and Peg-interferon, according to the note.
The data will be presented at the annual meeting of the European Association for the Study of the Liver starting March 30 in Berlin.
To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Source
Gilead Sciences Inc. (GILD)’s four-drug combination eliminated hepatitis C virus in patients in an early-stage study, RBC Capital Markets LLC analysts said.
The findings support an ongoing mid-stage study of the combination, the analysts, led by Michael Yee in San Francisco, wrote yesterday in a note to investors, citing an abstract of the trial. The analysts said they expect data next year from a mid-stage study by the Foster City, California-based company.
The early-stage study examined a combination of Gilead’s GS-9256 and GS-9190 with two older drugs that are the standard of care, ribavirin and Peg-interferon, according to the note.
The data will be presented at the annual meeting of the European Association for the Study of the Liver starting March 30 in Berlin.
To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Source
New Data on Multiple Bristol-Myers Squibb Investigational Hepatitis C Compounds to be Presented at The International Liver Congress 2011
March 07, 2011 01:51 PM Eastern Time
Data Demonstrate Focused Execution of the Company’s Hepatitis C R&D Strategy
PRINCETON, N.J.--(BUSINESS WIRE)--New Phase II data on multiple Bristol-Myers Squibb Company (NYSE: BMY) investigational hepatitis C compounds will be presented at The International Liver Congress (ILC), the 46th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany, from March 30 to April 2. The data presentations, including three late-breaker presentations, demonstrate the rigorous execution of the company’s strategy to develop potential improvements in the care of patients living with Hepatitis C infection by using multiple approaches to target the virus.
Bristol-Myers Squibb will present three late-breaker presentations, including a poster presentation of the first public disclosure of 12-week data on sustained virologic response (SVR) with the NS5A inhibitor BMS-790052 in combination with PEG-Interferon alpha-2a and ribavirin (IFNα/RBV) in treatment-naïve HCV patients. Additionally, SVR 12-week data on quadruple therapy with BMS-790052, the NS3 inhibitor BMS-650032 and IFNα/RBV in null responders will be presented in the late-breaker oral presentation session on Saturday, April 2. Complete early virology response (cEVR) data from the Phase IIb EMERGE study of PEG-Interferon lambda and ribavirin versus IFNα/RBV in treatment-naïve patients will also be presented in a late-breaker oral presentation.
“Bristol-Myers Squibb is focused on advancing the science to address significant unmet medical needs for patients with liver disease,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The data at the International Liver Congress reflect the breadth of our hepatitis C pipeline and the multiple approaches we are taking to bring forward potential new options for a disease that today impacts approximately 170 million people worldwide.”
BMS-790052 and BMS-650032 were discovered by Bristol-Myers Squibb Research and Development. PEG-Interferon lambda was discovered by ZymoGenetics, Inc., a wholly-owned subsidiary of Bristol-Myers Squibb.
The Bristol-Myers Squibb data presentations at ILC are as follows:
March 31
First report of SVR12 for a NS5A Replication complex inhibitor, BMS-790052 in combination with PEG-IFNα-2A and RBV: Phase 2a trial in treatment-naïve HCV-Genotype 1 subjects (Poster Board # 1373)
S. Pol
Hôpital Cochin
Paris, France
--------------------
April 1
In Vitro DAA combination studies to address HCV clinical findings (Poster Board # 803)
J.A. Lemm
Bristol-Myers Squibb
--------------------
April 1
BMS-766, A Novel HCV NS5a inhibitor with enhanced resistance coverage (Poster Board # 787)
M. Gao
Bristol-Myers Squibb
--------------------
April 1,
4:45 –5:00 p.m.
Characterization of Virologic Escape in HCV Genotype 1 Null responders receiving a combination of the NS3 protease inhibitor BMS-650032 and NS5A inhibitor BMS-790052 (Oral Session)
F. McPhee
Bristol-Myers Squibb
--------------------
April 2
BMS-650032, an NS3 inhibitor, in combination with Peginterferon Alfa-2a and Ribavirin in treatment-naïve subjects with genotype-1 chronic hepatitis C infection (Poster Board # 1195)
J. Bronowicki
Hôpital Adultes De Brabois
Vandoeuvre Les Nancy, France
--------------------
April 2
No early virologic breakthrough observed with the HCV NS3 protease inhibitor BMS-650032 in multiple dose monotherapy studies and Phase 2a combination studies with PEG-INF alpha/RBV (Poster Board # 1223)
F. McPhee
Bristol-Myers Squibb
--------------------
April 2
The burden of hepatitis C in Europe: a propensity analysis of patient outcomes (Poster Board # 1192)
M. daCosta
DiBonaventura
Kantar Health
New York, New York
--------------------
April 2
Estimating the incidence and prevalence of hepatitis C infection in England using back projection methods (Poster Board # 1166)
P. McEwan
Cardiff Research Consortium
Cardiff, UK
Swansea University
Swansea, UK
--------------------
April 2
Cost benefit analysis of response guided therapy: dynamic disease Markov modeling for patients with chronic hepatitis (HCV) by fibrosis stages (Poster Board # 1167)
P. McEwan
Cardiff Research Consortium
Cardiff, UK
Swansea University
Swansea, UK
--------------------
April 2,
3:30 – 5:30 p.m.
Pegylated Interferon-Lambda (PEGIFN-λ) shows superior viral response with improved safety and tolerability versus PEGIFNα-2A in HCV patients (G1/2/3/4): EMERGE Phase IIb through week 12 (Late-Breakers Oral Session)
S. Zeuzem
Klinikum der Johann-Wolfgang Goethe-Universität, Frankfurt/Main, Germany
--------------------
April 2,
3:30 – 5:30 p.m.
Quadruple therapy with BMS-790052, BMS-650032 and PEG-IFN/RBV for 24 weeks results in 100% SVR12 in HCV Genotype 1 null responders (Late-Breakers Oral Session)
A. Lok
University of Michigan
Ann Arbor, Michigan
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com/ or follow us on Twitter at http://twitter.com/bmsnews.
Contacts
Bristol-Myers Squibb
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com
Source
Data Demonstrate Focused Execution of the Company’s Hepatitis C R&D Strategy
PRINCETON, N.J.--(BUSINESS WIRE)--New Phase II data on multiple Bristol-Myers Squibb Company (NYSE: BMY) investigational hepatitis C compounds will be presented at The International Liver Congress (ILC), the 46th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany, from March 30 to April 2. The data presentations, including three late-breaker presentations, demonstrate the rigorous execution of the company’s strategy to develop potential improvements in the care of patients living with Hepatitis C infection by using multiple approaches to target the virus.
Bristol-Myers Squibb will present three late-breaker presentations, including a poster presentation of the first public disclosure of 12-week data on sustained virologic response (SVR) with the NS5A inhibitor BMS-790052 in combination with PEG-Interferon alpha-2a and ribavirin (IFNα/RBV) in treatment-naïve HCV patients. Additionally, SVR 12-week data on quadruple therapy with BMS-790052, the NS3 inhibitor BMS-650032 and IFNα/RBV in null responders will be presented in the late-breaker oral presentation session on Saturday, April 2. Complete early virology response (cEVR) data from the Phase IIb EMERGE study of PEG-Interferon lambda and ribavirin versus IFNα/RBV in treatment-naïve patients will also be presented in a late-breaker oral presentation.
“Bristol-Myers Squibb is focused on advancing the science to address significant unmet medical needs for patients with liver disease,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The data at the International Liver Congress reflect the breadth of our hepatitis C pipeline and the multiple approaches we are taking to bring forward potential new options for a disease that today impacts approximately 170 million people worldwide.”
BMS-790052 and BMS-650032 were discovered by Bristol-Myers Squibb Research and Development. PEG-Interferon lambda was discovered by ZymoGenetics, Inc., a wholly-owned subsidiary of Bristol-Myers Squibb.
The Bristol-Myers Squibb data presentations at ILC are as follows:
March 31
First report of SVR12 for a NS5A Replication complex inhibitor, BMS-790052 in combination with PEG-IFNα-2A and RBV: Phase 2a trial in treatment-naïve HCV-Genotype 1 subjects (Poster Board # 1373)
S. Pol
Hôpital Cochin
Paris, France
--------------------
April 1
In Vitro DAA combination studies to address HCV clinical findings (Poster Board # 803)
J.A. Lemm
Bristol-Myers Squibb
--------------------
April 1
BMS-766, A Novel HCV NS5a inhibitor with enhanced resistance coverage (Poster Board # 787)
M. Gao
Bristol-Myers Squibb
--------------------
April 1,
4:45 –5:00 p.m.
Characterization of Virologic Escape in HCV Genotype 1 Null responders receiving a combination of the NS3 protease inhibitor BMS-650032 and NS5A inhibitor BMS-790052 (Oral Session)
F. McPhee
Bristol-Myers Squibb
--------------------
April 2
BMS-650032, an NS3 inhibitor, in combination with Peginterferon Alfa-2a and Ribavirin in treatment-naïve subjects with genotype-1 chronic hepatitis C infection (Poster Board # 1195)
J. Bronowicki
Hôpital Adultes De Brabois
Vandoeuvre Les Nancy, France
--------------------
April 2
No early virologic breakthrough observed with the HCV NS3 protease inhibitor BMS-650032 in multiple dose monotherapy studies and Phase 2a combination studies with PEG-INF alpha/RBV (Poster Board # 1223)
F. McPhee
Bristol-Myers Squibb
--------------------
April 2
The burden of hepatitis C in Europe: a propensity analysis of patient outcomes (Poster Board # 1192)
M. daCosta
DiBonaventura
Kantar Health
New York, New York
--------------------
April 2
Estimating the incidence and prevalence of hepatitis C infection in England using back projection methods (Poster Board # 1166)
P. McEwan
Cardiff Research Consortium
Cardiff, UK
Swansea University
Swansea, UK
--------------------
April 2
Cost benefit analysis of response guided therapy: dynamic disease Markov modeling for patients with chronic hepatitis (HCV) by fibrosis stages (Poster Board # 1167)
P. McEwan
Cardiff Research Consortium
Cardiff, UK
Swansea University
Swansea, UK
--------------------
April 2,
3:30 – 5:30 p.m.
Pegylated Interferon-Lambda (PEGIFN-λ) shows superior viral response with improved safety and tolerability versus PEGIFNα-2A in HCV patients (G1/2/3/4): EMERGE Phase IIb through week 12 (Late-Breakers Oral Session)
S. Zeuzem
Klinikum der Johann-Wolfgang Goethe-Universität, Frankfurt/Main, Germany
--------------------
April 2,
3:30 – 5:30 p.m.
Quadruple therapy with BMS-790052, BMS-650032 and PEG-IFN/RBV for 24 weeks results in 100% SVR12 in HCV Genotype 1 null responders (Late-Breakers Oral Session)
A. Lok
University of Michigan
Ann Arbor, Michigan
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com/ or follow us on Twitter at http://twitter.com/bmsnews.
Contacts
Bristol-Myers Squibb
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com
Source
Merck Announces New Data Analyses for VICTRELIS™ (Boceprevir) will be Presented at The International Liver CongressTM / 2011 EASL Annual Meeting
March 07, 2011 10:44 AM Eastern Time
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that several new data analyses from Phase III studies of VICTRELIS™ (boceprevir), its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver (EASL) annual meeting. The meeting will be held from March 30 – April 3 in Berlin. In total, more than 20 abstracts highlighting Merck medicines and investigational therapies for chronic hepatitis C virus (HCV) infection will be presented, including 3 oral presentations and 17 posters for VICTRELIS.
Presented for the first time will be final results from a Phase III study of VICTRELIS administered in combination with Pegasys® (peginterferon alfa-2a) and ribavirin in adult patients with chronic HCV genotype 1 infection who were non-responders or relapsers to previous pegylated interferon and ribavirin therapy.
The EASL presentations will also include new analyses of the pivotal Phase III data for VICTRELIS administered in combination with PEGINTRON® (peginterferon alfa-2b) and ribavirin from the HCV SPRINT-2 and HCV RESPOND-2 studies:
• Response-guided therapy with VICTRELIS in combination with current standard therapy among patients with chronic HCV genotype 1, including special populations such as those with advanced fibrosis / cirrhosis;
• Overall safety profile of VICTRELIS administered in combination with current standard therapy for chronic HCV; and
• Potential predictive factors for chronic HCV treatment success, including response following 4 weeks of lead-in therapy and IL28B polymorphism.
The abstracts were published today and can be accessed on the EASL website. For program information, please visit http://www2.kenes.com/liver-congress/Pages/Home.aspx.
VICTRELIS (Boceprevir) Oral Presentations
Parallel Session: HCV Therapy, Thursday, March 31, 17:00 – 19:00, Hall 1
Boceprevir in Addition to Standard of Care Enhanced SVR in Hepatitis C Virus (HCV) Genotype-1 with Advanced Fibrosis/Cirrhosis: Subgroup Analysis of SPRINT-2 and RESPOND-2 Studies; S. Bruno et al. 17:15 – 17:30 CET
Boceprevir Resistance-Associated Variants (RAVS) are Observed More Frequently in HCV (Gt1)-Infected Patients with Poor Response to Peginterferon Alfa-2b/Ribavirin; S. Zeuzem et al. 17:45 – 18:00 CET
IL28B Polymorphism Predicts Virologic Response in Patients with Hepatitis C Genotype 1 Treated with Boceprevir (BOC) Combination Therapy. F. Poordad et al. 18:30 – 18:45 CET
VICTRELIS (Boceprevir) Key Poster Presentations
High Sustained Virologic Response (SVR) Among Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin When Re-Treated With Boceprevir Plus Peginterferon Alfa-2A/Ribavirin. S. Flamm et al. Late-Breaker Abstract 1366. Thursday, March 31.
Response-Guided Therapy with Boceprevir Plus Peginterferon Alfa-2b/Ribavirin Reduces Duration in Naive and Peginterferon Alfa-2b/Ribavirin Previous-Treatment-Failure Patients with HCV Genotype 1. M.P. Manns et al. Abstract 448. Thursday, March 31.
Overall Safety Profile of Boceprevir Plus Peginterferon Alfa-2b/Ribavirin. M.P. Manns et al. Abstract 449. Thursday, March 31.
Four-Week Therapy with Peginterferon Alfa-2b/Ribavirin Effectively Predicts Sustained Virologic Response in Treatment-Naïve and Previous-Treatment-Failure Patients with HCV-1 Treated with Boceprevir Plus Peginterferon Alfa-2b/Ribavirin. J.M. Viering et al. Abstract 481. Thursday, March 31.
Utility of Historical Data Compared to Lead-In Response in Predicting Sustained Virologic Response in Non-Responders and Relapsers to Peginterferon/Ribavirin When Re-Treated With Boceprevir+Peginterferon Alfa-2b/Ribavirin (P/R). R. Esteban et al. Abstract 418. Thursday, March 31.
About the HCV RESPOND-2 and HCV SPRINT-2 Studies
The HCV RESPOND-2 study in treatment-failure patients and the HCV SPRINT-2 study in previously untreated patients each evaluated two treatment strategies with VICTRELIS administered in combination with PEGINTRON and ribavirin to assess the ability to improve sustained virologic response (SVR) 1 and potentially shorten overall treatment duration compared to treatment with PEGINTRON and ribavirin alone:
• Response-guided therapy, in which treatment-failure patients with undetectable virus at week 8 were able to stop all treatment at 36 weeks, and in which previously untreated
• patients with undetectable virus during weeks 8 through 24 were able to stop all treatment at 28 weeks; and
• 48 weeks of treatment (4-week PEGINTRON and ribavirin lead-in followed by the addition of VICTRELIS for 44 weeks).
In both studies, all patients were treated with a 4-week lead-in of PEGINTRON (1.5 mcg/kg/week) and an investigational dose of ribavirin (600-1,400 mg/day), followed by the addition of VICTRELIS (800 mg three times a day).
As previously reported, the U.S. Food and Drug Administration has granted priority review status to the New Drug Application (NDA) for VICTRELIS and the Marketing Authorization Application (MAA) for VICTRELIS has been accepted for accelerated assessment by the European Medicines Agency. Data in the NDA and MAA have been provided in support of the proposed use of boceprevir for the treatment of chronic HCV genotype 1 infection, in combination with peginterferon alpha and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous 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. 2011 marks the 10-year anniversary of the introduction of PEGINTRON and ribavirin in combination therapy, a current standard therapy for chronic HCV worldwide. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.
About PEGINTRON
PEGINTRON is indicated for use in combination with ribavirin for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease.
The following points should be considered when initiating therapy with PEGINTRON in combination with ribavirin: (1) These indications are based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. (2) Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. (3) No safety and efficacy data are available for treatment of longer than one year.
PEGINTRON is also indicated for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age.
The following points should be considered when initiating therapy with PEGINTRON alone: Combination therapy with ribavirin is preferred over PEGINTRON monotherapy unless there are contraindications to, or significant intolerance of, ribavirin. Combination therapy provides substantially better response rates than monotherapy.
Selected Safety Information on PEGINTRON
WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON therapy.
Use with Ribavirin: Ribavirin may cause birth defects and death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.
Contraindications
PEGINTRON is contraindicated in patients with known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis to interferon alpha or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. PEGINTRON/ribavirin combination therapy is additionally contraindicated in women who are pregnant or may become pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL per min.
Pregnancy
Ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for six months after completion of therapy. If this drug is used during pregnancy, or if a patient becomes pregnant, the patient should be apprised of the potential hazard to a fetus. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for six months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Patients with the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:
• Hemolytic anemia with ribavirin
• Neuropsychiatric events
• History of significant or unstable cardiac disease
• Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that cannot be effectively treated by medication
• New or worsening ophthalmologic disorders
• Ischemic and hemorrhagic cerebrovascular events
• Severe decreases in neutrophil or platelet counts
• History of autoimmune disorders
• Pancreatitis and ulcerative or hemorrhagic/ischemic colitis and pancreatitis
• Pulmonary infiltrates or pulmonary function impairment
• Child-Pugh score greater than 6 (Class B and C)
• Increased creatinine levels in patients with renal insufficiency
• Serious, acute hypersensitivity reactions and cutaneous eruptions
• Dental/periodontal disorders reported with combination therapy
• Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL)
• Weight loss and growth inhibition reported with combination therapy in pediatric patients.
Life-threatening or fatal neuropsychiatric events, including suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior, sometimes directed towards others, have occurred in patients with and without a previous psychiatric disorder during PEGINTRON treatment and follow-up.
Adverse Events
Serious adverse reactions have occurred in approximately 12 percent of subjects in clinical trials. The most common serious events occurring in subjects treated with PEGINTRON and ribavirin were depression and suicidal ideation, each occurring at a frequency of less than 1 percent. The most common fatal events occurring in subjects treated with PEGINTRON and ribavirin were cardiac arrest, suicidal ideation, and suicide attempt, all occurring in less than 1 percent of subjects.
The incidence of serious adverse reactions was comparable between PEGINTRON monotherapy (about 12 percent) and PEGINTRON/ribavirin combination therapy weight-based (12 percent) or flat-dose (17 percent). In many but not all cases, adverse reactions resolved after dose reduction or discontinuation of therapy. Some patients experienced ongoing or new serious adverse reactions during the 6-month follow-up period. In a study with PEGINTRON/ribavirin (weight-based) combination therapy in adult patients, anemia with weight-based dosing occurred at an increased rate (29 percent vs. 19 percent); however, the majority of these cases were mild and responded to dose reductions. The incidence of serious adverse reactions reported for the weight-based ribavirin group was 12 percent. There were 31 deaths in clinical trials which occurred during treatment or during follow-up. Of the deaths, 19 were patients on either PEGINTRON or PEGINTRON/ribavirin combination therapy and three occurred during the follow-up period but had been on PEGINTRON/ribavirin combination therapy.
Additional serious adverse reactions seen in clinical trials at a frequency of equal to or less than 1 percent included psychosis, aggressive reaction, relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); cardiomyopathy, angina, pericardial effusion, retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (sepsis, pneumonia, abscess, cellulitis); emphysema, bronchiolitis obliterans, pleural effusion, gastroenteritis, pancreatitis, gout, hyperglycemia, hyperthyroidism and hypothyroidism, autoimmune thrombocytopenia with or without purpura, rheumatoid arthritis, interstitial nephritis, lupus-like syndrome, sarcoidosis, aggravated psoriasis, urticaria, injection site necrosis, vasculitis, and phototoxicity.
Greater than 96 percent of all subjects in clinical trials experienced one or more adverse events. Most common adverse reactions (greater than 40 percent) in adult patients receiving either PEGINTRON or PEGINTRON/ribavirin are injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and anxiety/emotional lability/irritability.
The adverse reaction profile was similar between weight-based and flat-dose PEGINTRON/ribavirin therapies. Weight-based PEGINTRON/ribavirin dosing resulted in increased rates of anemia. Most common adverse reactions with PEGINTRON/ribavirin (weight-based) therapy were psychiatric, which occurred among 68-69 percent of patients and included depression, irritability, and insomnia, each reported by approximately 30-40 percent of subjects in all treatment groups. Suicidal behavior (ideation, attempts, and suicides) occurred in 2 percent of all patients during treatment or during follow-up after treatment cessation. Other common reactions included injection site reactions, fatigue/ asthenia, headache, rigors, fever, nausea, myalgia, anxiety/emotional lability/irritability. The severity of some of these systemic symptoms tends to decrease as treatment continues.
Subjects receiving PEGINTRON/ribavirin as re-treatment after failing a previous interferon combination regimen reported adverse reactions similar to previous treatment-naïve patients receiving this regimen.
In general, the adverse reaction profile in the pediatric population was similar to that observed in adults. Most common adverse reactions (greater than 25 percent) in pediatric patients receiving PEGINTRON/ribavirin are pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, abdominal pain, and vomiting.
Please see full prescribing information at http://www.spfiles.com/pipeg-intron.pdf.
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 http://www.merck.com/.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (http://www.sec.gov/).
Please see attached Prescribing Information, Medication Guide, and Instructions for Use including Boxed Warning for PEGINTRON. The Prescribing Information, Medication Guide, and Instructions for Use are also available at http://www.spfiles.com/pipeg-intron.pdf, http://www.spfiles.com/mgpeg-intron.pdf and http://www.spfiles.com/ifupeg-intron.pdf.
Endnote
1 SVR, the protocol specified primary efficacy endpoint, 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™ and PEGINTRON® are trademarks of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA
Pegasys® is a trademark of its respective owner and is not a trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Source
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that several new data analyses from Phase III studies of VICTRELIS™ (boceprevir), its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver (EASL) annual meeting. The meeting will be held from March 30 – April 3 in Berlin. In total, more than 20 abstracts highlighting Merck medicines and investigational therapies for chronic hepatitis C virus (HCV) infection will be presented, including 3 oral presentations and 17 posters for VICTRELIS.
Presented for the first time will be final results from a Phase III study of VICTRELIS administered in combination with Pegasys® (peginterferon alfa-2a) and ribavirin in adult patients with chronic HCV genotype 1 infection who were non-responders or relapsers to previous pegylated interferon and ribavirin therapy.
The EASL presentations will also include new analyses of the pivotal Phase III data for VICTRELIS administered in combination with PEGINTRON® (peginterferon alfa-2b) and ribavirin from the HCV SPRINT-2 and HCV RESPOND-2 studies:
• Response-guided therapy with VICTRELIS in combination with current standard therapy among patients with chronic HCV genotype 1, including special populations such as those with advanced fibrosis / cirrhosis;
• Overall safety profile of VICTRELIS administered in combination with current standard therapy for chronic HCV; and
• Potential predictive factors for chronic HCV treatment success, including response following 4 weeks of lead-in therapy and IL28B polymorphism.
The abstracts were published today and can be accessed on the EASL website. For program information, please visit http://www2.kenes.com/liver-congress/Pages/Home.aspx.
VICTRELIS (Boceprevir) Oral Presentations
Parallel Session: HCV Therapy, Thursday, March 31, 17:00 – 19:00, Hall 1
Boceprevir in Addition to Standard of Care Enhanced SVR in Hepatitis C Virus (HCV) Genotype-1 with Advanced Fibrosis/Cirrhosis: Subgroup Analysis of SPRINT-2 and RESPOND-2 Studies; S. Bruno et al. 17:15 – 17:30 CET
Boceprevir Resistance-Associated Variants (RAVS) are Observed More Frequently in HCV (Gt1)-Infected Patients with Poor Response to Peginterferon Alfa-2b/Ribavirin; S. Zeuzem et al. 17:45 – 18:00 CET
IL28B Polymorphism Predicts Virologic Response in Patients with Hepatitis C Genotype 1 Treated with Boceprevir (BOC) Combination Therapy. F. Poordad et al. 18:30 – 18:45 CET
VICTRELIS (Boceprevir) Key Poster Presentations
High Sustained Virologic Response (SVR) Among Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin When Re-Treated With Boceprevir Plus Peginterferon Alfa-2A/Ribavirin. S. Flamm et al. Late-Breaker Abstract 1366. Thursday, March 31.
Response-Guided Therapy with Boceprevir Plus Peginterferon Alfa-2b/Ribavirin Reduces Duration in Naive and Peginterferon Alfa-2b/Ribavirin Previous-Treatment-Failure Patients with HCV Genotype 1. M.P. Manns et al. Abstract 448. Thursday, March 31.
Overall Safety Profile of Boceprevir Plus Peginterferon Alfa-2b/Ribavirin. M.P. Manns et al. Abstract 449. Thursday, March 31.
Four-Week Therapy with Peginterferon Alfa-2b/Ribavirin Effectively Predicts Sustained Virologic Response in Treatment-Naïve and Previous-Treatment-Failure Patients with HCV-1 Treated with Boceprevir Plus Peginterferon Alfa-2b/Ribavirin. J.M. Viering et al. Abstract 481. Thursday, March 31.
Utility of Historical Data Compared to Lead-In Response in Predicting Sustained Virologic Response in Non-Responders and Relapsers to Peginterferon/Ribavirin When Re-Treated With Boceprevir+Peginterferon Alfa-2b/Ribavirin (P/R). R. Esteban et al. Abstract 418. Thursday, March 31.
About the HCV RESPOND-2 and HCV SPRINT-2 Studies
The HCV RESPOND-2 study in treatment-failure patients and the HCV SPRINT-2 study in previously untreated patients each evaluated two treatment strategies with VICTRELIS administered in combination with PEGINTRON and ribavirin to assess the ability to improve sustained virologic response (SVR) 1 and potentially shorten overall treatment duration compared to treatment with PEGINTRON and ribavirin alone:
• Response-guided therapy, in which treatment-failure patients with undetectable virus at week 8 were able to stop all treatment at 36 weeks, and in which previously untreated
• patients with undetectable virus during weeks 8 through 24 were able to stop all treatment at 28 weeks; and
• 48 weeks of treatment (4-week PEGINTRON and ribavirin lead-in followed by the addition of VICTRELIS for 44 weeks).
In both studies, all patients were treated with a 4-week lead-in of PEGINTRON (1.5 mcg/kg/week) and an investigational dose of ribavirin (600-1,400 mg/day), followed by the addition of VICTRELIS (800 mg three times a day).
As previously reported, the U.S. Food and Drug Administration has granted priority review status to the New Drug Application (NDA) for VICTRELIS and the Marketing Authorization Application (MAA) for VICTRELIS has been accepted for accelerated assessment by the European Medicines Agency. Data in the NDA and MAA have been provided in support of the proposed use of boceprevir for the treatment of chronic HCV genotype 1 infection, in combination with peginterferon alpha and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous 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. 2011 marks the 10-year anniversary of the introduction of PEGINTRON and ribavirin in combination therapy, a current standard therapy for chronic HCV worldwide. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.
About PEGINTRON
PEGINTRON is indicated for use in combination with ribavirin for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease.
The following points should be considered when initiating therapy with PEGINTRON in combination with ribavirin: (1) These indications are based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. (2) Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. (3) No safety and efficacy data are available for treatment of longer than one year.
PEGINTRON is also indicated for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age.
The following points should be considered when initiating therapy with PEGINTRON alone: Combination therapy with ribavirin is preferred over PEGINTRON monotherapy unless there are contraindications to, or significant intolerance of, ribavirin. Combination therapy provides substantially better response rates than monotherapy.
Selected Safety Information on PEGINTRON
WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON therapy.
Use with Ribavirin: Ribavirin may cause birth defects and death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.
Contraindications
PEGINTRON is contraindicated in patients with known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis to interferon alpha or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. PEGINTRON/ribavirin combination therapy is additionally contraindicated in women who are pregnant or may become pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL per min.
Pregnancy
Ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for six months after completion of therapy. If this drug is used during pregnancy, or if a patient becomes pregnant, the patient should be apprised of the potential hazard to a fetus. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for six months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Patients with the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:
• Hemolytic anemia with ribavirin
• Neuropsychiatric events
• History of significant or unstable cardiac disease
• Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that cannot be effectively treated by medication
• New or worsening ophthalmologic disorders
• Ischemic and hemorrhagic cerebrovascular events
• Severe decreases in neutrophil or platelet counts
• History of autoimmune disorders
• Pancreatitis and ulcerative or hemorrhagic/ischemic colitis and pancreatitis
• Pulmonary infiltrates or pulmonary function impairment
• Child-Pugh score greater than 6 (Class B and C)
• Increased creatinine levels in patients with renal insufficiency
• Serious, acute hypersensitivity reactions and cutaneous eruptions
• Dental/periodontal disorders reported with combination therapy
• Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL)
• Weight loss and growth inhibition reported with combination therapy in pediatric patients.
Life-threatening or fatal neuropsychiatric events, including suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior, sometimes directed towards others, have occurred in patients with and without a previous psychiatric disorder during PEGINTRON treatment and follow-up.
Adverse Events
Serious adverse reactions have occurred in approximately 12 percent of subjects in clinical trials. The most common serious events occurring in subjects treated with PEGINTRON and ribavirin were depression and suicidal ideation, each occurring at a frequency of less than 1 percent. The most common fatal events occurring in subjects treated with PEGINTRON and ribavirin were cardiac arrest, suicidal ideation, and suicide attempt, all occurring in less than 1 percent of subjects.
The incidence of serious adverse reactions was comparable between PEGINTRON monotherapy (about 12 percent) and PEGINTRON/ribavirin combination therapy weight-based (12 percent) or flat-dose (17 percent). In many but not all cases, adverse reactions resolved after dose reduction or discontinuation of therapy. Some patients experienced ongoing or new serious adverse reactions during the 6-month follow-up period. In a study with PEGINTRON/ribavirin (weight-based) combination therapy in adult patients, anemia with weight-based dosing occurred at an increased rate (29 percent vs. 19 percent); however, the majority of these cases were mild and responded to dose reductions. The incidence of serious adverse reactions reported for the weight-based ribavirin group was 12 percent. There were 31 deaths in clinical trials which occurred during treatment or during follow-up. Of the deaths, 19 were patients on either PEGINTRON or PEGINTRON/ribavirin combination therapy and three occurred during the follow-up period but had been on PEGINTRON/ribavirin combination therapy.
Additional serious adverse reactions seen in clinical trials at a frequency of equal to or less than 1 percent included psychosis, aggressive reaction, relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); cardiomyopathy, angina, pericardial effusion, retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (sepsis, pneumonia, abscess, cellulitis); emphysema, bronchiolitis obliterans, pleural effusion, gastroenteritis, pancreatitis, gout, hyperglycemia, hyperthyroidism and hypothyroidism, autoimmune thrombocytopenia with or without purpura, rheumatoid arthritis, interstitial nephritis, lupus-like syndrome, sarcoidosis, aggravated psoriasis, urticaria, injection site necrosis, vasculitis, and phototoxicity.
Greater than 96 percent of all subjects in clinical trials experienced one or more adverse events. Most common adverse reactions (greater than 40 percent) in adult patients receiving either PEGINTRON or PEGINTRON/ribavirin are injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and anxiety/emotional lability/irritability.
The adverse reaction profile was similar between weight-based and flat-dose PEGINTRON/ribavirin therapies. Weight-based PEGINTRON/ribavirin dosing resulted in increased rates of anemia. Most common adverse reactions with PEGINTRON/ribavirin (weight-based) therapy were psychiatric, which occurred among 68-69 percent of patients and included depression, irritability, and insomnia, each reported by approximately 30-40 percent of subjects in all treatment groups. Suicidal behavior (ideation, attempts, and suicides) occurred in 2 percent of all patients during treatment or during follow-up after treatment cessation. Other common reactions included injection site reactions, fatigue/ asthenia, headache, rigors, fever, nausea, myalgia, anxiety/emotional lability/irritability. The severity of some of these systemic symptoms tends to decrease as treatment continues.
Subjects receiving PEGINTRON/ribavirin as re-treatment after failing a previous interferon combination regimen reported adverse reactions similar to previous treatment-naïve patients receiving this regimen.
In general, the adverse reaction profile in the pediatric population was similar to that observed in adults. Most common adverse reactions (greater than 25 percent) in pediatric patients receiving PEGINTRON/ribavirin are pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, abdominal pain, and vomiting.
Please see full prescribing information at http://www.spfiles.com/pipeg-intron.pdf.
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 http://www.merck.com/.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (http://www.sec.gov/).
Please see attached Prescribing Information, Medication Guide, and Instructions for Use including Boxed Warning for PEGINTRON. The Prescribing Information, Medication Guide, and Instructions for Use are also available at http://www.spfiles.com/pipeg-intron.pdf, http://www.spfiles.com/mgpeg-intron.pdf and http://www.spfiles.com/ifupeg-intron.pdf.
Endnote
1 SVR, the protocol specified primary efficacy endpoint, 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™ and PEGINTRON® are trademarks of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA
Pegasys® is a trademark of its respective owner and is not a trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Source
Peregrine's Bavituximab HCV Abstract Accepted for Presentation at the 46th Annual Meeting of EASL
Mar 07, 2011 08:00 ET
TUSTIN, CA--(Marketwire - March 7, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that data from the company's Phase Ib dose escalation safety study of bavituximab in patients coinfected with chronic hepatitis C virus (HCV) and HIV has been accepted for presentation at the 46th annual meeting of the European Association for the Study of the Liver (EASL) taking place in Berlin, Germany from March 30 to April 3, 2011.
The abstract can be accessed through the EASL website http://www2.kenes.com/liver-congress/Pages/Home.aspx. In accordance with the EASL embargo policy, the accepted abstract titled "Escalating Repeat Dose Study of Bavituximab in Patients Co-infected with Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus" (poster 1239) will be presented in a poster session on Saturday, April 2, 2011.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com/), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com/.
Peregrine Contact:
Amy Figueroa
Peregrine Pharmaceuticals
(800) 987-8256
info@peregrineinc.com
Source
TUSTIN, CA--(Marketwire - March 7, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that data from the company's Phase Ib dose escalation safety study of bavituximab in patients coinfected with chronic hepatitis C virus (HCV) and HIV has been accepted for presentation at the 46th annual meeting of the European Association for the Study of the Liver (EASL) taking place in Berlin, Germany from March 30 to April 3, 2011.
The abstract can be accessed through the EASL website http://www2.kenes.com/liver-congress/Pages/Home.aspx. In accordance with the EASL embargo policy, the accepted abstract titled "Escalating Repeat Dose Study of Bavituximab in Patients Co-infected with Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus" (poster 1239) will be presented in a poster session on Saturday, April 2, 2011.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com/), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com/.
Peregrine Contact:
Amy Figueroa
Peregrine Pharmaceuticals
(800) 987-8256
info@peregrineinc.com
Source
New Data on Telaprevir and VX-222 for the Treatment of Hepatitis C Accepted For Presentation at EASL Annual Meeting
- Complete results from pivotal Phase 3 REALIZE study of telaprevir in people who had not achieved a viral cure (SVR) with currently available medicines -
- First presentation of data from ongoing Phase 2 study evaluating response-guided, 12- and 24-week regimens of telaprevir and VX-222 combined with pegylated-interferon and ribavirin -
- Analyses of the relationship between IL28B genotype status on viral cure rates from two Phase 3 studies -
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that 15 abstracts on the company's medicines in development for hepatitis C, including its protease inhibitor, telaprevir, and polymerase inhibitor, VX-222, were accepted for presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany, March 30 to April 3, 2011.
Highlights of data presentations include:
• Complete results from the pivotal Phase 3 REALIZE study will be presented for the first time. Topline results from this study, which evaluated telaprevir in combination with pegylated-interferon and ribavirin in people who had not achieved a viral cure (SVR) with currently available medicines, were announced in September 2010.
• The first data from an ongoing Phase 2 study evaluating 12- and 24-week response-guided regimens of telaprevir and VX-222 in combination with pegylated-interferon and ribavirin will be presented during a late-breaker session (Abstract #1363).
• Retrospective analyses of the relationship between IL28B genotype status and rates of viral cure with telaprevir-based combination therapy from the pivotal Phase 3 studies of REALIZE and ADVANCE will also be presented.
The titles of the abstracts related to Vertex's medicines in development for hepatitis C are included below and the complete abstracts are now available through the EASL website at http://www.easl.eu/.
"This is an exciting time for the treatment of hepatitis C and for Vertex," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "At EASL, we will present, for the first time, complete results from the Phase 3 REALIZE study and early findings of a new study evaluating both of our oral medicines in development for hepatitis C, telaprevir and VX-222 in combination with available medicines."
The regulatory applications for the approval of telaprevir have been granted Priority Review by the U.S. Food and Drug Administration (FDA) and Health Canada and accelerated assessment by the European Medicines Agency for the treatment of people chronically infected with genotype 1 hepatitis C virus (HCV). The applications include data from three registrational studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people with hepatitis C who were new to treatment as well as those who did not achieve a viral cure after treatment with currently available medicines. For complete information on the telaprevir clinical trials or a fact sheet on the trial designs visit: www.vrtx.com/press.cfm.
Oral Presentations
• "REALIZE Trial Final Results: Telaprevir-based Regimen in Genotype 1 Hepatitis C Virus infection in Patients with Prior Null Response, Partial Response or Relapse to Peginterferon/Ribavirin"; March 31, 2011, 4:15 - 4:30 p.m. CET.
• "Subanalyses of the telaprevir lead-in arm in the REALIZE study: response at week 4 is not a substitute for prior null response categorization"; March 31, 2011, 5:00 - 5:15 p.m. CET.
• "Evolution of Treatment-Emergent Resistant Variants in Telaprevir Phase 3 Clinical Trials (ADVANCE, ILLUMINATE, REALIZE)"; March 31, 2011, 5:30 - 5:45 p.m. CET.
• "Similar SVR Rates in IL28B CC, CT or TT Prior Relapsers, Partial- or Null-Responders Patients Treated with Telaprevir/Peginterferon/ Ribavirin: Retrospective Analysis of the REALIZE Study"; March 31, 2011, 6:45 - 7:00 p.m. CET.
Poster Presentations
• Late Breaker #1363: "VX-222 with TVR Alone or in Combination with Peginterferon ALFA-2A and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C: ZENITH Study Interim Results"; March 31 — April 2, 2011.
• Late Breaker #1369: "Telaprevir Substantially Improved SVR Rates Across All IL28B Genotypes in ADVANCE Trial"; March 31 — April 2, 2011.
• #451: "Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin: Analyses of Pre-Defined Subpopulations in the Phase 3 ADVANCE Trial"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #415: "Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin Increased Sustained Virologic Response Rates in Treatment-Naïve Patients Regardless of Race or Ethnicity"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #477: "Anemia Had no Effect on Efficacy Outcomes in Treatment-Naïve Patients who Received Telaprevir-Based Regimen in the ADVANCE and ILLUMINATE Phase 3 Studies"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #400: "Modeling, Clinical and Virology Data From Phase 2 and 3 Studies Support 12-week Telaprevir Duration In Combination with 24- or 48-week Peginterferon/Ribavirin Duration"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #1202: "Characterization of HCV Variants in Non-SVR Patients in the REALIZE Study Suggests that Telaprevir Exhibits a Consistent resistance profile Irrespective of a Lead-in", April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1244: "The Pharmacokinetic Interaction between Methadone and the Investigational HCV Protease Inhibitor Telaprevir"; April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1245: "The Effect of Severe Renal Impairment on the Pharmacokinetics of the Investigational HCV Protease Inhibitor Telaprevir"; April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1208: "Impact of Telaprevir-based Treatment Regimens on Fatigue in Genotype 1 HCV Treatment-naïve Patients: Results from ADVANCE and ILLUMINATE Studies"; April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1242: "Long-term Follow-up of Chronic Hepatitis C Infected Patients Treated with Telaprevir: Evaluation of Persistence of Resistant Variants by Ultra-deep Sequencing"; April 2, 2011, 12:30 — 1:30 p.m. CET.
About Telaprevir and VX-222
Vertex has two oral medicines in late-stage development for the treatment of hepatitis C: telaprevir and VX-222. Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies. Vertex has received priority review for its applications for the approval of telaprevir by the U.S. FDA and Health Canada.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
VX-222 is an investigational, oral, non-nucleoside inhibitor of HCV NS5B polymerase. VX-222 is currently being evaluated in combination with telaprevir, pegylated-interferon and ribavirin in a Phase 2 study. Vertex has worldwide commercial rights for VX-222.
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 Approximately 60 percent of genotype 1 hepatitis C patients who undergo treatment with an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,2,3,4 or viral cure.5 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10
More than 170 million people worldwide are chronically infected with hepatitis C. In the United States, up to 3.9 million people have chronic hepatitis C and of those, 75 percent are unaware of their infection.11 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 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.7 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.10
PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements regarding the data from clinical trials involving telaprevir and/or VX-222 that Vertex expects to feature in poster and oral presentations at EASL, March 30 to April 3, 2011. While Vertex believes these data will be presented at EASL, it is possible that future developments could adversely affect the content, timing or form of those presentations.
About Vertex
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize 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.
For more information and to view Vertex's press releases, please visit http://www.vrtx.com/.
(VRTX - GEN)
References:
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 May 25, 2010.
2 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.
3 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.
4 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.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
6 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).
7 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.
8 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.
9 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.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 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. 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 May 25, 2010.
Vertex Contacts:
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
Source: Vertex Pharmaceuticals
News Provided by Acquire Media
Source
- First presentation of data from ongoing Phase 2 study evaluating response-guided, 12- and 24-week regimens of telaprevir and VX-222 combined with pegylated-interferon and ribavirin -
- Analyses of the relationship between IL28B genotype status on viral cure rates from two Phase 3 studies -
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that 15 abstracts on the company's medicines in development for hepatitis C, including its protease inhibitor, telaprevir, and polymerase inhibitor, VX-222, were accepted for presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany, March 30 to April 3, 2011.
Highlights of data presentations include:
• Complete results from the pivotal Phase 3 REALIZE study will be presented for the first time. Topline results from this study, which evaluated telaprevir in combination with pegylated-interferon and ribavirin in people who had not achieved a viral cure (SVR) with currently available medicines, were announced in September 2010.
• The first data from an ongoing Phase 2 study evaluating 12- and 24-week response-guided regimens of telaprevir and VX-222 in combination with pegylated-interferon and ribavirin will be presented during a late-breaker session (Abstract #1363).
• Retrospective analyses of the relationship between IL28B genotype status and rates of viral cure with telaprevir-based combination therapy from the pivotal Phase 3 studies of REALIZE and ADVANCE will also be presented.
The titles of the abstracts related to Vertex's medicines in development for hepatitis C are included below and the complete abstracts are now available through the EASL website at http://www.easl.eu/.
"This is an exciting time for the treatment of hepatitis C and for Vertex," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "At EASL, we will present, for the first time, complete results from the Phase 3 REALIZE study and early findings of a new study evaluating both of our oral medicines in development for hepatitis C, telaprevir and VX-222 in combination with available medicines."
The regulatory applications for the approval of telaprevir have been granted Priority Review by the U.S. Food and Drug Administration (FDA) and Health Canada and accelerated assessment by the European Medicines Agency for the treatment of people chronically infected with genotype 1 hepatitis C virus (HCV). The applications include data from three registrational studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people with hepatitis C who were new to treatment as well as those who did not achieve a viral cure after treatment with currently available medicines. For complete information on the telaprevir clinical trials or a fact sheet on the trial designs visit: www.vrtx.com/press.cfm.
Oral Presentations
• "REALIZE Trial Final Results: Telaprevir-based Regimen in Genotype 1 Hepatitis C Virus infection in Patients with Prior Null Response, Partial Response or Relapse to Peginterferon/Ribavirin"; March 31, 2011, 4:15 - 4:30 p.m. CET.
• "Subanalyses of the telaprevir lead-in arm in the REALIZE study: response at week 4 is not a substitute for prior null response categorization"; March 31, 2011, 5:00 - 5:15 p.m. CET.
• "Evolution of Treatment-Emergent Resistant Variants in Telaprevir Phase 3 Clinical Trials (ADVANCE, ILLUMINATE, REALIZE)"; March 31, 2011, 5:30 - 5:45 p.m. CET.
• "Similar SVR Rates in IL28B CC, CT or TT Prior Relapsers, Partial- or Null-Responders Patients Treated with Telaprevir/Peginterferon/ Ribavirin: Retrospective Analysis of the REALIZE Study"; March 31, 2011, 6:45 - 7:00 p.m. CET.
Poster Presentations
• Late Breaker #1363: "VX-222 with TVR Alone or in Combination with Peginterferon ALFA-2A and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C: ZENITH Study Interim Results"; March 31 — April 2, 2011.
• Late Breaker #1369: "Telaprevir Substantially Improved SVR Rates Across All IL28B Genotypes in ADVANCE Trial"; March 31 — April 2, 2011.
• #451: "Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin: Analyses of Pre-Defined Subpopulations in the Phase 3 ADVANCE Trial"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #415: "Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin Increased Sustained Virologic Response Rates in Treatment-Naïve Patients Regardless of Race or Ethnicity"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #477: "Anemia Had no Effect on Efficacy Outcomes in Treatment-Naïve Patients who Received Telaprevir-Based Regimen in the ADVANCE and ILLUMINATE Phase 3 Studies"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #400: "Modeling, Clinical and Virology Data From Phase 2 and 3 Studies Support 12-week Telaprevir Duration In Combination with 24- or 48-week Peginterferon/Ribavirin Duration"; March 31, 2011, 1:30 — 2:30 p.m. CET.
• #1202: "Characterization of HCV Variants in Non-SVR Patients in the REALIZE Study Suggests that Telaprevir Exhibits a Consistent resistance profile Irrespective of a Lead-in", April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1244: "The Pharmacokinetic Interaction between Methadone and the Investigational HCV Protease Inhibitor Telaprevir"; April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1245: "The Effect of Severe Renal Impairment on the Pharmacokinetics of the Investigational HCV Protease Inhibitor Telaprevir"; April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1208: "Impact of Telaprevir-based Treatment Regimens on Fatigue in Genotype 1 HCV Treatment-naïve Patients: Results from ADVANCE and ILLUMINATE Studies"; April 2, 2011, 12:30 — 1:30 p.m. CET.
• #1242: "Long-term Follow-up of Chronic Hepatitis C Infected Patients Treated with Telaprevir: Evaluation of Persistence of Resistant Variants by Ultra-deep Sequencing"; April 2, 2011, 12:30 — 1:30 p.m. CET.
About Telaprevir and VX-222
Vertex has two oral medicines in late-stage development for the treatment of hepatitis C: telaprevir and VX-222. Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies. Vertex has received priority review for its applications for the approval of telaprevir by the U.S. FDA and Health Canada.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
VX-222 is an investigational, oral, non-nucleoside inhibitor of HCV NS5B polymerase. VX-222 is currently being evaluated in combination with telaprevir, pegylated-interferon and ribavirin in a Phase 2 study. Vertex has worldwide commercial rights for VX-222.
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 Approximately 60 percent of genotype 1 hepatitis C patients who undergo treatment with an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,2,3,4 or viral cure.5 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10
More than 170 million people worldwide are chronically infected with hepatitis C. In the United States, up to 3.9 million people have chronic hepatitis C and of those, 75 percent are unaware of their infection.11 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 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.7 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.10
PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements regarding the data from clinical trials involving telaprevir and/or VX-222 that Vertex expects to feature in poster and oral presentations at EASL, March 30 to April 3, 2011. While Vertex believes these data will be presented at EASL, it is possible that future developments could adversely affect the content, timing or form of those presentations.
About Vertex
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize 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.
For more information and to view Vertex's press releases, please visit http://www.vrtx.com/.
(VRTX - GEN)
References:
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 May 25, 2010.
2 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.
3 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.
4 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.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
6 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).
7 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.
8 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.
9 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.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 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. 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 May 25, 2010.
Vertex Contacts:
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
Source: Vertex Pharmaceuticals
News Provided by Acquire Media
Source
Interventional and combined approaches show promise in advanced liver Cancer
03/07/2011
Emerging interventional techniques appear promising for the treatment of hepatic tumours, even those at advanced stages. Attendees at the special focus session on transarterial procedures, taking place today at ECR, will find out just how far these techniques, as well as combined approaches, have gone.
Surgery and liver transplantation are being widely used to treat hepatocellular carcinoma (HCC), incidence of which has increased steadily, particularly due to the spread of the hepatitis C virus.
For around 80% of liver cancer patients, surgical options are no longer viable once the disease has been diagnosed, which means the patients become candidates for interventional approaches. Radiofrequency (RF) ablation is an effective option for patients with early-stage HCC, particularly if the tumour is no larger than 3–5 cm in diameter. For patients at an intermediate or advanced stage, because HCC is highly chemoresistant, the traditional method of classical systemic infusion chemotherapy is not very effective.
Chemotherapeutic agents such as doxorubicin must thus be infused locally in high concentrations into the artery supplying the tumour. After local application using a catheter, arterial flow to the tumour must be blocked by embolisation. This method, transarterial chemo-embolisation (TACE), has shown promise in randomised trials. Furthermore, drug-eluting beads allow small particles to be loaded with the chemotherapeutic agent to transport doxorubicin directly into the tumour, blocking arterial flow at the same time. Results published from a European multicentre randomised study (Johannes Lammer et al, Cardiovasc. Intervent. Radiol. 2009) show improved outcome compared to conventional TACE. Drug-eluting beads used with doxorubicin are now attracting attention as a palliative life-prolonging treatment. Compared with conventional TACE, drug-eluting beads have significantly fewer adverse side effects because the therapeutic agent remains in the tumour and does not circulate in the patient’s body.
“In terms of therapy options, this is likely to be news to many radiologists. It’s important for them to know that even for patients with advanced tumours there is now a viable treatment,” said session moderator Prof. Johannes Lammer, director of cardiovascular and interventional radiology at Vienna’s Medical University.
Another study published last year in Cardiovascular Interventional Radiology by Dr. Katarina Malagari demonstrated that chemo-embolisation using drug-eluting beads was significantly better in terms of subjective patient response and time to progression compared to bland embolisation.
Also under evaluation in large European multicentre studies is another therapeutic option that involves radioembolisation using beta-emitting Yttrium particles injected into the tumour-feeding artery. This highly effective local radiation can kill the tumour cells without damaging the liver. Additionally, therapies combining TACE with drug-eluting beads and RF ablation are being studied in a multicentre randomised trial now in its second year.
“TACE can first reduce the size of the tumour, so that those patients who aren’t candidates for surgery, or whose tumours are a little too large for ablation, can still profit from curative ablation rather than palliative treatment,” Lammer said.
“The efficacy of a combination therapy, including RFA plus the intra-arterial administration of drug-eluting beads has been recently demonstrated, while the use of intravenously administered, thermally sensitive drug carriers is currently being explored,” added Professor Riccardo Lencioni, Director of Diagnostic Imaging and Intervention at Cisanello University Hospital in Pisa. Experimental studies in animal tumour models have shown that lowering the temperature threshold at which cell death occurs by combining sublethal heating with cell exposure to chemotherapeutic agents is an attractive alternate strategy for increasing tumour necrosis.
Despite the advances in local treatment, the long-term outcome of treated patients remains unsatisfactory because new tumours emerge within five years in about 80% of the cases. Adjuvant molecular targeted therapies with anti-angiogenic and anti-proliferative activity may prove useful in preventing early recurrence after successful ablation. Clinical trials of these methods are currently ongoing. Surgery remains the gold standard in HCC therapy. But if research over the next couple of years proves that a combined approach is effective, its routine use in the clinical setting will increase, to the benefit of patients, experts predict.
Source
Emerging interventional techniques appear promising for the treatment of hepatic tumours, even those at advanced stages. Attendees at the special focus session on transarterial procedures, taking place today at ECR, will find out just how far these techniques, as well as combined approaches, have gone.
Surgery and liver transplantation are being widely used to treat hepatocellular carcinoma (HCC), incidence of which has increased steadily, particularly due to the spread of the hepatitis C virus.
For around 80% of liver cancer patients, surgical options are no longer viable once the disease has been diagnosed, which means the patients become candidates for interventional approaches. Radiofrequency (RF) ablation is an effective option for patients with early-stage HCC, particularly if the tumour is no larger than 3–5 cm in diameter. For patients at an intermediate or advanced stage, because HCC is highly chemoresistant, the traditional method of classical systemic infusion chemotherapy is not very effective.
Chemotherapeutic agents such as doxorubicin must thus be infused locally in high concentrations into the artery supplying the tumour. After local application using a catheter, arterial flow to the tumour must be blocked by embolisation. This method, transarterial chemo-embolisation (TACE), has shown promise in randomised trials. Furthermore, drug-eluting beads allow small particles to be loaded with the chemotherapeutic agent to transport doxorubicin directly into the tumour, blocking arterial flow at the same time. Results published from a European multicentre randomised study (Johannes Lammer et al, Cardiovasc. Intervent. Radiol. 2009) show improved outcome compared to conventional TACE. Drug-eluting beads used with doxorubicin are now attracting attention as a palliative life-prolonging treatment. Compared with conventional TACE, drug-eluting beads have significantly fewer adverse side effects because the therapeutic agent remains in the tumour and does not circulate in the patient’s body.
“In terms of therapy options, this is likely to be news to many radiologists. It’s important for them to know that even for patients with advanced tumours there is now a viable treatment,” said session moderator Prof. Johannes Lammer, director of cardiovascular and interventional radiology at Vienna’s Medical University.
Another study published last year in Cardiovascular Interventional Radiology by Dr. Katarina Malagari demonstrated that chemo-embolisation using drug-eluting beads was significantly better in terms of subjective patient response and time to progression compared to bland embolisation.
Also under evaluation in large European multicentre studies is another therapeutic option that involves radioembolisation using beta-emitting Yttrium particles injected into the tumour-feeding artery. This highly effective local radiation can kill the tumour cells without damaging the liver. Additionally, therapies combining TACE with drug-eluting beads and RF ablation are being studied in a multicentre randomised trial now in its second year.
“TACE can first reduce the size of the tumour, so that those patients who aren’t candidates for surgery, or whose tumours are a little too large for ablation, can still profit from curative ablation rather than palliative treatment,” Lammer said.
“The efficacy of a combination therapy, including RFA plus the intra-arterial administration of drug-eluting beads has been recently demonstrated, while the use of intravenously administered, thermally sensitive drug carriers is currently being explored,” added Professor Riccardo Lencioni, Director of Diagnostic Imaging and Intervention at Cisanello University Hospital in Pisa. Experimental studies in animal tumour models have shown that lowering the temperature threshold at which cell death occurs by combining sublethal heating with cell exposure to chemotherapeutic agents is an attractive alternate strategy for increasing tumour necrosis.
Despite the advances in local treatment, the long-term outcome of treated patients remains unsatisfactory because new tumours emerge within five years in about 80% of the cases. Adjuvant molecular targeted therapies with anti-angiogenic and anti-proliferative activity may prove useful in preventing early recurrence after successful ablation. Clinical trials of these methods are currently ongoing. Surgery remains the gold standard in HCC therapy. But if research over the next couple of years proves that a combined approach is effective, its routine use in the clinical setting will increase, to the benefit of patients, experts predict.
Source
Positive Phase 2 Interim Data from First Study of Telaprevir in People Co-Infected with Hepatitis C and HIV Presented at CROI Conference
CROI: Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions - (03/2/11)
CROI: Pharmacokinetic Interactions Between Antiretroviral Agents and the Investigational HCV Protease Inhibitor Telaprevir in Healthy Volunteers - (03/2/11)
from Jules of NATAP: the study was done in patients on Reyataz or efavirenz, darunavir and other protease inhibitors are not to be used right now with telaprevir due t drug drug interactions, although darunavir will be revisited, raltegravir interactions will soon be studied but an interaction with telaprevir is not expected.
- Early results from ongoing study showed that the hepatitis C virus was undetectable by week 4 in 70% of people treated with telaprevir-based combination therapy -
BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today interim results from an ongoing, two-part (A and B), Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV), also known as HCV-HIV co-infection. All people in this study were new to hepatitis C treatment. Part A of the study is evaluating telaprevir in people who are not currently being treated with antiretroviral therapy (ART) for HIV infection. Part B of the study is evaluating telaprevir in people receiving Atripla® or a Reyataz®-based regimen for HIV. These initial HIV regimens were selected based on current HIV treatment guidelines1 and data from drug-drug interaction studies of telaprevir and commonly used ART medicines. Data from the co-infection study were presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) taking place February 27 to March 2, 2011 in Boston.
The primary endpoint of the study is to evaluate the safety and tolerability of telaprevir-based combination therapy in people co-infected with hepatitis C and HIV. The interim analysis was conducted when all patients had reached week 4 of treatment. At that time, 70 percent (n=26/37) of people in the study (Parts A and B) who received telaprevir-based combination therapy had undetectable hepatitis C virus by week 4 (rapid viral response, RVR) compared to 5 percent (n=1/22) of people who received pegylated-interferon and ribavirin alone. HIV viral load and CD4 counts were stable among patients receiving a telaprevir-based regimen. Adverse events that occurred more frequently (≥10% difference) in the telaprevir arms compared to placebo were pruritus, nausea, dizziness, pyrexia, anorexia and vomiting. The majority of adverse events were mild or moderate.
"Research in hepatitis C has shown that people who respond early to treatment have a higher likelihood of achieving a viral cure," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. "These interim results are encouraging because they showed a high proportion of people in the study had a rapid viral response to telaprevir. We will use what we are learning from this study to inform the design of a Phase 3 co-infection study of telaprevir planned for the end of the year."
Interim Study Results
Sixty people were enrolled in this Phase 2 study. At the time of the analysis, all study participants had reached week 4 of treatment and 69 percent of patients (n=41/59) had completed a week 12 assessment. Data on one patient were not available when the analysis was performed. The preliminary results from this study are based on an interim analysis of 59 patients. For the purposes of this analysis, the 12-week results do not include patients who were still on treatment but had not yet reached the 12-week time point in the study.
Atripla (efavirenz, tenofovir disoproxil fumarate and emtricitabine): TVR was dosed at 1,125 mg, every 8 hours (q8h).
Reyataz-based regimen (ritonavir-boosted atazanavir, tenofovir disoproxil fumarate and emtricitabine or lamivudine): TVR was dosed at 750 mg, every 8 hours (q8h).
*RVR: rapid viral response; undetectable (<25IU/mL undetectable by Roche COBAS Taqman HCV test) at week 4. **cEVR: complete early viral response; undetectable (<25IU/mL undetectable by Roche COBAS Taqman HCV test) at week 12.
+12 weeks of telaprevir (TVR), Pegasys® (PEG, pegylated-interferon alfa-2a) and Copegus® (RBV, ribavirin) followed by 36 weeks of only PEG and RBV. ++48 weeks of PEG and RBV only for hepatitis C treatment.
The most common adverse events (≥15% of people) regardless of treatment arm were fatigue, pruritus, nausea, headache, dizziness, pyrexia, anorexia, vomiting, diarrhea and chills. Of these adverse events, pruritus, nausea, dizziness, pyrexia, anorexia and vomiting occurred more frequently in the telaprevir arms (≥10% difference) compared to placebo. The majority of adverse events were mild or moderate. Two people (n=2/14, or 14 percent) in a telaprevir-based treatment arm who were also receiving a Reyataz-based regimen discontinued part or all of the hepatitis C treatment regimen due to adverse events. There were no discontinuations due to adverse events in any of the other treatment arms. Final sustained viral response (SVR, or viral cure) results from this study in all 60 people are expected in 2012.
About the Ongoing Phase 2 Study
This study is a Phase 2, two-part (A and B), randomized, double-blind, placebo-controlled, parallel group, multi-center study in people chronically infected with both genotype 1 hepatitis C virus and human immunodeficiency virus (HIV) who were new to hepatitis C treatment. The study enrolled 60 people. This interim analysis includes 59 people who received at least one dose of telaprevir or placebo and for whom data were available. The primary endpoint of the study is to evaluate the safety and tolerability of telaprevir-based combination therapy in people co-infected with hepatitis C and HIV. A secondary endpoint is to evaluate rates of SVR. The study is being conducted by Vertex in collaboration with Tibotec BVBA.
People in Part A and Part B of the study were randomized to receive either 12 weeks of telaprevir or placebo in combination with peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) followed by 36 weeks of peginterferon alfa-2a and ribavirin alone. Part A (n=13) of the study enrolled people who were not receiving antiretroviral therapy (ART) for the treatment of HIV. Part B (n=47) enrolled people who were being treated for HIV with either Atripla (n=24) or a Reyataz-based regimen (n=23). For people in Part B who were receiving Atripla, telaprevir was dosed at 1,125 mg every eight hours (q8h) based on drug-drug interaction data from a Phase 1 study. For people in Part B who were receiving a Reyataz-based regimen telaprevir was dosed at 750 mg every eight hours (q8h). The ART regimens evaluated in this study were selected based on current HIV treatment guidelines from the U.S. Department of Health and Human Services and International AIDS Society and drug-drug interaction studies of telaprevir and HIV medicines.
Additional Data Presented at CROI: Results from Multiple Phase 1 Drug-Drug Interaction Studies
Results from multiple Phase 1 studies evaluating the drug-drug interactions between telaprevir and commonly used HIV medicines were also presented at the CROI conference. The HIV medicines evaluated in these studies included ritonavir, ritonavir-boosted protease inhibitors, a non-nucleoside reverse-transcriptase inhibitor (NNRTI) and a nucleotide analogue reverse-transcriptase inhibitor (NRTI). The ritonavir-boosted protease inhibitors studied were lopinavir, atazanavir, darunavir and fosamprenavir; the NNRTI was efavirenz and the NRTI was tenofovir.
Results from a Phase 1 study of telaprevir and ritonavir (Abstract #629)
· No significant boosting of telaprevir exposure by low-dose ritonavir was observed when telaprevir was given in combination with ritonavir. Results from multiple Phase 1 studies evaluating the interaction between telaprevir and ritonavir-boosted protease inhibitors, NNRTIs and NRTIs (Abstract #119)
· Telaprevir slightly increased the exposure to ritonavir-boosted atazanavir. Ritonavir-boosted atazanavir slightly reduced the exposure to telaprevir. This interaction was not considered to be clinically significant. A HIV regimen that includes ritonavir-boosted atazanavir is being evaluated in an ongoing Phase 2 study of telaprevir-based therapy in people infected with both hepatitis C and HIV.
· An interaction between efavirenz and telaprevir (750 mg, every eight hours) was observed, but a higher dose of telaprevir (1,125 mg, every eight hours) could largely offset the interaction. This higher dose of telaprevir is being evaluated as part of an ongoing Phase 2 study in people co-infected with hepatitis C and HIV who are also receiving efavirenz as part of their HIV treatment.
· Significant interactions were observed between telaprevir and boosted-lopinavir, darunavir and fosamprenavir, such that telaprevir-based combination therapy is not currently being evaluated for people taking these HIV medicines.
About Telaprevir
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
Telaprevir has been granted priority review by the U.S. Food and Drug Administration (FDA) and by Health Canada and accelerated assessment by the European Medicines Agency for the treatment of people chronically infected with genotype 1 hepatitis C virus (HCV). The applications include data from three registrational studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people with hepatitis C who were new to treatment as well as those who did not achieve a viral cure after treatment with currently available medicines. For complete information on the clinical trials or a fact sheet on the trial designs visit: www.vrtx.com/press.cfm.
About Hepatitis C and HIV Co-Infection
There are 1 million people living with HIV in the United States.2 It's estimated that up to 30 percent of people living with HIV/AIDS are also infected with hepatitis C. 3 There have been dramatic improvements in the treatment of HIV and the prognosis for people living with HIV. However, liver disease progresses more rapidly in people co-infected with hepatitis C and HIV, with an increased rate of progression to cirrhosis, decompensated liver disease, hepatocellular carcinoma and death.3,4,5
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.6 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.6 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.6 Approximately 60 percent of genotype 1 hepatitis C patients who undergo treatment with an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,7,8,9 or viral cure.10 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.11,12,13,14,15
More than 170 million people worldwide are chronically infected with hepatitis C. In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.16 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.15 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.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.15 PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche. Reyataz® is a registered trademark of Bristol-Myers Squibb.
Atripla® is a registered trademark of Bristol-Myers Squibb and Gilead Sciences, LLC.
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 interim results being encouraging because they showed a high proportion of people in the study had a rapid response to telaprevir; (ii) Vertex's plan to use what it is learning from the study to inform a Phase 3 co-infection study of telaprevir planned for the end of 2011; (iii) expectations that final SVR results from the study will be available in 2012 and (iv) the possibility that a higher dose of telaprevir could largely offset the interaction observed between efavirenz and telaprevir. While Vertex 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, the risks that efforts to develop telaprevir as a treatment for patients co-infected with genotype 1 HCV and HIV may not proceed due to technical, scientific, commercial, financial or other reasons; that final outcomes, including SVR rates, from this clinical trial and any future clinical trials of telaprevir in patients with HCV-HIV co-infection may not be favorable; that RVR and cEVR may not be predictive of SVR in patients with HCV-HIV co-infection 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 http://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 aims to discover, develop and commercialize 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. For more information and to view Vertex's press releases, please visit http://www.vrtx.com/.
(VRTX - GEN)
References:
1 2010 Guidelines for Antiretroviral Treatment of HIV From the International AIDS Society-USA Panel JAMA. 2010;304(17):1897
2 Centers for Disease Control and Prevention. HIV/AIDS and Viral Hepatitis. Available at http://www.cdc.gov/hepatitis/Populations/hiv.htm. Accessed February 17, 2011.
3 Health Resources and Services Administration. Care and Treatment for Hepatitis C and HIV Co-infection. Available at http://hab.hrsa.gov/tools/coinfection/coinfectionsub.html and http://hab.hrsa.gov/tools/coinfection/index.html Accessed February 28, 2011.
4 Benhamou Y, Bochet M, Di Martino V, Charlotte F, Azria F, Coutellier A, et al. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. Hepatology 1999;30(4):1054-58.
5 Martin-Carbonero L, Benhamou Y, Puoti M, Berenguer J, Mallolas J, Quereda C, et al. Incidence and predictors of severe liver fibrosis in human immunodeficiency virus-infected patients with chronic hepatitis C: a European collaborative study. CID 2004;38:128-33.
6Martinez-Sierra C, Arizcorreta A, Diaz F, Roldan R, Martin-Herrera M, Perez- Guzman E, et al. Progression of chronic hepatitis C to liver fibrosis and cirrhosis in patients coinfected with hepatitis C virus and human immunodeficiency virus. CID 2003;36:491-8.
7 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 May 25, 2010.
8 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.
9 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. 10 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.
11 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
12 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).
13 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.
14Volk 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.
15Veldt 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.
16 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc. Source: Vertex Pharmaceuticals Incorporated
Source
CROI: Pharmacokinetic Interactions Between Antiretroviral Agents and the Investigational HCV Protease Inhibitor Telaprevir in Healthy Volunteers - (03/2/11)
from Jules of NATAP: the study was done in patients on Reyataz or efavirenz, darunavir and other protease inhibitors are not to be used right now with telaprevir due t drug drug interactions, although darunavir will be revisited, raltegravir interactions will soon be studied but an interaction with telaprevir is not expected.
- Early results from ongoing study showed that the hepatitis C virus was undetectable by week 4 in 70% of people treated with telaprevir-based combination therapy -
BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today interim results from an ongoing, two-part (A and B), Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV), also known as HCV-HIV co-infection. All people in this study were new to hepatitis C treatment. Part A of the study is evaluating telaprevir in people who are not currently being treated with antiretroviral therapy (ART) for HIV infection. Part B of the study is evaluating telaprevir in people receiving Atripla® or a Reyataz®-based regimen for HIV. These initial HIV regimens were selected based on current HIV treatment guidelines1 and data from drug-drug interaction studies of telaprevir and commonly used ART medicines. Data from the co-infection study were presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) taking place February 27 to March 2, 2011 in Boston.
The primary endpoint of the study is to evaluate the safety and tolerability of telaprevir-based combination therapy in people co-infected with hepatitis C and HIV. The interim analysis was conducted when all patients had reached week 4 of treatment. At that time, 70 percent (n=26/37) of people in the study (Parts A and B) who received telaprevir-based combination therapy had undetectable hepatitis C virus by week 4 (rapid viral response, RVR) compared to 5 percent (n=1/22) of people who received pegylated-interferon and ribavirin alone. HIV viral load and CD4 counts were stable among patients receiving a telaprevir-based regimen. Adverse events that occurred more frequently (≥10% difference) in the telaprevir arms compared to placebo were pruritus, nausea, dizziness, pyrexia, anorexia and vomiting. The majority of adverse events were mild or moderate.
"Research in hepatitis C has shown that people who respond early to treatment have a higher likelihood of achieving a viral cure," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. "These interim results are encouraging because they showed a high proportion of people in the study had a rapid viral response to telaprevir. We will use what we are learning from this study to inform the design of a Phase 3 co-infection study of telaprevir planned for the end of the year."
Interim Study Results
Sixty people were enrolled in this Phase 2 study. At the time of the analysis, all study participants had reached week 4 of treatment and 69 percent of patients (n=41/59) had completed a week 12 assessment. Data on one patient were not available when the analysis was performed. The preliminary results from this study are based on an interim analysis of 59 patients. For the purposes of this analysis, the 12-week results do not include patients who were still on treatment but had not yet reached the 12-week time point in the study.
Atripla (efavirenz, tenofovir disoproxil fumarate and emtricitabine): TVR was dosed at 1,125 mg, every 8 hours (q8h).
Reyataz-based regimen (ritonavir-boosted atazanavir, tenofovir disoproxil fumarate and emtricitabine or lamivudine): TVR was dosed at 750 mg, every 8 hours (q8h).
*RVR: rapid viral response; undetectable (<25IU/mL undetectable by Roche COBAS Taqman HCV test) at week 4. **cEVR: complete early viral response; undetectable (<25IU/mL undetectable by Roche COBAS Taqman HCV test) at week 12.
+12 weeks of telaprevir (TVR), Pegasys® (PEG, pegylated-interferon alfa-2a) and Copegus® (RBV, ribavirin) followed by 36 weeks of only PEG and RBV. ++48 weeks of PEG and RBV only for hepatitis C treatment.
The most common adverse events (≥15% of people) regardless of treatment arm were fatigue, pruritus, nausea, headache, dizziness, pyrexia, anorexia, vomiting, diarrhea and chills. Of these adverse events, pruritus, nausea, dizziness, pyrexia, anorexia and vomiting occurred more frequently in the telaprevir arms (≥10% difference) compared to placebo. The majority of adverse events were mild or moderate. Two people (n=2/14, or 14 percent) in a telaprevir-based treatment arm who were also receiving a Reyataz-based regimen discontinued part or all of the hepatitis C treatment regimen due to adverse events. There were no discontinuations due to adverse events in any of the other treatment arms. Final sustained viral response (SVR, or viral cure) results from this study in all 60 people are expected in 2012.
About the Ongoing Phase 2 Study
This study is a Phase 2, two-part (A and B), randomized, double-blind, placebo-controlled, parallel group, multi-center study in people chronically infected with both genotype 1 hepatitis C virus and human immunodeficiency virus (HIV) who were new to hepatitis C treatment. The study enrolled 60 people. This interim analysis includes 59 people who received at least one dose of telaprevir or placebo and for whom data were available. The primary endpoint of the study is to evaluate the safety and tolerability of telaprevir-based combination therapy in people co-infected with hepatitis C and HIV. A secondary endpoint is to evaluate rates of SVR. The study is being conducted by Vertex in collaboration with Tibotec BVBA.
People in Part A and Part B of the study were randomized to receive either 12 weeks of telaprevir or placebo in combination with peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) followed by 36 weeks of peginterferon alfa-2a and ribavirin alone. Part A (n=13) of the study enrolled people who were not receiving antiretroviral therapy (ART) for the treatment of HIV. Part B (n=47) enrolled people who were being treated for HIV with either Atripla (n=24) or a Reyataz-based regimen (n=23). For people in Part B who were receiving Atripla, telaprevir was dosed at 1,125 mg every eight hours (q8h) based on drug-drug interaction data from a Phase 1 study. For people in Part B who were receiving a Reyataz-based regimen telaprevir was dosed at 750 mg every eight hours (q8h). The ART regimens evaluated in this study were selected based on current HIV treatment guidelines from the U.S. Department of Health and Human Services and International AIDS Society and drug-drug interaction studies of telaprevir and HIV medicines.
Additional Data Presented at CROI: Results from Multiple Phase 1 Drug-Drug Interaction Studies
Results from multiple Phase 1 studies evaluating the drug-drug interactions between telaprevir and commonly used HIV medicines were also presented at the CROI conference. The HIV medicines evaluated in these studies included ritonavir, ritonavir-boosted protease inhibitors, a non-nucleoside reverse-transcriptase inhibitor (NNRTI) and a nucleotide analogue reverse-transcriptase inhibitor (NRTI). The ritonavir-boosted protease inhibitors studied were lopinavir, atazanavir, darunavir and fosamprenavir; the NNRTI was efavirenz and the NRTI was tenofovir.
Results from a Phase 1 study of telaprevir and ritonavir (Abstract #629)
· No significant boosting of telaprevir exposure by low-dose ritonavir was observed when telaprevir was given in combination with ritonavir. Results from multiple Phase 1 studies evaluating the interaction between telaprevir and ritonavir-boosted protease inhibitors, NNRTIs and NRTIs (Abstract #119)
· Telaprevir slightly increased the exposure to ritonavir-boosted atazanavir. Ritonavir-boosted atazanavir slightly reduced the exposure to telaprevir. This interaction was not considered to be clinically significant. A HIV regimen that includes ritonavir-boosted atazanavir is being evaluated in an ongoing Phase 2 study of telaprevir-based therapy in people infected with both hepatitis C and HIV.
· An interaction between efavirenz and telaprevir (750 mg, every eight hours) was observed, but a higher dose of telaprevir (1,125 mg, every eight hours) could largely offset the interaction. This higher dose of telaprevir is being evaluated as part of an ongoing Phase 2 study in people co-infected with hepatitis C and HIV who are also receiving efavirenz as part of their HIV treatment.
· Significant interactions were observed between telaprevir and boosted-lopinavir, darunavir and fosamprenavir, such that telaprevir-based combination therapy is not currently being evaluated for people taking these HIV medicines.
About Telaprevir
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
Telaprevir has been granted priority review by the U.S. Food and Drug Administration (FDA) and by Health Canada and accelerated assessment by the European Medicines Agency for the treatment of people chronically infected with genotype 1 hepatitis C virus (HCV). The applications include data from three registrational studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people with hepatitis C who were new to treatment as well as those who did not achieve a viral cure after treatment with currently available medicines. For complete information on the clinical trials or a fact sheet on the trial designs visit: www.vrtx.com/press.cfm.
About Hepatitis C and HIV Co-Infection
There are 1 million people living with HIV in the United States.2 It's estimated that up to 30 percent of people living with HIV/AIDS are also infected with hepatitis C. 3 There have been dramatic improvements in the treatment of HIV and the prognosis for people living with HIV. However, liver disease progresses more rapidly in people co-infected with hepatitis C and HIV, with an increased rate of progression to cirrhosis, decompensated liver disease, hepatocellular carcinoma and death.3,4,5
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.6 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.6 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.6 Approximately 60 percent of genotype 1 hepatitis C patients who undergo treatment with an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,7,8,9 or viral cure.10 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.11,12,13,14,15
More than 170 million people worldwide are chronically infected with hepatitis C. In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.16 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.15 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.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.15 PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche. Reyataz® is a registered trademark of Bristol-Myers Squibb.
Atripla® is a registered trademark of Bristol-Myers Squibb and Gilead Sciences, LLC.
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 interim results being encouraging because they showed a high proportion of people in the study had a rapid response to telaprevir; (ii) Vertex's plan to use what it is learning from the study to inform a Phase 3 co-infection study of telaprevir planned for the end of 2011; (iii) expectations that final SVR results from the study will be available in 2012 and (iv) the possibility that a higher dose of telaprevir could largely offset the interaction observed between efavirenz and telaprevir. While Vertex 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, the risks that efforts to develop telaprevir as a treatment for patients co-infected with genotype 1 HCV and HIV may not proceed due to technical, scientific, commercial, financial or other reasons; that final outcomes, including SVR rates, from this clinical trial and any future clinical trials of telaprevir in patients with HCV-HIV co-infection may not be favorable; that RVR and cEVR may not be predictive of SVR in patients with HCV-HIV co-infection 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 http://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 aims to discover, develop and commercialize 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. For more information and to view Vertex's press releases, please visit http://www.vrtx.com/.
(VRTX - GEN)
References:
1 2010 Guidelines for Antiretroviral Treatment of HIV From the International AIDS Society-USA Panel JAMA. 2010;304(17):1897
2 Centers for Disease Control and Prevention. HIV/AIDS and Viral Hepatitis. Available at http://www.cdc.gov/hepatitis/Populations/hiv.htm. Accessed February 17, 2011.
3 Health Resources and Services Administration. Care and Treatment for Hepatitis C and HIV Co-infection. Available at http://hab.hrsa.gov/tools/coinfection/coinfectionsub.html and http://hab.hrsa.gov/tools/coinfection/index.html Accessed February 28, 2011.
4 Benhamou Y, Bochet M, Di Martino V, Charlotte F, Azria F, Coutellier A, et al. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. Hepatology 1999;30(4):1054-58.
5 Martin-Carbonero L, Benhamou Y, Puoti M, Berenguer J, Mallolas J, Quereda C, et al. Incidence and predictors of severe liver fibrosis in human immunodeficiency virus-infected patients with chronic hepatitis C: a European collaborative study. CID 2004;38:128-33.
6Martinez-Sierra C, Arizcorreta A, Diaz F, Roldan R, Martin-Herrera M, Perez- Guzman E, et al. Progression of chronic hepatitis C to liver fibrosis and cirrhosis in patients coinfected with hepatitis C virus and human immunodeficiency virus. CID 2003;36:491-8.
7 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 May 25, 2010.
8 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.
9 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. 10 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.
11 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
12 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).
13 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.
14Volk 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.
15Veldt 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.
16 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc. Source: Vertex Pharmaceuticals Incorporated
Source
February 15, 2011
What Would You Do If You Witnessed AIDS Discrimination?
By MARY BETH LAVENDER
Feb. 15, 2011
Customers React as HIV-Positive Actor Faces Prejudice at Diner in WWYD Scenario
It's been exactly thirty years since AIDS -- the acquired immune deficiency syndrome -- was first recognized in the United States. Since then, more than half a million people have died from the disease in this country alone, and more than a million Americans are currently living with HIV, the virus that causes AIDS.
In the early days of the epidemic, little was known about what caused the illness or how it was transmitted, and rumors soon circulated that it could be spread by sneezing, a handshake, kissing or even sharing utensils. Growing public fear led some to call for a quarantine of those diagnosed with the disease. And in 1985, a 13-year-old boy named Ryan White, who contracted AIDS from a blood transfusion, made headlines when he was banned from attending school. It was just one of many instances of people living with AIDS being stigmatized and ostracized. Three decades later, we wanted to see if people still misunderstood the disease. Would they feel uneasy if they were near an individual who they knew was carrying the AIDS virus? We decided to find out and brought our hidden cameras to the Colonial Diner in Lyndhurst, N.J.
In our first scene, our hired actress playing the waitress engages in conversation with another actor, who is playing a customer who happens to be HIV positive. It's only partly an act: the actor, Daniel Logan, is HIV positive in real life. In conversation, Daniel reveals to the waitress that he is HIV positive. Vince, another actor hired by "WWYD" to play a customer, seated at the next stool at the counter, is alarmed.
"You have AIDS?" Vince asks. "No. That's different, it's HIV," Daniel replies. Vince then gets up from his seat and moves away from Daniel. Reactions like this were not uncommon 30 years ago. So how will it play today? Customer Joe Smith comforts Daniel and encourages him to ignore our rude actor, saying, "Don't talk to him. It doesn't pay. He doesn't understand."
Man Agrees That AIDS Might Be Spread Like Common Cold
But another customer seems to agree with our hypochondriac actor, Vince, who argues that the disease could be spread the same way a common cold or flu is: by sneezing or coughing. "He's right in a way," the customer tells Vince. "Think about it. If I get the flu and I sneeze on you, you're going to get the flu," and he wonders if HIV is spread the same way.
He is not the only one who's not sure how HIV is spread. A recent nationwide study from the Kaiser Family Foundation found that more than a quarter of adults still believe the virus can be transmitted simply by sharing a drinking glass. This, despite decades of scientific evidence that shows that HIV is primarily spread through infected blood.
That lack of awareness doesn't surprise our actor, Daniel, who says he's heard it all. "Growing up in Long Island in the suburbs," says Daniel, "you hear, you know, ignorance like that all the time. I mean there's some people out there that either refuse to accept it and learn about it more," he says.
Back at the diner, as soon as our waitress, Traci, tries handing Vince the same menu Daniel was holding, Vince starts hurling inappropriate comments. This time, the restaurant is all ears.
"C'mon he touched it," Vince complains. "I don't want it."
"You think you can get this from something I touched?" Daniel asks. "I'm just telling you I don't want to take any chances," Vince says.
But not everyone feels the way our actor, Vince, does. In fact, fellow diner Kelly Rivera not only consoles Daniel, she invites him to sit and have lunch with her and her neighbor. Later, she tells John Quinones, "I thought he was being treated really badly, and nobody should be treated like that. That's terrible."
In another scene, we have our female actress play the role of the anxious diner to see how people will react. As she informs other diners sitting nearby that Daniel has AIDS, they seem more irritated with her.
Traci asks, "Nobody has a problem with this?" "No one has a problem with this!" customer Rick Gimello responds. "You should just leave," adds customer Janis Mitchell.
When we caught up with Rick Gimello later to get his thoughts, he tells Quinones, "This is 2011. You know? The world ought to be educated enough to know what's going on."
Source
February 14, 2011
Suicide risk in hepatitis C and during interferon-alpha therapy: a review and clinical update
Journal of Viral Hepatitis
Volume 18, Issue 3, pages 153–160, March 2011
S. Sockalingam 1,2,3, P. S. Links 3,4, S. E. Abbey 1,2,3
Article first published online: 10 NOV 2010
DOI: 10.1111/j.1365-2893.2010.01393.x
© 2010 Blackwell Publishing Ltd
Author Information
1 University Health Network, Toronto General Hospital, Toronto, ON, Canada
2 Medical Psychiatry Program, Toronto, ON, Canada
3 Department of Psychiatry, University of Toronto, Toronto, ON, Canada
4 Arthur Sommer Rotenberg Chair in Suicide Studies, Toronto, ON, Canada
* Correspondence: Sanjeev Sockalingam, University Health Network, Toronto General Hospital, 200 Elizabeth Street – 8EN-228, Toronto, ON M5G 2C4, Canada. E-mail: sanjeev.sockalingam@uhn.on.ca
Abstract
Keywords: depression; hepatitis C; interferon-alpha; suicide
Summary.Chronic hepatitis C (CHC) affects over 170 million individuals worldwide and is a growing public health concern. Despite the availability of CHC treatment, specifically interferon-α and ribavirin, treatment of CHC is limited by concerns about psychiatric side effects including risks of suicide. Although depression has been the focus of neuropsychiatric complications from interferon-alpha (IFNα), emerging evidence has contributed to our understanding of IFNα-induced suicidal ideation and attempts. Using Pubmed, we performed a literature review of all English articles published between 1989 and April 1, 2010 on suicide in untreated and IFNα-treated patients with CHC. References in all identified review articles were scanned and included in our review. A total of 17 articles were identified. Studies have suggested that the first 12 weeks of IFNα therapy are the high-risk period. Moreover, the emergence of suicidal ideation can be linked to neuropsychiatric abnormalities, specifically serotonin depletion. Pretreatment with antidepressant treatment should be reserved for high-risk groups, as this may reduce the risk of depression and thus decrease the suicide risk indirectly. Although there is a paucity of literature on suicide and suicide risk during IFNα therapy for CHC, recent studies on IFNα-induced depression have provided some potential insights into suicide in this patient population. Further research examining the effects of pharmacological and nonpharmacological interventions on suicide risk during IFNα treatment is needed.
Source
Volume 18, Issue 3, pages 153–160, March 2011
S. Sockalingam 1,2,3, P. S. Links 3,4, S. E. Abbey 1,2,3
Article first published online: 10 NOV 2010
DOI: 10.1111/j.1365-2893.2010.01393.x
© 2010 Blackwell Publishing Ltd
Author Information
1 University Health Network, Toronto General Hospital, Toronto, ON, Canada
2 Medical Psychiatry Program, Toronto, ON, Canada
3 Department of Psychiatry, University of Toronto, Toronto, ON, Canada
4 Arthur Sommer Rotenberg Chair in Suicide Studies, Toronto, ON, Canada
* Correspondence: Sanjeev Sockalingam, University Health Network, Toronto General Hospital, 200 Elizabeth Street – 8EN-228, Toronto, ON M5G 2C4, Canada. E-mail: sanjeev.sockalingam@uhn.on.ca
Abstract
Keywords: depression; hepatitis C; interferon-alpha; suicide
Summary.Chronic hepatitis C (CHC) affects over 170 million individuals worldwide and is a growing public health concern. Despite the availability of CHC treatment, specifically interferon-α and ribavirin, treatment of CHC is limited by concerns about psychiatric side effects including risks of suicide. Although depression has been the focus of neuropsychiatric complications from interferon-alpha (IFNα), emerging evidence has contributed to our understanding of IFNα-induced suicidal ideation and attempts. Using Pubmed, we performed a literature review of all English articles published between 1989 and April 1, 2010 on suicide in untreated and IFNα-treated patients with CHC. References in all identified review articles were scanned and included in our review. A total of 17 articles were identified. Studies have suggested that the first 12 weeks of IFNα therapy are the high-risk period. Moreover, the emergence of suicidal ideation can be linked to neuropsychiatric abnormalities, specifically serotonin depletion. Pretreatment with antidepressant treatment should be reserved for high-risk groups, as this may reduce the risk of depression and thus decrease the suicide risk indirectly. Although there is a paucity of literature on suicide and suicide risk during IFNα therapy for CHC, recent studies on IFNα-induced depression have provided some potential insights into suicide in this patient population. Further research examining the effects of pharmacological and nonpharmacological interventions on suicide risk during IFNα treatment is needed.
Source
HIV Regimens Similar but Not Equivalent
By Michael Smith, North American Correspondent, MedPage Today
Published: February 14, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
A large clinical trial fell short of showing that two commonly used approaches to a first anti-HIV treatment regimen are formally equivalent.
But the two -- based on either the ritonavir-boosted protease inhibitor atazanavir (Reyataz) or the non-nucleoside reverse transcriptase inhibitor efavirenz (Sustiva) -- still appeared to have similar efficacy, according to Eric Daar, MD, of Harbor-UCLA Medical Center in Torrance, Calif., and colleagues.
The failure to reach formal equivalence -- as defined before the study started -- was probably the result of a lower than expected rate of virologic failure two years into the study, Daar and colleagues reported online in Annals of Internal Medicine.
But a post-hoc analysis of the data suggested the probability of remaining free of failure differed by less than 10%, a threshold commonly used for defining equivalence, the researchers argued.
Treatment guidelines for initial HIV therapy suggest two nucleoside reverse transcriptase inhibitors combined with either a non-NRTI, a ritonavir-boosted protease inhibitor, or an integrase inhibitor, the researchers noted.
But there are limited data comparing atazanavir/ritonavir with efavirenz, they noted.
To help fill the gap, they conducted a randomized trial, in which the two lead compounds were added to common, once-daily combinations of nucleoside reverse transcriptase inhibitors -- either abacavir/lamivudine (Kivexa) or tenofovir/emtricitabine (Truvada).
The trial ran from September 2005 to November 2007, with a median of 138 weeks of follow-up, and the primary outcomes were time to virologic failure, safety, and tolerability.
All told, 1,857 patients were randomly assigned to one of the four treatment regimens and 1,331 completed the follow-up.
The primary efficacy hypothesis was that, within each of the NRTI arms, boosted atazanavir would be equivalent to efavirenz, Daar and colleagues noted.
The drugs were specified to be equivalent if a Cox proportional hazards model, using efavirenz as the reference, found the two-sided 95% confidence interval for the hazard ratio to be between 0.71 and 1.40.
But analysis showed:
• Among those randomized to the abacavir/lamivudine arms, the hazard ratio for time to virologic failure was 1.13 with a 95% confidence interval from 0.82 to 1.56. The difference was not statistically significant, at P=0.147.
• For those assigned to the tenofovir/emtricitabine arms, the hazard ratio was 1.01 with a 95% confidence interval from 0.70 to 1.46, which again was not significant, at P=0.37.
Although neither hazard ratio showed a significant difference, "neither met prespecified equivalence boundaries," the researchers reported.
However, analysis also showed that the probability of remaining free of virologic failure at week 96 was 83.4% for boosted atazanavir and 85.3% for efavirenz when they were combined with abacavir/lamivudine. The difference was -1.9 with a 95% confidence interval from -6.8 to 2.9, or 9.7 percentage points.
Values in the tenofovir/emtricitabine arms were 89% for boosted atazanavir and 89.8% for efavirenz, with a difference of -0.8 and a 95% confidence interval from -4.9 to 3.3, or 8.2 percentage points, the researchers reported.
Although the results did not meet the specified equivalence mark, the results suggest "for the first time in a large randomized study" that the two drugs have similar efficacy, the researchers argued.
They also found that safety and tolerability were slightly better for atazanavir than efavirenz when combined with abacavir/lamivudine, but there were no differences when they were combined with tenofovir/emtricitabine.
Daar and colleagues cautioned that when the study started it was not routine practice to test for HLA-B*5701 before using abacavir -- something that might have affected safety and tolerability results.
They also noted that study limitations include baseline drug resistance testing in only 40% to 50% of patients because of changing practices over time, premature unblinding of the NRTIs in the group of patients with high baseline viral loads, and change or discontinuation of the third drug in almost a third of patients.
The study was supported by the National Institute of Allergy and Infectious Diseases, and the National Center for Research Resources. Abbott Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, and GlaxoSmithKline provided the study medications.
Daar reported financial links with Abbott Laboratories, Merck Laboratories, GlaxoSmithKline, Pfizer, Gilead Sciences, Bristol Myers Squibb, Tibotec, Schering-Plough, and Ardea Biosciences. Several authors reported being employed by the companies that supplied the study drugs.
Primary source: Annals of Internal Medicine
Source reference:
Daar ES, et al "Atazanavir plus ritonavir or efavirenz as part of a three drug regimen for initial treatment of HIV-1: A randomized trial " Ann Intern Med 2011.
Source
Published: February 14, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
A large clinical trial fell short of showing that two commonly used approaches to a first anti-HIV treatment regimen are formally equivalent.
But the two -- based on either the ritonavir-boosted protease inhibitor atazanavir (Reyataz) or the non-nucleoside reverse transcriptase inhibitor efavirenz (Sustiva) -- still appeared to have similar efficacy, according to Eric Daar, MD, of Harbor-UCLA Medical Center in Torrance, Calif., and colleagues.
The failure to reach formal equivalence -- as defined before the study started -- was probably the result of a lower than expected rate of virologic failure two years into the study, Daar and colleagues reported online in Annals of Internal Medicine.
But a post-hoc analysis of the data suggested the probability of remaining free of failure differed by less than 10%, a threshold commonly used for defining equivalence, the researchers argued.
Treatment guidelines for initial HIV therapy suggest two nucleoside reverse transcriptase inhibitors combined with either a non-NRTI, a ritonavir-boosted protease inhibitor, or an integrase inhibitor, the researchers noted.
But there are limited data comparing atazanavir/ritonavir with efavirenz, they noted.
To help fill the gap, they conducted a randomized trial, in which the two lead compounds were added to common, once-daily combinations of nucleoside reverse transcriptase inhibitors -- either abacavir/lamivudine (Kivexa) or tenofovir/emtricitabine (Truvada).
The trial ran from September 2005 to November 2007, with a median of 138 weeks of follow-up, and the primary outcomes were time to virologic failure, safety, and tolerability.
All told, 1,857 patients were randomly assigned to one of the four treatment regimens and 1,331 completed the follow-up.
The primary efficacy hypothesis was that, within each of the NRTI arms, boosted atazanavir would be equivalent to efavirenz, Daar and colleagues noted.
The drugs were specified to be equivalent if a Cox proportional hazards model, using efavirenz as the reference, found the two-sided 95% confidence interval for the hazard ratio to be between 0.71 and 1.40.
But analysis showed:
• Among those randomized to the abacavir/lamivudine arms, the hazard ratio for time to virologic failure was 1.13 with a 95% confidence interval from 0.82 to 1.56. The difference was not statistically significant, at P=0.147.
• For those assigned to the tenofovir/emtricitabine arms, the hazard ratio was 1.01 with a 95% confidence interval from 0.70 to 1.46, which again was not significant, at P=0.37.
Although neither hazard ratio showed a significant difference, "neither met prespecified equivalence boundaries," the researchers reported.
However, analysis also showed that the probability of remaining free of virologic failure at week 96 was 83.4% for boosted atazanavir and 85.3% for efavirenz when they were combined with abacavir/lamivudine. The difference was -1.9 with a 95% confidence interval from -6.8 to 2.9, or 9.7 percentage points.
Values in the tenofovir/emtricitabine arms were 89% for boosted atazanavir and 89.8% for efavirenz, with a difference of -0.8 and a 95% confidence interval from -4.9 to 3.3, or 8.2 percentage points, the researchers reported.
Although the results did not meet the specified equivalence mark, the results suggest "for the first time in a large randomized study" that the two drugs have similar efficacy, the researchers argued.
They also found that safety and tolerability were slightly better for atazanavir than efavirenz when combined with abacavir/lamivudine, but there were no differences when they were combined with tenofovir/emtricitabine.
Daar and colleagues cautioned that when the study started it was not routine practice to test for HLA-B*5701 before using abacavir -- something that might have affected safety and tolerability results.
They also noted that study limitations include baseline drug resistance testing in only 40% to 50% of patients because of changing practices over time, premature unblinding of the NRTIs in the group of patients with high baseline viral loads, and change or discontinuation of the third drug in almost a third of patients.
The study was supported by the National Institute of Allergy and Infectious Diseases, and the National Center for Research Resources. Abbott Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, and GlaxoSmithKline provided the study medications.
Daar reported financial links with Abbott Laboratories, Merck Laboratories, GlaxoSmithKline, Pfizer, Gilead Sciences, Bristol Myers Squibb, Tibotec, Schering-Plough, and Ardea Biosciences. Several authors reported being employed by the companies that supplied the study drugs.
Primary source: Annals of Internal Medicine
Source reference:
Daar ES, et al "Atazanavir plus ritonavir or efavirenz as part of a three drug regimen for initial treatment of HIV-1: A randomized trial " Ann Intern Med 2011.
Source
New hepatitis C drug
14 February 2011
Scientists in the UK have developed a compound to combat the hepatitis C virus that could be taken as a pill.
David Pryde and his team from Pfizer Global Research and Development, Sandwich, have made new compounds to activate a protein in the immune system called TLR7 - toll-like receptor 7 - which fights the infection. Toll-like receptors identify foreign DNA, such as a virus, and produce proteins that inhibit the virus' replication.
300 million people suffer from hepatitis C worldwide. The virus that causes the disease resides in the liver and can lead to cirrhosis, with some sufferers requiring liver transplants. Current treatments only cure half of patients and are administered intravenously. Recent research has focused on increasing the effectiveness of the drugs and on developing oral treatments.
Pryde's team made heterocyclic analogues based on the structure of purines, known activators of TLR7 and the basis of current oral drugs. 'The most potent TLR7 agonists are purine-based,' explains Pryde. 'But we wanted to design potent non-purine based agonists to maximise the chances of avoiding any unwanted off-target pharmacology.'
The compounds activate a protein in the immune
When they tested the compounds against a hepatitis C cell line, the team found that one of the compounds, a trifluoromethyl derivative, was highly selective for TLR7. The agonist also had comparable performance to injected alternatives at doses below 50mg.
'Medicinal chemistry is often castigated for surrendering synthetic elegance in order to gain compound access. Pryde elegantly repudiates this, accomplishing both elegance and access,' says Adam McCluskey, an expert in drug design and discovery from the University of Newcastle, Australia.
Pryde and his team hope to make the agonist more soluble and to increase its potency further before moving on to human trials.
Catherine Bacon
Link to journal articleThe discovery of a novel prototype small molecule TLR7 agonist for the treatment of hepatitis C virus infection
David C. Pryde, Thien-Duc Tran, Peter Jones, Gemma C. Parsons, Gerwyn Bish, Fiona M. Adam, Mya C. Smith, Donald S. Middleton, Nick N. Smith, Frederick Calo, Duncan Hay, Michael Paradowski, Katie J. W. Proctor, Tanya Parkinson, Carl Laxton, David N. A. Fox, Nigel J. Horscroft, Giuseppe Ciaramella, Hannah M. Jones, Jonathan Duckworth, Neil Benson, Anthony Harrison and Rob Webster, Med. Chem. Commun., 2011
DOI: 10.1039/c0md00197j
Source
Scientists in the UK have developed a compound to combat the hepatitis C virus that could be taken as a pill.
David Pryde and his team from Pfizer Global Research and Development, Sandwich, have made new compounds to activate a protein in the immune system called TLR7 - toll-like receptor 7 - which fights the infection. Toll-like receptors identify foreign DNA, such as a virus, and produce proteins that inhibit the virus' replication.
300 million people suffer from hepatitis C worldwide. The virus that causes the disease resides in the liver and can lead to cirrhosis, with some sufferers requiring liver transplants. Current treatments only cure half of patients and are administered intravenously. Recent research has focused on increasing the effectiveness of the drugs and on developing oral treatments.
Pryde's team made heterocyclic analogues based on the structure of purines, known activators of TLR7 and the basis of current oral drugs. 'The most potent TLR7 agonists are purine-based,' explains Pryde. 'But we wanted to design potent non-purine based agonists to maximise the chances of avoiding any unwanted off-target pharmacology.'
The compounds activate a protein in the immune
system, which fights hepatitis C
'Medicinal chemistry is often castigated for surrendering synthetic elegance in order to gain compound access. Pryde elegantly repudiates this, accomplishing both elegance and access,' says Adam McCluskey, an expert in drug design and discovery from the University of Newcastle, Australia.
Pryde and his team hope to make the agonist more soluble and to increase its potency further before moving on to human trials.
Catherine Bacon
Link to journal articleThe discovery of a novel prototype small molecule TLR7 agonist for the treatment of hepatitis C virus infection
David C. Pryde, Thien-Duc Tran, Peter Jones, Gemma C. Parsons, Gerwyn Bish, Fiona M. Adam, Mya C. Smith, Donald S. Middleton, Nick N. Smith, Frederick Calo, Duncan Hay, Michael Paradowski, Katie J. W. Proctor, Tanya Parkinson, Carl Laxton, David N. A. Fox, Nigel J. Horscroft, Giuseppe Ciaramella, Hannah M. Jones, Jonathan Duckworth, Neil Benson, Anthony Harrison and Rob Webster, Med. Chem. Commun., 2011
DOI: 10.1039/c0md00197j
Source
Success rates for experimental drugs falls: study
By Bill Berkrot
NEW YORK
Mon Feb 14, 2011 8:09am EST
NEW YORK (Reuters) - The success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.
And while oncology has been one of the hottest and most active therapeutic areas for drug development, drugmakers may want to take note of a finding that new cancer drugs have proven far more difficult to gain approval than medicines for infectious and autoimmune diseases.
Drugmakers have been complaining about the difficulty of bringing new products to market in a regulatory climate that has become increasingly unpredictable and more likely to err on the side of safety in deciding risk/benefit ratios of experimental medicines.
Data from this new study appears to bear that out.
"It ain't getting any easier to develop new therapies." said Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), putting the findings succinctly.
"Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing," he said.
The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.
The study, conducted by BIO and BioMedTracker, which collects data on drugs in development, reviewed more than 4,000 drugs from companies large and small and both publicly traded and private. It was released in conjunction with the annual BioCEO and Investor conference in New York.
Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.
When broken down by therapeutic categories, the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, such as hepatitis and HIV drugs, at 12 percent, followed by endocrine system drugs, featuring diabetes treatments, at 10.4 percent, and autoimmune diseases, such as rheumatoid arthritis, at 9.4 percent, the study found.
John Craighead, BIO's managing director for investor relations, said clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established.
"The Phase II results are very predictive of the Phase III outcomes and very predictive of approval," he said.
"The overall success rate in oncology was the lowest of the therapeutic areas that we looked at," he said, noting that cancer studies vary dramatically in design and extending survival sets a high bar for approval.
The cancer drug success rate was a mere 4.7 percent, with cardiovascular drugs second-worst at 5.7 percent, as regulators are increasingly demanding proof that heart drugs reduce heart attacks and strokes rather than just lower a risk factor, such as cholesterol levels.
The largest dropout rate along the clinical pathway came in advancing drugs from mid-stage Phase II studies to late-stage Phase III testing.
Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.
Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.
Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.
The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years.
Source
NEW YORK
Mon Feb 14, 2011 8:09am EST
NEW YORK (Reuters) - The success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.
And while oncology has been one of the hottest and most active therapeutic areas for drug development, drugmakers may want to take note of a finding that new cancer drugs have proven far more difficult to gain approval than medicines for infectious and autoimmune diseases.
Drugmakers have been complaining about the difficulty of bringing new products to market in a regulatory climate that has become increasingly unpredictable and more likely to err on the side of safety in deciding risk/benefit ratios of experimental medicines.
Data from this new study appears to bear that out.
"It ain't getting any easier to develop new therapies." said Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), putting the findings succinctly.
"Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing," he said.
The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.
The study, conducted by BIO and BioMedTracker, which collects data on drugs in development, reviewed more than 4,000 drugs from companies large and small and both publicly traded and private. It was released in conjunction with the annual BioCEO and Investor conference in New York.
Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.
When broken down by therapeutic categories, the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, such as hepatitis and HIV drugs, at 12 percent, followed by endocrine system drugs, featuring diabetes treatments, at 10.4 percent, and autoimmune diseases, such as rheumatoid arthritis, at 9.4 percent, the study found.
John Craighead, BIO's managing director for investor relations, said clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established.
"The Phase II results are very predictive of the Phase III outcomes and very predictive of approval," he said.
"The overall success rate in oncology was the lowest of the therapeutic areas that we looked at," he said, noting that cancer studies vary dramatically in design and extending survival sets a high bar for approval.
The cancer drug success rate was a mere 4.7 percent, with cardiovascular drugs second-worst at 5.7 percent, as regulators are increasingly demanding proof that heart drugs reduce heart attacks and strokes rather than just lower a risk factor, such as cholesterol levels.
The largest dropout rate along the clinical pathway came in advancing drugs from mid-stage Phase II studies to late-stage Phase III testing.
Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.
Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.
Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.
The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years.
Source
Caring Ambassadors Program Launches Unique New DVD Series "Hepatitis C: Choices in Care"
Feb 14, 2011 11:31 ET
OREGON CITY, OR--(Marketwire - February 14, 2011) - The Caring Ambassadors Program (CAP) proudly announces the release of the new DVD series "Hepatitis C: Choices in Care -- Distinctive Viewpoints on Choices for Your Hepatitis C Journey." The 2-disc set offers over nine hours of leading expert physician interviews, patient consultations, panel discussions, Power Point presentations and 30 minutes of Qi Gong exercises specifically geared towards people living with hepatitis C.
About five million Americans are infected with HCV, making hepatitis C the most common chronic blood-borne viral illness in the U.S. HCV is the leading cause of chronic liver disease and liver cancer in the U.S. and the most common indication for liver transplantation. In January 2010, the Institute of Medicine (IOM) released its report, "Hepatitis and Liver Cancer, A National Strategy for the Prevention and Control of Viral Hepatitis." The committee found that many health care providers lack an adequate knowledge of HCV and that chronic hepatitis C patients are often confused about their treatment and disease management options.
The DVD series addresses these knowledge gaps by providing a shorter version of the book, Hepatitis C Choices, 4th Edition. The book presents evidence-based conventional and alternative treatment options and is the collective effort of leading medical experts and hepatitis C patient advocates. It is still the only book, and now DVD, of its kind.
"I was scared and did not know which way to turn when I was diagnosed with hepatitis C. I had a lot of unanswered questions," said Randy Dietrich, Board Chair of the Caring Ambassadors Program. "This information combined with the book was what I wanted to make an informed decision about my care."
The Caring Ambassadors Program produced "Hepatitis C: Choices in Care" to educate the public and health care community about hepatitis C. CAP believes it is vitally important that everyone with hepatitis C virus (HCV) know their disease status and have accurate and ample information to make the best health care decisions. Education is essential for making informed choices and taking charge of one's health.
"Hepatitis C: Choices in Care" is available for free viewing at the Caring Ambassadors Program Hepatitis C website at http://www.hepcchallenge.org/. The entire DVD series "Hepatitis C: Choices in Care" can also be purchased for $10.00 plus shipping and handling.
Contact:
Lorren Sandt
503-632-9030
Lorren@HepCChallenge.org
Source
OREGON CITY, OR--(Marketwire - February 14, 2011) - The Caring Ambassadors Program (CAP) proudly announces the release of the new DVD series "Hepatitis C: Choices in Care -- Distinctive Viewpoints on Choices for Your Hepatitis C Journey." The 2-disc set offers over nine hours of leading expert physician interviews, patient consultations, panel discussions, Power Point presentations and 30 minutes of Qi Gong exercises specifically geared towards people living with hepatitis C.
About five million Americans are infected with HCV, making hepatitis C the most common chronic blood-borne viral illness in the U.S. HCV is the leading cause of chronic liver disease and liver cancer in the U.S. and the most common indication for liver transplantation. In January 2010, the Institute of Medicine (IOM) released its report, "Hepatitis and Liver Cancer, A National Strategy for the Prevention and Control of Viral Hepatitis." The committee found that many health care providers lack an adequate knowledge of HCV and that chronic hepatitis C patients are often confused about their treatment and disease management options.
The DVD series addresses these knowledge gaps by providing a shorter version of the book, Hepatitis C Choices, 4th Edition. The book presents evidence-based conventional and alternative treatment options and is the collective effort of leading medical experts and hepatitis C patient advocates. It is still the only book, and now DVD, of its kind.
"I was scared and did not know which way to turn when I was diagnosed with hepatitis C. I had a lot of unanswered questions," said Randy Dietrich, Board Chair of the Caring Ambassadors Program. "This information combined with the book was what I wanted to make an informed decision about my care."
The Caring Ambassadors Program produced "Hepatitis C: Choices in Care" to educate the public and health care community about hepatitis C. CAP believes it is vitally important that everyone with hepatitis C virus (HCV) know their disease status and have accurate and ample information to make the best health care decisions. Education is essential for making informed choices and taking charge of one's health.
"Hepatitis C: Choices in Care" is available for free viewing at the Caring Ambassadors Program Hepatitis C website at http://www.hepcchallenge.org/. The entire DVD series "Hepatitis C: Choices in Care" can also be purchased for $10.00 plus shipping and handling.
Contact:
Lorren Sandt
503-632-9030
Lorren@HepCChallenge.org
Source
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