CAMBRIDGE, Mass., Mar 18, 2009 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that three abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir were accepted for presentation at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark, April 22-26, 2009. The accepted abstracts include a late breaker oral presentation of sustained viral response (SVR) rates from the PROVE 3 clinical trial of telaprevir in patients who failed prior HCV therapy. In addition, three abstracts related to Vertex's HCV polymerase inhibitor VCH-222 were accepted as poster presentations, including a presentation of the first clinical results for VCH-222 in HCV patients. The abstracts can be accessed through the EASL website, www.easl.ch. In accordance with the EASL embargo policy, the accepted abstract titles are provided below:
Telaprevir Late Breaker Presentation:
1. Telaprevir in Hepatitis C Genotype-1-Infected Patients with Prior Non-Response, Viral Breakthrough or Relapse to Peginterferon-alfa-2a/b and Ribavirin Therapy: SVR Results of the PROVE 3 Study; April 25, 2009, 5:00 - 5:15 p.m. CET (11:00 - 11:15 a.m. ET), Oral Presentation
2. Results of a Proof of Concept Study (C210) of Telaprevir Monotherapy and in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Genotype 4 HCV Patients; April 23, 2009, 5:45 - 6:00 p.m. CET, Oral Presentation
3. Activity of Telaprevir Alone or in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Genotype 2 and 3 Hepatitis-C Patients: Interim Results of Study C209; April 24, 2009, 11:45 a.m. - 12:00 p.m. CET, Oral Presentation
1. Safety, Tolerability and Pharmacokinetics of the HCV Polymerase Inhibitor VCH-222 Following Single Dose Administration in Healthy Volunteers and Antiviral Activity in HCV-Infected Individuals; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
2. Identification and characterization of VCH-222, A Novel Potent and Selective Non-Nucleoside HCV Polymerase Inhibitor; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
3. Preclinical Pharmacokinetic and ADME Characterization of VCH-222, A Novel Non-Nucleoside HCV NS5B Polymerase Inhibitor; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
Other EASL Presentations:
Two abstracts related to VCH-916, an additional polymerase inhibitor that Vertex gained as part of its acquisition of ViroChem Pharma in March 2009, were also accepted for presentation at EASL and are listed below:
Safety, Tolerability and Antiviral Activity of VCH-916, A Novel Non-Nucleoside HCV Polymerase Inhibitor in Patients with Chronic HCV Genotype-1 Infection; April 24, 2009, 5:45 - 6:00 p.m. CET, Oral Presentation
Genotypic and Phenotypic Analysis of HCV NS5B Variants Selected From Patients Treated with VCH-916; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
About Telaprevir and VCH-222
Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational antiviral agents in development that specifically targets HCV. Telaprevir is in Phase 3 clinical trials in treatment-naive and treatment-failure patients.
Vertex retains commercial rights to telaprevir in North America. Vertex and Tibotec are collaborating to develop and commercialize telaprevir in Europe, South America, Australia, the Middle East and other countries. Vertex is collaborating with Mitsubishi Tanabe Pharma to develop and commercialize telaprevir in Japan and certain Far East countries.
VCH-222 is a small molecule non-nucleoside inhibitor of HCV NS5B polymerase that completed a viral kinetic study involving five treatment-naive genotype 1a and 1b HCV infected patients. In the study, VCH-222 was dosed as 750 mg twice daily. Vertex gained VCH-222 as part of its acquisition of ViroChem Pharma Inc. in March 2009. VCH-222 is in Phase 1 clinical development.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease. HCV, a serious public health concern affecting 3.4 million individuals in the United States, is spread through direct contact with the blood of infected people. Though many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Chronic HCV significantly increases a person's risk for developing long-term infection, chronic liver disease, cirrhosis or death. The burden of liver disease associated with HCV infection is increasing, and current therapies typically provide sustained benefit in less than half of patients with genotype 1 HCV, the most common strain of the virus. As many as 250,000 patients in the United States have received at least one course of treatment with pegylated interferon and ribavirin but have not achieved sustained virologic response (SVR). Patients who have failed interferon-based treatment typically have few or no available treatment options, and are at risk for progressive liver disease. In a recent study, the risk of liver failure, cancer or death following unsuccessful HCV treatment was 23% after 4 years, and 43% after 8 years. (1).
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
1. Veldt et al, "Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis," Annals of Internal Medicine, 20 November 2007; 147: 677-684.
Safe Harbor Statement
This press release contains a forward-looking statement that telaprevir, VCH-222 and VCH-916 data will be featured in poster and oral presentations at EASL, April 22-26, 2009. While we believe this statement to be correct, it is based on information we have received from EASL and that information is subject to future developments that could adversely affect the content, timing or form of that presentation.
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Michael Partridge, 617-444-6108
Lora Pike, 617-444-6755
Jane A. Kramer, 617-444-6924
Zachry Barber, 617-444-6470
Copyright Business Wire 2009