CAMBRIDGE, Mass., Mar 16, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that multiple abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir and the HCV polymerase inhibitor VX-222 were accepted for presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010. The accepted abstracts include an oral presentation of results from Study 107, which evaluated telaprevir in HCV patients with well-characterized prior response to HCV therapy, including those with prior null response, partial response, viral breakthrough or relapse. Additionally, an abstract related to results from a Phase 1b/2a clinical trial of VX-222 in treatment-naïve genotype 1 HCV patients was accepted for oral presentation. 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 Oral Presentations:
1. Study 107: "SVR with Telaprevir, Peginterferon Alfa-2a and Ribavirin in HCV Patients with Well-Characterized Prior Null Response, Partial Response, Viral Breakthrough or Relapse After PR"; April 15, 2010, 3:45 - 4:00 p.m. CET.
2. Study C208: "On-treatment Response-guided Therapy with Telaprevir Q8h or Q12h Combined with Peginterferon Alfa-2a or Peginterferon Alfa-2b and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C (STUDY C208)"; April 16, 2010, 4:45 - 5:00 p.m. CET.
3. Study C209: "Activity of Telaprevir Alone or in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-naïve Genotype 2 and 3 Hepatitis-C Patients: Final Results of Study C209"; April 16, 2010. 5:00 - 5:15 p.m. CET.
VX-222 Oral Presentation:
1. "Safety and Antiviral Activity of the HCV Non-Nucleoside Polymerase Inhibitor VX-222 in Treatment-Naïve Genotype 1 HCV-Infected Patients"; April 15 2010, 5:00 - 5:15 p.m. CET.
1. "Improved Sustained Virologic Response (SVR) Rates in "Difficult-to-Cure" Patients Treated with Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin: an Analysis From the PROVE3 Study"; April 15, 2010.
2. "Early Virological Response Profiles with Telaprevir (T) in Combination with Peginterferon-Alfa-2a (P) and ribavirin (R) in Genotype 1 HCV Treatment-Naïve and Treatment-Experienced Patients are Similar"; April 15, 2010.
3. "Genotypic and Phenotypic Characterization of Genotype 2/3 HCV Variants in Patients Treated with Telaprevir Alone or in Combination with Peginterferon Alfa-2a/Ribavirin in Study C209"; April 15, 2010.
4. "Discrepancies Between Definitions of Null Response to Treatment with Peginterferon Alfa-2a and Ribavirin: Implications for New HCV Drug Development"; April 15, 2010.
5. "Impact of Sustained Virological Response (SVR) on Life Expectancy and Quality-adjusted Life-years (QALYs) in Chronic Hepatitis C (CHC) Patients"; April 17, 2010.
About Telaprevir and VX-222
Telaprevir is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being evaluated as part of a global Phase 3 registration program in more than 2,200 treatment-naïve and treatment-failure patients. Vertex is collaborating with Tibotec and Mitsubishi to develop telaprevir. Vertex retains commercial rights to telaprevir in North America. Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and 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. Vertex added VX-222 to its development pipeline as part of the acquisition of ViroChem Pharma Inc. in March 2009. Vertex retains worldwide commercial rights to VX-222.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), which is found in the blood of people with the disease. HCV, a serious public health concern affecting 3.2 million individuals in the United States, is spread through direct contact with the blood of infected people.1 Though many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever.1 Chronic HCV significantly increases a person's risk for developing long-term infection, chronic liver disease, cirrhosis or death.1
Current therapies for HCV typically provide sustained benefit in about half of patients with genotype 1 HCV, the most common strain of the virus.2 If treatment is not successful and patients do not achieve an SVR, they remain at risk for progressive liver disease.1 In a recent study, the risk of liver failure, cancer or death following unsuccessful HCV treatment was assessed at 23% after 4 years, and 43% after 8 years.3
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, epilepsy, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of companies.
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, September 24, 2009.
2 Strader DB, Wright T, Thomas DL, Seeff LB, AASLD practice guideline: diagnosis, management and treatment of hepatitis C. Hepatology: 2004(39):1147-1171.
3 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.
Special Note Regarding Forward Looking Statements
This press release contains a forward-looking statement that telaprevir and VX-222 data, as well as other information on the treatment of HCV, will be featured in poster and oral presentations at EASL, April 14-18, 2010. 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.
Vertex's press releases are available at www.vrtx.com.
(VRTX - GEN)
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Michael Partridge, 617-444-6108
Lora Pike, 617-444-6755
Zachry Barber, 617-444-6470
Amy Pasqua, 617-444-6075
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