Vertex Pharmaceuticals to present SVR data at the 60th Annual Meeting of the American Association

Sep 25 2009

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that sustained virologic response (SVR) data from Study C208, which evaluated twice-daily dosing of Vertex’s investigational hepatitis C virus (HCV) protease inhibitor telaprevir, will be presented in an oral presidential plenary session at the 60^th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place Oct. 30 – Nov. 3, 2009 in Boston. Additionally, final results from PROVE 3 will be presented in an oral session at the conference. Results from a pooled analysis of PROVE 1 and PROVE 2 in “difficult-to-cure” patients, which include patients with factors potentially having an effect on SVR rates (viral load, race, age, sex, body mass index, genotype subtype and liver fibrosis stage), will be presented in a poster session.

The C208 presentation at AASLD will include SVR data (defined as undetectable HCV RNA at 24 weeks after completion of treatment) and represents the first SVR data for telaprevir-based regimens as part of a response-guided therapy trial design, similar to that being used in the Phase 3 trials of telaprevir. Study C208 is a four-arm, randomized, open label, Phase 2 clinical trial that was conducted by Tibotec in Europe in 161 treatment-naïve patients with genotype 1 HCV infection. Two different dosing regimens of telaprevir (750mg three-times daily or 1125mg twice daily) each were studied in combination with either peg-IFN-alfa-2a (PEGASYS^®) or peg-IFN-alfa-2b (PEGINTRON™) and ribavirin (RBV), the standard therapies for chronic HCV infection.

The abstracts were published today and can be accessed on the AASLD website. In accordance with the AASLD embargo policy, the accepted abstract titles are provided below. Vertex is developing telaprevir in collaboration with Tibotec and Mitsubishi Tanabe Pharma.

Telaprevir Presentations

Twice-daily compared to three-times daily telaprevir-based therapy: Study C208

1. “Virological Analysis of Patients Receiving Telaprevir Administered q8h or q12h with Peginterferon-Alfa-2a or -Alfa-2b and Ribavirin in Treatment-Naïve Patients with Genotype 1 Hepatitis C: Study C208” (#194) will be presented in an oral presidential plenary session on Nov. 3, 2009 at 8:15 a.m. EST. The authors of the study are Marcellin, Patrick; Forns, Xavier, Goeser, Tobias; Ferenci, Peter; Nevens, Frederik; Carosi, Giampiero; Drenth, Joost P.; De Backer, Koen; van Heeswijk, Rudolf; Luo Donghan; Picchio, Gaston; Beumont-Mauviel, Maria.

Telaprevir-based therapy in treatment-experienced patients: PROVE 3 Final Analysis

2. “PROVE 3 Final Results and 1-Year Durability of SVR with Telaprevir-Based Regimen in Hepatitis C Genotype 1-Infected Patients with Prior Non-response, Viral Breakthrough or Relapse to Peginterferon-Alfa-2a/b and Ribavirin Therapy” (#66) will be presented in an oral parallel session on Nov. 1, 2009 at 6:00 p.m. EST. The authors of the study are McHutchison, John G.; Manns, Michael P.; Muir, Andrew J.; Terrault, Norah; Jacobson, Ira M.; Afdhal, Nezam H.; Heathcote, E. Jenny; Zuezem, Stefan; Reesink, Hendrik W.; Bsharat, Mohammad; George, Shelley; Adda, Nathalie; Di Bisceglie, Adrian M.

Telaprevir-based therapy in “difficult-to-cure” treatment-naïve patients: PROVE 1 & PROVE 2 Pooled Analysis

3. “Telaprevir, Peginterferon Alfa-2a and Ribavirin Improved Rates of Sustained Virologic Response (SVR) in “Difficult-to-Cure” Patients With Chronic Hepatitis C (CHC): a Pooled Analysis From the PROVE 1 and PROVE 2 Trials” (#1565) will be presented in a poster session on Nov. 3, 2009 at 8:00 a.m. EST. The authors of the study are Everson, Gregory T.; Dusheiko, Geoffrey M.; Ferenci, Peter; Alves, Katia; Bengtsson, Leif; McNair, Lindsay; McHutchison, John G.; Muir, Andrew; Pawlotsky, Jean-Michel; Zeuzem, Stefan.

http://www.vrtx.com/