Vertex Pharmaceuticals Presents Data on Telaprevir and VX-222 at EASL Meeting

Strategic Insights -

Vertex Pharmaceuticals Incorporated has announced that 15 abstracts on its medicines in development for hepatitis C, including telaprevir and VX-222, have been accepted for presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. The data presentations will provide insights into the efficacy and safety of these investigational treatments in patients with genotype 1 hepatitis C virus (HCV). Telaprevir, a protease inhibitor, has shown promising results in Phase 3 studies, including the REALIZE trial, which evaluated its use in combination with pegylated-interferon and ribavirin in patients who had not achieved a viral cure with currently available medicines.

Key Takeaways:

  • The REALIZE study will present complete results, including top-line results from the study, which evaluated telaprevir in combination with pegylated-interferon and ribavirin in people who had not achieved a viral cure with currently available medicines.
  • 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.
  • 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.
  • Telaprevir has 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 HCV.
  • Vertex has developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma, with rights to commercialize in North America, Europe, Japan, and other countries.
  • Telaprevir has shown a consistent resistance profile and a substantial improvement in sustained virologic response rates across all IL28B genotypes in the ADVANCE trial.

Statistics:

  • More than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
  • Telaprevir has been granted priority review by the U.S. FDA and Health Canada.
  • The European Medicines Agency has granted accelerated assessment for telaprevir.
  • The REALIZE study enrolled 1,106 patients with genotype 1 HCV.
  • The ADVANCE trial enrolled 848 patients with genotype 1 HCV.

Sources:

  • Vertex Pharmaceuticals Incorporated press release, March 2011.
  • European Association for the Study of the Liver (EASL) website, www.easl.eu.
  • U.S. Food and Drug Administration (FDA) website, www.fda.gov.
  • Health Canada website, www.hc-sc.gc.ca.
  • Vertex Pharmaceuticals Incorporated website, www.vrtx.com.