Vertex Presents Positive Data - Analyst Blog

Recently, Vertex Pharmaceuticals (VRTX) announced positive results from a phase III trial of its lead pipeline candidate, telaprevir. It was observed that 75% of treatment naïve patients infected with hepatitis C virus (HCV) achieved sustained viral response (SVR or viral cure) after receiving telaprevir in combination with the current treatment option of pegylated-interferon and ribavirin for 12 weeks. 

After receiving the same combination therapy for 8 weeks, 69% of the patients achieved SVR. However, patients receiving the current standard therapy alone achieved an SVR of 44% after 48 weeks of treatment. 

Vertex has collaboration with Johnson & Johnson (JNJ) and Mitsubishi Tanabe Pharma for telaprevir. While J&J will be responsible for the commercialization of the drug outside North America and the Far East, Mitsubishi Pharma will be responsible for Japan and certain areas of the Far East. 

A New Drug Application (NDA) is expected to be submitted to the US Food and Drug Administration (FDA) in the second half of 2010 for both treatment-naïve and treatment-failure patients. On approval, Vertex plans to launch the drug in the US in 2011. 

HCV infection causes an inflammation of the liver called chronic hepatitis. The condition can deteriorate to scarring of the liver, called fibrosis, or more advanced scarring, called cirrhosis. Further complications including liver failure or liver cancer may develop as a result of cirrhosis. According to estimates from the World Health Organization, HCV infection is responsible for more than 50% of all liver cancer cases and two-thirds of all liver transplants in the developed world. 

In addition to telaprevir, Vertex is also developing VX-813, VX-985, VX-222, and VX-759 for the treatment of HCV infection. VX-222 and VX-759 have been included in the portfolio subsequent to the 2009 acquisition of ViroChem. Other pipeline candidates are VX-770 and VX-809, both of which are being developed for the treatment of cystic fibrosis (CF), VX-509 for inflammatory diseases and VX-689/MK-5108 for cancer.
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