Recently, Vertex Pharmaceuticals (VRTX) announced positive results from a late-stage study (n=662) of its lead pipeline candidate, telaprevir. It was observed that 65% patients infected with hepatitis C virus (HCV) achieved sustained viral response (SVR or viral cure) on being treated with a telaprevir-based therapy. This compared favorably to 17% patients achieving viral cure on being treated with placebo.
Vertex has joined hands 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.
The randomized, double-blind, study (REALIZE) evaluated the safety, efficacy and tolerability of telaprevir-based therapies in patients infected with genotype 1 chronic HCV. The safety and efficacy of telaprevir was found to be consistent with other late-stage studies involving the candidate.
The study, conducted in more than 100 international sites with the majority in Europe and North America, enrolled three groups of patients infected with genotype 1 chronic HCV who had undergone at least one prior therapy with pegylated-interferon and ribavirin (the current standard of care) but failed to achieve SVR. There were two telaprevir-based cohorts (a simultaneous and another delayed start) in addition to a control arm.
A New Drug Application (NDA) is expected to be submitted to the US Food and Drug Administration (FDA) in the fourth quarter of 2010 for both treatment-naïve and treatment-failure patients. On approval, Vertex plans to launch the drug in the US in 2011. In addition to telaprevir, Vertex is also developing VX-813, VX-985, VX-222, and VX-759 for the treatment of HCV infection.
HCV infection causes a liver inflammation called chronic hepatitis. The condition can deteriorate and lead 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. The incidence of the disease is on the rise.
Vertex Pharmaceuticals currently has a Zacks #3 Rank, which translates into a short-term Hold rating. We are also Neutral on the stock in the long term. Our Neutral stance indicates that the stock is expected to perform in line with the US equity market over the next 6+ months. We advise investors to retain the stock over the time period.
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