Vertex Unveils More Upbeat Hep C Drug Data

John Alam, Vertex's chief medical officer, says it is still too early to comment on the company's ultimate plans for telaprevir in treatment-failure patients. The company intends on sharing final data from PROVE 3 with the U.S. Food and Drug Administration by the end of the year or early 2009. In the meantime, Vertex and Johnson & Johnson are moving ahead on finalizing the design for the phase III study of telaprevir in treatment-failure patients, Alam said.

If telaprevir is found to be effective for these hardest-to-treat hepatitis C patients, the commercial potential for Vertex is significant. There are an estimated 250,000 to 300,000 hepatitis C patients in the U.S. who have failed current interferon-ribavirin therapy and are waiting for something new and more effective to be approved so they can be retreated, and hopefully cured.

This is one of the major reasons why the race to develop and market a new hepatitis C drug is so frenzied. Vertex and J&J are facing off with companies like Schering-Plough (SGP Quote - Cramer on SGP - Stock Picks), InterMune (ITMN Quote - Cramer on ITMN - Stock Picks), Roche and Pharmasset (VRUS Quote - Cramer on VRUS - Stock Picks) -- all of which are hoping that their respective hepatitis C drugs are superior or can be approved first to be the go-to drug for treatment-resistant patients.

A phase III study of telaprevir in hepatitis C patients not previously treated is underway, with data expected in the first half of 2010. If positive, Vertex plans to seek regulatory approval in the second half of 2010.

PROVE 3 Data Breakdown

Breaking down the PROVE 3 interim results further, 41% of telaprevir-treated patients who had previously not responded at all to standard treatment (non-responders) reached undetectable levels of viral load at 12 weeks post treatment. For those patients who did respond to standard treatment but then relapsed during follow-up, treatment with telaprevir led to an undetectable viral load rate of 73% after 12 weeks of follow-up.

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