Vertex continues VX-950's broad phase 2 program in 2006; New Drug Application seen in 2008

By Rebecca Melvin

Princeton, N.J., Feb. 14 - Vertex Pharmaceuticals Inc.'s promising investigational oral hepatitis C virus protease inhibitor will continue to undergo study trials in 2006 and 2007, with a New Drug Application seen in 2008, president and chief executive Joshua Boger said Tuesday.

"That's a very achievable timeline based on results to date," Boger said, calling VX-950's antiviral activity "unprecedented."

"We believe that the rapidity and depth of antiviral response will support a much shorter treatment period than is the standard of care now and at a much greater than 50% antiviral response," he said.

Boger was speaking at the Biotechnology Industry Organization CEO and Investor Conference in New York.

VX-950 received fast track designation from the Food and Drug Administration in December.

Cambridge, Mass.-based Vertex is a biotechnology company that develops small molecule drugs for the treatment of serious diseases such as viral diseases, inflammation, autoimmune diseases and cancer.

In addition to the broad phase 2 development program designed to establish the safety and antiviral activity of VX-950 in studies of up to three months duration, the company expects in the next few months to begin a three-month phase 2 trial with more than 200 participants that will study VX- 950 dosed in combination with pegylated interferon, both with and without ribavirin, another standard hepatitis C treatment.

This study will include a comparison to the current standard of care in hepatitis C treatment.

Phase 3 development will get underway in 2007.

Boger mentioned other compounds in the Vertex pipeline such as VX-702, a once a day 5 mg to 10 mg pill aimed at treating rheumatoid arthritis and other inflammatory diseases; VX-770 which is being developed, albeit further back in the process, to treat cystic fibrosis, namely the decreased lung function that this genetic disease promotes; VX-409, which is a pain blocker being developed in partnership with Glaxo Smith Kline; and VX-680, which is a potential cancer fighting drug.

Cancer, however, is not a chosen area of focus for Vertex, Boger said.

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