October 24, 2002
Vertex (NASDAQ: VRTX) announced that GW433908 (fosamprenavir, formerly VX-175) met a series of pivotal study endpoints that have set the stage for U.S. and E.U. regulatory submissions. Submission preparations are underway. No data were made available. GW433908 is being developed by Vertex and GlaxoSmithKline (NYSE: GSK).
GW433908 is a second-generation version of the companies’ HIV protease inhibitor Agenerase (amprenavir). Despite its efficacy, Agenerase has languished in the protease inhibitor market likely due to a combination of the drug’s average 16-capsule per day requirement and commercial factors relating to later market entry and suboptimal promotion.
GW433908 has pharmacological advantages that make it preferable to Agenerase. GW433908 is a prodrug of Agenerase, meaning that it is processed into active Agenerase inside the body. Prodrugs often have preferable pharmacokinetic and pharmacodynamic profiles compared to active drugs, which can lead to better activity and dosing schedules. Clinical data suggests that GW433908 has these favorable properties. It has been tested in twice and once daily dosing regimens, and in various combinations that would make it favorable for use in today’s combination-based anti-HIV armamentarium.
Interim 24-week data out of phase III study presented at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) late last month demonstrated that 1400 mg of GW433908 taken as 2 tablets twice daily compared favorably to 1250 mg of Pfizer’s (NYSE: PFE) Viracept taken as 5 tablets twice a day. According to our modeling, GW433908 has an 80-90% probability of FDA approval.
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