Biotech Tracker: Lexiva Approved

BiotechTracker: Lexiva Approved

October 22, 2003 The FDA has approved GlaxoSmithKline (NYSE: GSK) and Vertex’s (NASDAQ: VRTX) Lexiva (fosamprenavir, formerly GW433908, “908,” and VX-175), an antiretroviral protease inhibitor indicated for the suppression of human immunodeficiency virus (HIV) infection. Dosing options, in combination with ritonavir, offer HIV-infected patients improved convenience compared with several treatment options. Vertex reasonably expects Lexiva to cannibalize much of its Agenerase market, and also to take some of the market share held by Viracept, Kaletra, and certain other antiretroviral agents. The degree of penetration greatly depends upon clinical acceptance of Lexiva during its first few months on the market. Caretakers and recipients will have to reconcile the drug’s limited improvements in terms of treatment effect magnitudes compared to some agents versus its convenience and adversity benefits.

Lexiva is a second-generation version of Vertex and Glaxo’s 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.

Lexiva’s pharmacological advantages make it preferable to Agenerase. Lexiva 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 trial data suggests that Lexiva 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.

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