Prospects for an HIV drug candidate licensed by GlaxoSmithKline are now clouded after the U.S. Food and Drug Administration halted further clinical trial work on the compound.
Cambridge, Massachusetts-based Idenix Pharmaceuticals (NASDAQ:IDIX) gave no details on what prompted the FDA’s action, but typically such clinical holds are made when information about the toxicity of a compound comes to light. Idenix only said that it was informed by GSK (NYSE:GSK) affiliate ViiV Healthcare that the compound now called GSK2238761 has been placed on clinical hold.
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ViiV is a company formed in 2009 by GSK and Pfizer (NYSE:PFE) specializing in AIDS and HIV drugs. Under the 2009 licensing agreement, ViiV has full responsibility for development of the ‘761 compound. Including ‘761, ViiV has seven compounds in development; five of them in mid- to late-stage clinical trials. England-based ViiV has its U.S. headquarters on GlaxoSmithKline’s campus in North Carolina’s Research Triangle Park.
The clinical hold on ‘761 could jeopardize up to $390 million in additional milestone payments to Idenix tied to further development of the HIV compound. Idenix has already received $60.5 million in milestones. The most recent payment was for a $20 million milestone reached in November when the compound entered phase II b clinical trials.