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.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.