Human Genome's lupus drug Benlysta -- to which it owns 50% rights -- has been struggling commercially since launch. Although sales will likely grow, I think it will be a slog, and competitors -- notably Anthera Pharmaceuticals -- will have data for similar lupus drugs around mid-year. Finally, it's hard to know what to make of darapladib, Human Genome and Glaxo's Lp-PLA2 inhibitor -- don’t ask; it's an unproven inflammation inhibitor -- for the treatment of chronic coronary disease. The drug could work in ongoing Phase III trials, but if it fails Human Genome shares will return to the doldrums and stay there.
I don't feel like I have any edge on darapladib, so I'd rather just pay the $1.05 postage for my thank you letter and move on to more promising opportunities.
Prophylaxis and Treatment: Together at Last?
(GILD - Get Report)
had a busy week, receiving two favorable FDA advisory panel recommendations for its HIV medicines. As expected, the Quad -- a combination of Truvada, the integrase inhibitor elvitegravir, and the pharmacokinetic booster cobicistat -- received a 13-to-1 vote for approval in treatment-naive adults with HIV. Although not a surprise, Quad is a critical step in the company's HIV lifecycle management strategy and some investors had worried that the FDA's desire for a panel implied heretofore hidden issues with the data. That wasn't the case.
The favorable vote, which included manageable recommendations for monitoring of kidney function -- a minor, safety worry -- is a good "check the box" milestone that should further ease investor anxiety about Gilead's prospects and lower the hurdle for multiple expansion. I expect Quad to receive final FDA approval by the late August approval decision date and to launch shortly thereafter.
A more interesting recommendation came last Thursday, when the same FDA advisory panel voted solidly in favor of approving Gilead's Truvada for HIV prophylaxis in uninfected adults. No drug has yet received an FDA approval for this indication.
I'm skeptical the FDA will actually approve this prevention regimen, called pre-exposure prophylaxis, or PrEP. (The FDA takes panel guidance into consideration, but is not obligated to follow its recommendations.) If the FDA does approve PrEP, I suspect there will be lots of restrictions to ensure appropriate usage.