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?
Gilead Sciences (GILD) 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.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV