The new HIV drug GS-7340 -- nicknamed "Son of Viread" by investors -- is an important component in Gilead's strategy to extend the life of its HIV franchise through the expiration of Viread patents starting in 2018.
GS-7340 is designed to better deliver tenofivir, the active ingredient in Viread, while also reducing kidney toxicity and other side effects. Best yet, patents on GS-7340 extend out to 2025 in the U.S. and 2027 in Europe.
In addition to patent expiration concerns, Gilead's market-leading HIV franchise faces a threat from dolutegravir, a new but still expiremental HIV drug being developed by GlaxoSmithKline (GSK), Pfizer (PFE) and Shionogi.On Wednesday, Gilead announced results from a mid-stage study that compared the efficacy and safety of GS-7340 and Viread as part of a single-pill combination regimen. Efficacy was similar after 24 weeks, with 87% of patients on the GS-7340 regimen achieving a viral load response compared to 90% of patients treated with Viread regimen. [The single-pill combination regimen used in the study was Gilead's newly approved Stribild, with GS-7340 swapped for the Viread component.] Compared to Stribild, the GS-7340 regimen resulted in a smaller loss of bone mineral density and improved creatinine clearance (a biomarker for kidney health.) The frequency and nature of adverse events reported were similar between both patient arms, Gilead said. "These interim findings are encouraging and warrant advancing this TAF-containing single tablet regimen into Phase 3 development," said Gilead R&D chief Norbert Bischofberger, in a statement. [TAF refers to GS-7340.] In a research note to clients Wednesday morning, Wells Fargo analyst Brian Abrahams said, "Although we expected '7340 to demonstrate advantages vs. Viread over the longer term based on pilot data and the drug's improved targeting, the fact that the agent already showed clear bone and safety benefits even in a relatively short, small study is impressive, in our view. This should address some of the outstanding concerns that GILD wouldn't be able to clearly demonstrate the commercial advantages of '7340 within the durations of standard ph.III HIV studies."
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