This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Gilead's 'Son of Viread' HIV Drug Passes First Test

FOSTER CITY, Calif. ( TheStreet) -- Gilead Sciences (GILD - Get Report) will start phase III studies next year with a second-generation version of its core HIV drug Viread, the company said Wednesday.

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 - Get Report), Pfizer (PFE - Get Report) 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."
1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
GSK $39.47 -3.57%
GILD $101.49 -3.41%
PFE $31.36 -2.67%
AAPL $107.72 -4.47%
FB $87.23 -2.46%

Markets

Chart of I:DJI
DOW 16,058.35 -469.68 -2.84%
S&P 500 1,913.85 -58.33 -2.96%
NASDAQ 4,636.1050 -140.4030 -2.94%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs