This Day On The Street
Continue to site
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

Pharmasset Takes Lead in Race to Develop Hep C Therapy By Pill

Content on this page requires a newer version of Adobe Flash Player.

Get Adobe Flash player

Updated with new information, stock prices.

PRINCETON, N.J. ( TheStreet) -- Pharmasset (VRUS) is starting late-stage clinical trials of its lead hepatitis C drug with the goal of becoming the first company to reach the market with an all-oral therapy against the chronic liver disease.

Three phase III studies will combine Pharmasset's once-daily experimental pill PSI-7977 with another oral medicine ribavirin. Most notably, the treatment regimen used in these studies will exclude weekly injections of interferon, a standard drug used today to treat hepatitis C.

If results from these PSI-7977 studies are positive, Pharmasset plans to seek U.S. and European approval in the second half of 2013. This strategy and timeline establishes Pharmasset as the current leader in the race to develop the first all-oral hepatitis C therapy, ahead of competitors including Vertex Pharmaceuticals (VRTX - Get Report), Abbott (ABT - Get Report), Bristol-Myers Squibb (BMY - Get Report) and Johnson & Johnson (JNJ - Get Report).

Roche (RHHBY) recently acquired Anadys Pharmaceuticals to accelerate its development of an all-oral hepatitis C regimen.

"This would result in a launch of PSI-7977 in 2014, well ahead of expectations for a launch in 2015/2016," writes JP Morgan biotech analyst Geoff Meacham in a note to clients Tuesday morning.

Pharmasset is the top-performing biotech stock this year with a valuation that now tops $5 billion, largely because of previously presented data from ongoing mid-stage studies demonstrating PSI-7977's ability to eliminate the hepatitis C virus quickly and without concerns about resistance or rebound.

Pharmasset shares were up $7.89, or 11% to $78.36 in early Tuesday trading. Vertex shares were down 4% to $37.95 on concerns that the company's current hepatitis C drug Incivek faces earlier competition.

By announcing the start of PSI-7977 phase III studies Tuesday, Pharmasset is also engaging in a bit of gamesmanship against its competitors. The American Association for the Study of Liver Disease (AASLD) annual meeting, a closely followed confab for hepatitis C drug research, begins on Saturday. Pharmasset was already expected to garner a large share of the investor spotlight at the AASLD meeting, but Tuesday's announcement guarantees even more buzz.

The Pharmasset PSI-7977 phase III studies will enroll mainly hepatitis C patients with genotype genotype 2 and 3, a less common and more easily treated variant of the disease. The larger and more commercially lucrative opportunity is in patients with genotype 1, which is more difficult to treat. Vertex's Incivek and Merck's Victrelis are both approved as a treatments for genotype 1 patients. Pharmasset is also studying PSI-7977 in patients with genotype 1. --Written by Adam Feuerstein in Boston.

>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to

>To submit a news tip, send an email to:

Follow TheStreet on Twitter and become a fan on Facebook.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
RHHBY $31.38 0.75%
ABT $37.21 0.57%
BMY $61.08 0.10%
JNJ $101.73 -0.24%
VRTX $81.73 1.98%


Chart of I:DJI
DOW 15,914.74 -99.64 -0.62%
S&P 500 1,851.86 -0.35 -0.02%
NASDAQ 4,283.5920 +14.8290 0.35%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs