This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Idenix Pharma's Hep C Drug Safe But Slow (And Ready For Sale)

Stocks in this article: IDIX BMY GILD INHX VRUS

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

Get Adobe Flash player

SAN FRANCISCO ( TheStreet) -- Idenix Pharmaceuticals' (IDIX) experimental hepatitis C drug IDX184 looks to be safe (whew!) but doesn’t appear to work particularly fast (uh oh….)

On Monday morning, relief over the apparently clean safety report for IDX184 combined with a healthy dose of hepatitis C drug takeover speculation was all the fuel needed to send Idenix shares up $2.84, or 43%, to $10 in the pre-market session.

Achillion Pharmaceuticals (ACHN) share, likewise, are up 35% to $10.65 on takeover speculation and positive data reported on its pipeline of hepatitis C drugs.

Idenix's lead drug, IDX184, belongs to the same "nucleoside" or "nuc" class of oral Hep C drugs as Pharmasset's (VRUS) PSI-7977 and Inhibitex's (INHX) INX-189. Since both were acquired for huge premiums recently, popular thinking is that Idenix's turn at the M&A altar is imminent.

After 31 hepatitis C patients completed 28 days of treatment with IDX184 in combination with weekly interferon and ribavirin, no serious adverse events were reported and an independent safety monitoring board recommended that more patients can be enrolled in the phase II study, Idenix said Monday.

Based on this clean safety report, Idenix plans to ask U.S. regulators to remove a clinical hold on IDX184 put in place last year. The company reported the new IDX184 in advance of its presentation this afternoon at the J.P. Morgan Healthcare Conference.

Idenix said that 73% of patients treated with a 100 mg dose of IDX184 reported undetectable levels of the hepatitis C virus after 28 days. At a median treatment duration of 8 weeks in the study, 87% of these patients are now undetectable.

For patients treated with a lower, 50 mg dose of IDX184, 63% were undetectable at 28 days and 94% were undetectable at a median treatment duration of 8 weeks. None of these patients in the study have so far reported a re-emergence of the hepatitis C virus in their systems.

These efficacy data suggest that IDX184 works slower and perhaps is not as potent as the competing "nucs" being developed by Pharmasset and Inhibitex. For example, Pharmasset's PSI-7977 demonstrated a 4-week early response rate of 98% in a similar setting and patient population. Moreover, Idenix enrolled relatively healthier hepatitis C patients for this initial IDX184 study, suggesting that the drug may further underperform when hepatitis C patients with more advanced disease are treated.

"For us, this trial was about solidifying the safety profile of IDX184 as much as anything else. We believe we have demonstrated that and hope the FDA agrees with us. Our goal is to get to interferon-free regimens as soon as possible," said Idenix CEO Ron Renaud, in an email.

Renaud downplayed questions about the speed at which IDX184 can clear the hepatitis C virus, arguing that combinations of different types of oral drugs will likely be needed ultimately, but it's not clear yet what those combinations might be.

It's certainly true that big players in the race to develop an all-oral hepatitis C therapy -- Bristol-Myers Squibb (BMY - Get Report), Gilead Sciences (GILD - Get Report) most prominently -- are betting on a "nuc" being the backbone of whatever regimen emerges. And right now, Idenix is sitting on a nuc -- IDX184 -- that appears safe and is certainly available to any interested bidder for the right price.

--Written by Adam Feuerstein in San Francisco.



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

>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.

>To submit a news tip, send an email to: tips@thestreet.com.

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

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,695.27 +22.67 0.13%
S&P 500 2,053.81 +1.99 0.10%
NASDAQ 4,765.0460 +7.1670 0.15%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs