Friday, August 17, 2012

IDX184 :Heart-related side effects not specifically linked to drug-Have been seen in IDX184 and standard drugs

AP News
Ahead of the Bell: Analyst upgrades Idenix shares

After a huge stock slide this week, shares of Idenix Pharmaceuticals, Stifel Nicolaus advised clients that the company is now fairly valued.

Shares rose more than 5 percent in premarket trading Friday.

The stock slumped by 29 percent Thursday after the Cambridge, Mass., company revealed that placed a hold on testing of its potential hepatitis C drug, IDX184 because of the potential for heart damage in patients.

That puts the stock within the Stifel Nicolaus estimated fair value range of $5 to $6, analyst Stephen Wiley said. Wiley raised his rating on the stock to "hold" from "sell."

The company said no heart-related side effects have been specifically linked to the drug, although some have been seen in patients treated with IDX184 and standard drugs.

Two weeks ago, Bristol-Myers shut down a clinical trial of a similar hepatitis C treatment because a patient suffered heart failure during a clinical trial. That drugmaker has said it was not clear that the side effects in the trial were linked to the drug itself.

The FDA also placed a clinical hold on trials of IDX184 in 2010 because of concerns about the effects of the drug on the liver. It removed that hold in February. Idenix recently completed a mid-stage clinical trial of IDX184 and is preparing to report results from that trial. No patients are currently being treated with the drug.

"We believe this news likely limits additional downside risk over the near-term and, as a result, we are upgrading our rating of (Idenix) shares," Wiley wrote.
Shares of Idenix Pharmaceuticals Inc. sank $2.47 to $5.84 on Thursday, but bounced back above $6 Friday before the market opened.

Stifel Nicolaus makes a market in Idenix securities and expects to receive or intends to seek investment banking services compensation from Idenix.


Seeking Alpha: Idenix And The High-Stakes Ping-Pong Of Hep C Treatments
Aug 16
It's pretty remarkable just how quickly a hepatitis C (HCV) drug candidate can go from hero to villain in today's market. Investors cheered Gilead's (GILD) bold (and expensive) bid for Pharmasset ... until some concerns about the efficacy of lead drug GS-7977 popped up. Then there was Bristol-Myers Squibb (BMY) making its bold play for Inhibitex, only to see serious safety worries emerge on the key asset (now known as BMS-094).

Now it's the turn of Idenix (IDIX). In a case of what looks to me like guilt by association, the FDA has put lead drug IDX184 on a partial clinical hold due to worries about cardiac safety.

Please click here for more:
Idenix And The High-Stakes Ping-Pong Of Hep C Treatments

Aug 16 press release-

Idenix Provides Update on IDX184 Clinical Development Program

CAMBRIDGE, Mass., Aug. 16, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. /quotes/zigman/90571/quotes/nls/idixIDIX-29.72%, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company received verbal notice from the U.S. Food and Drug Administration (FDA) that a partial clinical hold has been placed on IDX184, the Company's nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV).
As a result of the recent occurrence of a serious cardiac-related adverse event encountered with a competitor's nucleotide polymerase inhibitor for the treatment of HCV, the FDA has expressed an interest in further reviewing the safety of IDX184 and has placed IDX184 on partial clinical hold. In previous clinical trials as well as the ongoing phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV), there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV beyond that seen with PegIFN/RBV alone. There are currently no patients receiving IDX184 worldwide.
The FDA has requested additional data on patients treated with IDX184. Patient safety is our main concern and Idenix will immediately begin work to comply with the FDA request and expects to submit these data to the FDA in the coming weeks. The Company intends to have an ongoing discussion with the FDA following the submission of this data.

IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. The Company reported interim data in June 2012 for the first cohort of 31 patients from an ongoing phase IIb clinical trial of IDX184 in combination with PegIFN/RBV. Of the patients who achieved an extended rapid virologic response (undetectable levels of virus at 4 weeks and 12 weeks) and completed an additional 12 weeks of PegIFN/RBV (n=9), 100% of patients (4/4) in the 100 mg arm and 80% of patients (4/5) in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment (SVR4).
In July 2012, an independent data safety monitoring board reviewed the safety data for this study and confirmed that the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.
A partial clinical hold is a delay or suspension of only part of the clinical work requested under the investigational new drug (IND) application (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND). Under the partial clinical hold, Idenix cannot enroll patients into additional clinical trials until agreement is reached with the FDA on the next clinical trial design.
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to .
Idenix will hold a conference call today at 8:30 a.m. ET. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 22005490. A slide presentation will accompany the conference call and can be accessed on the Investor section of the Idenix website at . Please log on approximately 10 minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.
A replay of the conference call and webcast will be available until August 27, 2012, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 22005490.

No comments:

Post a Comment