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Idenix Shares Plunge on Hepatitis C Treatment Heart Fears: IDX184 On Hold by FDA
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By Drew Armstrong - Aug 16, 2012 12:38 PM ET
Idenix Pharmacuticals fell as much as 35 percent after a trial of the company's hepatitis C drug was placed on hold because of heart failure concerns raised in a competitor's study of a similar medicine.
The U.S. Food and Drug Administration is looking at other compounds from the same class of medicines called nucleotide polymerase inhibitors, Idenix Chief Executive Officer Ron Renaud said on a conference call today. Gilead Sciences, Bristol- Myers Squibb Co. and Vertex Pharmaceuticals are developing similar treatments.
Idenix declined to $5.87 at 12:37 p.m. New York time after sinking to $5.40, its biggest intraday drop in almost two years. The experimental drug is Cambridge, Massachusetts-based Idenix's main pipeline prospect. Bristol-Myers said Aug. 1 that it halted trials of its treatment after a patient developed heart failure.
"This event is likely to raise concerns about the risks of nuke programs across the spectrum, but we believe it is important to understand the difference among the assets," said Geoffrey Porges, an analyst with Sanford C. Bernstein & Co. in New York. The Vertex and Gilead drugs have different structures and may not raise the same worries, he said in a note to clients.
Gilead fell 1.7 percent to $57. Vertex rose less than 1 percent to $54.74. Erin Emlock, a spokeswoman for Cambridge- based Vertex, and Cara Miller, a spokeswoman for Foster City, California-based Gilead, said their companies hadn't been contacted by the FDA about cardiac safety issues with their drugs.
Agency Review
The U.S. Food and Drug Administration gave a "verbal notice" that a "partial clinical hold" has been placed on the Idenix trial while the agency reviews the medicine's safety, Idenix said. The company said today it plans to give the FDA data on the treatment, which isn't being given to any patients right now.
"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," Idenix said in a statement.
"We believe this will be temporary, unfortunately we can't give any concrete answer on our timeline," Renaud said on the conference call.
Idenix, Gilead, Vertex and Bristol-Myers experimental drugs stop the hepatitis C virus from replicating, and could be used in combination with other pills to replace the current regimen of side-effect heavy injections.
Seeking Patients
Idenix is trying to track down 67 patients who took its drug so they can perform cardiac tests on them. All of the patients have been off the medicine for at least a month, Chief Scientific Officer Douglas Mayers said on the conference call.
Renaud said he didn't know whether the FDA would look at all of the related drugs that are in clinical trials, or just some. "They did mention they'd be looking at, to start, NS5B polymerase inhibitors," he said of the company's discussions with regulators.
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August 16, 2012
Idenix Provides Update on IDX184 Clinical Development Program
IDX184 has been placed on partial clinical hold by FDA
Management to host a conference call webcast today at 8:30 am ET
CAMBRIDGE, Mass., Aug. 16, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), 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.
ABOUT IDX184
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.
ABOUT PARTIAL CLINICAL HOLD
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.
ABOUT IDENIX
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 www.idenix.com.
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