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Idenix: FDA Places Hep C Tx on Clinical Hold

Idenix: FDA Places Hepatitis C Treatment on Clinical Hold

Published August 27, 2012

Dow Jones Newswires

Idenix Pharmaceuticals Inc. (IDIX) said the Food and Drug Administration placed a clinical hold on one of its treatments for hepatitis C, the latest setback for the drug developer.

The clinical hold on the treatment--IDX19368--is related to the regulator's heart-safety concerns about rival Bristol-Myers Squibb Co.'s (BMY) closely watched treatment for the liver disease, which belongs to the same class of drugs--known as nucleotide polymerase inhibitors.

Idenix earlier this month had seen the FDA place a partial hold on further trials of another hepatitis C treatment, IDX184, also following concerns about the Bristol-Myers treatment. On Monday, Idenix said the FDA has also requested additional cardiac testing of patients in a continuing Phase IIb trial of IDX184. The company said it is set to submit the data in coming weeks.

Bristol-Myers last week said it had stopped development of its treatment, known informally as 094, after one patient died in testing and eight others were hospitalized.

Idenix said that no patients have been exposed to IDX19368. President and Chief Executive Ron Renaud also said that while both of its compounds fall into the same broader class, "there are many attributes of our compounds, particularly the prodrug approach, that we believe favorably differentiate the toxicity profiles" from the Bristol-Myers drug.

Mr. Renaud said "Bristol-Myers Squibb has agreed to share relevant information on BMS-986094 with us and hope this helps us to resolve this issue quickly."

The company had submitted an investigational new drug application for IDX19368 with the FDA in the current quarter, a period in which it also had planned to begin a clinical trials.

Hepatitis C is a blood-borne virus that afflicts an estimated four million Americans and 170 million people world-wide. The disease is often contracted during sex or by sharing needles and at tattoo parlors. Left untreated, it can require a liver transplant and eventually prove fatal.

Current treatment of the disease requires long courses of painful injections and often doesn't work. Drug makers have been racing to find pills that are both more potent and easier to take.

Read more: http://www.foxbusiness.com/news/2012/08/27/idenix-fda-places-hepatitis-c-treatment-on-clinical-hold/#ixzz24miYoeCP

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