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Idenix Says FDA Needs More Time to Review Hold on Hepatitis C Drug

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The company's shares are falling as investors are anxious about the US agency's risk assessment. Idenix hopes for an answer in the first quarter.

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US officials told Idenix Pharmaceuticals (NASDAQ:IDIX) that they will require extra time to review a partial hold placed on testing the company's lead experimental drug for hepatitis C due to safety concerns.

The company also says in an investor presentation to be delivered late-day Wednesday that it anticipates a response from the Food and Drug Administration by the end of March. A company spokeswoman says Idenix initially hoped to hear within 30 days of filing an answer to the agency.

Last month, Idenix filed a response to the FDA after the agency placed two drugs on hold in August, citing concerns about serious heart risk. Idenix says there is no evidence of such risk with its drugs and that the FDA is simply being cautious after problems were found with a similar drug tested by Bristol-Myers Squibb (NYSE:BMY). Bristol discontinued its research program for its treatment.

Idenix responded to the FDA about the "partial" clinical hold on lead hepatitis drug IDX184 in December. The company hasn't said when it will submit a response for the hold on a second drug, IDX19368.

The FDA actions last year torpedoed Idenix's stock. (See: Idenix Drops After FDA Puts Hold on Another Hepatitis Drug.) The shares are down by more than half in the past six months. The stock dropped 6% to $4.75 midday Wednesday.

Idenix CEO Ronald Renaud will give the presentation at 5 p.m. ET Wednesday from a JPMorgan health care conference in San Francisco. View the presentation slides here.

The Idenix drugs and the Bristol-Myers medicine that was scrapped are part of a class known as nucleotide polymerase inhibitors. The drugs target an enzyme needed for the hepatitis C virus to replicate. Other companies are studying similar drugs, including Gilead Sciences (NASDAQ:GILD) and Vertex Pharmaceuticals (NASDAQ:VRTX). Drugs by those companies continue to be studied. Gilead's stock has been untainted by Idenix's woes. That company's stock has jumped more than 50% in the past six months, trading at $77.49 Wednesday.

Idenix maintains in a regulatory filing in November that "both of these holds were due to serious cardiac-related adverse events observed" in Bristol-Myers' drug. It says it has found no evidence of toxicity in its own drug.

"We are reviewing additional pre-clinical and clinical data and conducting further testing to respond to the FDA's concerns," the filing says. "There is no assurance that the FDA will allow us to pursue further development of either of these drug candidates."

Twitter: @brettchase

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No positions in stocks mentioned.
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