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Idenix Pharmaceuticals, Inc.’s pipeline woes continue with the company recently receiving a verbal communication from the US Food and Drug Administration (FDA) for its lead uridine nucleotide prodrug candidate, IDX20963.

The FDA has asked the company to provide additional preclinical safety information on IDX20963, which is being developed for the treatment of hepatitis C virus (HCV). Idenix was looking to move IDX20963 into clinical studies this year. However, these plans will now have to be put on hold as the company needs to provide satisfactory answers to the FDA before it can commence clinical studies in the US.

Idenix has been hit by several pipeline-related setbacks over the past few quarters. Last year in August, the FDA had put IDX184 on partial clinical hold and IDX19368 on clinical hold due to safety concerns after serious cardiac-related adverse events were found to be associated with Bristol-Myers Squibb Company’s (BMY - Analyst Report) BMS-986094. All three candidates were 2′-methyl guanosine nucleotide prodrugs being studies for the treatment of HCV.

Idenix subsequently submitted the requested cardiac safety data for IDX184 to the FDA in Dec 2012.  However, the FDA informed Idenix that the IDX184 and IDX19368 programs would remain on clinical hold. Hence, the company decided to discontinue the development of these programs in Feb 2013.

Our Take

The delay in the initiation of clinical studies for IDX20963 is a major disappointment for Idenix and we expect shares to be negatively impacted by the news. Currently, we have low visibility on when the company will be allowed to move the candidate into phase I studies.

The HCV market is highly competitive with several companies working on bringing new treatments to market. Therefore, any delay in the development process would give competitors an edge.

Currently, companies like Vertex Pharmaceuticals (VRTX - Analyst Report) and Bristol-Myers Squibb among others are working on bringing new HCV treatments to market.

Idenix currently carries a Zacks Rank #3 (Hold). At present, Biogen Idec (BIIB - Analyst Report) looks more attractive with the company carrying a Zacks Rank #1 (Strong Buy).

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