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Idenix Pharmaceuticals Reports Fourth Quarter And Year Ended 2012 Financial Results

CAMBRIDGE, Mass., Feb. 25, 2013 (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 reported unaudited financial results for the fourth quarter and year ended December 31, 2012.

HCV Pipeline and Business Review

IDX719, NS5A Inhibitor Program

  • In January 2013, Idenix entered into a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. for the clinical development of all-oral direct-acting antiviral (DAA) HCV combination therapies. The collaboration will evaluate combinations including IDX719, Idenix's once-daily pan-genotypic NS5A inhibitor, simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen and Medivir AB, and TMC647055, a once-daily non-nucleoside polymerase inhibitor, boosted with low dose ritonavir, being developed by Janssen. Clinical development plans include an initial drug-drug interaction study to begin in the first quarter of 2013, followed by phase II studies as agreed between the companies and pending approval from regulatory authorities.

Nucleotide Inhibitor Program

  • The Company expects to file an investigational new drug application (IND) for a lead uridine-based nucleotide analog candidate from its next-generation nucleotide prodrug discovery program in the first half of 2013. The Company also expects to conduct IND-enabling studies for additional nucleotide prodrugs in 2013.  
  • In February 2013, Idenix elected to discontinue the development of IDX184 and IDX19368, the Company's guanosine-based nucleotide prodrug programs, after the U.S. Food and Drug Administration (FDA) communicated that the programs would remain on a clinical hold that began in August 2012 due to cardiac adverse events seen in a competitor's phase II clinical trial of BMS-986094.

"In 2013, one of our primary goals is to generate IDX719 data in all-oral combination therapies, initially through collaborations beginning in the first half of the year, and subsequently with our own nucleotide prodrug by year end. Also, we have an intensive, rapidly accelerating nucleotide discovery effort and are on track to file one IND from this program in the first half of 2013 and at least one additional IND by the end of the year," said Ron Renaud, Idenix's President and Chief Executive Officer. "With promising candidates from two HCV classes advancing in the clinic by the end of the year, we believe we will be in a good position to evaluate multiple all-oral combination therapies for HCV."

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