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Idenix Pharmaceuticals Reports Second Quarter And Six Month 2012 Financial Results And HCV Program Update

Stocks in this article: IDIX

CAMBRIDGE, Mass., Aug. 8, 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 reported unaudited financial results for the second quarter and six months ended June 30, 2012 and provided an update of its hepatitis C virus (HCV) development programs.

Operational Highlights

IDX184, an HCV nucleotide polymerase inhibitor

  • The Company reported interim data in June for the first cohort of 31 patients from an ongoing phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (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).
  • Recently 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.

IDX719, an HCV NS5A inhibitor

  • IDX719 demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1- 4, treatment-naive HCV patients, as reported in June. After administration of 100 mg IDX719 once daily for three days, mean maximal viral load reductions were > 3.4 log 10 in genotype 1, 3 and 4 HCV-infected patients. There was greater variability in responses among genotype 2 HCV-infected patients, who had mean maximal viral load reductions of 2.0 log 10. As previously announced, the Company is conducting pharmacokinetic and sequencing analyses to further characterize the results in the genotype 2 study cohort. In addition, more detailed findings from the study will be presented at the American Association for the Study of Liver Diseases (AASLD) in November 2012.
  • Idenix recently announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IDX719. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which would reduce the length of the standard FDA review period.

IDX19368, an HCV nucleotide polymerase inhibitor

  • Idenix recently submitted an investigational new drug application (IND) for its drug candidate, IDX19368. Idenix expects to initiate clinical trials in the third quarter of 2012.

Novartis Termination and Revised Relationship Agreement

  • Idenix entered into a development and commercialization collaboration in May 2003 with Novartis Pharma AG (Novartis). In July 2012, Novartis and Idenix amended the collaboration and executed a termination and revised relationship agreement. This agreement allows Idenix increased flexibility to optimize the value of its pipeline and to be well-positioned to develop all-oral direct-acting antiviral combination treatments with potential collaborators.

Underwritten Offering

  • In August 2012, Idenix issued 25.3 million shares of its common stock pursuant to an underwritten offering and received net proceeds of approximately $190.6 million.

"In the second quarter, data from our two lead clinical programs reaffirmed the antiviral activity of IDX184 and its potential as a key component in combination HCV therapy, as well as highlighted the pan-genotypic activity of IDX719. As we continue to advance these drug candidates, we also are on track to begin our third clinical program shortly," said Ron Renaud, Idenix's President and Chief Executive Officer. "With this progress, we believe we have substantially increased the value of our pipeline in 2012, further enhancing our position as a lead innovator in new treatments for HCV."

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