Idenix Reports Financial Results and HCV Program Update

Idenix Pharmaceuticals Reports Third Quarter and Nine Month 2012 Financial Results and HCV Program Update

CAMBRIDGE, Mass., Nov. 1, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (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 third quarter and nine months ended September 30, 2012 and provided an update of its hepatitis C virus (HCV) development programs.

 

HCV Pipeline and Third Quarter Business Review
IDX719, an NS5A inhibitor

• The Company previously reported early clinical results demonstrating a favorable safety profile and potent pan-genotypic activity for IDX719. Idenix anticipates that a phase II clinical trial evaluating IDX719 in combination therapy will begin in the first half of 2013.

Nucleotide polymerase inhibitor program

• In August 2012, the U.S. Food and Drug Administration (FDA) placed IDX184 on partial clinical hold due to serious cardiac--related adverse events seen with a competitor's nucleotide polymerase inhibitor, BMS-986094 (formerly INX-189). Idenix has obtained cardiac safety measurements from the ongoing phase IIb study of IDX184 in combination with pegylated interferon and ribavirin and has found no evidence of severe cardiac findings to date. Idenix is reviewing additional preclinical and clinical data and conducting further testing . The Company anticipates submitting the complete response package to the FDA by year-end.
• In July 2012, Idenix submitted an investigational new drug (IND) application for IDX19368, a 2'methyl guanosine nucleotide inhibitor. In August 2012, FDA placed IDX19368 on clinical hold due to serious cardiac-related adverse events seen with BMS-986094 and has requested additional toxicology and metabolic preclinical studies for IDX19368 prior to permitting the initiation of clinical studies.
• As part of the ongoing extensive nucleotide discovery effort, the Company is exploring a diverse spectrum of nucleotides with novel bases, prodrugs and sugar moieties. IND-enabling studies have begun for a new nucleotide prodrug and an IND is expected to be filed in 2013.

"We are working diligently to assemble all of the data requested by the FDA regarding IDX184, and we expect to receive a response from the FDA in early 2013," said Ron Renaud, Idenix's President and Chief Executive Officer. "We also are excited about IDX719, a potentially best-in-class pan-genotypic NS5A inhibitor, and look forward to moving it into phase II clinical development in the near term. Additionally, in 2013 we expect to see the results of our robust discovery efforts focused on next-generation nucleotide inhibitors, with the objective of filing at least one IND next year."
Renaud continued, "Our goal remains to develop an all-oral pan-genotypic regimen that will play a significant role in future HCV treatments. With a strong cash position and the restructured Novartis collaboration, we are able to maximize opportunities for advancing our programs in order to achieve that goal."

Upcoming Meeting
The 63^rd Annual Meeting for the American Association for the Study of Liver Diseases (AASLD) will take place in Boston from November 9 -- November 13, 2012.

• A poster titled "IDX719, HCV NS5A Inhibitor, Demonstrates Pan-Genotypic Activity after Three Days of Monotherapy in Genotype 1, 2, 3 or 4 HCV-Infected Subjects," by D. Mayers, et al, will be presented on November 13 at 8:00 am ET.
• A poster titled "High Rates of Rapid Virologic Response (RVR) and Complete Early Virologic Response (cEVR) with IDX184, Pegylated Interferon and Ribavirin in Genotype 1 HCV-Infected Subjects: Interim Results," by E. Lawitz, et al, will be presented on November 13, 2012 at 8:00 am ET.

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