IDX719 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection

CAMBRIDGE, Mass., Jul 25, 2012 (GlobeNewswire via COMTEX) -- Idenix Pharmaceuticals, Inc. IDIX +2.83%  , a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IDX719 for the treatment of chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients.

"We are pleased and encouraged by the receipt of Fast Track designation from the FDA for IDX719 as we believe this reflects the critical need for new treatment regimens to address HCV infection," stated Ron Renaud, President and Chief Executive Officer of Idenix. "We remain focused on executing our goal of creating an interferon-free direct acting antiviral combination to cure HCV for a patient population that currently has limited treatment options. As previously reported, we are on track to initiate a phase II combination study of IDX719 with IDX184, our other lead HCV product candidate, by the end of this year."

Under the FDA Modernization Act of 1997, Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file a New Drug Application (NDA) on a rolling basis. This permits the FDA to review the filing as it is received, rather than waiting for the entire submission prior to commencing the review process. 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.


IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, IDX719 has been safe and well tolerated after single and multiple doses of up to 100 mg in healthy volunteers (n=36; up to 7 days duration) and HCV-infected patients (n=69; up to 3 days duration). There have been no treatment-emergent serious adverse events reported in the program. IDX719 has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients. Maximal viral load reductions were > 3 log10 after a single 100 mg dose in an exploratory cohort of genotype 1, 2 and 3 HCV-infected patients. These results have been confirmed in a subsequent proof-of-concept, three-day monotherapy study. After administration of 100 mg IDX719 once daily for 3 days, mean maximal viral load reductions were >3.4 log10 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 log10. The Company is currently conducting pharmacokinetic and sequencing analyses to further characterize these results.


Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with HCV. For further information about Idenix, please refer to .


This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates; and the successful development of novel combinations of direct-acting antivirals for the treatment of HCV. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2012, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

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SOURCE: Idenix Pharmaceuticals