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Achillion Nominates ACH-3422 as Nucleotide for the Treatment of Chronic HCV
  - Advancement of ACH-3422 Complements Achillion's Portfolio of 2nd Generation Protease and NS5A Inhibitors Providing the Opportunity to Optimize Treatment Duration and Outcomes for All HCV Patients -
NEW HAVEN, Conn., May 30, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced the nomination of the preclinical compound, ACH-3422, a novel small molecule nucleotide prodrug of a uridine analog designed to inhibit HCV NS5B polymerase. This compound will be advanced as a development candidate for the treatment of chronic hepatitis C (HCV) viral infection.
Achillion plans to complete regulatory submissions during the first quarter of 2014, with first-in-human studies anticipated in the first half of 2014, followed by combination development in the second half of 2014.
"Our research and discovery team has always maintained the highest standards for developing proprietary best-in-class compounds, and this has led to the nomination of ACH-3422, which we are now advancing toward the clinic," commented Milind Deshpande, Ph.D., President and Chief Executive Officer. "The addition of ACH-3422 gives Achillion a portfolio of assets that also includes a 2nd generation protease inhibitor, sovaprevir, and a 2nd generation NS5A inhibitor, ACH-3102, which together provide Achillion the opportunity to potentially optimize treatment outcomes and duration of therapy across all HCV patients."
Dr. Deshpande further commented, "Along with the nomination of this candidate, we continue our efforts to accelerate the development time-lines for our all-oral, interferon-free combination of sovaprevir and ACH-3102, our protease and NS5A inhibitors, as a regimen for the treatment of HCV. Beginning in the third quarter of 2013, we expect to begin to report interim results from the ongoing -007 clinical trial of these agents for the treatment of HCV genotype 1 treatment-na•ve patients."
Preclinical profile of ACH-3422
ACH-3422 is a small-molecule, nucleotide prodrug inhibitor of HCV NS5B polymerase. In vitro, ACH-3422 has demonstrated excellent potency, with activity demonstrated across all genotypes of HCV and an EC50 of approximately 50 to 65 nanomolar against genotype 1 HCV. To date, Achillion has completed 14-day safety studies in animals, where no significant findings were noted at the highest dose tested. ACH-3422 appears to have high oral bioavailability, rapid uptake and conversion of the prodrug into the monophosphate within the liver, and a pharmacokinetic profile supportive of once-daily dosing. Manufacturing and IND-enabling studies have been initiated, with the expectation of submitting an IND to the FDA in the first quarter of 2014.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including more than 5 million people in the United States, making HCV more than twice as widespread as HIV.
Three-fourths of the global HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
For additional information on Achillion's ongoing clinical trial please visit: http://clinicaltrials.gov
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's discovery, clinical development, and commercial teams have advanced multiple novel product candidates with proven mechanisms of action into studies and toward the market. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.

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