Replies to post #160798 on Biotech Values

[DewDiligence]

ACHN CEO, Michael Kishbauch, retires:

http://finance.yahoo.com/news/achillion-names-milind-deshpande-ph-200500430.html

Kishbauch was 63, which is not that old for a CEO. Under the circumstances, it seems reasonable to infer that ACHN’s incessant predictions of a major HCV partnership were exaggerated.

The new CEO is Milind Deshpande, 55, who had been CSO.

[oc631]

Achillion Nominates ACH-3422 as Nucleotide for the Treatment of Chronic HCV




NEW HAVEN, Conn., May 30, 2013 (GLOBE NEWSWIRE) --Achillion Pharmaceuticals, Inc. (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-naive 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.