Winston-Salem 1/26/2010 11:15:46 PM
News / Business

SmallCapReview AddsDynavax Technologies (DVAX) and Achillion Pharmaceuticals (ACHN)

Dynavax Technologies (DVAX) is a clinical-stage biopharmaceutical company, that discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines.

 

DVAX Investor Highlights

  • Announced data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist (1) is well tolerated and safe and (2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.

  • Announced the addition of two new senior executives to direct key commercial and clinical activities prior to the launch of HEPLISAV(TM), an investigational adult hepatitis B vaccine.

  • Announced that its GMP manufacturing facility in Dusseldorf, Germany has been approved for the commercial production of hepatitis B surface antigen, a key component of HEPLISAV, the Company's investigational adult hepatitis B vaccine.

  • Announced that enrollment has been completed for the first of three cohorts of patients receiving DV-601 hepatitis B therapy in a Phase 1b clinical trial.

 

Achillion Pharmaceuticals (ACHN) is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. The company's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease – HCV, HIV and resistant bacterial infections.

 

Its products include ACH-1095, a NS4A antagonist that is in late-stage preclinical studies for the treatment of chronic hepatitis C infections; ACH-1625, a protease inhibitor, which is in the preparation for phase I initiation for the treatment of chronic hepatitis C infections; ACH-702, a preclinical candidate that is in preclinical stage with potency against a spectrum of bacterial pathogens, including methicillin-resistant staphylococcus aureus for drug resistant bacterial infections; and Elvucitabine, which completed phase II studies for the treatment of HIV infection. The company has a collaboration arrangement with Gilead Sciences, Inc. to develop and commercialize compounds for use in treating hepatitis C infection, which inhibit viral replication through a mechanism of action.

 

ACHN Investor Highlights

  • Announced that Michael D. Kishbauch, Achillion's President and Chief Executive Officer, will lead the Company's management team in hosting a Corporate and Clinical Update conference call on Monday, February 1, 2010 at 4:30 p.m. Eastern time. Management will bring investors up to date on the Company's progress and plans in its three distinct HCV programs.

  • Reported additional preliminary data from its on-going phase 1b clinical trial of ACH-1625 which demonstrated that the second dosing cohort receiving treatment with ACH-1625 achieved a mean 4.25 log10 reduction in HCV RNA after five-day monotherapy, with continued good safety and tolerability in patients with hepatitis C (HCV). ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.

  • Elvucitabine is currently completing its Phase 2 clinical development program. To date, multiple Phase 2 trials have been successfully completed, and data has been presented at a variety of medical meetings. 


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