| press release Feb. 2, 2012, 9:01 a.m. EST Dynavax Reports on Heplisav(TM) Pre-BLA Meeting With FDA
BERKELEY, CA, Feb 02, 2012 (MARKETWIRE via COMTEX) --Dynavax Technologies Corporation DVAX +2.99% announced todaythat it met with the Food and Drug Administration (FDA) in aPre-Biologics License Application (pre-BLA) meeting, and Dynavax andthe FDA have agreed that the initial HEPLISAV BLA submission will befor an indication in healthy adults 18-70 years of age. Thisagreement represents a significant expansion of the previouslyanticipated population of healthy adults age 40 and over. Inaddition, it was confirmed that a supplemental BLA with an indicationfor patients with chronic kidney disease will be filed when theinitial BLA is approved. According to Dr. Tyler Martin, President and Chief Medical Officer ofDynavax, "This meeting with the FDA marks an important milestone forDynavax. We have clarified the indication, scope and structure of theBLA submission. Following the submission, the BLA will undergo reviewand the HEPLISAV manufacturing facilities must be inspected prior toregulatory approval." Dynavax said it is now making the required modifications to the BLAto support the expanded indication and plans to submit the BLA by themiddle of May. About HEPLISAV HEPLISAV is an investigational adult hepatitis B vaccine. In earlierPhase 3 trials, HEPLISAV demonstrated increased, rapid protectionwith fewer doses than current licensed vaccines. Dynavax hasworldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitisB surface antigen with a proprietary Toll-like Receptor 9 agonistknown as ISS to enhance the immune response. About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceuticalcompany, discovers and develops novel products to prevent and treatinfectious and inflammatory diseases. The Company's lead productcandidate is HEPLISAV, a Phase 3 investigational adult hepatitis Bvaccine designed to provide rapid and superior protection with fewerdoses than current licensed vaccines. For more information visit www.dynavax.com . Forward-Looking Statements This press release contains "forward-looking statements," includingthose relating to the HEPLISAV BLA, planned indications, timing ofthe submissions and the FDA regulatory process, that are subject to anumber of risks and uncertainties. Actual results may differmaterially from those set forth in this press release due to therisks and uncertainties inherent in our business, including whethersuccessful clinical and regulatory development and approval ofHEPLISAV and our process for its manufacture can occur in a timelymanner or without significant additional studies or difficulties ordelays in development or clinical trial enrollment, whether ourstudies can support registration for commercialization of HEPLISAV;the results of clinical trials and the impact of those results on theinitiation and completion of subsequent trials and issues arising inthe regulatory process, including whether the BLA will be acceptedfor filing; the Company's ability to obtain additional financing tosupport the development and commercialization of HEPLISAV and itsother operations, possible claims against the Company based on thepatent rights of others; and other risks detailed in the "RiskFactors" section of our current periodic reports with the SEC. Weundertake no obligation to revise or update information herein toreflect events or circumstances in the future, even if newinformation becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company'scurrent periodic reports with the SEC. Contact: Michael Ostrach Vice President and Chief Business Officer 510-665-7257 Email Contact SOURCE: Dynavax Technologies | 
发表于 2012-2-2 23:08
