Dynavax Reports HEPLISAV(TM) BLA Submission
This submission is a very important milestone for
We have requested priority review for HEPLISAV, as we believe it is a significant improvement compared to marketed products. We look forward to working with the
The Company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the initial HEPLISAV BLA,
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines.
About
Forward-Looking Statements
This press release contains "forward-looking statements," including those relating to the HEPLISAV planned indications and regimens and timing of BLA and MAA submissions, that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process, including whether
the BLA will be accepted for filing; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the
Contact:Michael Ostrach Vice President and Chief Business Officer 510-665-7257 Email Contact
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