Dynavax Announces FDA Advisory Committee Meeting Outcome for

Dynavax Announces FDA Advisory Committee Meeting Outcome for
HEPLISAV(TM) 
BERKELEY, CA -- (Marketwire) -- 11/15/12 --  Dynavax Technologies
Corporation (NASDAQ: DVAX) today announced that the U.S. Food and
Drug Administration (FDA) Vaccines and Related Biological Products
Advisory Committee (Committee) voted 13 to one that HEPLISAV data
adequately demonstrated immunogenicity. Additionally, the Committee
voted eight to five with one abstention that there was insufficient
data to adequately support the safety of HEPLISAV. 
Now that Dynavax has received the Committee's input and vote, the
Company will continue working with the FDA as it completes its review
of the HEPLISAV application. The scheduled Prescription Drug User Fee
Act (PDUFA) date for HEPLISAV is February 24, 2013. 
About HEPLISAV 
HEPLISAV is an investigational adult hepatitis B vaccine for which
U.S. and European licensure applications have been accepted for
review by the FDA and the EMA. The PDUFA date for completion of the
FDA review of the HEPLISAV Biologic License Application (BLA) is
February 24, 2013. Dynavax has worldwide commercial rights to
HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a
proprietary Toll-like Receptor 9 agonist to enhance the immune
response. 
About Dynavax 
Dynavax, a clinical-stage biopharmaceutical company, discovers and
develops novel products to prevent and treat infectious and
inflammatory diseases. Dynavax's lead product candidate is HEPLISAV,
a Phase 3 investigational adult hepatitis B vaccine. For more
information visit www.dynavax.com.  
Forward-Looking Statements 
This press release may contain "forward-looking" statements. 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
review 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; 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 and the European licensure
application will be approved; our ability to obtain additional
financing to support the development and commercialization of
HEPLISAV and our other operations; our ability to successfully
transition to a commercial operation and execute on our commercial
strategy; possible claims against us, including enjoining sales of
HEPLISAV, based on the patent rights of others; and other risks
detailed in the "Risk Factors" section of our current periodic
reports with the SEC. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the future,
even if new information becomes available. Information on Dynavax's
website at www.dynavax.com is not incorporated by reference in our
current periodic reports with the SEC.  
Contact:
Michael Ostrach
Vice President and Chief Business Officer 
510-665-7257
mostrach@dynavax.com 
 
 
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