Dynavax Marketing Authorization Application for HEPLISAV(TM) Accepted for Review
by European Medicines Agency
BERKELEY, CA, Aug 22, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) announced today that the European Medicines Agency (EMA) has
accepted the filing of the Marketing Authorization Application (MAA) for
HEPLISAV, pursuing an indication for immunization against infection caused by all
known subtypes of hepatitis B virus in adults 18 through 70 years of age and in
patients with chronic kidney disease. Acceptance of the MAA confirms that the
submission is sufficiently complete to permit a substantive review by the EMA.
"This milestone marks the initiation of the regulatory review for HEPLISAV in
Europe," said Dynavax President and Chief Medical Officer, Tyler Martin, M.D. "We
look forward to working through the review process with our designated rapporteur
from Sweden and co-rapporteur from Belgium."
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has
been accepted for review by the FDA and a MAA has been accepted for review by the
EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with
fewer doses than currently licensed vaccines. 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 Technologies Corporation, a clinical-stage biopharmaceutical company,
discovers and develops novel products to prevent and treat infectious and
inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase
3 investigational adult hepatitis B vaccine designed to provide higher and
earlier protection with fewer doses than currently licensed vaccines. For more
information visit 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 MAA 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 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
Email Contact |
