BERKELEY, CA -- (Marketwire) -- 08/22/12 --
Dynavax Technologies Corporation (NASDAQ: 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 www.dynavax.com.
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