BERKELEY, CA and DUSSELDORF, GERMANY--(Marketwire - December 09, 2009) -
Corporation (NASDAQ: DVAX
) announced today that its GMP manufacturing
facility in Düsseldorf, Germany has been approved for the commercial
production of hepatitis B surface antigen, a key component of HEPLISAV,
the Company's investigational adult hepatitis B vaccine. The approval
comes as a result of an upgrade expanding production capacity. With an
updated European Union GMP manufacturing license in place, Dynavax can meet
the initial commercial production demands for the anticipated launch of
Dynavax's German subsidiary Rhein Biotech has manufactured the hepatitis B
surface antigen for HEPLISAV clinical trials in this facility since 2006.
The facility upgrade also enhances integrated product development and
manufacturing services Rhein Biotech provides to third party partners.
HEPLISAV is an investigational adult hepatitis B vaccine. In a completed
pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection
with fewer doses than current licensed vaccines. Dynavax has worldwide
commercial rights to HEPLISAV and is developing the vaccine for large,
high-value populations that are less responsive to current licensed
vaccines, including individuals with chronic kidney disease. HEPLISAV
combines hepatitis B surface antigen with a proprietary Toll-like Receptor
9 agonist known as ISS to enhance the immune response.
About Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six
months to achieve full immunogenicity in healthy patient populations.
Because compliance with this vaccine regimen is low, new vaccines are
needed to provide increased protection in a shorter timeframe. Furthermore,
currently available vaccines do not fully address the needs of several
patient populations, including those with chronic kidney disease, HIV or
chronic liver disease. In particular, patients with comprised immune
systems require both rapid and enhanced protection, either because they are
less responsive to conventional vaccine regimens or because they are at
high risk of infection.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical
company, discovers and develops novel products to prevent and treat
infectious diseases. The Company's lead product candidate is HEPLISAV, a
Phase 3 investigational adult hepatitis B vaccine designed to provide more
rapid and increased protection with fewer doses than current licensed
vaccines. For more information visit www.dynavax.com.
About Dynavax Europe (Rhein Biotech GmbH)
Headquartered in Düsseldorf, Germany Dynavax's fully-owned subsidiary Rhein
Biotech manufactures hepatitis B surface antigen for HEPLISAV. With 20
years in business, Rhein Biotech also provides integrated product
development services to enable its partners to bring products to market.
For more information visit www.rheinbiotech.de.
Forward Looking Statements
This press release contains "forward-looking statements" 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 can occur in a
timely manner or without significant additional studies or difficulties or
delays in development, whether the studies can support registration for
commercialization of HEPLISAV, the potential size and value of the chronic
kidney disease market addressable with HEPLISAV, the commercial potential
for HEPLISAV, and 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 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.