Dynavax's European Manufacturing Facility Approved for Commercial Production of HEPLISAV Hepatitis B Surface Antigen
December 09 2009 - 1:00AM
Marketwired
Dynavax Technologies 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 HEPLISAV.
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.
About HEPLISAV
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.
About Dynavax
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.
Contact: Michael Ostrach Vice President and Chief Business
Officer 510-665-7257 Email Contact
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