Dynavax Receives Canadian Approval to Conduct Phase 3 Trials of HEPLISAV(TM)
BERKELEY, CA--(Marketwire - February 16, 2010) - Dynavax Technologies Corporation (NASDAQ: DVAX) announced that Health Canada, the Canadian equivalent of the U.S.
Food and Drug Administration, has approved the initiation of the Company's
next Phase 3 trials in Canada. Initiation of the Canadian studies is
expected to facilitate enrollment for the multi-center trials.
Immunizations in the U.S. have begun, while the Canadian sites are expected
to begin enrollment shortly. In Canada, the Health Products and Food Branch
(HPFB) of Health Canada regulates the development of new drugs and
vaccines.
One trial is designed to demonstrate the lot-to-lot consistency of
commercial vaccine and to complete the safety database for HEPLISAV™,
the Company's investigational adult hepatitis B vaccine. The second trial
compares HEPLISAV to Engerix-B® in patients with chronic kidney disease.
These studies are directed toward fulfilling licensure requirements in
Canada, in addition to the U.S and Europe. HEPLISAV has been shown in two
previous Phase 3 trials to enhance protection more rapidly and with fewer
doses than a currently licensed vaccine.
The lot-to-lot consistency trial will enroll approximately 2,000 patients
in Canada and in the U.S., 1600 of whom will receive HEPLISAV. Patients
randomized to the comparator arm will receive Engerix-B, a currently
licensed hepatitis B vaccine. The chronic kidney disease trial will enroll
approximately 600 patients in Canada, the U.S. and Germany, 300 of whom
will receive HEPLISAV. Patients randomized to the comparator arm will
receive Engerix-B.
Data from these trials are expected in mid-2011. The hepatitis B surface
antigen in the HEPLISAV lots being evaluated was produced in Dynavax's
manufacturing facility in Düsseldorf, Germany. This facility was recently
upgraded and licensed in the European Union for commercial production of
hepatitis B surface antigen.
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, an
investigational adult hepatitis B vaccine designed to enhance protection
more rapidly and with fewer doses than current licensed vaccines. For more
information visit www.dynavax.com.
Forward-looking Statements
This press release contains "forward-looking statements" that are subject
to a number of risks and uncertainties, including statements regarding the
nature of planned HEPLISAV clinical trials and the timing of their
initiation and completion. 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 or clinical trial enrollment, whether the studies can support
registration for commercialization of 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.
Engerix-B® is a trademark of GlaxoSmithKline.
Contact Information: Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257