FDA Agrees With Dynavax on Consistency of HEPLISAV(TM) Lots
BERKELEY, CA, Jul 28, 2011 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today announced that the Center for Biologics Evaluation and
Research (CBER) of the U.S. Food and Drug Administration (FDA) advised the
company that "CBER agrees that clinical consistency of three consecutively
manufactured lots of HEPLISAV has been demonstrated." In a written communication
to Dynavax, FDA noted that "Although lot consistency criteria were not met at the
pre-specified time point of 4 weeks PLD (post last dose), lot consistency
criteria were met 8 weeks PLD, the time point corresponding to the primary
immunogenicity endpoint, as well as at several other time points."
According to Dr. Tyler Martin, President and Chief Medical Officer, "As expected,
the FDA has confirmed our assessment of lot consistency in the Phase 3 trial we
just announced. With their concurrence, we can now move forward towards our goal
of preparing a BLA for submission by the end of the year for hyporesponsive
populations aged 40 and older."
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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 rapid and
superior protection with fewer doses than current licensed vaccines. For more
information visit 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 timing of
the BLA submission. 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 and our process for its manufacture can occur in a timely manner or
without significant additional studies or difficulties or delays in development
or clinical trial enrollment, 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; 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. Information on Dynavax's website at
dynavax.com is not incorporated by reference in the Company's current
periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact |
