Dynavax Confirms HEPLISAV(TM) Submission Strategies With U.S. FDA and EMA
BERKELEY, CA, Oct 27, 2011 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today said that the U.S. Food and Drug Administration (FDA)
had concurred with the company's plan to submit a Biologics License Application
(BLA) for HEPLISAV for persons over 40 years of age, followed by a supplemental
BLA for licensure of a specific regimen for vaccinating chronic kidney disease
(CKD) patients against hepatitis B infection at the time the initial application
is approved. Dynavax also updated its timeline for the company's first BLA
submission saying it expected to submit in the first quarter of 2012.
Dynavax also said that the European Medicines Agency (EMA) has advised the
company it could submit the primary endpoint immunogenicity data and associated
safety data for the over-40 population as well as the CKD indication as part of
the initial Marketing Authorization Application (MAA) and that the outstanding
CKD data can be submitted in the course of the application's review. Dynavax
confirmed its plan to submit the MAA for European approval after the submission
of its BLA in the U.S.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3
trials, 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. |
