Dynavax Embarks on Transition to Commercialization
BERKELEY, CA, May 08, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) announced today, that following the recent submission of the
U.S. Biologics License Application (BLA) to the Food and Drug Administration
(FDA), it intends to begin developing a commercial operation capable of
independently launching HEPLISAV(TM) in the U.S. The Company believes that being
able to bring HEPLISAV to the market successfully will ultimately help maximize
long-term value for its shareholders.
With the goal of laying the foundation for long-term success, Dynavax plans to
strengthen its senior team with the addition of experienced commercial
leadership. Subsequent to a recommendation from Dino Dina, the Company's Chief
Executive Officer, the Company's Board of Directors has agreed to initiate a
process that they anticipate will include his succession. Dr. Dina plans to
continue in his role as CEO through this process and will support the transition
to his eventual successor. He will also continue as a member of the Company's
Board thereafter.
Dr. Dina joined Dynavax in May 1997 and has led the transformation of the Company
from its early days through the research and development phase. Said Dr. Dina, "I
believe now is the right time to prepare Dynavax to effectively capitalize on the
significant market opportunity we have ahead of us when we are able to bring the
benefits of HEPLISAV to the public. I am committed to working with our Board to
plan for the success of Dynavax."
"Dino's leadership and vision have been critical in making Dynavax what it is
today, a diversified company with an important product candidate in HEPLISAV and
a maturing pipeline. We fully endorse the strategic direction for Dynavax that
Dino has set and appreciate Dino's commitment to a smooth and seamless transition
process," said Arnold Oronsky, Ph.D., Chairman of the Board. "We are confident
that Dino and the leadership team will remain focused on Dynavax's success and
building value for shareholders in the years ahead."
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has
been submitted to the FDA and a European Marketing Authorization Application
(MAA) is expected to be submitted in the third quarter of 2012. HEPLISAV may not
be marketed in the U.S. unless and until a BLA is approved and may not be
marketed in Europe unless and until a MAA is approved. In Phase 3 trials,
HEPLISAV demonstrated higher and earlier protection with fewer doses than
currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV.
HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like
Receptor 9 agonist to enhance the immune response. |
