Dynavax to Hold Conference Call Today, Monday, March 17, at 4:30
p.m. EDT
BERKELEY, Calif. & WHITEHOUSE STATION, N.J.--(Business Wire)--
Dynavax Technologies Corporation (Nasdaq:DVAX) and Merck & Co.,
Inc. announced today that the U.S. Food and Drug Administration (FDA)
has placed a clinical hold on the two Investigational New Drug (IND)
applications for HEPLISAV(TM), an investigational hepatitis B vaccine
being jointly developed for use in adults by Dynavax and Merck. A
clinical hold is an order issued by FDA to the sponsor to delay a
proposed clinical trial or suspend an ongoing clinical trial.
The FDA has placed the clinical hold on the investigational
vaccine because of a serious adverse event (SAE) that occurred in one
subject who received HEPLISAV in a Phase 3 study being conducted
outside the United States. The subject was preliminarily diagnosed as
having Wegener's granulomatosis, an uncommon disease in which the
blood vessels are inflamed. All subjects in this Phase 3 study have
received all doses per the study protocol and all will continue to be
monitored. Administration of vaccine has been suspended in the only
study of HEPLISAV in which injections were being administered
actively, a fully enrolled Phase 2 study in End Stage Renal Disease
subjects being conducted in Canada. A total of approximately 2,500
individuals have been vaccinated with more than 5,000 doses of
HEPLISAV in 10 clinical trials spanning approximately seven years.
There were no prior reports of Wegener's granulomatosis in these
trials.
No additional clinical trials with HEPLISAV will be initiated
until the clinical hold has been resolved. Dynavax and Merck, along
with additional collaborators, including clinical investigators and
leading experts, are evaluating the medical history of the individual
who experienced the SAE to understand better the timing and onset of
the disease symptoms, including whether it was a pre-existing
condition or was related to vaccine administration.
Dynavax Conference Call
Dynavax will hold a conference call today at 4:30 p.m. EDT (1:30
p.m. PDT) to discuss the current status of its HEPLISAV program. The
live webcast can be accessed by visiting the investor relations
section of the Company's website at
http://investors.dynavax.com/events.cfm. A replay of the webcast will
be available on the Dynavax website approximately two hours after
completion of the call and will be archived for two weeks on the
Investor page of the Dynavax website.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends
to commercialize innovative TLR9 agonist-based products to treat and
prevent infectious diseases, allergies, cancer, and chronic
inflammatory diseases using versatile, proprietary approaches that
alter immune system responses in highly specific ways. Our TLR9
agonists are based on immunostimulatory sequences, or ISS, which are
short DNA sequences that enhance the ability of the immune system to
fight disease and control chronic inflammation. Our product candidates
include: HEPLISAV, a hepatitis B vaccine in Phase 3 partnered with
Merck & Co. Inc.; TOLAMBA(TM), a ragweed allergy immunotherapy in
Phase 2; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for
metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B
also in Phase 1. Our preclinical asthma and COPD program is partnered
with AstraZeneca. The National Institutes of Health (NIH) partially
funds our preclinical work on a vaccine for influenza. Symphony
Dynamo, Inc. (SDI) funds our colorectal cancer trials and our
preclinical hepatitis C therapeutic program, and Deerfield Management
has committed funding for our allergy programs. While Deerfield, NIH
and SDI provide program support, Dynavax has retained rights to seek
strategic partners for future development and commercialization. For
more information, please visit http://www.dynavax.com.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical
company dedicated to putting patients first. Established in 1891,
Merck currently discovers, develops, manufactures and markets vaccines
and medicines to address unmet medical needs. The Company devotes
extensive efforts to increase access to medicines through far-reaching
programs that not only donate Merck medicines but help deliver them to
the people who need them. Merck also publishes unbiased health
information as a not-for-profit service. For more information, visit
www.merck.com.
Dynavax Forward-looking Statement
This press release contains "forward-looking statements,"
including statements related to the clinical status of HEPLISAV, the
timing of discussions with the FDA regarding the current clinical hold
and whether or not and under what additional requirements, if any,
further clinical development will be permitted. Actual results may
differ materially from those set forth in this press release due to
the risks and uncertainties inherent in our business, including
difficulties or delays in development, initiation and completion of
clinical trials, 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; achieving our Merck
collaborative agreement objectives and obtaining regulatory approval
for HEPLISAV; the scope and validity of patent protection and the
possibility of claims against us based on the patent rights of others;
our ability to obtain additional financing to support our operations;
and other risks detailed in the "Risk Factors" section of our Annual
Report on Form 10-K. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the future,
even if new information becomes available.
Merck Forward-Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995. These statements are based on management's current expectations
and involve risks and uncertainties, which may cause results to differ
materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development,
product potential or financial performance. No forward-looking
statement can be guaranteed and actual results may differ materially
from those projected. Merck undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events, or otherwise. Forward-looking statements
in this press release should be evaluated together with the many
uncertainties that affect Merck's business, particularly those
mentioned in the risk factors and cautionary statements in Item 1A of
Merck's Form 10-K for the year ended Dec. 31, 2007, and in its
periodic reports on Form 10-Q and current reports on Form 8-K, if any,
which the Company incorporates by reference.
Dynavax
Shari Annes, 1-650-888-0902
1-510-665-7210
(Investor Relations & Media)
sannes@dynavax.com
or
Merck
Graeme Bell, 1-908-423-5185 (Investor Relations)
Kelley P. Dougherty, 1-215-652-0059 (Communications)
Copyright Business Wire 2008
