Dynavax and Merck & Co., Inc. Update Status of Clinical Hold of
Investigational Vaccine HEPLISAV™
BERKELEY, Calif. & WHITEHOUSE STATION, N.J. (Business Wire EON) April 17, 2008 --
Dynavax Technologies Corporation (Nasdaq:DVAX)
and Merck & Co, Inc. announced today the receipt of formal written
notification from the US Food and Drug Administration (FDA) detailing a
request for information relating to the previously announced clinical
hold placed on the two Investigational New Drug Applications for HEPLISAVTM,
an investigational hepatitis B vaccine being jointly developed by
Dynavax and Merck for use in adults and in patients with end stage renal
disease. The FDA is requesting a review of clinical and preclinical
safety data for HEPLISAV. Additionally, the FDA has
requested all available information about the single case of Wegener's
granulomatosis reported in the Phase 3 trial. Dynavax and Merck plan to
provide a complete response to the FDA query in a timely manner.
The FDA will then determine whether the data provided are satisfactory
for the continuation of the clinical program.
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.; TOLAMBATM,
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 nature and
timing of communications 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.
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