PRINCETON, N.J., April 25 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced
that, after meeting with the U.S. Food and Drug Administration (FDA), the
companies will delay the Biologics License Application (BLA) submission for
ipilimumab, an investigational immunotherapy for patients with advanced
metastatic melanoma. The FDA has requested additional overall survival (OS)
data to further demonstrate the benefit of ipilimumab. Revised timelines
are under development, but a BLA for ipilimumab will not be submitted to
the FDA in 2008.
The randomized Phase 3 trial evaluating the efficacy of ipilimumab in
combination with dacarbazine versus dacarbazine alone in patients with
untreated unresectable Stage III or Stage IV melanoma is ongoing under
Special Protocol Assessment (SPA). The companies are engaged in discussions
with the FDA to change the primary endpoint in this trial from progression
free survival (PFS) to OS. A potential submission for melanoma would
include survival data from patients in the Phase 2 second-line studies and
the randomized Phase 3 first-line trial currently ongoing.
Bristol-Myers Squibb and Medarex remain committed to the development of
ipilimumab. The companies also have ongoing Phase 2 studies in
hormone-refractory prostate cancer and lung cancer as well as a Phase 3
study, to be initiated shortly, in adjuvant melanoma.
Twelve abstracts evaluating ipilimumab in melanoma will be presented at
the American Society of Clinical Oncology (ASCO) Annual Meeting this year.
These include data from the three Phase 2 trials evaluating ipilimumab in
patients with advanced Stage III or Stage IV metastatic melanoma (Abstract
#9010, 9021 and 9025).
Ipilimumab is being developed through a joint partnership between
Bristol-Myers Squibb and Medarex. Based on nonclinical and clinical studies
showing that antibody blockade of CTLA-4 plays an important role in
sustaining an active immune response to fight cancer, the companies are
pursuing a broad clinical development program with ipilimumab. More than
2,000 patients have been treated in clinical trials with ipilimumab as a
monotherapy or in combination with other agents.
For further information about ipilimumab clinical trials, please visit
http://www.clinicaltrials.gov.
About Ipilimumab
Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T
lymphocyte-associated antigen 4), a molecule on T-cells that plays a
critical role in regulating natural immune responses. The absence or
presence of CTLA-4 can augment or suppress the immune system's T-cell
response in fighting disease. Ipilimumab is designed to block the activity
of CTLA-4, thereby sustaining an active immune response in its attack on
cancer cells.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. More than 40 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the subject of regulatory
applications for marketing authorization. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more information about Medarex, visit
its Web site at http://www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements that are subject
to certain risks and uncertainties that could cause actual results to
differ materially from any future results, performance or achievements
expressed or implied by such statements. Statements that are not historical
facts, including statements preceded by, followed by, or that include the
words "potential"; "believe"; "expect"; "could"; "may"; or similar
statements are forward-looking statements. Medarex disclaims, however, any
intent or obligation to update these forward-looking statements. These
risks and uncertainties include whether the development of ipilimumab will
be successful, whether the clinical studies described in this release will
support the filing of a BLA with the FDA, or whether, if a BLA is filed
with the FDA, it will be filed in the timeframe developed by the parties or
will receive regulatory approval, as well as risks detailed from time to
time in Medarex's public disclosure filings with the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form 10-K for the
fiscal year ended December 31, 2007 and its quarterly reports on Form 10-Q.
There can be no assurance that such development efforts will succeed or
that other developed products will receive required regulatory clearance or
that, even if such regulatory clearance were received, such products would
ultimately achieve commercial success. Copies of Medarex's public
disclosure filings are available from its investor relations department.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical and related health
care products company whose mission is to extend and enhance human life.
Bristol-Myers Squibb Statement on Cautionary Factors
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995,
regarding the development of biological products and the submission of
applications to market such products. Such forward-looking statements are
based on current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and could
cause actual outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among other
risks, there can be no guarantee that the development of the product
described in this release will be successful or that the clinical studies
described in this release will support the filing of a Biological License
Application (BLA) with the U.S. Food and Drug Administration (FDA).
Furthermore, there can be no assurances that if a BLA is filed with the
FDA, that it will be filed in the timeframe described in this release or
that the BLA for the product described in this release will receive
regulatory approval. There can be no assurances that if approved, the
product described in this release will be commercially successful.
Forward-looking statements in the press release should be evaluated
together with the many uncertainties that affect Bristol-Myers Squibb's
business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2007, its Quarterly Reports on Form 10-Q, and
Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation
to publicly update any forward-looking statement, whether as a result of
new information, future events, or otherwise.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
SOURCE Medarex, Inc.
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Related links:
http://www.medarex.com
http://www.clinicaltrials.gov
http://www.prnewswire.com/comp/108265.html/
CONTACT:
Investors: Laura S. Choi of Medarex, Inc.,
+1-609-430-2880, ext. 2216, or John Elicker of Bristol-Myers
Squibb, +1-212-546-3775, John.Elicker@bms.com; or Media: Nichol
Harber, Corporate Communications of Medarex, Inc.,
+1-609-430-2880, ext. 2214, or Sarah Koenig of Bristol-Myers
Squibb Company, +1-609-252-4145, +1-908-397-5379,
Sarah.Koenig@bms.com
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