Press Release Archive

Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of Ipilimumab

PRINCETON, N.J., April 25, 2008 /PRNewswire-FirstCall via COMTEX News Network/ --
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
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
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.

http://www.medarex.com

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