Medarex Announces Allowance of Investigational New Drug Application for Wholly Owned Fully Human Anti-CD70 Antibody, MDX-1411

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Medarex Announces Allowance of Investigational New Drug Application for Wholly Owned Fully Human Anti-CD70 Antibody, MDX-1411
PRINCETON, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX)
announced today the allowance of an investigational new drug application (IND) filed
with the U.S. Food & Drug Administration (FDA) for MDX-1411 for the treatment of
CD70-expressing malignancies, with the initial clinical study to focus on the
treatment of clear cell renal cell carcinoma (ccRCC). MDX-1411 was generated by
Medarex's UltiMAb Human Antibody Development System(R).

    The open-label, multi-center, dose-escalation, multi-dose Phase I clinical trial
is expected to enroll up to 40 patients with advanced ccRCC. The trial is designed
to determine the safety, tolerability and maximum tolerated dose of MDX-1411 as well
as characterize preliminary efficacy and pharmacokinetics.

    "The advancement of this antibody into the clinical trial process adds to our
internal pipeline and expands our portfolio of potentially new oncology
therapeutics," said Howard H. Pien, President and CEO of Medarex. "We expect the
growth of our pipeline to continue through the addition of proprietary products
along with new antibodies that are developed through collaborations."

    About MDX-1411

    MDX-1411 is a fully human monoclonal antibody that targets the CD70 receptor,
which is a member of the tumor necrosis factor (TNF) family. CD70 is expressed in a
number of cancers, including ccRCC primary tumors and metastatic lesions. 
Preclinical in vitro studies showed that MDX-1411 binds to CD70 positive cells and
induces antibody-dependent cellular cytotoxicity (ADCC), an important mechanism of
action of therapeutic antibodies that induces the destruction of targeted cells by
the immune system. Preclinical in vivo studies conducted in ccRCC xenograft models
demonstrated anti-tumor activity.

    About Renal Cell Carcinoma (RCC)

    According to the American Cancer Society there were almost 39,000 new cases of
RCC and 13,000 deaths caused by RCC in 2006.  About 80% of RCC cases are clear cell
renal cell carcinoma making it the most common among five types of RCC.  Renal cell
carcinoma generally starts as one or more tumors in one or both kidneys and in
advanced stages can spread to other organs. Current treatment options for RCC
include surgery, radiation, chemotherapy, immunotherapy and targeted therapeutics.

    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 30 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 III 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.

    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"; "expect"; "could"; "may"; or similar
statements are forward-looking statements. Medarex disclaims, however, any intent or
obligation to update these forward-looking statements. Risks and uncertainties
include risks associated with product discovery and development, uncertainties
related to the outcome of clinical trials, slower than expected rates of patient
recruitment, unforeseen safety issues resulting from the administration of MDX-1411
in patients, uncertainties related to product manufacturing 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, 2006 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.

    Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of
Medarex, Inc. All rights are reserved.

SOURCE  Medarex, Inc.
    -0-                             01/08/2008
    /CONTACT:  Laura S. Choi, Investor Relations, +1-609-430-2880, x2216, or Jean
Mantuano, Corporate Communications (media), +1-609-430-2880, x2221, both of Medarex,
Inc./
    /Company News On-Call:  http://www.prnewswire.com/comp/108265.html/
    /Web site:  http://www.medarex.com/
    (MEDX)

CO:  Medarex, Inc. ST:  New Jersey IN:  BIO MTC HEA SU:  TRI

AZ-JO -- NETU026 -- 2998 01/08/2008 07:00 EST http://www.prnewswire.com