Medarex Announces MDX-060 Receives Orphan Drug Designation for Treatment of Hodgkin's Disease

Medarex Announces MDX-060 Receives Orphan Drug Designation for Treatment of Hodgkin's Disease
    PRINCETON, N.J., Oct. 6 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) today announced that under the U.S. Orphan Drug Act, the U.S.
Food and Drug Administration (FDA) has granted orphan drug designation to
Medarex's fully human anti-CD30 antibody, MDX-060, for the treatment of
Hodgkin's disease. Orphan drug designation is granted to products that treat
rare diseases or conditions that affect fewer than 200,000 people in the U.S.
Orphan Drug designation provides eligibility for a special seven-year period
of market exclusivity at marketing approval, potential tax credits for
research, grant funding for research and development, possibly reduced filing
fees for marketing applications, and assistance with the review of clinical
trial protocols.

    "We believe that the MDX-060 has the potential to address a serious unmet
medical need, and we expect to continue to rapidly develop this antibody for
patients with Hodgkin's disease," said Donald L. Drakeman, President and CEO
of Medarex.

    About MDX-060

    MDX-060 is a fully human antibody that targets CD30, a member of the tumor
necrosis factor receptor superfamily and a molecule found on activated
lymphocytes. CD30 has been found to be over-expressed in several
lymphoproliferative disorders and is present on malignant cells of Hodgkin's
disease (HD) and anaplastic large cell lymphoma (ALCL), as well as other CD30-
positive lymphomas. Currently, Medarex is conducting an expanded dose-ranging
Phase II study with MDX-060 in patients with CD30-positive lymphomas.

    Of the nearly 500,000 Americans with lymphoma, 168,000 have HD. According
to the American Cancer Society, in 2004 there will be approximately 7,880 new
cases of Hodgkin's disease in the United States, and an estimated 1,320 people
will die of the disease. The frequency of ALCL in the United States is not
known, but worldwide, ALCL accounts for approximately 5% of all non-Hodgkin's
lymphoma.

    About Medarex

    Medarex is a biopharmaceutical company focused on the discovery and
development of fully human antibody-based therapeutics to treat life-
threatening and debilitating diseases, including cancer, inflammation,
autoimmune and infectious diseases. Medarex applies its UltiMAb(TM) technology
and product development and clinical manufacturing experience to generate,
support and potentially commercialize a broad range of fully human antibody
products for itself and its partners. Twenty of these therapeutic products
derived from Medarex technology are currently in human clinical testing, with
the most advanced candidate currently in a Phase III clinical trial. 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 website at http://www.medarex.com.

    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;" "anticipate;" "intend;" "plan;" "expect;" "estimate;" "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-060 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, 2003 and subsequent Quarterly Reports on Form 10-Q.  There
can be no assurance that such development efforts will succeed, that MDX-060
or 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 Human Antibody Development
System(R) are registered trademarks of Medarex, Inc.  UltiMAb(TM) is a
trademark of Medarex, Inc.  All rights are reserved.

SOURCE  Medarex, Inc.
    -0-                             10/06/2004
    /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/
    /Company News On-Call:  http://www.prnewswire.com/comp/108265.html/
    /Web site:  http://www.medarex.com /
    (MEDX)

CO:  Medarex, Inc.; U.S. Food and Drug Administration
ST:  New Jersey
IN:  HEA MTC BIO
SU:  SVY

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