Medarex to Receive Milestone Payment for the Approval of Ilaris for the Treatment of Cryopyrin-Associated Periodic Syndrome

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Tue Jun 30, 2009 8:00am EDT

Other Inflammatory Disease Studies Underway in Systemic Juvenile Idiopathic
Arthritis, Some Forms of Gout and Type 2 Diabetes
PRINCETON, N.J.--(Business Wire)--
Medarex, Inc. (NASDAQ:MEDX) today announced it will receive a milestone payment
of an undisclosed amount from Novartis Pharma AG (Novartis), in connection with
the marketing approval from the U.S. Food and Drug Administration (FDA), to
market Ilaris® (canakinumab, previously known as ACZ885) for the treatment of
children as young as four years old and adults with cryopyrin-associated
periodic syndrome, or CAPS, a serious life-long auto-inflammatory disease caused
by rare genetic mutations. 

CAPS comprises three disorders of increasing severity: familial cold
auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS) and
neonatal-onset multisystem inflammatory disease (NOMID). A clinical study is
ongoing to evaluate the potential of Ilaris® to treat patients with NOMID. In
addition to ongoing studies in CAPS, clinical trials are also under way with
Ilaris® in systemic juvenile idiopathic arthritis (SJIA), and more common
disorders such as some forms of gout, chronic obstructive pulmonary disorder
(COPD) and type 2 diabetes. 

Ilaris® is a fully human monoclonal antibody generated using Medarex's UltiMAb®
technology that rapidly and selectively blocks interleukin-1 beta (IL-1β).
Regulatory applications have also been filed in Europe, Switzerland, Australia
and other countries. Under the agreement with Novartis, Medarex will receive
future sales-based royalty payments from the commercial sales of Ilaris®. 

"Ilaris® represents the third antibody generated from our UltiMAb® technology to
receive regulatory approval and reinforces the important role of our antibody
technology platform in developing new treatment options for unmet medical
needs," said Howard H. Pien, Chairman and CEO of Medarex. "The royalty stream
generated from future product sales will provide valuable financial support to
advancing our own maturing product pipeline toward commercialization." 

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®
technology, 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. Over forty of these
therapeutic product candidates derived from Medarex technology are in human
clinical testing or have had INDs submitted for such trials, with the most
advanced product candidates currently approved for commercial sale, the subject
of regulatory applications for marketing authorization or in Phase 3 clinical
trials. 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 www.medarex.com. 

Medarex Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein
may constitute forward-looking statements, as defined in the Private Securities
Litigation Reform Act of 1995, 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 "will"; "believe"; "future";
"potential" 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 the
development and commercialization of Ilaris®, 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, 2008 and its quarterly reports on Form 10-Q.
There can be no assurance that future milestone payments will be paid or that
Ilaris® will be commercially successful. Copies of Medarex`s public disclosure
filings are available from its investor relations department. 

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





Medarex, Inc.
Laura S. Choi
Investor Relations
609-430-2880, x2216
or
Nichol Ochsner
Corporate Communications (media)
609-430-2880, x2214



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