PRINCETON, N.J., March 20 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) today announced that it has received a milestone payment of
an undisclosed amount from its licensing partner, Centocor, Inc., for the
submission of a Marketing Authorization Application to the European
Medicines Agency requesting approval of golimumab (CNTO 148) for the
treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing
spondylitis.
Golimumab is a human anti-TNF monoclonal antibody that was generated by
Medarex's UltiMAb Human Antibody Development System. Medarex may receive
future milestone payments and royalties should this product candidate
progress to commercialization and achieve commercial sales.
"We are excited by this regulatory filing for approval of a fully human
antibody developed by Medarex's technology, and we are pleased by the
advancements that Centocor continues to make with these antibodies," said
Howard H. Pien, President and CEO of Medarex. "We have seen the
accomplishment of a number of development milestones for UltiMAb antibodies
-- both by our partners and by Medarex -- and look ahead to similar
accomplishments that we believe will lead to important medicines to address
underserved medical needs."
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 website 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"; "anticipate"; "expect"; "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 development, unforeseen
safety issues resulting from the administration of antibody products in
humans, uncertainties concerning Centocor's activities under its agreement
with Medarex, 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 future milestone payments will be paid, whether the product
development efforts will succeed, or whether 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.
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Related links: http://www.medarex.com
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CONTACT: Laura S. Choi, Investor Relations, +1-609-430-2880, ext. 2216, or Jean Mantuano, Corporate Communications (media), +1-609-430-2880, ext. 2221, both of Medarex, Inc.
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