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Medarex Receives Milestone Payment for Submission of Regulatory Application Requesting Approval of Golimumab (CNTO 148) in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis 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
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.
-0- 03/20/2008
/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./
/Company News On-Call: http://www.prnewswire.com/comp/108265.html /
/Web site: http://www.medarex.com /
(MEDX)
CO: Medarex, Inc.; Centocor, Inc. ST: New Jersey IN: MTC HEA BIO SU:
AM-KG -- NETH050 -- 1412 03/20/2008 10:32 EDT http://www.prnewswire.com
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