PRINCETON, N.J., March 20 /PRNewswire-FirstCall/ -- Medarex, Inc. 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.
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.
Web site: http://www.medarex.com/
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