- The second approved antibody generated from Medarex’s UltiMAb(R) technology platform -
PRINCETON, N.J., April 14 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced that it will receive a milestone payment of an undisclosed amount from its licensing partner, Centocor Ortho Biotech Inc., in connection with the marketing approval from Health Canada’s Biologics and Genetic Therapies Directorate, to market SIMPONI(TM) (golimumab, also known as CNTO 148) as a once-monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
SIMPONI is a new, human anti-tumor necrosis factor (TNF) monoclonal antibody that was generated by Medarex’s UltiMAb(R) technology that targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha. Regulatory applications seeking marketing authorization for SIMPONI have also been filed in the United States and Europe. Under the agreement with Centocor Ortho Biotech, Medarex will receive future sales-based royalty payments from the commercial sales of SIMPONI.
“SIMPONI is the second antibody generated from our UltiMAb(R) technology to receive regulatory approval, further demonstrating the potential of our antibody technology platform for generating therapeutics addressing underserved medical needs,” said Howard H. Pien, Chairman and CEO of Medarex. “As antibodies continue to grow as a source of breakthrough medicines for many diseases, we believe that therapeutics from our core technology will continue to play a prominent role in expanding treatment options for patients.”
Centocor Ortho Biotech Inc. first licensed Medarex’s UltiMAb(R) technology for the generation of human antibodies in 1997. The agreement was expanded in 2000 and later extended in 2007 to provide Centocor Ortho Biotech Inc. with continued access to Medarex’s UltiMAb(R) technology. Other antibodies generated from Medarex’s UltiMAb(R) technology in development by Centocor Ortho Biotech Inc. or its partners include STELARA(TM) (ustekinumab), a human antibody approved in Canada and Europe for the treatment of moderate to severe plaque psoriasis; and CNTO 95, an anti-integrin human antibody in Phase 2 development for the treatment of cancer.
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. 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 in Phase 3 clinical trials, the subject of regulatory applications for marketing authorization or approved in Canada and Europe. 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 “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 SIMPONI, 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 SIMPONI will be commercially successful. 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. SIMPONI(TM) and STELARA(TM) are trademarks of Centocor Ortho Biotech Inc. All rights are reserved.
CONTACT: Investor Relations, Laura S. Choi, +1-609-430-2880, ext. 2216, or
Media, Nichol Ochsner, Corporate Communications, +1-609-430-2880, ext.
2214, both of Medarex, Inc.
Web site: http://www.medarex.com/
