Medarex, Inc. to Receive Milestone Payment for Approval of STELARA(TM) (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis
- The first approval for an antibody generated from Medarex's UltiMAb(R) technology platform -
PRINCETON, N.J., Dec. 15 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced that it will receive a milestone payment from its licensing partner, Centocor Inc., in connection with the recently announced marketing approval from Health Canada's Biologics and Genetic Therapies Directorate, to market STELARA (ustekinumab, previously known as CNTO 1275) for the treatment of moderate to severe plaque psoriasis, as an infrequently administered subcutaneous injection.
STELARA, generated using Medarex's UltiMAb(R) technology, is a human monoclonal antibody with a novel mechanism of action that targets certain cytokines, naturally occurring proteins that are important in the body's regulation of immune responses and that are believed to play a role in immune-mediated inflammatory disorders, including psoriasis. Regulatory applications for marketing authorization for STELARA have been filed in the United States and Europe. Under the agreement with Centocor Inc., Medarex will receive future sales-based royalty payments from the commercial sale of STELARA.
"STELARA marks the first approval by a major regulatory authority of an antibody generated from our UltiMAb(R) technology platform and represents a great achievement for Medarex," said Howard H. Pien, Chairman and CEO of Medarex. "This approval marks a highly visible milestone for our UltiMAb(R) technology platform and the important role of Medarex in enabling human monoclonal antibodies in expanding treatment options for patients with underserved medical needs. In addition, we look forward to the royalty stream generated by future sales of this product which will assist with continued investment in our own research and development programs."
Centocor first licensed Medarex's UltiMAb(R) technology for the generation of human antibodies in 1997. The agreement was expanded in 2000 to allow Centocor greater access to Medarex's technology. In 2007, the relationship was extended to provide Centocor with continued access to Medarex's UltiMAb(R) technology. Other antibodies generated from Medarex's UltiMAb(R) technology in development by Centocor or its partners include golimumab (also known as CNTO 148), currently under review for marketing approval as a once-monthly subcutaneous anti-TNF-alpha human antibody in the U.S. and in Europe for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and in Phase 2 for the treatment of ulcerative colitis; 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 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, 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 STELARA, 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 or that STELARA 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. STELARA(TM) is a trademark of Centocor, Inc. All rights are reserved.
CONTACT: Laura S. Choi, Investor Relations, +1-609-430-2880, x2216, or
Nichol Ochsner, Corporate Communications (media), +1-609-430-2880, x2214,
both of Medarex
Web site: http://www.medarex.com/