Medarex to Receive Milestone Payment for Approval of SIMPONI(TM) for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
- The second approved antibody generated from Medarex's UltiMAb® technology platform -
PRINCETON, N.J., April 14 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) 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® 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® 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® 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® technology. Other antibodies generated from Medarex's UltiMAb® 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. |