Medarex to Receive Milestone Payment for Approval of STELARA(TM) (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis
Monday December 15, 12:22 pm ET
- The first approval for an antibody generated from Medarex's UltiMAb® technology platform -
PRINCETON, N.J., Dec. 15 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) 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® 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® 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® 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® 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® technology. Other antibodies generated from Medarex's UltiMAb® 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. |
