Amgen Inc and Serono S.A. have signed a license and commercialization agreement by which Serono will sell the marketed drug Novantrone (mitoxantrone for injection concentrate) in the United States. Novantrone is approved by the FDA in the United States for secondary progressive, progressive relapsing and worsening relapsing-remitting multiple sclerosis, as well as for certain forms of cancer in the United States. The terms were undisclosed.
Novantrone was acquired by Amgen in connection with Amgen's acquisition of Immunex Corporation in July 2002. The drug was approved by the FDA for MS indications in October, 2000, and had US sales of $71 million last year. It has also been approved for certain oncology indications since 1987.
Closing of the transaction is subject to review and clearance by U.S. regulatory authorities.