BioWorld International Correspondent

PARIS - Serono SA signed a licensing agreement with OSI Pharmaceuticals Inc., granting OSI exclusive rights to market and promote Novantrone in the U.S. in its approved oncology indications.

OSI Pharmaceuticals, of Melville, N.Y., is paying Geneva-based Serono initial fees totaling $55 million, plus maintenance fees in return for commissions on net sales of Novantrone in oncology.

The drug is approved in the U.S. for the treatment of acute non-lymphocytic leukemia (ANLL), which includes myelogenous, promyelocytic, monocytic and erythroid acute leukemias, as well as the relief of pain associated with advanced hormone-refractory prostate cancer (HRPC).

It also is approved for certain advanced forms of multiple sclerosis (MS), but Serono remains responsible for marketing in that indication. The Swiss company, which acquired in December the U.S. rights to Novantrone (mitoxantrone concentrate for injection) for both MS and oncology from Amgen Inc., of Thousand Oaks, Calif., also will continue to book all U.S. sales in all indications.

Worldwide sales of Novantrone totaled about $80 million in 2002. It was approved by the FDA for ANLL in 1987, for the relief of HRPC-associated pain in 1996 and for MS in 2000. The drug was originally developed by Wyeth, which granted U.S. marketing rights to Immunex Corp. but continued to market it elsewhere. Immunex was acquired by Amgen in July 2002. Novantrone is a DNA-reactive agent that intercalates into DNA through hydrogen bonding, causing crosslinks and strand brakes. It also interferes with RNA and is an inhibitor of topoisomerase II.