Serono S.A. and OSI Pharmaceuticals Inc have entered into an agreement by which OSI will market and promote the drug Novantrone (mitoxantrone concentrate for injection) for the approved oncology indications in the United States. In consideration for these exclusive rights, OSI will pay Serono initial fees totaling $55 million plus maintenance fees in return for commissions on net sales in oncology. To support Novantrone, OSI intends to build commercial operations which will include a sales force and an associated marketing and sales management infrastructure.
Novantrone is approved by the U.S. Food and Drug Administration for the treatment of acute nonlymphocytic leukemia (ANLL), which includes myelogenous, promyelocytic, monocytic and erythroid acute leukemias, and the relief of pain associated with advanced hormone-refractory prostate cancer (HRPC). The drug is also approved for certain advanced forms of multiple sclerosis (MS). Serono will continue to be responsible for the marketing of the multiple sclerosis indication for Novantrone and book all U.S. sales in all indications. Total sales of Novantrone in 2002, were approximately $80 million. Serono acquired from Amgen the U.S. rights to Novantrone for both MS and oncology in December 2002.
"Gaining access to a high-quality, marketed oncology product to both build a revenue base and allow us to seed a commercial organization has been a key corporate goal over the last two years," stated Colin Goddard, Chief Executive Officer of OSI Pharmaceuticals. "We see Novantrone as a well established therapeutic product in oncology of about the right size that became available at the right time and have moved aggressively to secure this opportunity. We believe our new relationship with Serono represents a win-win for both parties. Further, we believe this deal, coupled with our recently announced intention to acquire Cell Pathways' pro-apoptotic pipeline and the marketed oncology-care product Gelclair, represent major steps forward in continuing to build a high quality oncology organization."
"We have found an excellent partner in OSI, who have a significant commitment to developing a commercial presence in the field of oncology," said Ernesto Bertarelli, Serono's Chief Executive Officer. "This agreement enables Serono to focus on Novantrone in our specialist area of multiple sclerosis, while ensuring that the product continues to be well supported in its oncology indications."
Novantrone (mitoxantrone for injection concentrate) is a synthetic antineoplastic anthracenedione used intravenously as an anti-cancer agent. The product was approved by the FDA in 1987 for ANLL and in 1996 for the relief of pain associated with HRPC. It was registered for MS indications in October 2000. It is a DNA-reactive agent that intercalates into DNA through hydrogen bonding, causing crosslinks and strand breaks. Novantrone also interferes with RNA and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA.