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Rebif (serum-free)

Merck KGaA

Drug Names(s): Rebif New Formulation, Recombinant Beta InterFeron, IFN beta-1a FBS-free/HSA-free (serum-free)

Description: Interferon beta plays an important role in regulating infection and inflammation. In MS, inflammation in the brain and spinal cord results in the destruction of the nerve covering (myelin) and the nerve fiber itself. Although the significant benefits of interferon beta-1a for MS patients are well known, the role of neutralising antibodies (NAbs) continues to be debated. Reducing NAbs may deliver benefits in some patients. A new formulation of IFN beta-1a that is fetal bovine serum (FBS) and human serum albumin (HSA)-free has therefore been developed with the objective of reducing NAbs and improving tolerability.

Revenue from the new formulation of Rebif is included in the Rebif (original formulation) revenue model.

Deal Structure: In July 2002, Serono and Pfizer announced an agreement to co-promote Serono's multiple sclerosis (MS) treatment Rebif in the United States. Under the terms of the agreement, Pfizer will pay Serono an up front fee of $200 million, will share all commercialization and development costs in the U.S., and will receive a payment based on Rebif sales in the United States. Serono will record all sales, distribute the product in the U.S., and continue to be the sole marketer for Rebif in the rest of the world.

In January 2007, the acquisition of Serono S.A. (now Merck Serono S.A.) by Merck KGaA and the integration of the business with the former Merck KGaA Ethicals Division was completed. Merck Serono is now the division of Merck KGaA which specializes in prescription pharmaceuticals. Its North American business operates in the United States and Canada under EMD Serono.

Partners: Pfizer Inc.

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