First Round To Biogen In Berlex Interferon-Beta Battle

Following the first salvos being fired earlier this year in the battle for dominance of the interferon beta market for multiple sclerosis treatment between US company Biogen and Berlex (the US subsidiary of Germany's Schering AG; Marketletter January 22), the first round has gone the way of Biogen.

Berlex had filed a suit against the US Food and Drug Administration to block the approval of Biogen's Avonex (interferon beta-1a). The company was seeking to protect the orphan drug status of its Betaseron (interferon beta-1b) awarded by the FDA in 1993. This was denied on April 30 by the US District Court.

Biogen says it is pleased the FDA will now be able to proceed without delay to conclude its review of the Biogen application to market Avonex, adding that it expects the agency will follow the unanimous recommendation of a December 4, 1995 advisory committee, and "grant a license to market Avonex in a timely fashion."