16:30 EDT Friday, July 13, 2001
Swiss drug maker Serono SA, Europe's largest biotechnology company, may be able to start selling the multiple sclerosis treatment Rebif in the United States early next year, Chief Executive Ernesto Bertarelli says.
The Geneva-based company conducted a study in hopes of convincing U.S. regulators that its medicine is better than Cambridge, Mass.-based Biogen Inc.'s MS drug Avonex in order to bring Rebif into the $1.1 billion U.S. market. Currently, Avonex, which is produced exclusively at Biogen's facility at the Research Triangle Park, has exclusive marketing rights until mid-2003.
Analysts say the U.S. Food and Drug Administration may now approve Rebif within six months, allowing Serono to start selling the medicine earlier than expected. Previously, Serono had said Rebif might reach the U.S. market in the middle of next year.
"It could be in early 2002," Bertarelli said in an interview with Bloomberg Business News.
Rebif has captured 55 percent of new prescriptions outside the United States, Pictet & Cie analyst Andrew Fellows told Bloomberg. He estimated the treatment might have sales of $1.6 billion by 2005.
According to the data, patients on Rebif reported a relapse after an average of 3.9 months, compared with 2.9 months for those on Avonex.
Still, 14 percent of Rebif patients had low-grade liver complications, while only 7 percent of those using Avonex did.
In both groups, 1 percent had serious liver complications.
For Rebif patients, 43 percent reported
inflammation from injections, while 5 percent of Avonex patients did. Researchers
said that this was because Rebif is injected three times a week, and Avonex
Copyright 2001 American City Business
Copyright 2001 American City Business Journals Inc.