Berlex Betaseron loses 20% of MS patients to Biogen Avonex -- Schering AG's Vita.

BERLEX BETASERON LOSES 20% OF PATIENTS TO BIOGEN AVONEX since the introduction of the second interferon beta product in May 1996, Schering AG Chairman Giuseppe Vita said at a press conference in Berlin March 19. He said that as a result of the Avonex launch, "we recorded a decline of 6,000 patients." This "did not surprise us," Vita continued. "A loss of 20% during the transition from a situation as a sole supplier to a competition situation is nearer the lower limit of other experiences."

The Schering AG subsidiary has not recorded further decline in Betaseron's multiple sclerosis patients "for quite some time now," Vita claimed. At the end of 1996, "around 24,000 patients" were being treated with Betaseron (interferon beta-1b) in the U.S. Vita noted that Betaseron was still the market leader with an approximately 60% market share at the end of 1996. Biogen CEO James Vincent said in January that about 3,000 patients were starting on Avonex (interferon beta-1a) every month and had between 21,000 and 23,000 patients on the drug ("The Pink Sheet" Jan. 13, T&G-9).

U.S. sales of Betaseron in 1996 were just under DM 350 mil. (approximately $210 mil.), slightly lower than in 1995, Vita reported. Worldwide sales of the beta interferon product, however, rose 34% to $320 mil. Vita said the company expects worldwide Betaseron sales to hit $350 mil. in 1997, despite expected Avonex launches into European markets.

Berlex is "examining the expansion of the range of indications" for Betaseron and is "convinced" the product "will also demonstrate success in the secondary- progressive and hence more severe course of the disease," Vita said. Betaseron is currently indicated for relapsing-remitting MS.

A 900-patient nationwide study of Betaseron in secondary-progressive multiple sclerosis is being conducted by Berlex in conjunction with Kaiser Permanente San Diego. The double- blind, placebo-controlled study, which began enrollment in 1995, has as its primary endpoint the time to progression of neurologic impairment over three years of patients who previously had relapsing-remitting MS. Secondary endpoints will look at disability, magnetic resonance imaging scans, relapse rates, hospitalization, systemic corticosteroid use and quality of life. Schering AG is conducting a similar study in Europe in 1,350 patients.

Berlex' Climara estradiol transdermal system gained a U.S. market share of "over 25%" in 1996, Vita reported. In addition, the company's Betapace (sotalol) and Fludara (fludarabine phosphate) sales showed "excellent growth rates" in the U.S. Worldwide sales growth was 44% for Betapace and 41% for Fludara. Vita noted that Berlex is Schering AG's largest subsidiary by sales, with a "volume-driven increase in sales" of 21% in 1996, to $521 mil.