Published on June 14, 1999
By Jim Finkle BLOOMBERG NEWS
EMERYVILLE -- Chiron Corp. and Schering AG's Betaseron treatment for multiple sclerosis is unlikely to win expanded approval in the United States by the end of June, as some analysts had forecast, according to the two companies.
The two companies already have U.S. approval to market the drug for treatment of relapsing-remitting MS, a form of the disease that affects most patients. They're now seeking permission to expand that approval to include an advanced form of the disease known as secondary progressive MS.
The companies declined to discuss the reason for the delay or estimate when the drug is likely to be approved. They said that can't happen until they resolve several outstanding issues with the Food and Drug Administration.
Winning the expanded approval could give Betaseron an edge in a hotly contested rivalry with Biogen Inc.'s Avonex for the title of the world's best-selling MS drug. While Betaseron had stronger sales in 1998, Avonex was the leader in the first quarter of this year.
"The delay is a modest negative for Betaseron," said Jim McCamant, a biotechnology analyst and editor of the Biotechnology Stock Letter.
The drug is still likely to win the expanded approval, though the chances that it could fail have increased from about 2 percent to 10 percent, said McCamant.
Shares of Chiron, which is 45 percent owned by Swiss drugmaker Novartis AG, fell Þ to close at 18 15/16.
McCamant said he's not concerned by the companies' silence on the reasons for the delay because drugmakers are generally reluctant to discuss the specifics of drug-approval negotiations with the FDA out of concern that doing so could anger regulators.
The drug already is already approved in Europe for treating secondary progressive patients. And the companies said they're confident that it will win U.S. approval as well.
"Our position is that the data we submitted is clear and compelling evidence of safety and efficacy in secondary progressive MS," said Jeffrey Latts, chief medical officer of Schering's Berlex Laboratories Inc. unit, which markets Betaseron in the United States.
"The FDA asks a lot of questions. That's their job. We understand that and we'll work with them," Latts said. Latts and Chiron spokeswoman Shari Annes declined to say how long it would take to resolve the issue with the FDA. "The conversations are continuing and we're hopeful we'll have more information sooner, rather than later," Annes said.
The drug is sold in Europe under the brand name Betaferon, where it competes with Ares-Serono Group SA's Rebif treatment. Rebif has only been approved for relapsing-remitting forms of multiple sclerosis. Ares-Serono last week said a study of the drug on advanced MS patients failed to meet its goal of delaying disability in patients with the most advanced forms of the disease.
Rebif is not available in the United States because Biogen and Chiron/Schering
have exclusive marketing rights stemming from the so-called orphan-drug
law, designed to reward manufacturers for developing treatments for rare