ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Saturday, May 18, 1996 TAG: 9605200039
SECTION: NATIONAL/INTERNATIONAL PAGE: A-4 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
The first drug to slow the progression of multiple sclerosis has been approved by the Food and Drug Administration, but the maker of a competing medicine plans to ask a court to block its introduction.
The FDA announced Friday that it will permit marketing of Avonex for the treatment of relapsing forms of multiple sclerosis, or MS.
Avonex, made by Biogen Inc. in Cambridge, Mass., is the second approved MS drug that is based on interferon, one of the natural proteins produced by the immune system to fight infection by viruses.
Another drug, Betaseron, was licensed in July 1993. It is based on a protein called interferon beta-1b and is slightly different from Avonex, which is based on interferon beta-1a.
Betaseron's marketer, Berlex Laboratories Inc., filed a lawsuit last month in U.S. District Court in Washington, attempting to stop Avonex, but a judge rejected the request, saying it was premature prior to Avonex's approval.
Berlex executive Dr. Jeffrey Latts said Friday the company will go back into court seeking an injunction that stops sales of Avonex until the suit is resolved.
Berlex contends Avonex is so close to Betaseron that its approval would violate a seven-year period of exclusive marketing rights granted to Betaseron. Those rights were granted under the federal Orphan Drug Act, which gives companies a financial reward for developing drugs for rare diseases.
Unless the court acts, however, Biogen plans to make Avonex available by prescription starting Monday. Latts said a hearing on Berlex's injunction request hasn't been scheduled.
Stephen Reingold, vice president for research and medicine at the National Multiple Sclerosis Association, said Avonex is the only therapy that has been shown to slow the progression of the disease and to reduce the frequency of attacks.
Reingold said that Betaseron has been shown effective in slowing the rate of disease flare-ups in MS patients, but it has not been shown to slow the progression of the disease.
``Avonex does not stop the progression, but it is the first to slow it down,'' he said. ``In the trials, it showed a 40 percent reduction in the rate of progression.''
Avonex is injected into muscle once a week while Betaseron is injected just below the skin every other day.
Biogen said the wholesale price of the drug will be about $710 for a four-week supply. Betaseron's wholesale price is about $1,000 for the same period.
LENGTH: Medium: 54 linesby CNB