FDA ACCUSES MS DRUG MAKER OF MAKING FALSE CLAIMS

BOSTON(Reuters) - The U.S. Food and Drug
Administration accused a pharmaceutical company of making false
statements about its drug's powers in treating multiple sclerosis, a
disease that afflicts three million people worldwide.

The federal agency ordered Teva Marion Partners, a Kansas City,
Missouri-based firm to immediately halt promoting its drug Copaxone,
generically known as glatiramer acetate, as effective in ``slowing,
preventing or reversing...the progression of MS.''

The FDA in a letter, obtained by Reuters on Thursday, said such claims
were misleading.

Phone calls to the company -- a joint venture of pharmaceutical giant
Hoechst Marion Roussel, a unit of Germany's Hoechst AG , and the
Israeli biotech firm Teva Pharmaceutical Industries Ltd. -- were not
immediately returned.

The FDA also charged that Teva Marion Partners' claims that its drug
given by injection was ``safer, more tolerable or more effective than
other therapies for MS are false or misleading.''

The National Multiple Sclerosis Society estimates that there are
approximately three million people living with multiple sclerosis
worldwide. The disease of the central nervous system generally attacks
individuals between the ages of 20 and 40. Women develop multiple
sclerosis at a rate almost double that of men.

There are two other FDA-approved drugs for the treatment of MS: Avonex
made by Cambridge, Mass.-based Biogen Inc. ; and Betaseron, made by
Berlex Laboratories Inc., the U.S. pharmaceutical affiliate of
German-based Schering AG .

The FDA also demanded in its August 27 letter that Teva Marion
Partners halt the distribution of all promotional materials with the
false claims and submit a letter that the company would send to
doctors and health care professionals alerting them to the alleged
false statements.

Once approved by the federal agency, the FDA said Teva should mail the
letter and advertise its corrections in professional journals for the
next 12 months.

Checked-by: Patrick Henry