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| |  Betaseron Fast Tracked In Canada For Multiple Sclerosis MONTREAL, QC -- Aug. 26, 1998 -- The Health Protection Branch of Health Canada will conduct a fast track review of a new indication for Berlex Canada Inc.’s Betaseron(R), a Multiple Sclerosis medication which was the first available treatment for people with relapsing remitting MS. Once approved, Betaseron will become the first medication for MS patients with a more advanced form of the disease, known as secondary progressive MS (SPMS). Recent interim results from a European clinical trial show Betaseron delays disease progression in patients with secondary progressive MS. The two-year (interim) results were so convincing, that an independent advisory committee recommended that the trial be stopped for ethical reasons, allowing placebo patients to be offered Betaseron. "This is the first evidence that there is an effective treatment for secondary progressive patients. This should provide people with secondary progressive MS a reason to have hope." said Dr. Chris Polman, one of the principle researchers on the European clinical trial, and an internationally renown expert on multiple sclerosis. HPB priority review, or fast track decisions are normally delivered in six months from the moment that the file is accepted for review. It is estimated that there are between 35,000 and 50,000 Canadians who have MS. About 70 percent of people are diagnosed with the relapsing remitting form of MS. Approximately half of them develop secondary progressive MS within 10 years of diagnosis. If approved, it is expected that thousands of Canadian SPMS patients could eventually benefit from the new indication. Related Links: Berlex Canada Inc., Betaseron
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