16-Year follow-up study reinforces Betaseron long-term efficacy, safety and tolerabi...( ion with Betaseron of the analyzed tria...)

"The 16-year LTF is ground-breaking in that it is the longest follow-up study of patients on disease modifying MS therapy," said Richard Nieman, MD, Vice President, Head of Medical Affairs at Berlex. "These results show that first-line and long-term use of Betaseron for relapsing MS patients is safe, effective and well-tolerated. These data are very reassuring given the chronic nature of relapsing forms of MS, and the need for long-term therapy."

Sixteen Years of Betaseron Use in Patients with MS
The 16-Year LTF Study provides clinical assessment of patients who first enrolled in the Betaseron pivotal trial between 1988 and 1990. Of the original 372 patients involved in the pivotal trial, 328 (88.2 percent) have been identified. It is a multicenter, open-label, observational study designed to evaluate the impact of Betaseron treatment on long-term outcomes in patients with relapsing forms of MS. The study constitutes the longest follow up for any disease-modifying therapy in MS.

The results support a previously reported trend, in that there was a lower number of deaths in patients that were initially treated with Betaseron 250 mcg during the pivotal trial. This trend needs to be further evaluated.

The Betaseron pivotal trial was the first large, randomized, placebo-controlled study of any therapy in MS. This groundbreaking study was conducted in North America and led to the approval of Betaseron, the first disease-modifying agent for MS, in 1993. Patients were randomly assigned to one of three study arms, Betaseron 50 mcg , Betaseron 250 mcg or placebo, with a median duration of observation of 45 months. Analysis after two years demonstrated that significantly more patients receiving Betaseron were relapse-free, that those relapses that occurred were less frequent and that hospitalization
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Contact: Sean McMahill
sean.mcmahill@ogilvypr.com
212-880-5368
Ogilvy Public Relations
4-Apr-2006