16-Year follow-up study reinforces Betaseron long-term efficacy, safety and tolerabi...( San Diego CA Berlex announced today t...)

San Diego, CA Berlex announced today that Betaseron (interferon beta 1b) remained consistently safe, effective and well tolerated over the long term, according to results of the Betaseron 16-Year Long-Term Follow-up (16-Year LTF) Study presented at the 58th Annual Meeting of the American Academy of Neurology. This is the longest follow-up study for any disease modifying therapy in multiple sclerosis (MS).

Patients with relapsing forms of MS taking Betaseron (known as Betaferon outside the US) had a sustained reduction in the annual rate of relapses of up to 40 percent over 16 years.

The data also showed that patients remaining on long-term Betaseron treatment had a slower disease progression compared to patients who did not. Among the patients who reached EDSS level 6.0 (e.g., needing a cane for walking), those on long-term Betaseron treatment reached EDSS 6.0 after a median time of 13 years compared to seven years for patients on short-term treatment. Long-term treatment was defined as use of Betaseron for more than 80 percent of the time since the start of the pivotal trial (approx. 12 years or longer), while short-term treatment was defined as use for less than 10 percent of the time (approx. 1.6 years or less). The impact of long-term treatment on disease progression is being studied further using historical control groups.

"This study has comprehensively re-evaluated patients after 16 years," said Professor George Ebers, lead investigator of the study, Department of Clinical Neurology, Radcliffe Infirmary, University of Oxford. "The evidence for relapse rate reduction, combined with further support for long-term safety of Betaseron, is convincing. More studies are being done to further analyze the impact of treatment on disease progression."

The long-term use of Betaseron over 16 years revealed no new or unexpected adverse events. Betaseron was well accepted by patients in this long-term study. The median treatment durat
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Contact: Sean McMahill
sean.mcmahill@ogilvypr.com
212-880-5368
Ogilvy Public Relations
4-Apr-2006

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