FDA Approves Betaseron for Use After the First Event Suggestive of Multiple Sclerosis |PRESS RELEASE With Video
Early treatment with Betaseron significantly delayed the time to a second clinical event

Wayne, NJ, October 23, 2006 /PRNewswire/ -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication of Betaseron® (interferon beta-1b) to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS. Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaseron is the only high-dose, high-frequency interferon beta indicated for patients at the earliest stage of MS.

The new indication is based on results from the BENEFIT (BEtaseron in Newly Emerging multiple sclerosis for Initial Treatment) Study of patients with a first clinical demyelinating event and MRI features suggestive of MS. The two-year study showed that treatment with Betaseron delayed the time to a second clinical event by one year compared to placebo.1 BENEFIT is the only trial to demonstrate the efficacy of a high dose, high frequency interferon beta, Betaseron, as an effective treatment for patients with early MS . In addition to establishing efficacy in this group of patients, the study also showed that patients with early MS found Betaseron to be a safe and well-tolerated treatment, as evidenced by the findings that 93 percent of patients completed the study.

"We are very happy to offer people at the earliest stages of MS the benefit of an early start with high-dose, high-frequency Betaseron and its proven, long-term safety and efficacy profile," said Ludger Heeck, Ph.D., Vice President and General Manager, Specialized Therapeutics, Berlex. "Experts convened by the American Academy of Neurology2 have suggested that higher doses of interferon beta, taken more frequently, appear to be more effective in fighting MS than lower doses taken less often. Betaseron is the only high-dose, high-frequency interferon beta approved in the U.S. for patients who have experienced a first clinical event suggestive of MS."

About the BENEFIT Study
Two-year data from the BENEFIT Study were recently published in Neurology3. In the randomized, double-blind, placebo-controlled, multicenter trial, 468 FULLPRESS RELEASE With Video