Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Inclusion Criteria:

• Signed and dated statement of informed consent
• Completion of Protocol 307000A
• Negative serum pregnancy test results
• Agreement to adequate contraception, for female patients

Exclusion Criteria:

• Pregnancy or lactation
• History of alcohol or drug abuse
• Inability to administer subcutaneous injections either by self or by caregiver
• Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study
• Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study