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| |  FDA Approves Room-Temperature Formulation of Betaseron (Interferon Beta-1b) for Multiple Sclerosis MONTVILLE, NJ/EMERYVILLE, CA -- January 15, 2002 -- Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, and Chiron Corporation today announced the approval of a new room-temperature formulation of Betaseron® (interferon beta-1b) for subcutaneous injection. Betaseron, the first therapy approved in the United States to treat relapsing-remitting multiple sclerosis (MS), will be the first and only MS therapy available as a room-temperature formulation (25 degrees Celsius/77 degrees Fahrenheit), providing a convenient option for MS patients in the United States. The new formulation will be available for patients during the middle of 2002. "Because it requires no refrigeration, the new room-temperature formulation provides greater convenience for patients and pharmacies, allowing many more options when traveling and for storage. With fewer potential interruptions in their medication regimen, these patients can continue their treatment and, in many cases, remain active in their endeavors," said Ralph Makar, Vice President, Marketing, Therapeutics, of Berlex Laboratories. Multiple Sclerosis is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect up to 350,000 people in the United States, and is the major acquired neurologic disease in young adults. People who develop MS may not immediately recognize their condition because the symptoms of MS are nonspecific and may be similar to those of other diseases. Common signs and symptoms of MS include fatigue, psychological and cognitive changes, weakness or paralysis of limbs, numbness, vision problems, speech difficulties, problems with walking or motor skills, bladder problems, and sexual dysfunction. Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. People with this form of MS typically have mild to moderate disability. About 50 percent of people with the relapsing-remitting disease advance into the secondary progressive form within 10 years. Betaseron is approved for secondary progressive MS in Europe, Canada, and Australia. In these regions, it is the only approved therapy for the treatment of both the relapsing-remitting form as well as the more advanced secondary progressive form of MS. Betaseron is not approved for secondary progressive MS in the United States. The recommended dose of Betaseron is 250 mcg (8 MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per week. Serious side effects include depression, suicide, suicidal ideation, and injection site necrosis (skin breakdown, drainage of fluid and tissue destruction), which have been reported in 5 percent of patients in a controlled MS trial. The necrotic lesions are typically 3 cm or less in diameter, but larger areas have been reported, and they may occur at single or multiple sites. Common side effects of Betaseron therapy include flu-like symptoms, shortness of breath, menstrual disorders, and injection site reactions (redness, pain, swelling, and blue-black discoloration have been reported). SOURCE: Chiron Corporation
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