More MS news articles for May 2002

Room-Temperature Betaseron Available Nationwide

Innovative MS Therapy Makes Treatment Easier, More Convenient

http://www.docguide.com/news/content.nsf/News/8525697700573E1885256BBA006067EB

May 15, 2002
MONTVILLE, N.J.

Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, announced that the new room temperature formulation of Betaseron® (interferon beta- 1b) for SC injection is now available to consumers across the United States.

Betaseron®, the first therapy approved in the United States to treat relapsing-remitting multiple sclerosis (MS), is the first and only room-temperature (25°C/77°F) MS therapy approved for relapsing-remitting MS. The innovation provides greater convenience for MS patients and pharmacies, allowing more options for traveling and storage. The FDA approved the new formulation of Betaseron in January.

"Berlex is building on its legacy of providing practical solutions for the MS community. Room-temperature Betaseron is our latest innovation to reach more patients and improve the compliance, retention, and expediency of their treatment," said Ralph Makar, vice president of marketing, Therapeutics, Berlex Laboratories. "Because the new formulation requires no refrigeration, patients have many more options for storage-and fewer precautions-when traveling or pursuing activities outside their homes."

Delbert Richardson, who's been treated with Betaseron since he was diagnosed with MS in 1997, went on an eight-month cross-country cycling trip last year to raise awareness of the disease. He noted, "During my cycling trip the new formulation would have been a helpful added convenience."

Richardson added, "This is another innovation to allow more freedom for people with MS. Now transportation of Betaseron will be easier, and keeping it out of a common space like the refrigerator is especially helpful."

About MS

MS 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.

About Betaseron

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 with EDSS scores of 0-5.5. 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. Currently, in the United States, Betaseron is not approved for secondary progressive MS.

In January 2002, the FDA approved a new room-temperature formulation of Betaseron. Betaseron is the first and only therapy available as a room-temperature formulation (25°C/77°F) for relapsing-remitting MS, providing a convenient option for MS patients in the United States. Injections of this formulation should be administered immediately after preparation. If the injection is delayed, the solution should be refrigerated and injected within a three hour time period.

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 3cm 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).

About Berlex Laboratories

Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE:SHR), researches, develops, manufactures, and markets ethical pharmaceuticals in five strategic areas: Female Healthcare, Diagnostic Imaging, Dermatology, Oncology, and Therapeutics for life-threatening and disabling diseases. Berlex Laboratories, Inc. has business operations in Montville and Wayne, New Jersey and in Richmond, California. For more information about Berlex and its products, you may visit our Web site at www.berlex.com <http://www.berlex.com/>.

In order to utilize the "Safe Harbor" provision of the U.S. Private Securities Litigation Reform Act of 1995, the Company is providing the following cautionary statement. Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including, but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Company plans and objectives to differ materially from those expressed or implied in the forward-looking statements (or from the past results). Although not exhaustive, the following factors could cause such differences: action by the Company's competitors or the failure or demand for the Company's products to develop as anticipated; legislative and regulatory changes and general changes in public health and approaches to health care and the treatment of ideas; unanticipated difficulties in the design or implementation of clinical trials, studies and investigations, or results that are inconsistent with previous results and the Company's expectations; the failure to obtain and maintain required authorizations from governmental authorities or the loss of or inability to patent or trademark protection for products; the risk of substantial product liability claims; unexpected costs or difficulties in production or distribution or in integrating the business and operations of the Company. These factors and other factors that could effect these forward-looking statements are described in our Form 20-F and our Form 6-K reports filed with the US Securities and Exchange Commission. The Company disclaims any obligation to publicly update or revise these forward-looking statements, whether to reflect new information or future events or circumstance or otherwise.

SOURCE: Berlex Laboratories, Inc.
 

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