March 17, 2003
MONTVILLE, NJ and EMERYVILLE, CA
Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE: SHR), and Chiron Corporation (Nasdaq: CHIR) today announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for the multiple sclerosis (MS) treatment Betaseron® (interferon beta-1b) for SC Injection. The new labeling includes revisions to the clinical studies section to include data from two studies conducted in patients with secondary progressive MS. In addition, the indication section has been revised to now reflect that, "Betaseron is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations." Relapses are repeat attacks during which new symptoms appear or existing symptoms worsen, followed by periods of recovery. Relapsing forms of MS include relapsing-remitting, the most common form, and secondary progressive MS with relapses.
"We are pleased with the FDA's approval of our label expansion. The enhanced labeling is testament to more than a decade's worth of research and clinical experience demonstrating the unsurpassed benefits of Betaseron use in treating MS," said Ayad Abdulahad, MD, PhD, Medical Director, CNS, of Berlex Laboratories. "We believe this important research -- one of the largest data sets ever collected in MS -- will enhance understanding of treatment options for the entire MS community."
"Betaseron's strong clinical results help ensure its continued growth, and this expanded label will increase treatment options for a broader population of MS patients," said Bruce Scharschmidt, MD, Vice President, Clinical Development, Chiron Corporation. "Chiron and Berlex are committed to further improvements to increase convenience and ease of use for patients."
The new labeling for Betaseron also includes updated safety information. In addition, a new patient Medication Guide will be available that provides information on Betaseron use.
Data Summarized in Clinical Trials Section The expanded Betaseron label now will contain data from both the pivotal two-year study of 372 patients with relapsing-remitting MS and two secondary progressive MS trials involving more than 1,600 patients collectively. The first secondary progressive MS trial was a double-blind, placebo-controlled European study of 718 patients in 32 centers, and the second was a double-blind, randomized North American trial of 939 patients in 35 centers in the United States and Canada. Although the findings from these studies were discordant, the European study did meet the primary efficacy endpoint. Both secondary progressive studies showed that treatment with Betaseron significantly reduced the incidence of relapses and the amount and activity of brain lesions detected by magnetic resonance imaging (MRI).
MS is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect more than 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.
Relapsing-remitting forms of MS are characterized by periods of attacks, interspersed with stable periods. Most symptomatic patients are classified at onset with the relapsing-remitting form of the disease. About 50 percent of patients with relapsing-remitting disease advance into the secondary progressive form within 10 years. At this stage, after periods of intermittent attacks and remissions, the disease begins a course of steady progression.
Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. In January 2002, the FDA approved a new room-temperature formulation of Betaseron. Betaseron is the first and only interferon therapy available as a room-temperature formulation (25.C/77.F) for MS, providing a convenient option for MS patients in the United States.
The recommended dose of Betaseron (interferon beta-1b ) 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). For full prescribing information, please visit http://www.betaseron.com.
About Berlex Laboratories and Chiron Corporation Betaseron was jointly developed by Chiron Corporation and Berlex Laboratories, Inc. It is manufactured by Chiron and sold in the U.S. and Canada by Berlex. Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc., a U.S. affiliate of the Schering AG, Germany Group (NYSE: SHR), develops and markets ethical pharmaceuticals in the areas of 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, Richmond and San Diego, California as well as Bothell and Seattle, Washington. For more information about Berlex and its products, you may visit our website at http://www.berlex.com.
Chiron Corporation, headquartered in Emeryville, California, is a global pharmaceutical company that leverages a diverse business model to develop and commercialize high-value products that make a difference in people's lives. The company has a strategic focus on cancer and infectious disease. Chiron applies its advanced understanding of the biology of cancer and infectious disease to develop products from its platforms in proteins, small molecules and vaccines. The company commercializes its products through three business units: biopharmaceuticals, vaccines and blood testing. For more information about Chiron, visit the company's website at http://www.chiron.com.
SCHERING AG GERMANY:
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.
This news release contains forward-looking statements, including statements regarding sales growth, product development initiatives, and new product marketing that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-K for the year ended December 31, 2002, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activity will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including shareholder and regulatory approvals and the integration of operations.
Consistent with SEC Regulation FD, we do not undertake an obligation to update the forward-looking information we are giving today.
SOURCE: Berlex Laboratories; Chiron Corporation
Copyright (c) 1995-2003 Doctor's Guide Publishing Limited