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More MS news articles for October 2003

Betaseron(R) Gains FDA Approval for Pre-Filled Diluent Syringe

October 13, 2003
Source: Chiron Corporation
Montville, N.J. and Emeryville, Calif.

Berlex, Inc., the U.S. affiliate of Schering AG, Germany , and Chiron Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved a new pre-filled diluent syringe for Betaseron(R) (interferon beta-1b) for SC Injection, making it easier to use for people with multiple sclerosis (MS).

Designed with patient comfort in mind, the pre-filled diluent syringe will continue to provide patients with the proven efficacy of Betaseron. The drug's formulation remains unchanged while the drug delivery mode is enhanced.

This new innovation shortens preparation, helping to simplify injections. This adds another level of convenience for Betaseron users, who already benefit when traveling because the drug does not need to be refrigerated. Betaseron is the first and only FDA-approved interferon therapy that is stable at room temperature for more than 30 days.(1)

"Berlex is committed to developing new therapies and enhancing existing products to provide MS patients with convenient and efficacious therapeutic options. Our latest innovation, the new pre-filled diluent syringe, makes it easier to administer Betaseron than before by reducing the number of steps in the injection process," said Ayad Abdulahad, M.D., Ph.D., vice president, medical director, CNS, of Berlex Laboratories. "We also have an aggressive clinical research program, through which we're conducting the world's largest head-to-head MS studies to help guide treatment decisions."

"Building on Betaseron's 10-year history of treating MS, we continue to pursue innovations that help ease the burden for MS patients," said Bruce Scharschmidt, M.D., vice president, Clinical Development, Chiron Corporation. "The pre-filled diluent syringe is another step forward in this effort. Similarly, Betaseron's strong clinical results show that we are providing MS patients with important therapeutic benefits."

The new pre-filled diluent syringe for Betaseron is expected to be available nationwide in the next few months.

About Multiple Sclerosis (MS)

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.

About Betaseron

Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. 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.

In January 2002, the FDA approved a new room-temperature-stable formulation of Betaseron. Betaseron is the first and only interferon therapy available in the United States that is stable at room temperature (25 degrees C/77 degrees F) for more than 30 days, providing a convenient option for MS patients. Injections for 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 (interferon beta-1b) is 250 mcg (8 MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per week.

The most commonly reported adverse reactions are lymphopenia, injection site reaction, asthenia, flu-like symptom complex, headache and pain. Betaseron should be used with caution in patients with depression. Injection site necrosis has been reported in 5 percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be cautioned about the potential risk of pregnancy. Cases of anaphylaxis have been reported rarely. (See "Warnings," "Precautions," and "Adverse Reactions" sections of Prescribing Information).

Chiron Corporation and Berlex, Inc. jointly developed Betaseron. It is manufactured by Chiron and sold in the United States and Canada by Berlex.

Committed to addressing unmet medical needs, Berlex Laboratories, a U.S. affiliate of Schering AG, Germany, develops and markets diagnostic imaging agents, treatments in the areas of female health care and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems, oncology, and gastroenterology. Berlex has business operations in New Jersey, California, New Hampshire and Washington. For more information, please visit 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/.

Berlex: 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 U.S. 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.

Chiron: This news release contains forward-looking statements, including statements regarding sales growth, product development initiatives, new product indications, new product marketing, and in- and out-licensing activities, 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-Q for the quarter ended June 30, 2003, and 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.

Consistent with SEC Regulation FD, we do not undertake an obligation to update the forward-looking information we are giving today.

NOTE:  Betaseron is a trademark of Schering AG.

(1) Betaseron is the only immunomodulatory MS therapy that can be stored at room temperature for >30 days.  After reconstitution, if not used immediately, the product should be refrigerated and used within three hours.

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