January 1, 2004
Source: Berlex, Inc.
Berlex, Inc., the U.S. affiliate of Schering AG, Germany, today announced that the new pre-filled diluent syringe for Betaseron(R) (interferon beta-1b) for SC Injection is available to multiple sclerosis (MS) patients. The new pre-filled diluent syringe system reduces the number of preparation steps, helping to simplify injections -adding another level of convenience for Betaseron users, who already benefit when traveling because the drug does not need to be refrigerated.
Delbert Richardson, a Betaseron patient since 1997, who last week began a solo, 14,000-mile cycling trip across the United States, said, "The pre-filled diluent syringe reduces the number of steps in the injection process, so I spend less time administering Betaseron and more time on the road. It will make it easier for me to manage my disease."
Betaseron is the first and only FDA-approved interferon therapy that is stable at room temperature for more than 30 days(i), and the only interferon for the treatment of relapsing forms of MS in a non-acidic formulation. With the pre-filled diluent syringe, the neutral formulation of Betaseron remains unchanged, helping minimize stinging on injection while continuing to provide patients with proven efficacy.
FDA approved the pre-filled diluent syringe for Betaseron last October.
"The pre-filled diluent syringe represents our continued pursuit of innovations that enhance MS patients' lifestyles," said Ralph Makar, R.Ph., Vice President and General Manager, Therapeutics, Berlex, Inc. "Berlex is committed to developing new therapies and enhancing existing products to provide MS patients with convenient, efficacious treatment options. We also have a strong clinical research program that seeks further therapeutic benefits for patients."
An introductory education and training kit for the pre-filled diluent syringe system is available through MS Pathways(SM). Patients should call the 24-hour nurse hotline at MS Pathways (1-800-788-1467) to receive a training kit.
MS is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect more than 400,000 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.
Chiron Corporation and Berlex, Inc. jointly developed Betaseron. It is manufactured by Chiron and sold in the United States by Berlex.
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 warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. (See "Warnings," "Precautions," and "Adverse Reactions" sections of Prescribing Information).
For full prescribing information, please visit http://www.betaseron. com.
About Berlex, Inc.
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR), develops and markets diagnostic imaging agents and treatments in the areas of female healthcare 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 and Washington. For more information, please visit http://www.berlex. com.
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 Schering AG's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
(i) 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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