Healthcare Industry News: Betaseron
News Release - July 11, 2006
New Autoinjection Device Designed to Work With Betaseron(R) Now Available For Patients With Multiple SclerosisBetaject(R)3 Offers Convenient Delivery Option
WAYNE, N.J., July 11 (HSMN NewsFeed) -- Berlex, Inc. today announced the availability of Betaject® 3, a new autoinjection device specifically designed to work with Betaseron® (interferon beta-1b) as an optional injection method for patients with relapsing forms of multiple sclerosis (MS). The Betaject 3 autoinjection device is an easy-to-use, mechanical device that automatically delivers subcutaneous injections and may help make it easier for patients to inject their medication.
"With Betaject 3, we've simplified the process for patients by eliminating an entire set-up step prior to each injection," said Dr. Ludger Heeck, Vice President and General Manager of Specialized Therapeutics at Berlex. "It complements the convenient, refrigeration free-formulation Betaseron offers, and provides patients with an optional tool to help make using Betaseron therapy quick and easy."
Ease of Use, Convenience and Support
The Betaject 3 autoinjection device is the latest innovation designed to assist patients on Betaseron treatment. Eliminating a calibration step prior to each injection, this optional injection device automatically delivers subcutaneous injections of Betaseron at a standard preset needle depth, allowing patients to more easily self-inject their medication than with devices that require calibration.
Betaseron is the only available refrigeration-free MS therapy that can be stored at room temperature for longer than 30 days(1). This unique product attribute simplifies the injection process by eliminating waiting time and allows patients more options for traveling with and storing their medication in a discrete, safe manner.
Along with the availability of products designed to help simplify the treatment process, Berlex offers personal support programs for people using Betaseron through its MS Pathways and B.E.T.A. Nurse programs. The B.E.T.A. Nurses assist people with MS beginning therapy with Betaseron by providing in- person injection training. B.E.T.A. Nurses maintain ongoing communication throughout the course of therapy to help them and their caregivers adjust to treatment and ease some of the challenges often associated with the disease. Research has shown that Betaseron patients who participated in the B.E.T.A. Nurse program were more likely to maintain their course of therapy with nearly 90 percent of people in the program remaining on treatment after one year.
For more information about the optional Betaject 3 autoinjection device, Betaseron or the B.E.T.A. Nurse program is available by calling MS Pathways at 1.800.788.7467.
Betaseron® is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Treatment with Betaseron has been shown to sustain reduction in the annual rate of relapses of up to 40 percent over 16 years. Patients remaining on long-term(2) Betaseron treatment have shown slower disease progression, nearly doubling the time it took to reach confirmed EDSS 6(3).
Approved in 1993 as the first disease-modifying therapy for the treatment of MS, Betaseron has more than 16 years of clinical experience, with a well- established safety profile resulting from more than 600,000 patient years of treatment. The 16-Year Long-Term Follow-up Study is the longest follow-up study for any disease-modifying therapy in MS, demonstrating that Betaseron remains consistently safe, effective and well tolerated over the long term. Berlex remains committed to its clinical study program, which continues to generate data that reinforce the role of Betaseron as a groundbreaking first- line therapy for the treatment of relapsing MS patients.
The most commonly reported adverse reactions associated with Betaseron treatment 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 five 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. Please see full Prescribing Information available at http://www.Betaseron.com.
Berlex, a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health, diagnostics and neurology. Berlex also markets diagnostic imaging agents, innovative treatments in the areas of female health care and oncology, as well as specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system. Berlex has business operations in New Jersey, California and Washington states. 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 Berlex's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Berlex, Inc. 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.
(1) Betaseron is the only immunomodulatory therapy that can be stored at room temperature for greater than 30 days. After reconstitution, if not used immediately, the product should be refrigerated and used within 3 hours.
(2) Results from the Betaseron 16-Year Long-Term Follow-up Study presented at the 58th Annual Meeting of the American Academy of Neurology. Among the patients who reached EDSS(*1) level 6.0 (e.g., needing a cane for walking), those on long-term Betaseron treatment reached EDSS 6.0 after a median time of 13 years compared to seven years for patients on short-term treatment. Long-term treatment was defined as use of Betaseron for more than 80 percent of the time since the start of the pivotal trial (approx. 12 years or longer), while short-term treatment was defined as use for less than 10 percent of the time (approx. 1.6 years or less).
(3) EDSS or Expanded Disability Status Scale is a standard method of evaluating a person's level of impairment due to MS. EDSS level of 6.0 is defined as being able to walk, but needing a cane, crutch or brace for assistance.
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