BOSTON, May 03, 2007 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals announced today the results of three clinical studies with Betaseron(R) (interferon beta-1b), presented this week at the American Academy of Neurology's (AAN) 59th Annual Meeting, demonstrating early efficacy, long-term tolerability, and high patient satisfaction with treatment in patients with relapsing forms of multiple sclerosis (MS).
"Collectively, these studies highlight the important clinical benefits and long-term safety and tolerability of Betaseron treatment," said Ludger Heeck, Ph.D., Vice President and General Manager, Specialized Therapeutics, Bayer HealthCare Pharmaceuticals. "Betaseron is the first immunomodulatory MS treatment shown to significantly delay disability and disease progression in patients with the first event suggestive of MS. In addition, key attributes, such as a high level of patient satisfaction and tolerability of the medication, may help improve a person's adherence to treatment and consequently, the effectiveness of the treatment."
In the first study, known as BENEFIT(1) (BEtaseron in Newly Emerging multiple sclerosis For Initial Treatment), immediate initiation of Betaseron(R) treatment in patients after a first event suggestive of MS significantly reduced the risk of disability as measured by the Expanded Disability Status Scale (EDSS) by 40 percent(2). The results of the prospectively designed and blinded study were measured over three years and compared early treatment to delayed treatment, defined as receiving treatment after the second clinical event or after two years.
The second study - known as the Betaseron 16-Year Long-Term Follow-up (16- Year LTF) Study(3)- found long-term(4) use of Betaseron to be safe and tolerable. The 16-Year LTF Study followed patients with the relapsing form of MS who had already participated in the pivotal Betaseron trial, the results of which led to t he drug's approval in 1993. The long-term use of Betaseron was associated with a delay of clinically significant disability (e.g. time to use of a cane) and delayed onset of the secondary progressive phase of the disease. Results from the study also found that patients who started the pivotal trial with a lower EDSS score showed less accumulated disability at the long-term follow-up visit. This finding offers further support for the importance of early treatment with Betaseron. Use of Betaseron over 16 years revealed no new or unexpected adverse events.
The results of a third study, known as BRIGHT (Betaseron versus Rebif(R)* InvestigatinG Higher Tolerability),(5) showed that significantly more of the 306 Betaseron patients than the 148 Rebif patients were pain-free over 15 injections at three time points after injection (for example: at 30 minutes after injection, 42.6 percent versus 19.7 percent, respectively). Fewer patients treated with Betaseron versus Rebif reported injection-site reactions. Moreover, with autoinjectors being used by more than 92 percent of participants, there were significantly more pain-free patients in the Betaseron group versus Rebif at all time points (example: at 30 minutes after injection, 40.2 percent versus 16.2 percent, respectively). More patients treated with Betaseron compared to Rebif either had no pain or were satisfied with their treatment (76.9 percent versus 64.1 percent).
Betaseron (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
The most commonly reported adverse reactions are lymphopenia, injection- site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and us e of analgesics during treatment initiation may help reduce flu-like symptoms. Betaseron should be used with caution in patients with depression. Injection-site necrosis has been reported in 4 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 full Prescribing Information.
About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the US, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
(1) Mark S. Freedman, et al: Betaseron in New ly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT): Effects of Immediate vs. Early Onset of Interferon Beta-1b Treatment, American Academy of Neurology, 59th Annual Meeting
(2) By proportional hazards regression, adjusted for T2-lesion volume at screening.
(3) George Ebers et al: The Interferon Beta-1b 16-Year Long-term Follow-up Study: Predictive Clinical and MRI Markers
(4) 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).
(5) Karl A Baum et al: Evaluation of Injection Site Pain and Reactions during Interferon Beta Treatment: Results from the BRIGHT (Betaseron(R) versus Rebif(R) InvestigatinG Higher Tolerability) Study.
* Trademarks are the property of their respective owners. Rebif(R) is a registered trademark of EMD Serono, Inc.
CONTACT: Marcy Funk, Bayer HealthCare, +1-973-305-5385
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