2014

Studies Presented at Neurology Conference Highlight Early Efficacy, Long-Term Tolerability, and High Patient Satisfaction with Betaseron(R)

    BOSTON, May 3 /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 the 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).
     About Betaseron
     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 use 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 Newly 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.
 
 

SOURCE Bayer HealthCare Pharmaceuticals

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