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Five-Year Data Confirm That Early Treatment with Betaseron(R) at First Sign of Disease Can Delay Progression to MS

- BENEFIT is first and only prospectively planned 5-year study to show long

lasting benefit of early treatment -

MONTREAL, Sept. 20 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals announced today that new data from its BENEFIT (BEtaseron in Newly Emerging multiple sclerosis For Initial Treatment) study confirm that early initiation of Betaseron(R) (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) significantly delayed the onset of clinically-definite MS (CDMS) by 37 percent (p=0.003) and McDonald MS by 45 percent (p<0.0001) over five years compared to delayed treatment. The results confirm a continued benefit of initiating treatment with Betaseron shortly after the first event.(1) These five-year findings from the BENEFIT study were presented today at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRIMS).

"The BENEFIT five-year results are the first and only prospectively planned data to confirm a continuous benefit over five years when treatment is initiated shortly after the earliest sign of MS," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and investigator of the study. "These results confirm that treatment with Betaseron after the first MS event or attack can reduce the risk of developing MS over five years compared to delayed treatment."

The study also demonstrated that early treatment with Betaseron had a beneficial effect on cognition that became even more pronounced over time. At five years, patients with early treatment had better cognitive function (mean PASAT score) compared to patients with delayed treatment (p= 0.0045).(1) PASAT, or the Paced Auditory Serial Addition Test, is a widely accepted tool that measures intellectual function and cognition.

"Changes in cognitive function have important implications for a patient's quality of life. Changes in cognition, along with fatigue, can be a reason for early departure from the workforce. Patients treated early with Betaseron fared better in tests of cognitive function compared to those with delayed treatment, which is good news for people with MS," Dr. Freedman said.

The BENEFIT study was the first to demonstrate a reduction in the risk of confirmed EDSS progression, as measured by the Expanded Disability Status Scale (EDSS), with early versus delayed treatment. This effect first appeared at year three, with a significant risk reduction of 40 percent (p=0.022).(2) Over five years, a nominal risk reduction of 24 percent (p=0.177) was observed for early treatment compared to delayed treatment. This difference over five years was not statistically significant.(1)

The key findings from the BENEFIT five-year study showed that:(1)

-- Starting Betaseron after the first clinical event delayed the development of CDMS by more than two years (750 days) in the 40th percentile.

-- Patients treated early with Betaseron had a greater reduction in relapse rate over five years compared to patients with delayed treatment, (0.21 versus 0.27) despite the latter receiving at least three years of treatment after the second attack or after two years (p=0.014; Poisson model). This effect was mainly due to the differences between the groups during the first two years.

-- Early treatment significantly reduced the development of newly active brain lesions (new or enlarging T2 lesions, Gd-enhancing lesions) compared to delayed treatment (p=0.0062).

-- In the BENEFIT study there was a high level of study completion of Betaseron by patients with the earliest signs of MS. Two-thirds of patients (67 percent) in the early treatment group continued on Betaseron for five years.

-- Patients consistently reported a high Health-Related Quality of Life over the five-year study period.

Adverse events (AEs) reported at five years were consistent with the product label.


BENEFIT is the first and only prospectively planned five-year MS study to demonstrate the long-lasting benefits of initiating Betaseron (interferon beta-1b) after the first clinical event suggestive of MS. Overall, results from the trial showed that early initiation of Betaseron treatment in patients with the earliest signs of the disease delayed the progression to CDMS and McDonald MS, and improved cognitive function as measured by PASAT.

The multi-center trial was conducted at 98 sites in 20 countries and included patients presenting with a single clinical episode suggestive of MS. A total of 468 patients with a first clinical demyelinating event suggestive of MS and typical MRI findings were randomized to receive either 250 micrograms of Betaseron every other day or placebo as a subcutaneous injection in a double blind fashion for a maximum of two years. The study was designed to encompass a representative population of patients with the earliest signs of MS, including patients with mono- or multifocal lesions.

The placebo-controlled treatment period lasted up to 24 months or up to the time when patients were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaseron to prospectively assess the impact of such early versus delayed treatment with Betaseron on the long-term course of the disease for a total observation time of five years.

"Early treatment" refers to treatment initiated after the first clinical event; "delayed treatment" refers to treatment initiated after the second clinical event or after two years, whichever occurs first.

About Betaseron

Betaseron 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 four 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. More information, including the full Prescribing Information, is available at

About Multiple Sclerosis

MS is a chronic, progressive disease of the central nervous system and the likelihood of disability increases the longer someone has MS. Symptoms of MS vary from person to person and can be unpredictable. They may include: fatigue or tiredness, dimness of vision in one or both eyes, weakness in one or more extremities, numbness and tingling in the face, arms, legs and trunk of the body, spasticity (muscle stiffness), dizziness, double vision, slurred speech and loss of bladder control.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. 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) MS Freedman, L Kappos, CH Polman, et al. Impact of Early Interferon beta-1b Treatment on Disease Evolution Over 5 Years in Patients with a First Event Suggestive of Multiple Sclerosis. World Congress on Treatment and Research in Multiple Sclerosis 2008.

(2) Kappos L et al. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet 2007 Aug 4; 370(9585): 389-97

SOURCE Bayer HealthCare Pharmaceuticals Inc.
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