Friday, October 12, 2007

Betaferon® treatment delays disability in early MS; strong efficacy not affected by neutralizing antibodies

Prague, October 12, 2007 – Betaferon® (interferon beta-1b) significantly delays the development of confirmed disability progression and the development of clinically definite multiple sclerosis (MS) in patients who are treated shortly after their first clinical MS event or “attack”. The presence of neutralizing antibodies (NAbs) does not affect the efficacy of early Betaferon® treatment.(1) This is according to new evidence from the landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) study presented today at the 23rd Congress of the European Committee for Treatment and Research in MS (ECTRIMS).

Neutralizing antibodies can develop in MS patients being treated with any of the currently available immunomodulatory therapies. However, there has been debate over whether or not such antibodies can affect a treatment’s efficacy.

“BENEFIT is a significant trial that provided the medical community with the first clear evidence on the value of treating patients with Betaferon® at the first clinical sign of MS to delay the accumulation of disability,” said Dr. Mark S. Freedman, Professor of Neurology at the University of Ottawa and investigator of the study. “The new data show that the presence of NAbs, regardless of the titre, does not reduce the efficacy of Betaferon® out to 3 years when administered after the first attack of MS. These results do not support the suggestion that the propensity for developing NAbs be a determining factor when making treatment decisions regarding Betaferon®.”

The study presented at ECTRIMS shows that:

• In patients starting treatment after a first MS attack, the efficacy of Betaferon® treatment in delaying the development of CDMS (Clinically Definite MS) and delaying confirmed disability was not affected by NAbs, regardless of NAb titre. Disability was measured using a validated, well-established scale called EDSS (Expanded Disability Status Scale) (2)

• Of 277 patients treated early with Betaferon®, 31.8 percent (88) were tested positive at least once for NAbs (≥1:20 NU/ml). 16.6 percent (46) of 277 patients had NAb titres ≥1:100 NU/ml, and 9 percent (25) had titres ≥1:400 NU/ml.

• 46.6 percent (41 of 88) of all patients with a documented NAb status reverted to NAb-negative status by Year 3. Among patients with higher NAb titres, 37 percent and 32 percent with NAb titres ≥1:100 NU/ml and ≥1:400 NU/ml, respectively, reverted to NAb-negative status by Year 3.

"The data from the BENEFIT study continue to provide the medical community with important insights that will help to optimize the treatment of patients in the earliest stages of MS. These results support previously published, peer-reviewed research showing that the NAb status does not affect the efficacy of Betaferon®," said Darlene Jody, M.D., Senior Vice President and President of Bayer HealthCare’s Specialized Therapeutics Global Business Unit.

Previously presented and published results of BENEFIT(3) demonstrated that over 3 years, patients treated with Betaferon® after the first MS attack had a 40 percent lower risk of developing confirmed disability and a 41 percent lower risk of developing clinically definite MS when compared to patients in whom treatment was delayed. No other MS therapy has demonstrated this effect in this early patient population.

Around the world, Betaferon® is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations, as well as for use in patients after the first attack of MS.

BENEFIT is a multi-center trial conducted at 98 sites in 20 countries and included patients presenting with a first clinical episode suggestive of MS and typical MRI findings. The primary outcome measures are time to diagnosis of CDMS (Clinically Definite MS), time to confirmed EDSS (Expanded Disability Status Scale) progression and patient reported Quality of Life outcomes (FAMS-TOI). A total of 468 patients were randomized to receive either 250 micrograms of interferon beta-1b (Betaferon®) every other day or placebo as a subcutaneous injection in a double-blind fashion. The placebo-controlled treatment period lasted up to 24 months or up to the time when patients experienced a second attack and were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaferon® to prospectively assess the impact of such early versus delayed treatment with Betaferon® on the long-term course of the disease for a total observation time of five years. The three-year results are from a pre-planned analysis.

Previous published studies in this patient population have been criticized as less scientifically rigorous, because of their retrospective nature, unblinded assessments and the high number of patients lost to follow-up. The BENEFIT study was the first study in early MS patients designed to overcome these shortcomings.

About Betaferon® / Betaseron®
Betaferon®, which is marketed in the U.S. and Canada under the trademark Betaseron®, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. In the U.S., Europe and Japan, Betaferon® has been approved for all relapsing forms of MS. It is able to reduce the number of MS episodes by one-third, and the frequency of moderate to severe episodes by as much as 50 percent. Sixteen years’ follow-up of people treated with Betaferon® has shown that it is safe and well tolerated.

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 of one or both legs, 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.

(1) Freedman MS, Edan G, Hartung H-P, et al. Neutralising antibodies did not affect clinical outcomes after 3 years in the BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) study. 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis, 2007
(2) Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444–52
(3) 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

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at

About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at

Forward-Looking Statements
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 annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.