Positive CHMP Vote For Betaferon® Label To Include Disability Progression Delay In Patients With The Earliest Sign Of MS

Main Category: Multiple Sclerosis
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 10 Dec 2007 - 0:00 PDT

email to a friend   printer friendly   opinions  

The Committee for Medicinal Products for Human Use (CHMP) has recommended to include new results from the landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) study in the Betaferon® (interferon beta-1b) label. The BENEFIT study has demonstrated a delay in disability progression with early Betaferon® treatment.

Specifically, the BENEFIT results show that treatment with Betaferon® shortly after the first clinical multiple sclerosis (MS) event or "attack" delays the development of sustained disability progression over three years by 40 percent, when compared to delayed treatment. No other MS therapy has demonstrated this effect in this early patient population. The endorsement after scientific assessment of the CHMP's proposal by the European Commission is due end of December 2007, and, if legally approved, will enhance the label of Betaferon®.

"We are happy to receive this CHMP recommendation. Betaferon® is the only disease modifying agent approved for the treatment of MS that has been demonstrated to delay disease progression in a very early patient population. In spite of the fact that many patients with such early MS do not show marked progression in disability, treatment with Betaferon®, when initiated early, was able to significantly slow down the progression of disability compared to later initiation of treatment," said Darlene Jody, M.D., Senior Vice President and President of Bayer HealthCare's Specialized Therapeutics Global Business Unit. "Adding the disability data to our label will clearly differentiate Betaferon® from all other products in the market place and strengthen our position."

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

About BENEFIT

BENEFIT is a multi-center trial, sponsored by Bayer Schering Pharma AG, comparing Betaferon® treatment initiated after a first clinical event with delayed treatment. The study is being conducted at 98 sites in 20 countries and includes 468 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 disability progression (measured by EDSS, Expanded Disability Status Scale) and patient-reported Quality of Life outcomes (FAMS-TOI). At the beginning of the study, 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 event 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.

In the placebo-controlled phase, Betaferon® delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 47% (hazard ratio = 0.53, 95% confidence interval (0.39, 0.73), p<0.0001). This treatment effect was still evident after the additional year of follow-up at which stage the risk reduction was 41% (hazard ratio = 0.59, 95% confidence interval (0.42, 0.83), p = 0.0011). The persistence of the treatment effect was observed although the majority of patients from the placebo-group were treated with Betaferon® in the third year of the study. In addition, early Betaferon® treatment reduced the risk for confirmed disability progression by 40% over three years (hazard ratio = 0.60, 95% confidence interval (0.39 - 0.92), p = 0.022) as compared to delayed start of treatment.

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. 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 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

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 http://www.bayerhealthcare.com.

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 http://www.bayerscheringpharma.de.

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.

• Additional
• References
• Citations