New Analyses from 16-Year Follow-up Trial with Betaseron Demonstrated that Early and Sustained Treatment of Multiple Sclerosis Patients Enrolled in the Trial Affected Their Long-term Outcomes

SEATTLE, April 29 /PRNewswire/ -- New analyses of data from the 16-Year Long-term Follow-up study with Betaseron(R) (interferon beta-1b), sponsored by Bayer HealthCare Pharmaceuticals, were presented at the American Academy of Neurology's (AAN) 61st Annual Meeting. The study results showed that early and sustained exposure to Betaseron in study participants with multiple sclerosis (MS) were more likely to avoid a negative clinical outcome as demonstrated years later.(1)

In this study, early initiation and sustained exposure to Betaseron were strongly associated with a reduced risk of a negative outcome (i.e., EDSS score greater than or equal to 6.0, wheelchair use or conversion to SPMS) after 16 years.

"Our analyses showed the potential for long-term benefits of starting Betaseron treatment early and staying on therapy, even after accounting for known potential biases that may arise in the long-term follow-up observational studies," said Dr. Douglas Goodin, Director of the Multiple Sclerosis Center at UCSF Medical Center, who performed these analyses and presented his findings. "More importantly, these findings show that among study patients who were treated for an equal length of time, the ones who started therapy earlier were more likely to avoid a negative clinical outcome over the long term."

Dr. Goodin continued, "We are now continuing to follow these patients to the 20-year mark. The data from this 20-year follow-up will provide us with more information regarding impact of treatment on disease progression."

About the Study

The 16-Year Long-term Follow-up Study is a multicenter observational study that collected data from patients with relapsing-remitting MS (RRMS) who participated in the pivotal North American trials for Betaseron. Several statistical methods were used to assess patient data and examine the relationship between timing of drug exposure and long-term outcomes. Drug exposure was measured as the medication possession ratio (MPR) defined as the actual time the patient received therapy divided by the total time possible before a negative outcome was reached (or at data censor). A statistical method called recursive partitioning was then used to divide treatment groups into "high" or "low" exposure and to determine the relationship between length of drug exposure and long-term outcomes. The use of MPR reduces the bias introduced in long-term trials by the tendency of patients who are doing well on therapy stay on therapy and for patients who are doing poorly to stop a particular therapy. Other statistical approaches including Propensity Scoring were used to control for other known sources of bias.(1) The study, sponsored by Bayer HealthCare Pharmaceuticals, is the longest follow-up of a registrational MS trial cohort. Longitudinal data from 372 patients, collected 16 years after the start of the registrational trial, were used to develop an analytical strategy to investigate the relationship between timing of drug initiation and exposure and long-term outcomes.

INDICATIONS AND USAGE

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.

IMPORTANT SAFETY INFORMATION

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% 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 www.betaseron.com.

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 operation of Bayer HealthCare, an affiliate 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 United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, 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.

Betaseron(R) is a registered trademark of Bayer

(1) DS Goodin, G Ebers, AT Reder, et al. Early Treatment with Interferon Beta-1b is Associated with Improved Long-Term Outcome in Multiple Sclerosis. World Congress on Treatment and Research in Multiple Sclerosis 2008.

Source: Bayer HealthCare Pharmaceuticals Inc.

CONTACT: Joanne Marlin, Bayer HealthCare Pharmaceuticals,
+1-551-804-9944

Web Site: http://www.betaseron.com/

Posted: April 2009

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