New Analyses from 16-Year Follow-up Trial with Betaseron(R) Demonstrated that Early...

New Analyses from 16-Year Follow-up Trial with Betaseron(R) 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.

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