Betaferon(r) approved in Europe as a first-line treatment for the earliest
stages of multiple sclerosis
Berlin, June 7, 2006 - Schering AG, Germany (FSE: SCH, NYSE: SHR) announced
today that Betaferon(r) (interferon beta-1b) has been granted marketing
authorization by the European Commission for an extension of its indication
to include the treatment of patients with a first clinical event suggestive
of multiple sclerosis (MS) in all 25 European member states, as well as
Iceland and Norway.
With this approval, Betaferon(r) becomes the only high-dose high-frequency
therapy approved for the treatment of the earliest stages of MS. The
approval provides an important treatment option for patients to reduce the
risk of developing clinically definite MS (CDMS), and the chance to delay
the progression of the disease. The new label now allows for treatment of
the majority of patients at risk for MS, i.e., those with a first clinical
event (attack) suggestive of MS.
"Effective treatment early in the course of the disease is important since
studies have shown that irreversible nerve damage and brain atrophy can
occur in the earliest stages of MS. We now have the ability to treat
patients from the earliest sign of MS with therapy that has an excellent
safety profile over 16 years," said David Bates, Professor of Clinical
Neurology at the University of Newcastle upon Tyne, UK, and Chairman of the
MS Forum.
The label extension is based on results from the BENEFITa study which
showed that Betaferon(r) 250 mcg treatment in the early phase of the disease
reduced the risk of developing CDMS by 50 percent compared with placebo.1,b
Furthermore, patients in the Betaferon(r) group were two times better
protectedc than placebo-treated patients against developing MS as defined
by the McDonald diagnostic criteria.2 Left untreated in the placebo group,
85 percent of people who experienced a first clinical event went on to be
diagnosed with MS within two years.
"The results of the BENEFIT trial show that Betaferon can substantially
slow down the course of MS in early patients, especially those at the
earliest stage of the disease, when it has the greatest impact," said
Darlene Jody, MD, Head of Specialized Therapeutics Global Business Unit at
Schering Group.
A supplemental biologics license application (sBLA) requesting an expanded
label for Betaferon(r) (marketed as Betaseron(r) in the U.S.) was filed with
the U.S. Food and Drug Administration by Berlex, Inc., a U.S. affiliate of
Schering AG, in February 2006 and is pending review.
The Betaferon(r) extended indication is for the treatment of patients with a
single demyelinating event with an active inflammatory process, if it is
severe enough to warrant treatment with intravenous corticosteroids, if
alternative diagnoses have been excluded, and if they are determined to be
at high risk of developing clinically definite multiple sclerosis. The
results of the BENEFIT study were used to define the high risk criteria for
identifying patients appropriate for Betaferon(r) treatment. The criteria
reflect the differences in disease dissemination among patients with
monofocald and multifocald onset of disease with a first clinical event
suggestive of MS.
Betaferon is also indicated for the treatment of:
*	Patients with relapsing remitting MS and two or more relapses within the
last two years
*	Patients with secondary progressive MS with active disease, evidenced by
relapses.

Footnotes
a 	Betaferon(r)/Betaseron(r) in Newly Emerging MS For Initial Treatment.
b 	50 Percent risk reduction based on adjustment for a standard set of
baseline covariates.
c At the end of the study period of two years.
d 	Monofocal onset of disease is where clinical findings are explained by a
single lesion in the central nervous system (CNS). Multifocal onset of
disease is where clinical findings are explained by at least two
underlying CNS lesions.
References
1. L Kappos. Betaferon(r) in Newly Emerging Multiple Sclerosis for Initial
Treatment (BENEFIT): clinical results. Presented at ECTRIMS/ACTRIMS
2005.
2. McDonald et al. Recommended Diagnostic Criteria for MS. Ann Neurol 2001;
50:121-127.


Additional information
ABOUT BENEFIT
The multi-center, double-blind, randomized, phase III BENEFIT study was
conducted in 98 centers in 20 countries and included a total of 487
patients presenting with a single clinical episode suggestive of MS.
Patients with a first clinical demyelinating event suggestive of MS and
typical MRI findings received either eight million units of interferon
beta-1b (Betaferon(r)) every other day or placebo as a subcutaneous
injection. Treatment continued for up to 24 months unless patients
experienced a second attack and were diagnosed with clinically definite MS.
The two co-primary efficacy outcomes were time to CDMS, based on a second
clinical demyelinating event or an Expanded Disability Status Scale (EDSS)
progression >=1.5 points, and time to MS according to the McDonald
criteria. All study participants completing the double blind study were
then invited to participate in a separate open-label follow-up study with
Betaferon(r) which will prospectively assess the impact of such early
treatment with Betaferon(r) on the long-term course of the disease for a
total observation time of five years, including the impact of early
treatment on the formation of new brain lesions as measured by magnetic
resonance imaging (MRI).
BENEFIT patients included those who had a first clinical demyelinating
event either monofocal (i.e. clinical evidence of a single lesion) or
multifocal (i.e. clinical evidence of more than one lesion). Inclusion of
both patient groups is important because this is representative for the
patient population with a single event.

ABOUT BETAFERON
Betaferon(r)/Betaseron(r) was the first disease-modifying drug introduced for
MS and is a well-established treatment around the world. Betaferon(r) has the
broadest experience of any MS medication. In the US, Europe and Japan,
Betaferon(r) 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.

Schering AG is a research-based pharmaceutical company. Its activities are
focused on four business areas: Gynecology & Andrology, Oncology,
Diagnostic Imaging as well as Specialized Therapeutics for disabling
diseases. As a global player with innovative products Schering AG aims for
leading positions in specialized markets worldwide. With in-house R&D and
supported by an excellent global network of external partners, Schering AG
is securing a promising product pipeline. Using new ideas, Schering AG aims
to make a recognized contribution to medical progress and strives to
improve the quality of life: making medicine work

This press release has been published by Corporate Communication of
Schering AG, Berlin, Germany.
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