Betaferon(R) Approved in Australia for Earliest Stages of Multiple Sclerosis
23 Novembre 2006 - 10:40AM
PR Newswire (US)
BERLIN, November 23 /PRNewswire-FirstCall/ -- Schering AG, Germany
(FSE: SCH, NYSE: SHR), majority-owned by the Bayer Group, announced
today that the Australian Therapeutic Goods Administration has
expanded the indication of Betaferon(R) (interferon beta-1b) to
include patients with a first clinical event suggestive of multiple
sclerosis (MS). This approval provides an important treatment
option for patients in Australia to reduce the risk of developing
clinically definite MS (CDMS), and thus creates the potential to
delay the progression of the disease. Earlier this year, Betaferon
was granted marketing authorization in Europe, the United States
and Canada for the treatment of patients with a first clinical
event suggestive of multiple sclerosis. "We are pleased that
Betaferon is now available also for treatment of early MS in
Australia where it is already the most prescribed MS treatment.
With this approval, physicians and patients have a trusted
treatment option for the early stages of the disease, when it has
the greatest impact," said Dr. Darlene Jody, Head of Specialized
Therapeutics at Schering Group." The label extension is based on
results from the BENEFIT[a] study which showed that Betaferon 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 group were two times better
protected[c] than placebo-treated patients against developing MS as
defined by the McDonald diagnostic criteria[2]. Betaferon was also
very well accepted in the BENEFIT study, with 93 percent of
patients completing the two-year study period. 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. 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) 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 which will prospectively assess the impact of such
early treatment with Betaferon 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/Betaseron was the first disease-modifying drug introduced
for MS and is a well-established treatment around the world.
Betaferon has the broadest experience of any MS medication. 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. 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 It is
planned that Schering AG will be renamed Bayer Schering Pharma
Aktiengesellschaft. A corresponding resolution was passed at the
Extraordinary General Meeting of Schering AG on September 13, 2006.
Until the name change has been registered in the commercial
register, the company will continue to operate under the name
Schering AG. According to the resolution of the General Meeting,
the Executive Board will not file an application for registration
before December 1, 2006. This press release has been published by
Corporate Communication of Schering AG, Berlin, Germany. Certain
statements in this press release that are neither reported
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undertakes no obligation to update publicly or revise any of these
forward-looking statements, whether to reflect new information or
future events or circumstances or otherwise. Your contacts at
Corporate Communication: Media Relations: Oliver Renner T:
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+49-30-468-158-05 Find additional information at:
http://www.schering.de/eng DATASOURCE: Schering AG CONTACT: Your
contacts at Corporate Communication: Media Relations: Oliver
Renner, T: +49-30-468-124-31, ; Investor Relations: Dr Jost
Reinhard, T: +49-30-468-150-62, ; Pharma Communication: Dr Claudia
Schmitt; T: +49-30-468-158-05,
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