FDA Approves Betaseron(R) for Use After the First Event Suggestive of Multiple Sclerosis
October 23 2006 - 9:39AM
PR Newswire (US)
Early Treatment With Betaseron Significantly Delayed the Time to a
Second Clinical Event - Video Available WAYNE, N.J., Oct. 23
/PRNewswire/ -- Berlex, Inc., a U.S. affiliate of Schering AG,
Germany (FSE: SCH; NYSE: SHR), announced today that the U.S. Food
and Drug Administration (FDA) has expanded the indication of
Betaseron(R) (interferon beta-1b) to include patients with multiple
sclerosis (MS) who have experienced a first clinical episode and
have MRI features consistent with MS. Betaseron is indicated for
the treatment of relapsing forms of multiple sclerosis to reduce
the frequency of clinical exacerbations. Betaseron is the only
high-dose, high-frequency interferon beta indicated for patients at
the earliest stage of MS. To view the Multimedia News Release, go
to: http://prnewswire.com/mnr/berlex/25881/ The new indication is
based on results from the BENEFIT (BEtaseron in Newly Emerging
multiple sclerosis for Initial Treatment) Study of patients with a
first clinical demyelinating event and MRI features suggestive of
MS. The two-year study showed that treatment with Betaseron delayed
the time to a second clinical event by one year compared to
placebo(1). BENEFIT is the only trial to demonstrate the efficacy
of a high dose, high frequency interferon beta, Betaseron, as an
effective treatment for patients with early MS. In addition to
establishing efficacy in this group of patients, the study also
showed that patients with early MS found Betaseron to be a safe and
well- tolerated treatment, as evidenced by the findings that 93
percent of patients completed the study. "We are very happy to
offer people at the earliest stages of MS the benefit of an early
start with high-dose, high-frequency Betaseron and its proven,
long-term safety and efficacy profile," said Ludger Heeck, Ph.D.,
Vice President and General Manager, Specialized Therapeutics,
Berlex. "Experts convened by the American Academy of Neurology(2)
have suggested that higher doses of interferon beta, taken more
frequently, appear to be more effective in fighting MS than lower
doses taken less often. Betaseron is the only high- dose,
high-frequency interferon beta approved in the U.S. for patients
who have experienced a first clinical event suggestive of MS."
About the BENEFIT Study Two-year data from the BENEFIT Study were
recently published in Neurology(3). In the randomized,
double-blind, placebo-controlled, multicenter trial, 468
participants were given either Betaseron 250 micrograms (mcg)
subcutaneously every other day or placebo until they experienced a
second clinical event or relapse, which confirms the diagnosis, or
they had been followed for at least 24 months. Dose titration
(increasing the dose slowly) was applied and analgesics were used
prior to injection. Patients were also provided instruction on
methods of self-injection. "The BENEFIT study has taught us many
things but most importantly has shown us that most patients who
appear to be at high risk of developing MS do so within only two
years. In the study, Betaseron cut the risk of progression to the
second clinical event by nearly 50 percent compared to placebo,"
said Mark S. Freedman, M.D., Professor of Neurology at the
University of Ottawa, Ontario, Canada, and a lead investigator of
the BENEFIT Study. "We have learned from BENEFIT and other studies
that early treatment is probably one of the keys to treatment
success since accumulated neurological damage is often irreversible
and much of this is not clinically apparent in these early phases.
Betaseron is well-accepted and provides an effective first
treatment option for people with relapsing MS and those with early
signs of disease." Results showed that: -- Treatment with Betaseron
reduced the risk of progression to clinically definite MS by about
50 percent and to MRI-defined MS(4,5) by 46 percent compared to
placebo. -- Treatment with Betaseron delayed the time to a second
clinical event by one year compared to patients in the placebo arm.
-- In the placebo group, over half of the patients reached
MRI-defined MS within six months and 85 percent reached MRI-defined
MS in the two-year study. The results of the BENEFIT trial also
showed that the patients were willing to initiate and continue
Betaseron treatment in an effort to gain control of the disease at
its earliest stages: -- More than nine out of 10 patients (93
percent) treated with Betaseron completed the study, a rate similar
to placebo. -- Ninety-six percent of all eligible patients opted to
participate in a three-year extension of the study. To date, no
other trial involving early MS patients has demonstrated such a
high level of patient acceptance. -- Only 2.7 percent of patients
in the trial discontinued therapy because of adverse events. About
Betaseron Betaseron is approved 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. Betaseron has more than 17 years of clinical experience,
with a well-established safety profile resulting from more than
700,000 patient years of treatment. A long-term follow-up study
demonstrated that Betaseron remains consistently safe, effective
and well tolerated over the long term. Results of the study show
that long-term continuous(6) use of Betaseron provided 13 years of
cane-free mobility, which is, on average, six years longer than
when compared to untreated patients from a natural history cohort.
The study also showed that patients who continuously used Betaseron
experienced a significant delay in progression to secondary
progressive multiple sclerosis (SPMS) by 6.6 years compared to
patients who were not on continuous Betaseron treatment. The most
commonly reported adverse reactions are lymphopenia, injection site
reaction, asthenia, flu-like symptom complex, headache, and pain.
Gradual dose titration and the 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 five percent 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. Please see full Prescribing Information available
at http://www.betaseron.com/. About Berlex Berlex, a U.S. affiliate
of Schering AG, Germany (FSE: SCH; NYSE: SHR), is committed to
addressing unmet medical needs through research and development in
the areas of oncology, gastroenterology, women's health,
diagnostics and neurology. Berlex also markets diagnostic imaging
agents, innovative treatments in the areas of female health care
and oncology, as well as specialized therapeutics for
life-threatening and disabling diseases of the central nervous
system and cardiovascular system. Berlex has business operations in
New Jersey, California and Washington. For more information, please
visit http://www.berlex.com/ Certain statements in this press
release that are neither reported financial results nor other
historical information are forward-looking statements, including
but not limited to, statements that are predictions of or indicate
future events, trends, plans or objectives. Undue reliance should
not be placed on such statements because, by their nature, they are
subject to known and unknown risks and uncertainties and can be
affected by other factors that could cause actual results and
Berlex's plans and objectives to differ materially from those
expressed or implied in the forward-looking statements. Berlex,
Inc. 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. (1)
Based on the 25th percentile (2) Goodin DS, Frohman EM, Garmany GP
Jr, et al. Disease modifying therapies in multiple sclerosis:
report of the Therapeutics and Technology Assessment Subcommitte of
the American Academy of Neurology and the MS Council for Clinical
Practice Guidelines. Neurology. 2002;58:169-178. (3) Kappos L et
al. Treatment with interferon beta-1b delays conversion to
clinically definite and McDonald MS in patients with clinically
isolated syndromes. Neurology 2006;67:1242-1249. (4) McDonald
criteria (5) The exact relationship between MRI findings and
patients' symptoms is not completely understood. (6) Long-term
continuous use is defined as > 80 percent of the study duration
(>12 years). http://prnewswire.com/mnr/berlex/25881DATASOURCE:
Berlex, Inc. CONTACT: Media: Marcy Funk, +1-973-305 5385, ; or
Investors: Joanne Marion, +1-973-487 2164, Web site:
http://www.berlex.com/
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