New Autoinjection Device Designed to Work With Betaseron(R) Now Available For Patients With Multiple Sclerosis
July 11 2006 - 10:00AM
PR Newswire (US)
Betaject(R)3 Offers Convenient Delivery Option WAYNE, N.J., July 11
/PRNewswire/ -- Berlex, Inc. today announced the availability of
Betaject(R) 3, a new autoinjection device specifically designed to
work with Betaseron(R) (interferon beta-1b) as an optional
injection method for patients with relapsing forms of multiple
sclerosis (MS). The Betaject 3 autoinjection device is an
easy-to-use, mechanical device that automatically delivers
subcutaneous injections and may help make it easier for patients to
inject their medication. "With Betaject 3, we've simplified the
process for patients by eliminating an entire set-up step prior to
each injection," said Dr. Ludger Heeck, Vice President and General
Manager of Specialized Therapeutics at Berlex. "It complements the
convenient, refrigeration free-formulation Betaseron offers, and
provides patients with an optional tool to help make using
Betaseron therapy quick and easy." Ease of Use, Convenience and
Support The Betaject 3 autoinjection device is the latest
innovation designed to assist patients on Betaseron treatment.
Eliminating a calibration step prior to each injection, this
optional injection device automatically delivers subcutaneous
injections of Betaseron at a standard preset needle depth, allowing
patients to more easily self-inject their medication than with
devices that require calibration. Betaseron is the only available
refrigeration-free MS therapy that can be stored at room
temperature for longer than 30 days(1). This unique product
attribute simplifies the injection process by eliminating waiting
time and allows patients more options for traveling with and
storing their medication in a discrete, safe manner. Along with the
availability of products designed to help simplify the treatment
process, Berlex offers personal support programs for people using
Betaseron through its MS Pathways and B.E.T.A. Nurse programs. The
B.E.T.A. Nurses assist people with MS beginning therapy with
Betaseron by providing in- person injection training. B.E.T.A.
Nurses maintain ongoing communication throughout the course of
therapy to help them and their caregivers adjust to treatment and
ease some of the challenges often associated with the disease.
Research has shown that Betaseron patients who participated in the
B.E.T.A. Nurse program were more likely to maintain their course of
therapy with nearly 90 percent of people in the program remaining
on treatment after one year. For more information about the
optional Betaject 3 autoinjection device, Betaseron or the B.E.T.A.
Nurse program is available by calling MS Pathways at
1.800.788.7467. About Betaseron Betaseron(R) is approved for the
treatment of relapsing forms of multiple sclerosis to reduce the
frequency of clinical exacerbations. Treatment with Betaseron has
been shown to sustain reduction in the annual rate of relapses of
up to 40 percent over 16 years. Patients remaining on long-term(2)
Betaseron treatment have shown slower disease progression, nearly
doubling the time it took to reach confirmed EDSS 6(3). Approved in
1993 as the first disease-modifying therapy for the treatment of
MS, Betaseron has more than 16 years of clinical experience, with a
well- established safety profile resulting from more than 600,000
patient years of treatment. The 16-Year Long-Term Follow-up Study
is the longest follow-up study for any disease-modifying therapy in
MS, demonstrating that Betaseron remains consistently safe,
effective and well tolerated over the long term. Berlex remains
committed to its clinical study program, which continues to
generate data that reinforce the role of Betaseron as a
groundbreaking first- line therapy for the treatment of relapsing
MS patients. The most commonly reported adverse reactions
associated with Betaseron treatment are lymphopenia, injection site
reaction, asthenia, flu-like symptom complex, headache, and pain.
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 states. 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)
Betaseron is the only immunomodulatory therapy that can be stored
at room temperature for greater than 30 days. After reconstitution,
if not used immediately, the product should be refrigerated and
used within 3 hours. (2) Results from the Betaseron 16-Year
Long-Term Follow-up Study presented at the 58th Annual Meeting of
the American Academy of Neurology. Among the patients who reached
EDSS(*1) level 6.0 (e.g., needing a cane for walking), those on
long-term Betaseron treatment reached EDSS 6.0 after a median time
of 13 years compared to seven years for patients on short-term
treatment. Long-term treatment was defined as use of Betaseron for
more than 80 percent of the time since the start of the pivotal
trial (approx. 12 years or longer), while short-term treatment was
defined as use for less than 10 percent of the time (approx. 1.6
years or less). (3) EDSS or Expanded Disability Status Scale is a
standard method of evaluating a person's level of impairment due to
MS. EDSS level of 6.0 is defined as being able to walk, but needing
a cane, crutch or brace for assistance. DATASOURCE: Berlex, Inc.
CONTACT: Media Relations - Marcy Funk, +1-973-305-5385, ; or
Investor Relations - Joanne Marion, +1-973-487-2164, Web site:
http://www.berlex.com/ http://www.betaseron.com/
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