Bayer HealthCare Pharmaceuticals Inc. announced that Betaseron(R)* (interferon
beta-1b), its treatment for relapsing forms of multiple sclerosis (MS), will
soon be available with a new 30-gauge needle, which will be the thinnest needle
of any injectable disease-modifying therapy for people with MS. The new needle
is as thin as the needle commonly used for insulin and pediatric injections.
"One of the barriers that many people with multiple sclerosis face in
starting an MS treatment is injection anxiety," said Ludger Heeck, Vice
President and General Manager, Specialty Medicine, Bayer HealthCare
Pharmaceuticals Inc. "Betaseron is a safe and effective treatment for people
with relapsing forms of MS, as well as those with the earliest signs of the
disease. By introducing the thinnest needle of any injectable disease-modifying
medication for MS, we are taking another important step in our commitment to
continuously improve Betaseron and its use to help people start and stay on
Betaseron long term, particularly those who may have resisted because of anxiety
and concerns about injections."
According to a recent North American
survey of people with MS, "Injection Anxiety and Barriers to MS Treatment
Commitment," the majority of people with MS have, at some point, felt anxiety,
nervousness, and fear associated with their injections. Also in the survey,
which interviewed 220 people in the United States and Canada who have been
diagnosed with MS in the past five years, the majority (56%) of respondents
named at least one thing about injections that made them uncomfortable, most
often the length (33%) and thickness (31%) of a needle. This was followed by
"the thought of a needle" (28%) and "the sight of a needle" (21%).
Additionally, two-thirds (67%) of participants in the survey agree they
would be more comfortable injecting themselves if they knew they were using the
thinnest needle possible, and about half of the patients surveyed who are not
currently on therapy stated they would consider/reconsider taking an injectable
MS drug if a thinner needle was shown to be less painful. Benefits cited by
participants to using a thinner needle include less pain during injection (55%),
less bruising (42%), less pain after injection (40%), and less anxiety
immediately before injection (34%).
"Discomfort and anxiety around
injections affect many people with MS. Injection anxiety actually can be so high
that it keeps people with MS from taking their medication consistently, which is
essential to help slow disease progression," stated Dr. Mark Cascione,
Neurologist, Tampa Neurology Associates and Medical Director, South Tampa
Multiple Sclerosis Center. "The new Betaseron 30-gauge needle is a welcome
advancement for people with MS, and particularly for those with anxiety about
Issues around injections, such as injection anxiety,
injection fatigue and injection site pain, are among the top reasons patients
cite for not starting or continuing an injectable medication. Betaseron therapy
requires half as many injections as Copaxone
(R)* (glatiramer acetate) with a needle that is 25
percent thinner. Additionally, in a study, significantly more Betaseron than Rebif
patients were pain-free at all time points measured (immediately after
injection, and 30 and 60 minutes after injection) over the course of 15
injections.(4) Also in that same study, Betaseron patients using the new
30-gauge needle reported more than 50 percent of their injections were pain-free
immediately after injection.
The new thinnest, 30-gauge needle will be
introduced with an optional new autoinjector called BETAJECT(R) Lite.*Section In
a survey of patients who used the new 30-gauge needle along with the new
autoinjector, 98 percent were "satisfied" or "very satisfied" with the new
thinner needle and autoinjector after their first injection,(5) and nearly all
of the patients who tried the BETAJECT LiteSection said the new autoinjector was
easy to use.
There have been no changes to the formulation or the mixing
process of Betaseron -- it is still the same effective medication that patients
and doctors have relied on for more than 15 years. People who are currently
taking Betaseron can log onto http://www.betaseron.com/thinner
information about the new needle and to request the optional BETAJECT Lite
autoinjector. About Betaseron
Betaseron 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.
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 four 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. See "Warnings,"
"Precautions," and "Adverse Reactions" sections of full Prescribing Information.
More information, including the full Prescribing Information, is available at http://www.betaseron.com
. About Bayer HealthCare
Bayer HealthCare Pharmaceuticals Inc. is the
U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of
Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies
in the healthcare and medical products industry, and combines the activities of
the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions.
Bayer HealthCare Pharmaceuticals comprises the following business units: Women's
Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and
Primary Care and Specialty Medicine, which includes Hematology, Oncology and
Multiple Sclerosis. The company's aim is to discover and manufacture products
that will improve human health worldwide by diagnosing, preventing and treating
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.