(U.S. and Canada)
is a medication manufactured by a biotechnological process from one of the
naturally occurring interferons (a type of protein). In a clinical trial of 372
ambulatory patients with relapsing-remitting MS, those taking the currently
recommended dose of the medication experienced fewer exacerbations, a longer
time between exacerbations, and exacerbations that were generally less severe
than those of patients taking a lower dose of the medication or a placebo.
Additionally, patients on interferon beta-1b had no increase in total lesion
area, as shown on MRI, in contrast to the placebo group, that had a significant
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is injected subcutaneously (between the fat layer just under the skin and
the muscles beneath) every other day. The physician or nurse will instruct you
in the preparation of the medication for injection and the injection procedure
itself, using a specially designed set of training materials. Do not attempt to
inject yourself until you are sure that you understand the procedures.
must be kept cold. Be sure to store it in a refrigerator before and after the
medication is mixed for injection.
not reuse needles or syringes. Dispose of the syringes as directed by your
physician and keep them out of the reach of children.
flu-like symptoms are a common side effect associated with at least the initial
weeks of taking Betaseron, it is recommended that the medication be taken at
bedtime. Taking acetaminophen (Tylenol®) or ibuprofen (Advil®) thirty minutes
before each injection will also help to relieve the flu-like symptoms.
injection site reactions (swelling, redness, discoloration, or pain) are
relatively common, it is recommended that the sites be rotated according to a
schedule provided for you by your physician.
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should not be used during pregnancy or by any woman who is trying to become
pregnant. Women taking Betaseron should use birth control measures at all times.
the clinical trial of interferon beta-1b, there were four suicide attempts and
one completed suicide among those taking interferon beta-1b. Although there is
no evidence that the suicide attempts were related to the medication itself, it
is recommended that individuals with a history of severe depressive disorder be
closely monitored while taking Betaseron.
side effects include flu-like symptoms (fatigue, chills, fever, muscle aches,
and sweating) and injection site reactions (swelling, redness, discoloration,
and pain). Most of these symptoms tend to disappear over time. If they continue,
become more severe, or cause significant discomfort, be sure to talk them over
with your physician. Contact your physician if the injection sites become
inflamed, hardened, or lumpy, and do not inject into any area that has become
hardened or lumpy.
including suicide attempts, has been reported by patients taking Betaseron.
Common symptoms of depression are sadness, anxiety, loss of interest in daily
activities, irritability, low self-esteem, guilt, poor concentration,
indecisiveness, confusion, and eating and sleep disturbances. If you experience
any of these symptoms for longer than a day or two, contact your physician
support line (Pathways): 800-788-1467; 800-948-5777 (financial issues)
Up of Betaferon (Interferon Beta-1b) in Multiple Sclerosis Shows Sustained
Benefits and Tolerability
BERLIN, GERMANY -- March 11, 2002 -- The effects
of long-term treatment of multiple sclerosis (MS) with Betaferon® (interferon
beta-1b) were presented at a Schering symposium for neurologists on March 9 in
Results from the 12-year follow-up study, the
longest period that any beta-interferon has been studied, showed sustained
clinical benefits for the patients and high long-term patient compliance and
Prof. George Rice, Department of Clinical
Neurological Sciences, University of Western Ontario, Canada, and lead
investigator of the follow-up study, commented: "We can see from this
follow-up that early and prolonged treatment of MS using Betaferon results in a
sustained benefit for patients in terms of their burden of disease when
monitored by magnetic resonance imaging (MRI). In those patients who continue
the treatment for 12 years, the drug was tolerated exceptionally well. The
follow up was designed to look at MRI-based disease activity measures, not to
examine the frequency and severity of attacks. Interferons are known to show a
clear influence on the disease measured in this way: It is reassuring that this
benefit is durable".
The follow-up study -- the longest ever
conducted on the treatment of MS -- followed 31 patients with MS who had
participated in the first placebo-controlled, double-blind clinical trial with a
beta interferon (Betaferon). Over 12 years, Betaferon-treated patients showed a
decrease in the burden of disease measured by MRI as compared to untreated
The flu-like symptoms, which are seen frequently
with beta-interferon use, were found to disappear over time, dropping from 66
percent to 5 percent in the 12th year. Another important observation from this
follow-up was that neutralising antibodies, which tend to develop in the first
years of treatment (about 40 percent of patients in this follow-up), disappeared
in almost all patients.
"Together with the positive long-term
benefit of Betaferon, the follow up has shown that many side effects that
initially concerned people with MS disappear over time, an important fact for
patients and physicians," said Dr Rice.
These encouraging results will be further
evaluated in the other patients who participated in the pivotal trial.
SOURCE: Schering AG
Approves Room-Temperature Formulation of Betaseron (Interferon Beta-1b) for
MONTVILLE, NJ/EMERYVILLE, CA -- January 15, 2002 -- Berlex Laboratories, Inc.,
the U.S. affiliate of Schering AG, Germany, and Chiron Corporation today
announced the approval of a new room-temperature formulation of Betaseron®
(interferon beta-1b) for subcutaneous injection.
Betaseron, the first therapy approved in the United States to treat
relapsing-remitting multiple sclerosis (MS), will be the first and only MS
therapy available as a room-temperature formulation (25 degrees Celsius/77
degrees Fahrenheit), providing a convenient option for MS patients in the United
States. The new formulation will be available for patients during the middle of
"Because it requires no refrigeration, the new room-temperature
formulation provides greater convenience for patients and pharmacies, allowing
many more options when traveling and for storage. With fewer potential
interruptions in their medication regimen, these patients can continue their
treatment and, in many cases, remain active in their endeavors," said Ralph
Makar, Vice President, Marketing, Therapeutics, of Berlex Laboratories.
Multiple Sclerosis is a disease of the central nervous system affecting the
brain and spinal cord. It is estimated to affect up to 350,000 people in the
United States, and is the major acquired neurologic disease in young adults.
People who develop MS may not immediately recognize their condition because the
symptoms of MS are nonspecific and may be similar to those of other diseases.
Common signs and symptoms of MS include fatigue, psychological and cognitive
changes, weakness or paralysis of limbs, numbness, vision problems, speech
difficulties, problems with walking or motor skills, bladder problems, and
Betaseron was the first therapy approved in the United States to treat
relapsing-remitting MS. People with this form of MS typically have mild to
moderate disability. About 50 percent of people with the relapsing-remitting
disease advance into the secondary progressive form within 10 years. Betaseron
is approved for secondary progressive MS in Europe, Canada, and Australia. In
these regions, it is the only approved therapy for the treatment of both the
relapsing-remitting form as well as the more advanced secondary progressive form
of MS. Betaseron is not approved for secondary progressive MS in the United
The recommended dose of Betaseron is 250 mcg (8 MIUs) every other day, which
delivers an average total of 875 mcg (28 MIUs) per week.
Serious side effects include depression, suicide, suicidal ideation, and
injection site necrosis (skin breakdown, drainage of fluid and tissue
destruction), which have been reported in 5 percent of patients in a controlled
MS trial. The necrotic lesions are typically 3 cm or less in diameter, but
larger areas have been reported, and they may occur at single or multiple sites.
Common side effects of Betaseron therapy include flu-like symptoms, shortness
of breath, menstrual disorders, and injection site reactions (redness, pain,
swelling, and blue-black discoloration have been reported).
SOURCE: Chiron Corporation
Interferon Beta-1b Produces Greater Benefit Than Interferon Beta-1a In Multiple Sclerosis
TURIN, ITALY -- October 4, 2001 --
Results from the Independent Comparison of Interferon (INCOMIN) trial, released
at this week's Italian Neurological Society (INS) meeting (1), reveal clinically
relevant differences of between 42 to 56 percent in the benefit of interferons
used to treat multiple sclerosis (MS) when studied for a significant period, and
that the beneficial effects of interferon beta-1b become more pronounced over
time when compared to interferon beta-1a.
Professor Luca Durelli, Chief, MS
Centre of University Department of Neurosciences, Turin, Italy, and principle
investigator of the INCOMIN trial said: "The final results from the INCOMIN
study confirm the interim, one-year data presented earlier this year at the
annual meetings of the American Academy of Neurology and European Society of
Neurology, where the study was granted with an award (2,3).
Over the full two-year duration of the
INCOMIN study, interferon beta-1b continues and extends the benefits of
treatment over interferon beta-1a on the first clinical outcomes we have
analyzed in relapsing-remitting MS (RRMS)."
"Similar effects have been seen in
other clinical studies, but those trials have been short term in the context of
a chronic disease that may have a 20-25 year course," continued Dr. Durelli.
"Our two-year study provides a clinically relevant result in terms of
guiding prescribing choice. There is now clear evidence that high dose and
frequent therapy with interferon beta-1b is superior to the current dosing of
once weekly with interferon beta-1a. We can clearly see that all beta interferon
regimens are not the same."
The prospective, randomized,
multi-center study on 188 people with relapsing-remitting MS was supported by
research grants from the Multiple Sclerosis Association of Italy and the Italian
Ministry of Health and was conducted independently of the pharmaceutical
industry. Patient randomization to treatment arms was performed by independent
statisticians with allocation concealment. The clinical evaluation was conducted
on an open-label basis, while medical resonance imaging (MRI) scans were
analyzed blind of the treatment used.
The primary clinical endpoint of the
INCOMIN study -- the number of relapse-free patients -- showed the significant
advantages of treatment with interferon beta-1b over interferon beta-1a during a
two-year period, with the clinical benefits for patients becoming more
pronounced over time.
The proportion of relapse-free patients
at two years was 51 percent in the interferon beta-1b group versus 36 percent in
the interferon beta-1a group (P=0.036). This means a 42 percent increased
probability that patients treated with interferon beta-1b remained free from
relapses compared to those treated with interferon beta-1a.
The treatment benefit was particularly
pronounced in the second year of the study, with 72 percent of the patients
receiving interferon beta-1b remaining relapse free, compared with 49 percent of
those receiving interferon beta-1a (P=0.001) and representing a 47 percent
increased probability that patients treated with interferon beta-1b would remain
free from attacks. These results underline the importance of conducting studies
for a sufficient time in order to provide a robust result.
In addition, progression of the disease
-- defined as a worsening of 1.0 or more on the EDSS scale, confirmed after six
months and maintained until the end of the follow-up -- was significantly slower
in patients treated with interferon beta-1b, with 14 percent of patients
worsening compared with 30 percent in those treated with interferon beta-1a: a
relative risk reduction of 56 percent in favor of interferon beta-1b (P=0.005).
The study's other primary endpoint --
the number of patients without new T2 lesions as detected by MRI -- reinforced
these clinical findings. Of the patients receiving interferon beta-1b over 24
months, 55 percent were free of new T2 lesions in the brain compared with only
26 percent of those on interferon beta-1a: a relative increase of 112 percent in
favor of interferon beta-1b (P=0.0003).
Lesion activity was also significantly
higher in patients receiving interferon beta-1a, with 75 percent showing disease
activity by MRI, compared with just 49 percent of those on interferon beta-1b
Treatment was discontinued due to lack
of a clinical response by 10 patients receiving interferon beta-1a and by only
three of those receiving interferon beta-1b.
Data for the other secondary endpoints
are still being analyzed and the full data will be published in due course.
Commenting on the results, Dr. Durelli
said: "The full results will be published shortly, but these are important
data that clearly differentiate between the beta interferon agents. The results
prove that high, frequent dosing is very important and is superior to
(1) Annual Meeting of the Italian
Neurological Society, 30 September to 3 October 2001 in Rimini, Italy
(2) Luca Durelli, Ferrero B, Ghezzi A,
Montanari E, Zaffaroni M, Bergui M, Verdun E, Barbero P and the INCOMIN Trial
Study Group. The Independent Comparison of Interferon (INCOMIN) Trial: a
multicenter randomized trial comparing clinical and MRI efficacy of IFN beta-1a
and beta-1b in multiple sclerosis. Annual meeting of the American Academy of
Neurology; Philadelphia; April 2001. Neurology April 2001; 56 (Suppl. 3).
(3) Durelli L, Ferrero B, Oggero A,
Verdun E, Ghezzi A, Montanari E, Zaffaroni M and the INCOMIN Trial Study Group.
A multicenter trial comparing clinical and MRI efficacy of interferon beta-1a
and beta-1b in multiple sclerosis. Annual meeting of the European Society of
Neurology; Paris, France; April 2001. Journal of Neurology April 2001;
248 (Suppl. 2).
SOURCE: Professor Luca Durelli, MS
Centre of University Department of Neurosciences, Turin, Italy
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Innovative MS Therapy Makes
Treatment Easier, More Convenient
MONTVILLE, N.J. -- May 15, 2002 --
Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, announced
that the new room temperature formulation of Betaseron® (interferon beta- 1b)
for SC injection is now available to consumers across the United States.
Betaseron®, the first therapy approved in the
United States to treat relapsing-remitting multiple sclerosis (MS), is the first
and only room-temperature (25°C/77°F) MS therapy approved for
relapsing-remitting MS. The innovation provides greater convenience for MS
patients and pharmacies, allowing more options for traveling and storage. The
FDA approved the new formulation of Betaseron in January.
"Berlex is building on its legacy of providing
practical solutions for the MS community. Room-temperature Betaseron is our
latest innovation to reach more patients and improve the compliance, retention,
and expediency of their treatment," said Ralph Makar, vice president of
marketing, Therapeutics, Berlex Laboratories. "Because the new formulation
requires no refrigeration, patients have many more options for storage-and fewer
precautions-when traveling or pursuing activities outside their homes."
Delbert Richardson, who's been treated with
Betaseron since he was diagnosed with MS in 1997, went on an eight-month
cross-country cycling trip last year to raise awareness of the disease. He
noted, "During my cycling trip the new formulation would have been a
helpful added convenience."
Richardson added, "This is another innovation
to allow more freedom for people with MS. Now transportation of Betaseron will
be easier, and keeping it out of a common space like the refrigerator is
MS is a disease of the central nervous system
affecting the brain and spinal cord. It is estimated to affect up to 350,000
people in the United States, and is the major acquired neurologic disease in
young adults. People who develop MS may not immediately recognize their
condition because the symptoms of MS are nonspecific and may be similar to those
of other diseases. Common signs and symptoms of MS include fatigue,
psychological and cognitive changes, weakness or paralysis of limbs, numbness,
vision problems, speech difficulties, problems with walking or motor skills,
bladder problems, and sexual dysfunction.
Betaseron was the first therapy approved in the
United States to treat relapsing-remitting MS. People with this form of MS
typically have mild to moderate disability with EDSS scores of 0-5.5. About 50
percent of people with the relapsing-remitting disease advance into the
secondary progressive form within 10 years. Betaseron is approved for secondary
progressive MS in
Europe, Canada, and Australia. In these regions, it
is the only approved therapy for the treatment of both the relapsing-remitting
form as well as the more advanced secondary progressive form of MS. Currently,
in the United States, Betaseron is not approved for secondary progressive MS.
In January 2002, the FDA approved a new
room-temperature formulation of Betaseron. Betaseron is the first and only
therapy available as a room-temperature formulation (25°C/77°F) for
relapsing-remitting MS, providing a convenient option for MS patients in the
United States. Injections of this formulation should be administered immediately
after preparation. If the injection is delayed, the solution should be
refrigerated and injected within a three hour time period.
The recommended dose of Betaseron is 250 mcg (8
MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per
Serious side effects include
depression, suicide, suicidal ideation, and injection site necrosis (skin
breakdown, drainage of fluid and tissue destruction), which have been reported
in 5 percent of patients in a controlled MS trial. The necrotic lesions are
typically 3cm or less in diameter, but larger areas have been reported, and they
may occur at single or multiple sites.
Common side effects of Betaseron therapy include
flu-like symptoms, shortness of breath, menstrual disorders, and injection site
reactions (redness, pain, swelling, and blue-black discoloration have been
About Berlex Laboratories
Committed to developing novel
diagnostics and therapeutics that address unmet medical needs, Berlex
Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE:SHR),
researches, develops, manufactures, and markets ethical pharmaceuticals in five
strategic areas: Female Healthcare, Diagnostic Imaging, Dermatology, Oncology,
and Therapeutics for life-threatening and disabling diseases. Berlex
Laboratories, Inc. has business operations in Montville and Wayne, New Jersey
and in Richmond, California. For more information about Berlex and its products,
you may visit our Web site at www.berlex.com <http://www.berlex.com/>.
In order to utilize the
"Safe Harbor" provision of the U.S. Private Securities Litigation
Reform Act of 1995, the Company is providing the following cautionary statement.
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 Company plans and objectives to differ materially from
those expressed or implied in the forward-looking statements (or from the past
results). Although not exhaustive, the following factors could cause such
differences: action by the Company's competitors or the failure or demand for
the Company's products to develop as anticipated;
legislative and regulatory changes and general changes in public health and
approaches to health care and the treatment of ideas; unanticipated difficulties
in the design or implementation of clinical trials, studies and investigations,
or results that are inconsistent with previous results and the Company's
expectations; the failure to obtain and maintain required authorizations from
governmental authorities or the loss of or inability to patent or trademark
protection for products; the risk of substantial product liability claims;
unexpected costs or difficulties in production or distribution or in integrating
the business and operations of the Company. These factors and other factors that
could effect these forward-looking statements are described in our Form 20-F and
our Form 6-K reports filed with the US Securities and Exchange Commission. The
Company disclaims any obligation to publicly update or revise these
forward-looking statements, whether to reflect new information or future events
or circumstance or otherwise.
SOURCE: Berlex Laboratories, Inc.
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