European Patent Office Grants Patent Related to TECFIDERA® (Dimethyl Fumarate)
June 21 2022 - 6:37AM
European Patent Office Grants Patent Related to TECFIDERA®
(Dimethyl Fumarate)
Biogen Inc. (Nasdaq: BIIB) today announced that the European Patent
Office has granted a patent that expires in February 2028 related
to TECFIDERA
® (dimethyl fumarate). The patent, EP
2 653 873, is directed to treating multiple sclerosis using
dimethyl fumarate dosed at 480mg per day, which is the European
Medicines Agency (EMA) recommended maintenance dose for TECFIDERA.
Patent EP 2 653 873 was granted from a divisional patent
application of European Patent No. 2 137 537 and includes amended
claims, which the European Patent Office Examining Division
determined were allowable under the relevant provisions of the
European Patent Convention.
Biogen expects the patent to be published in the European Patent
Bulletin in the coming weeks.
About
TECFIDERA® (dimethyl
fumarate) TECFIDERA, a treatment for relapsing forms
of multiple sclerosis (MS) in adults, is the most prescribed oral
medication for relapsing MS in the world and has been shown to
reduce the rate of MS relapses, slow the progression of disability
and impact the number of MS brain lesions, while demonstrating a
well-characterized safety profile in people with relapsing forms of
MS. TECFIDERA is approved in 69 countries, and more than
560,000 patients have been treated with it, representing more than
1,100,000 patient-years of exposure across clinical trial use and
patients prescribed TECFIDERA.1
TECFIDERA is contraindicated in patients with a known
hypersensitivity to dimethyl fumarate or any of the excipients of
TECFIDERA. Serious side effects include anaphylaxis and angioedema,
and cases of progressive multifocal leukoencephalopathy, a rare
opportunistic viral infection of the brain which has been
associated with death or severe disability, have been seen with
TECFIDERA patients in the setting of prolonged lymphopenia although
the role of lymphopenia in these cases is uncertain. Other serious
side effects include a decrease in mean lymphocyte counts during
the first year of treatment, herpes zoster and other serious
infections, liver injury and flushing. In clinical trials, the most
common adverse events associated with TECFIDERA were flushing,
abdominal pain, diarrhea and nausea.
Please click here for Important Safety
Information and full Prescribing Information,
including Patient Information for TECFIDERA in the U.S.,
or visit your respective country’s product website.
About BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
We routinely post information that may be important to investors
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Biogen Safe Harbor This news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, about certain patent grants and the
timing thereof; These forward-looking statements may be identified
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“possible,” “potential,” “will,” “would” and other words and terms
of similar meaning. Drug development and commercialization involve
a high degree of risk, and only a small number of research and
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Results in early stage clinical trials may not be indicative of
full results or results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements or the scientific data
presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
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results of operations and financial condition. The foregoing sets
forth many, but not all, of the factors that could cause actual
results to differ from our expectations in any forward-looking
statement. Investors should consider this cautionary statement as
well as the risk factors identified in our most recent annual or
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of new information, future developments or otherwise.
References:
- Combined post-marketing data based
on prescriptions and clinical trials exposure to TECFIDERA as of
December 31, 2021.
MEDIA CONTACT:Ashleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
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INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com
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