US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™
– Patent Offers Protection Until 2028 and Strengthens Growing Product Patent
– European Patent Office Also Determines Patent Application Covering the Same
Dosing Regimen Allowable –
WESTON, Mass. -- March 19, 2013
Biogen Idec (NASDAQ: BIIB) today announced that the U.S. Patent and Trademark
Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional
protection for TECFIDERA™ (dimethyl fumarate), the company’s oral therapeutic
candidate for the treatment of multiple sclerosis (MS). The patent, which will
expire in 2028, covers the dosing regimen of daily administration of 480 mg of
TECFIDERA. This regimen is included in the proposed marketing application for
TECFIDERA, which is currently under review by the U.S. Food and Drug
“The patent for this dosing regimen is recognition of the remarkable
innovation TECFIDERA represents for the MS community,”said George A. Scangos,
Ph.D., chief executive officer of Biogen Idec.“The tremendous research
investment required to study and validate the patented dosing regimen is an
example of innovation that leads to meaningful benefits to patients.”
The European Patent Office also recently determined that Biogen Idec’s
application for a patent covering the same dosing regimen of TECFIDERA is
allowable. Once granted, this patent would also expire in 2028.
The TECFIDERA dose regimen patents add to the growing portfolio of granted
patents covering TECFIDERA.
TECFIDERA is the only currently known investigational compound for the
treatment of relapsing-remitting multiple sclerosis (RRMS) that has
experimentally demonstrated activation of the Nrf-2 pathway. This pathway
provides a way for cells in the body to defend themselves against inflammation
and oxidative stress caused by conditions like MS.
In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM,
two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg
of TECFIDERA, administered either twice a day (BID) or three times a day
(TID), for two years. TECFIDERA is currently under review by regulatory
authorities in the United States, European Union, Australia, Canada and
Through cutting-edge science and medicine,Biogen Idecdiscovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in
1978,Biogen Idecis the world’s oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies, and
the company generates more than$5 billionin annual revenues. For product
labeling, press releases and additional information about the company, please
This press release contains forward-looking statements, including statements
about the innovation TECFIDERA may represent for the MS community. These
statements may be identified by words such as "believe," "expect," "may,"
"plan," "potential," "will" and similar expressions, and are based on our
current beliefs and expectations. You should not place undue reliance on these
statements. These statements involve risks and uncertainties that could cause
actual results to differ materially from those reflected in such statements,
including obtaining regulatory approval for TECFIDERA, uncertainty of success
in commercialization of TECFIDERA, our ability to protect our intellectual
property rights, and the other risks and uncertainties that are described in
the Risk Factors section of our most recent annual or quarterly report and in
other reports we have filed with the SEC. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new information,
future events or otherwise.
Kate Niazi-Sai, +1 781-464-3260
Kia Khaleghpour, +1 781-464-2442
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