Biogen Acquires Remedy Pharmaceuticals’ CIRARA™ for Large Hemispheric Stroke
15 May 2017 - 9:30PM
Business Wire
Phase 3-ready program complements Biogen’s
ongoing development efforts in stroke
Biogen will pay a $120 million upfront payment
plus potential milestone and royalty payments
Biogen (NASDAQ: BIIB) announced today that it has completed an
asset purchase of Remedy Pharmaceuticals’ Phase 3 candidate,
CIRARA™ (intravenous glyburide). The target indication for CIRARA
is large hemispheric infarction (LHI), a severe form of ischemic
stroke where brain swelling (cerebral edema) often leads to a
disproportionately large share of stroke-related morbidity and
mortality. The U.S. Food and Drug Administration (FDA) recently
granted CIRARA Orphan Drug Designation for severe cerebral edema in
patients with acute ischemic stroke. The FDA has also granted
CIRARA Fast Track designation.
Each year approximately 1.7 million ischemic strokes occur
across the U.S., Europe and Japan, and approximately 15 percent of
these are LHI strokes. In pre-clinical studies, CIRARA has been
shown to block SUR1-TRPM4 channels that mediate stroke related
brain swelling. Clinical proof-of-concept studies have demonstrated
the potential of CIRARA to reduce brain swelling, disability and
the risk of death in patients with LHI.
“Building on our leading position in multiple sclerosis, spinal
muscular atrophy, and Alzheimer’s disease research, we see a
compelling opportunity in stroke where we can leverage our core
expertise in neuroscience to make a major difference in patient
care. CIRARA represents a potential breakthrough stroke
treatment that accelerates our efforts to build a portfolio of new
therapies for neurologic diseases,” said Michael Ehlers, M.D.,
Ph.D., Executive Vice President, Research and Development at
Biogen. “We believe the data supporting the potential of CIRARA are
compelling and that CIRARA can be a first-in-class therapy that
gives physicians the ability to meaningfully improve patient
outcomes in an area where effective treatments have been few and
far between.”
This transaction complements Biogen’s broader efforts to build a
portfolio of best-in-class treatments for acute ischemic stroke and
further strengthen its leadership in neuroscience. Biogen currently
is conducting a Phase 2b study to determine whether its monoclonal
antibody natalizumab can help patients with acute
ischemic stroke improve functional outcomes by limiting brain
inflammation in the post-stroke period. If
successful, natalizumab and CIRARA
will provide new approaches to treating
different populations of stroke patients.
Biogen plans to continue the development and commercialization
of CIRARA. Under the terms of the agreement, Remedy will share in
the cost of development for the target indication for CIRARA in LHI
stroke. Biogen will make an upfront payment of $120 million to
Remedy and may also pay additional milestone payments and
royalties.
About Remedy PharmaceuticalsRemedy Pharmaceuticals, Inc.
is a privately-held, clinical stage pharmaceutical company focused
on developing and bringing lifesaving treatments to people affected
by acute central nervous system (CNS) disease and injuries.
About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers worldwide innovative
therapies for people living with serious neurological and
neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in
biotechnology, and today the company has the leading portfolio of
medicines to treat multiple sclerosis; has introduced the first and
only approved treatment for spinal muscular atrophy; and is at the
forefront of neurology research for conditions including
Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral
sclerosis. Biogen also manufactures and commercializes biosimilars
of advanced biologics. For more information, please visit
www.biogen.com. Follow us on social media – Twitter, LinkedIn,
Facebook, YouTube.
Biogen Safe HarborThis press release contains
forward-looking statements, made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including statements relating to the potential benefits and results
that may be achieved through the license agreement with Remedy
Pharmaceuticals, risks and uncertainties associated with drug
development and commercialization, the potential benefits, safety
and efficacy of investigational drugs including CIRARA and
natalizumab and the anticipated completion and timing of the
transaction. These forward-looking statements may be accompanied by
words such as “anticipate,” “believe,” “could,” “estimate,”
“except,” “forecast,” “intend,” “may,” “plan,” “potential,”
“possible,” “will” and other words and terms of similar meaning.
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
such statements, including, without limitation: risks that the
transaction will be completed in a timely manner or at all;
uncertainty as to whether the anticipated benefits of the
transaction can be achieved; risks of unexpected costs or delays;
uncertainty of success in the development and potential
commercialization of natalizumab and/or CIRARA, which may be
impacted by, among other things, unexpected concerns that may arise
from additional data or analysis, the occurrence of adverse safety
events, failure to obtain regulatory approvals in certain
jurisdictions, failure to protect and enforce our data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; product liability claims; and third party collaboration
risks. 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
Biogen’s most recent annual or quarterly report and in other
reports Biogen has filed with the U.S. Securities and Exchange
Commission. These statements are based on our current beliefs and
expectations and speak only as of the date of this press release.
We do not undertake any obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise.
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BiogenMEDIA CONTACT:Jason Glashow, +1
781-464-3260public.affairs@biogen.comorINVESTOR CONTACT:Mike Henke,
+1 781-464-2442IR@biogen.com
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