- Company Sees Potential in
Development of BMS-986168 in both Alzheimer’s Disease and
Progressive Supranuclear Palsy
- Biogen Will Pay $300 Million Upfront
Plus Potential Milestone Payments and Royalties
Biogen (NASDAQ:BIIB) today announced an agreement to
exclusively license BMS-986168, a Phase 2-ready experimental
medicine with potential in Alzheimer’s disease (AD) and progressive
supranuclear palsy (PSP), from Bristol-Myers Squibb (NYSE:BMY).
BMS-986168 is an antibody targeting extracellular tau, the
protein that forms the deposits, or tangles, in the brain
associated with AD and other neurodegenerative tauopathies such as
PSP. PSP is a rare and devastating condition that affects movement,
speech, vision, and cognitive function. Biogen plans to rapidly
initiate Phase 2 studies for BMS-986168 in both AD and PSP.
“Biogen aims to be a leader in Alzheimer’s disease and we are
building a pipeline with multiple approaches to address the
complex, devastating process of neurodegeneration,” said Michael
Ehlers, executive vice president, research & development.
“Based on encouraging safety and efficacy data, we believe
BMS-986168 is a promising anti-tau candidate that may represent the
next wave of medicines for Alzheimer’s disease as well as the first
real answer for progressive supranuclear palsy.”
The addition of BMS-986168 to Biogen’s pipeline signifies both a
broader commitment to rare neurodegenerative diseases as well as a
strengthened focus on AD, a condition that affects millions of
patients and families. With an expanded AD pipeline that includes a
range of anti-tau and anti-amyloid candidates as well as a BACE
inhibitor program, Biogen is targeting multiple mechanisms
implicated in the disease.
Terms of the agreement
Under the agreement, Biogen will receive worldwide rights to
BMS-986168. Biogen will be responsible for the full development and
global commercialization of BMS-986168 in AD and PSP. Bristol-Myers
Squibb will receive an upfront payment of $300 million from Biogen
and may receive up to $410 million for additional milestone
payments and potential royalties.
Biogen will also assume all remaining obligations to the former
stockholders of iPierian, Inc. related to Bristol-Myers Squibb’s
acquisition of the company in 2014. Biogen may pay up to $550
million in remaining milestones plus royalties including a near
term $60 million milestone.
The transaction is subject to customary closing conditions,
including the expiration of the applicable waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United
States, and is expected to close in the second calendar quarter of
2017.
About Alzheimer’s Disease
Alzheimer’s disease (AD) is a progressive neurodegenerative
disorder characterized by cognitive decline and behavioral
disturbances that eventually result in a person’s inability to
perform daily activities. In 2010, it was estimated that 25 million
individuals were living with AD worldwide. Evidence suggests that
pathophysiological changes typically begin years prior to the
symptoms that lead to a clinical diagnosis. As the disease
progresses, cognitive impairments, behavioral changes and
functional disability commonly associated with AD begin to
manifest.
About Progressive Supranuclear Palsy
Progressive supranuclear palsy (PSP) is a rare neurodegenerative
brain disorder that affects movement, control of walking (gait) and
balance, speech, swallowing, vision, mood and behavior, and
thinking. PSP, like AD, is a tauopathy, which is a class of
neurodegenerative disease associated with the pathological
aggregation of tau protein in the human brain. Estimates vary, but
incidence is estimated to be about three to six in every 100,000
people worldwide. The disease progresses and causes weakness by
damaging certain parts of the brain above nerve cell clusters
called nuclei. These nuclei particularly control eye movements. One
of the classic signs of the disease is an inability to aim and move
the eyes properly, which individuals may experience as blurring of
vision.
About Biogen
Through cutting-edge science and medicine, Biogen discovers,
develops and delivers innovative therapies worldwide 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.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
Biogen Safe Harbor
This 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 Bristol-Myers Squibb, risks and
uncertainties associated with drug development and
commercialization, and the anticipated completion and timing of the
transaction. These forward-looking statements may be accompanied by
such words as “anticipate,” “believe,” “could,” “estimate,”
“expect,” “forecast,” “intend,” “may,” “plan,” “potential,”
“project,” “target,” “will” and other words and terms of similar
meaning. 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, 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;
unexpected concerns that may arise from additional data or
analysis; the occurrence of adverse safety events; failure to
protect and enforce our data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; and uncertainty of success in
developing, licensing or acquiring other product candidates or
additional indications for existing products. 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:Mark Dole, +1
781-464-3260public.affairs@biogen.comorInvestor:Matt Calistri +1
781-464-2442IR@biogen.com
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