Biogen to Acquire Novel Clinical Stage Asset with Application in Alzheimer’s Disease and Parkinson’s Disease from Pfizer ...
13 Januar 2020 - 01:30PM
Biogen to Acquire Novel Clinical Stage Asset with Application in
Alzheimer’s Disease and Parkinson’s Disease from Pfizer Inc.
Biogen Inc. (Nasdaq: BIIB) today announced an agreement to acquire
from Pfizer Inc. (NYSE: PFE) PF-05251749, a novel CNS-penetrant
small molecule inhibitor of casein kinase 1 (CK1), for the
potential treatment of patients with behavioral and neurological
symptoms across various psychiatric and neurological diseases. In
particular, Biogen plans to develop the Phase 1 asset for the
treatment of Sundowning in Alzheimer’s disease (AD) and Irregular
Sleep Wake Rhythm Disorder (ISWRD) in Parkinson’s disease (PD). The
purchase will include an upfront payment of $75 million with up to
$635 million in potential additional development and
commercialization milestone payments, as well as tiered royalties
in the high single digits to sub-teens.
“This asset is highly complementary to our existing pipeline of
potential disease-modifying therapies in Alzheimer’s and
Parkinson’s diseases,” said Alfred Sandrock Jr., M.D., Ph.D.,
Executive Vice President, Research and Development and Chief
Medical Officer at Biogen. “Many patients with Alzheimer’s and
Parkinson’s suffer from debilitating sleep disorders and agitation,
and we believe that the regulation of the circadian rhythm may hold
promise in addressing these challenging behavioral and neurological
symptoms.”
CK1 is a key regulator of the ‘central clock,’ the
suprachiasmatic nucleus of the hypothalamus, that controls
circadian rhythm and impacts nearly all vital physiology and
metabolism. The disruption of circadian rhythm is associated with
various psychiatric and neurological diseases, including certain
important symptoms of AD and PD.
Sundowning is a symptom that impacts 20% or more of AD patients
who become confused, anxious, aggressive, agitated or restless
later in the day. ISWRD is a circadian rhythm disorder where
patients experience fragmented nighttime sleep leading to daytime
sleepiness, severe fatigue and difficulty with activities of daily
living. It is one of the non-motor symptoms of PD, and usually
increases in frequency over the course of the disease and
disability progression. Biogen will explore the potential of
PF-05251749 to improve behavioral disturbances of Sundowning in AD
by correcting circadian rhythm, as well as its potential to treat
symptoms of ISWRD to improve daytime wakefulness, sleep quality,
behavior and daily function.
PF-05251749 has previously demonstrated an acceptable safety
profile and proof of mechanism in a Phase 1a clinical study. Biogen
aims to initiate a Phase 1b study in Q4 2020.
This transaction will be accounted for as an asset acquisition
and 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.
Biogen expects the transaction to close in the first quarter of
2020.
About BiogenAt Biogen, our mission is clear: we
are pioneers in neuroscience. Biogen discovers, develops and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative 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, Kenneth Murray and Nobel Prize winners
Walter Gilbert and Phillip Sharp. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. To learn more, please visit
www.biogen.com and follow us on social media – Twitter, LinkedIn,
Facebook, YouTube.
Safe HarborThis news 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 proposed transaction with Pfizer;
the anticipated completion and timing of the proposed transaction;
the potential benefits, safety and efficacy of PF-05251749; the
clinical development program for PF-05251749; the potential of our
commercial business and pipeline programs; our strategy and plans;
and risks and uncertainties associated with drug development and
commercialization. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,”
“plan,” “potential,” “possible,” “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 development programs result in
commercialization of a product. 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
such statements, including, without limitation: risks that the
proposed transaction will be completed in a timely manner or at
all; the possibility that certain closing conditions to the
proposed transaction will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed transaction can be
achieved; risks of unexpected hurdles, costs or delays; uncertainty
of success in the development and potential commercialization of
PF-05251749, 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 risks factors
identified in our most recent annual or quarterly report and in
other reports we have 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 news 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.
Contact:
MEDIA:David Caouette, +1 617 679
4945public.affairs@biogen.com
INVESTOR CONTACT:Joe Mara, +1 781 464 2442IR@biogen.com
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