Biogen and Innocare Announce License and Collaboration Agreement
For Orelabrutinib, an Innovative CNS Penetrant BTK Inhibitor For
the Potential Treatment of Multiple Sclerosis
Biogen Inc. (Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX:
09969) today announced that they have entered into a license and
collaboration agreement for orelabrutinib, an oral small molecule
Bruton’s tyrosine kinase inhibitor (BTKi) for the potential
treatment of multiple sclerosis (MS). Orelabrutinib is a covalent
BTKi with high selectivity and the ability to cross the blood-brain
barrier, and is currently being studied in a multi-country,
placebo-controlled Phase 2 trial in relapsing-remitting MS.
Orelabrutinib inhibits BTK, which is a key enzyme that is part
of the signaling cascade of immune cells including B cells and
myeloid cells. With the ability to cross the blood brain barrier,
orelabrutinib has the potential to inhibit B cell and myeloid cell
effector functions in the central nervous system (CNS), and may
provide a clinically meaningful benefit on progression in all forms
of MS. By addressing the progressive biology of the disease,
orelabrutinib may offer people living with MS an additional
treatment option and the possibility to slow disease
progression.
“Given the complex and chronic nature of MS, we believe the
unique characteristics of orelabrutinib, combining high selectivity
and CNS penetrance, may translate to potential clinical advantages
relative to other BTKi programs,” said Alfred Sandrock, Jr., M.D.,
Ph.D., Head of Research and Development at Biogen. “For over 30
years, Biogen has led in MS research and today has a leading
portfolio of MS products. We are focused on developing
next-generation approaches that we hope will improve outcomes for
those living with progressive and relapsing forms of MS.”
“Biogen is a recognized leader in neuroscience and we believe
this transaction will help advance the development of orelabrutinib
in MS,” said Jasmine Cui, Ph.D., Co-Founder, Chairwoman and Chief
Executive Officer at InnoCare. “We are excited about the potential
of orelabrutinib for the treatment of patients with all forms of MS
given the potential efficacy and safety profile, plus a promising
level of blood-brain barrier penetration. BTK inhibitors may have
the potential to transform the treatment paradigm of autoimmune
diseases, in particular MS.”
Under the terms of the agreement, Biogen will have exclusive
rights to orelabrutinib in the field of MS worldwide and certain
autoimmune diseases outside of China (including Hong Kong, Macau
and Taiwan), while InnoCare will retain exclusive worldwide rights
to orelabrutinib in the field of oncology and certain autoimmune
diseases in China (including Hong Kong, Macau and Taiwan). InnoCare
will receive a $125 million upfront payment and is eligible to
receive up to $812.5 million in potential development milestones
and potential commercial payments should the collaboration achieve
certain development, commercial milestones and sales thresholds.
InnoCare is also eligible to receive tiered royalties in the low to
high teens on potential future net sales of any product resulting
from the collaboration. Closing of the collaboration is contingent
on completion of review under antitrust laws, including the
Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the
U.S., and other customary closing conditions.About
Orelabrutinib Orelabrutinib is a small molecule Bruton’s
tyrosine kinase inhibitor (BTKi) developed for the treatment of
cancer and in development for the potential treatment of autoimmune
diseases.
In the field of multiple sclerosis, orelabrutinib is a BTKi with
high selectivity and ability to cross the blood-brain barrier and
could achieve high-target occupancy in the central nervous system.
It is currently being investigated in a global Phase 2 study in
RRMS patients.In the field of oncology, InnoCare received approval
for orelabrutinib from the China National Medical Products
Administration (NMPA) in two indications: the treatment of patients
with relapsed/refractory chronic lymphocytic leukemia (R/R
CLL)/small lymphocytic lymphoma (R/R SLL), and the treatment of
patients with relapsed/refractory mantle cell lymphoma (R/R
MCL).
About Bruton’s Tyrosine Kinase Inhibitors
Bruton’s tyrosine kinase (BTK) is a tyrosine kinase that is encoded
by the BTK gene in humans. BTK plays a crucial role in B-cell
receptor signaling cascade in B cells leading to B cell
proliferation, survival, differentiation and cytokine production.
BTK also plays a key function in myeloid cell signaling. Central
nervous system (CNS) penetrant BTK small molecule inhibitors work
by inhibiting B cells and myeloid cells in the periphery and in the
CNS. Among myeloid cells expressing BTK, microglia, which reside in
the CNS, have been shown to express high level of BTK in multiple
sclerosis.
About Biogen At 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, neuropsychiatry,
immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media –
Twitter, LinkedIn, Facebook, YouTube.
About InnoCare PharmaInnoCare Pharma
(HKEX:09969) is a commercial-stage biopharmaceutical company
committed to discovering, developing, and commercializing
first-in-class and/or best-in-class drugs for the treatment of
cancer and autoimmune diseases with high unmet medical needs in
China and worldwide. InnoCare was founded in 2015 by Dr. Jasmine
Cui, who has extensive experience in new drug development and
business management and the world-renowned structural biologist Dr.
Yigong Shi. InnoCare has branches in Beijing, Nanjing, Guangzhou,
Shanghai, New Jersey and Boston.
InnoCare has strong in-house innovation capabilities, holding
multiple foreign and domestic patents with a rich product pipeline
targeting liquid tumors, solid tumors, and autoimmune diseases. On
March 23, 2020, InnoCare was successfully listed on Hong Kong Stock
Exchange.Biogen Safe HarborThis news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, relating to the potential benefits
and results that may be achieved through Biogen’s proposed
collaboration with InnoCare; the anticipated completion of the
proposed collaboration; the potential benefit, safety and efficacy
of orelabrutinib; the potential clinical effects of orelabrutinib;
the clinical development program for orelabrutinib; the potential
treatment of MS and other autoimmune diseases; the potential of
Biogen’s commercial business and pipeline programs; Biogen’s
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,” “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 collaboration will not be completed in a timely manner or
at all; the possibility that certain closing conditions to the
proposed collaboration will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed collaboration can
be achieved; risks of unexpected costs or delays or other
unexpected hurdles; uncertainty of success in the development and
potential commercialization of orelabrutinib, 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 data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
business, 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 Biogen’s 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 Biogen’s current beliefs
and expectations and speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
InnoCare Forward-looking StatementsThis news
release contains the disclosure of some forward-looking statements.
Except for statements of facts, all other statements can be
regarded as forward-looking statements, that is, about our or our
management's intentions, plans, beliefs, or expectations that will
or may occur in the future. Such statements are assumptions and
estimates made by our management based on its experience and
knowledge of historical trends, current conditions, expected future
development and other related factors. This forward-looking
statement does not guarantee future performance, and actual
results, developments and business decisions may not match the
expectations of the forward-looking statement. Our forward-looking
statements are also subject to a large number of risks and
uncertainties, which may affect our short-term and long-term
performance.
BIOGEN MEDIA CONTACT:Allison Parks+1 (781)
464-3260Public.affairs@biogen.com |
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BIOGEN INVESTOR CONTACT:Mike Hencke+1 (781)
464-2442IR@biogen.com |
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INNOCARE MEDIA CONTACT:Chunhua
Lu+86-10-66609879chunhua.lu@innocarepharma.com |
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INNOCARE INVESTOR CONTACT:86+10-66609999ir@Innocarepharma.com |
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