Biogen and Sage Therapeutics Announce Global Collaboration to
Develop and Commercialize Potential Breakthrough Therapies in
Depression and Movement Disorders
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq:
SAGE) announced that they have executed a global collaboration and
license agreement to jointly develop and commercialize zuranolone
(SAGE-217) for major depressive disorder (MDD), postpartum
depression (PPD) and other psychiatric disorders and SAGE-324 for
essential tremor and other neurological disorders.
“We are excited about the potential to bring together Biogen’s
leading capabilities in neuroscience with Sage’s deep expertise in
psychiatry,” said Michel Vounatsos, Biogen’s Chief Executive
Officer. “Major depressive disorder affects approximately 17
million people in the U.S. alone, and is a common co-morbidity of
multiple neurological disorders in Biogen’s core therapeutic areas.
There is a tremendous unmet medical need in depression, and we are
optimistic about the potential for zuranolone to help transform the
treatment of depression and address the stigma often associated
with chronic use of antidepressants.”
“With the recent and pending data outputs for zuranolone and
SAGE-324, the timing is right for a collaboration between two
like-minded companies committed to patients and driven by a passion
for neuroscience and brain health,” said Mike Cloonan, Chief
Operating Officer at Sage Therapeutics. “Through this
collaboration, Sage and Biogen have the potential to build
something greater together than either could have done alone. We
will leverage each other’s existing expertise while continuing to
build new capabilities in our efforts to create paradigm shifts in
the treatment of depression, PPD and essential tremor -- disorders
that have gone too long with few treatment innovations.
Additionally, the cash from the collaboration is expected to enable
Sage to accelerate and expand value potential for its pipeline and
will enhance Sage’s strategic, financial and operational
flexibility as well as strengthening our multi-franchise
approach.”
Zuranolone, a potential first-in-class, two-week, once-daily
oral therapy in development for the treatment of MDD and PPD, is
currently in Phase 3 development as part of the LANDSCAPE and NEST
clinical programs. Zuranolone has breakthrough therapy designation
from the U.S. Food and Drug Administration (FDA) for MDD and, if
successfully developed and approved, has the potential to be a
novel treatment paradigm in depression.
The vision for zuranolone in MDD and PPD is based on its
potential, being evaluated in the LANDSCAPE and NEST development
programs, to work rapidly and to continue providing sustained
benefit beyond the period of dosing. Together, these two features,
if supported by positive clinical efficacy and safety data, could
provide an alternative option to how depression is treated today
based on a target profile of an “as-needed” short course of
treatment for a depressive episode, with rapid and sustained
efficacy and favorable tolerability. The development of an
“as-needed” treatment for depression may help ease the difficulties
associated with chronic use of antidepressants and may enhance
quality of life and patient adherence.
An estimated 17 million Americans experience symptoms of MDD
each year. Additionally, a September 2020 Journal of the American
Medical Association article found that, in the U.S., depression
symptoms are more than three times higher during the COVID-19
pandemic than before. MDD is one of the largest contributors to
disability in the U.S. and worldwide.
Postpartum depression is a major depressive episode that can
occur during pregnancy or postpartum and is one of the most common
medical complications during and after pregnancy. In the U.S., an
estimated 1 in 8 mothers experience symptoms of PPD which equates
to approximately 500,000 annual cases.
If approved, zuranolone would also be highly complementary to
several of Biogen’s therapeutic areas of focus, including multiple
sclerosis (MS), Alzheimer’s disease (AD), spinal muscular atrophy
(SMA), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease
(PD). Depression is a common co-morbidity in patients with these
neurological disorders and their caregivers. Biogen estimates that
~ 50 percent of patients with MS, ~ 40 percent of patients with AD,
~ 50 percent of patients with PD, ~ 30 percent of patients with ALS
and ~ 60 percent of SMA caregivers experience depression. In
addition, many patients with AD see psychiatrists as part of their
diagnostic and/or treatment journey.
Zuranolone is a next-generation positive allosteric modulator of
the gamma-aminobutyric acid (GABAA) receptor. The GABAA system is
the major inhibitory signaling pathway of the brain and central
nervous system (CNS), and contributes significantly to regulating
CNS function. This mechanism of action is a novel approach that may
enable a new class of antidepressants.
To date, two positive pivotal studies have been completed with
zuranolone 30 mg, one in MDD (MDD-201) and one in PPD (ROBIN
Study). Additionally, while the Phase 3 MOUNTAIN Study of
zuranolone in MDD did not meet its primary endpoint, the
encouraging data from the recently announced MOUNTAIN six-month
follow-up period and the topline interim SHORELINE Study analysis,
suggest the potential for zuranolone, if successfully developed and
approved, to be uniquely positioned as a disruptive, distinct and
novel treatment approach for patients. Biogen and Sage believe that
zuranolone is clinically active in MDD based on the data compiled
to date and look forward to planned data readouts in 2021.
Sage is pursuing three development pathways for zuranolone in
the U.S.: PPD; acute rapid response therapy (RRT) in MDD when
co-initiated with new standard antidepressant therapy; and
“as-needed,” or episodic, treatment of MDD. As a result, Sage is
advancing four additional pivotal studies evaluating a 50 mg dose
of zuranolone: a Phase 3 study in PPD (SKYLARK, PPD-301), a Phase 3
study of use as an acute RRT in patients with MDD when co-initiated
with new standard antidepressant therapy (CORAL, MDD-305), a Phase
3 study in the acute treatment of MDD (WATERFALL, MDD-301B) and an
open label Phase 3 study evaluating the long-term safety,
tolerability and efficacy of “as-needed” repeat treatment
(SHORELINE, MDD-303). Data from these studies are expected in
2021.
Upon closing of the transaction, Biogen and Sage will
collaborate to further define the development and commercialization
strategy for zuranolone. Beyond PPD and MDD, zuranolone may also
have potential in other psychiatric disorders including bipolar
disorder and generalized anxiety disorder.
SAGE-324 is a next-generation positive allosteric modulator of
GABAA receptors in Phase 2 development for essential tremor with
potential in other neurological conditions such as epilepsy and PD.
Essential tremor is one of the most common movement disorders
estimated to affect over six million patients in the U.S., and
current standard of care may be inadequate for many. Following
encouraging results from a Phase 1 open-label study in essential
tremor, Sage advanced SAGE-324 to the Phase 2a KINETIC Study, which
Sage is currently conducting. The KINETIC Study is a 28-day
placebo-controlled study in patients with essential tremor expected
to read out in 2021. Upon closing of the transaction, Biogen and
Sage will collaborate to further define the development and
commercialization strategy for SAGE-324 in essential tremor and, as
appropriate, for potential expansion into other neurological
disorders.
Terms of the CollaborationThe strategic
collaboration is global in scope and under the terms of the
agreement, Sage will receive $1.525 billion in cash to be comprised
of an upfront payment of $875 million and a $650 million equity
investment in Sage from the purchase of approximately 6.2 million
newly issued shares of Sage common stock at a price of $104.14 per
share, representing a premium of 40 percent over the 30-day
volume-weighted average share price of $74.39 per share as of
November 25, 2020.
Should the zuranolone and SAGE-324 programs achieve certain
development and commercial milestones, Sage will be eligible to
receive up to approximately $1.6 billion in potential milestone
payments.
Biogen and Sage will share responsibility and costs for
development as well as profits and losses for commercialization in
the U.S. (50 percent Biogen; 50 percent Sage). Outside the U.S.,
Biogen will be responsible for development and commercialization,
excluding Japan, Taiwan and South Korea with respect to zuranolone,
and will pay Sage tiered royalties in the high teens to low
twenties.
Closing of the transaction 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. The transaction is expected to close by the end
of January 2021.
BofA Securities and Guggenheim Securities acted as financial
advisors to Biogen. Goldman Sachs & Co. LLC is acting as the
exclusive financial advisor to Sage.
Conference Call InformationSage will host a
conference call to discuss the collaboration Monday, November 30 at
8:00 a.m. ET. The live webcast can be accessed on the investor page
of Sage's website at investor.sagerx.com. A replay of the webcast
will be available on Sage's website approximately two hours after
the completion of the event and will be archived for up to 30
days.
On Monday, November 30 at 9:00 a.m. ET, Biogen will host a live
conference call to discuss the collaboration, which will be
accessible through the Investors section of Biogen’s website,
www.biogen.com.
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. Follow us on social media –
Twitter, LinkedIn, Facebook, YouTube.
About Sage TherapeuticsSage
Therapeutics is a biopharmaceutical company committed to
developing novel therapies with the potential to transform the
lives of people with debilitating disorders of the brain. We are
pursuing new pathways with the goal of improving brain health, and
our depression, neurology and neuropsychiatry franchise programs
aim to change how brain disorders are thought about and treated.
Our mission is to make medicines that matter so people can get
better, sooner. For more information, please
visit www.sagerx.com.
Biogen Safe Harbor This 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 Biogen’s proposed
collaboration with Sage; the anticipated completion and timing of
the proposed transaction; the potential benefits, safety and
efficacy of zuranolone and SAGE-324; the clinical development
program and data readouts for zuranolone and SAGE-324; the
potential treatment of depression, including MDD and PPD, essential
tremor and other neurological disorders; the potential of Biogen’s
commercial business and pipeline programs; Biogen’s strategy and
plans; risks and uncertainties associated with drug development and
commercialization; and Biogen’s future financial and operating
results. 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 not 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 collaboration can
be achieved; risks of unexpected hurdles, costs or delays;
uncertainty of success in the development and potential
commercialization of zuranolone and SAGE-324, 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 risks 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.
Sage Therapeutics 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 Sage’s proposed collaboration with Biogen; the
anticipated completion of the proposed transaction; the anticipated
payments that may be received if all milestones under the agreement
with Biogen are met; the potential benefits, safety and efficacy of
zuranolone and SAGE-324, and the potential of the product
candidates, if successful, to change the way certain diseases and
disorders are treated; the planned clinical development program and
expected timing of data readouts for zuranolone and SAGE-324; the
potential for successful development and approval of zuranolone and
SAGE-324 and the potential for future commercialization; estimates
as to the number of patients with MDD, PPD and essential tremor;
and the goals, opportunity and potential for Sage’s business. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties, many of which are beyond Sage’s control, which could
cause actual results to differ materially from those contemplated
in these forward-looking statements, including the risks that: the
proposed transaction may not be completed in a timely manner or at
all; certain closing conditions to the proposed transaction may not
be satisfied; the anticipated benefits of the proposed
collaboration may never be achieved; results from interim data cuts
from a clinical study may not be reflective of the results that
will be achieved in the full study once completed; success in
non-clinical studies or in earlier clinical trials may not be
repeated or observed in ongoing or future studies, and ongoing and
future non-clinical and clinical results may not meet their primary
or key secondary endpoints or be sufficient to file for or gain
regulatory approval to market a product without further development
work or may not support further development at all; adverse results
may occur at any stage of development that negatively impact
further development or that require additional nonclinical and
clinical work which may not yield positive results; different or
more severe adverse events may occur at the higher doses of
zuranolone or SAGE-324 currently being studied; issues may arise
with the efficacy or durability of short-term treatment, or
co-initiated treatment with zuranolone or there may be safety and
efficacy concerns with respect to retreatment with zuranolone or
chronic treatment with SAGE-324 that require additional nonclinical
studies or clinical trials be conducted; delays in initiation of
dosing or conduct or completion of ongoing and planned clinical
trials may occur that may impact expected timelines; COVID-19 may
impact clinical development timelines; the FDA may ultimately
decide that the design or results of completed and planned clinical
trials for zuranolone or SAGE-324, even if positive, are not
sufficient for regulatory approval in the indications that are the
focus of our development plan; the actual size of the MDD, PPD and
essential tremor patient populations may be significantly lower
than estimates; Sage may not obtain the operational, strategic or
financial flexibility or value creation opportunities it expects
from the collaboration with Biogen; there may be other unexpected
hurdles in the development and manufacture of zuranolone or
SAGE-324 which may delay or impact planned activities or results;
as well as those risks more fully discussed in the section entitled
“Risk Factors” in Sage’s most recent Quarterly Report on Form 10-Q,
as well as discussions of potential risks, uncertainties, and other
important factors in our subsequent filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent Sage’s views only as of today, and should not be relied
upon as representing Sage’s views as of any subsequent date. We
explicitly disclaim any obligation to update any forward-looking
statements.
BIOGEN MEDIA
CONTACT: |
BIOGEN
INVESTOR CONTACT: |
David
Caouette |
Joe
Mara |
Biogen
Inc. |
Biogen
Inc. |
Tel: (781)
464-3260 |
Tel: (781)
464-2442 |
|
|
SAGE MEDIA
CONTACT: |
SAGE
INVESTOR CONTACT: |
Maureen L.
Suda |
Jeff
Boyle |
Sage
Therapeutics |
Sage
Therapeutics |
Tel: (617)
949-4289 |
Tel: (617)
949-4256 |
Email:
Maureen.Suda@sagerx.com |
Email:
Jeff.Boyle@sagerx.com |
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