Following the pre-NDA meeting, the companies
confirmed the current efficacy and safety databases are expected to
be adequate for filing with confirmed pathways for MDD and PPD
The planned initial submission package will be
for the treatment of MDD with an anticipated PPD filing
thereafter
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) today announced their plan to submit a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for
zuranolone, an investigational two-week, once-daily therapeutic in
the second half of 2022. The planned initial submission package
will seek approval of zuranolone for the treatment of major
depressive disorder (MDD) and an additional filing for postpartum
depression (PPD) is anticipated in the first half of 2023. The
decision to submit the application follows recent discussions with
the FDA, including a pre-NDA meeting held this fall. Data from
completed studies in the LANDSCAPE and NEST programs, as well as
data from the ongoing clinical and pharmacology studies, are
planned to be included as part of the submission packages.
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“In the pre-NDA meeting, the FDA’s response on the regulatory
pathway for zuranolone continued to be consistent with previous
discussions. In the clinical development programs, zuranolone has
shown remarkably consistent, rapid, and sustained reductions in
depressive symptoms, including anxiety and sleep loss, in addition
to a well-tolerated safety profile. We believe we have a solid
filing package with four adequate and well controlled trials now in
hand and, if approved, zuranolone will fill a real unmet need and
be welcomed by people living with depression,” said Barry Greene,
Chief Executive Officer at Sage Therapeutics. “We have identified
what we believe is the most efficient path forward for an FDA
filing and potential approval.”
Sage and Biogen also announced the CORAL Study is fully enrolled
and closed to further screening, with topline data expected in
early 2022. The CORAL Study is designed to demonstrate a rapid
onset of depression relief when zuranolone is co-initiated with a
standard antidepressant therapy.
“We are pleased to share what we believe is an efficient filing
pathway for zuranolone, with the goal of bringing a new treatment
option to the millions of people who suffer from depression
worldwide,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of
Research and Development at Biogen. “The efficacy and safety data
planned for FDA submission support our vision of zuranolone being
an as-needed, two-week, once-daily treatment option for MDD and PPD
that produces rapid relief from symptoms within days.”
Sage and Biogen plan to submit a separate and distinct filing
for PPD once the ongoing PPD 301-SKYLARK Study completes so as not
to affect the MDD review timeline. The companies plan to commence
marketing for the approved indications as soon as possible pending
the FDA’s approval. The review cycles may allow commercialization
of both indications simultaneously, if approved.
About Major Depressive Disorder (MDD)
Major depressive disorder (MDD) is a common but serious mood
disorder in which people experience depressive symptoms that impair
their social, occupational, educational, or other important
functioning, such as a depressed mood or loss of interest or
pleasure in daily activities, consistently for at least a two-week
period. It is estimated that approximately 19 million people in the
U.S. and more than 250 million people worldwide suffer from MDD
each year. While antidepressants are widely used to treat MDD,
large-scale studies have demonstrated the need for additional
therapies with a differentiated profile.
About Postpartum Depression (PPD)
Postpartum depression (PPD) is one of the most common medical
complications during and after pregnancy. PPD can have a serious
negative impact on a woman, including significant functional
impairment, depressed mood and/or loss of interest in her newborn,
and associated symptoms of depression such as loss of appetite,
difficulty sleeping, motor challenges, lack of concentration, loss
of energy and poor self-esteem. PPD is estimated to affect
approximately one in eight women who have given birth in the U.S.
or approximately over 500,000 women annually.
About Zuranolone
Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week,
investigational drug in development for the treatment of major
depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is an investigational oral neuroactive steroid (NAS)
GABA-A receptor positive allosteric modulator (PAM). The GABA
system is the major inhibitory signaling pathway of the brain and
central nervous system and contributes to regulating brain
function. Zuranolone has been granted Breakthrough Therapy
Designation by the U.S. Food & Drug Administration.
Zuranolone is being evaluated in the NEST and LANDSCAPE clinical
trial programs. The two development programs include multiple
studies examining use of zuranolone in several thousand patients
with a variety of dosing, clinical endpoints, and treatment
paradigms. The LANDSCAPE program includes five studies of
zuranolone in patients with MDD (MDD-201B, MOUNTAIN, SHORELINE,
WATERFALL, and CORAL Studies). The NEST program includes two
placebo-controlled studies of zuranolone in patients with PPD
(ROBIN and SKYLARK Studies). Additionally, Shionogi recently
completed a Phase 2 study of zuranolone in Japan.
About Sage Therapeutics
Sage 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.
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.
Forward-Looking Statements
Sage Therapeutics Safe Harbor
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation
statements regarding: plans for an NDA filing for zuranolone in MDD
and PPD, and the potential timing of such submissions; our belief
in the adequacy of the data we plan to submit in the NDA; the
potential for FDA acceptance of an NDA for zuranolone; the
potential for regulatory approval and commencement of
commercialization of zuranolone and our goals as to timing; our
planned timing for reporting of data from ongoing clinical trials;
the potential profile and benefit of zuranolone in MDD and PPD; our
belief in the regulatory filing pathways and opportunities for
zuranolone; other planned next steps for the program; our estimates
as to the number of patients with MDD and PPD; and other statements
regarding the goals, opportunity and potential for zuranolone and
for our business. These statements constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. 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 our control, which could cause actual results to differ
materially from those contemplated in these forward-looking
statements, including the risks that: we may experience delays or
unexpected hurdles in our efforts to submit an NDA for zuranolone
and we may not be able to submit the NDA on the timelines we expect
or at all; the FDA may find inadequacies and deficiencies in our
NDA for zuranolone, including in the data we submit, and may decide
not to accept the NDA for filing; even if the FDA accepts the NDA
for filing, the FDA may not meet expected review timelines and may
ultimately decide not to approve zuranolone in MDD or PPD; the FDA
may decide that the design, conduct or results of our completed and
ongoing clinical trials for zuranolone, even if positive, are not
sufficient for approval in MDD or PPD and may require additional
trials or data which may significantly delay and put at risk our
efforts to obtain approval and may not be successful; other
decisions or actions of the FDA or other regulatory agencies may
affect the zuranolone program and our plans, progress or results;
we may experience negative results in ongoing or future studies of
zuranolone that negatively affect our ability to obtain approval of
zuranolone or that impair the potential profile of zuranolone;
success in earlier clinical trials may not be repeated or observed
in ongoing or future studies, and ongoing and future clinical
trials may not meet their primary or key secondary endpoints or
generate results sufficient to gain regulatory approval to market
zuranolone without further development work; unexpected concerns
may arise from additional data, analysis or results from any of our
completed studies; we may encounter adverse results or adverse
events at any stage of development that negatively impact further
development or that require additional nonclinical and clinical
work which may not yield positive results; we may encounter delays
in conduct of our clinical trials, including slower than expected
site initiation or enrollment, that may impact our ability to meet
our expected time-lines; the actual size of the MDD and PPD patient
populations may be significantly lower than our estimates and, even
if zuranolone is approved, it may only be approved or used to treat
a subset of the relevant patient populations; we may encounter
technical and other unexpected hurdles in the development and
manufacture of zuranolone or our other product candidates which may
delay our timing or change our plans; as well as those risks more
fully discussed in the section entitled "Risk Factors" in our 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 our views only
as of today, and should not be relied upon as representing our
views as of any subsequent date. We explicitly disclaim any
obligation to update any forward-looking statements.
Biogen Safe Harbor
This 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, safety and efficacy of zuranolone; the
potential clinical effects of zuranolone; the clinical development
program for zuranolone; clinical development programs, clinical
trials and data readouts and presentations for zuranolone; the
potential treatment of MDD and PPD; the potential of Biogen’s
commercial business and pipeline programs, including zuranolone;
the anticipated benefits and potential of Biogen’s collaboration
arrangement with Sage; 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, uncertainty of
success in the development and potential commercialization of
zuranolone; unexpected concerns may arise from additional data,
analysis or results of clinical studies of zuranolone; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of Biogen’s
drug candidates, including zuranolone; the occurrence of adverse
safety events; the risks of other unexpected hurdles, costs or
delays; 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 our 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.
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SAGE MEDIA CONTACT: Maureen L. Suda (617) 949-4289
Maureen.Suda@sagerx.com
SAGE INVESTOR CONTACT: Helen Rubinstein (315) 382-3979
Helen.Rubinstein@sagerx.com
BIOGEN MEDIA CONTACT: Ashleigh Koss Tel: +1 908-205-2572
public.affairs@biogen.com
BIOGEN INVESTOR CONTACT: Mike Hencke +1 781 464 2442
IR@biogen.com
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