The companies expect to complete submission of
the NDA for treatment of MDD in the second half of 2022; associated
filing for postpartum depression anticipated in the first half of
2023
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) initiated a rolling submission of a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone
in the treatment of major depressive disorder (MDD). Zuranolone is
an investigational two-week, once-daily oral drug being developed
for MDD and postpartum depression (PPD). The companies have
submitted the nonclinical module of the NDA to the FDA and plan to
submit the remaining components for the MDD filing in the second
half of 2022.
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the full release here:
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Data from the completed studies of zuranolone in the LANDSCAPE
and NEST clinical development programs, including data from the
ongoing open-label SHORELINE Study in MDD, as well as data from the
completed clinical pharmacology studies, will comprise the full
submission package. The rolling submission process allows completed
sections of an NDA to be submitted to the FDA for review on an
ongoing basis.
“There are millions of people living with depression and the
initiation of the rolling NDA submission brings us one step closer
to our goal of offering zuranolone as a potential new treatment
option,” said Barry Greene, Chief Executive Officer at Sage. “We
believe the results from the LANDSCAPE and NEST programs, in which
zuranolone demonstrated rapid and sustained effects and a
well-tolerated safety profile in clinical trials, support
zuranolone as a potential novel treatment option for MDD, if
approved. We look forward to providing an update when the rolling
submission for zuranolone in MDD is complete, which we expect to
occur in the second half of this year.”
“Zuranolone has the potential to help address a significant
unmet medical need in depression as an innovative option in a
therapeutic area where little has changed in the past 30 years,”
said Priya Singhal, M.D., M.P.H., Head of Global Safety and
Regulatory Sciences and Interim Head of R&D at Biogen. “We are
committed to advancing the science and developing new approaches to
treating mental health, a major public health challenge that was
exacerbated by the COVID-19 pandemic.”
Zuranolone was granted Fast Track Designation by the FDA in 2017
in MDD and Breakthrough Therapy Designation in 2018. Sage and
Biogen plan to submit an associated NDA filing for PPD in the first
half of 2023.
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 Fast Track and Breakthrough
Therapy Designation for MDD and Fast Track Designation for PPD by
the U.S. Food & Drug Administration.
Zuranolone is being evaluated in the LANDSCAPE and NEST clinical
development programs. The two development programs include multiple
studies examining use of zuranolone in several thousand people with
a variety of dosing, clinical endpoints, and treatment paradigms.
The LANDSCAPE program includes five studies of zuranolone in people
with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL
Studies). The NEST program includes two placebo-controlled studies
of zuranolone in people with PPD (ROBIN and SKYLARK Studies).
Additionally, Shionogi completed a Phase 2 study of zuranolone in
Japan in people with MDD.
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 more than 21 million adults1 in the
U.S. and approximately 280 million people2 worldwide suffer from
depression. 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 500,0003 women annually.
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly
leading the way to create a world with better brain health. Our
mission is to pioneer solutions to deliver life-changing brain
health medicines, so every person can thrive. For more information,
please visit www.sagerx.com.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and
delivers worldwide innovative therapies for people living with
serious neurological 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, Sir Kenneth Murray, and Nobel Prize winners Walter
Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of
medicines to treat multiple sclerosis, has introduced the first
approved treatment for spinal muscular atrophy, and is providing
the first and only approved treatment to address a defining
pathology of Alzheimer’s disease. Biogen is also commercializing
biosimilars and focusing on advancing the industry’s most
diversified pipeline in neuroscience that will transform the
standard of care for patients in several areas of high unmet
need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
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 our
statements regarding: plans for completing the NDA filing for
zuranolone in MDD and for submitting an associated NDA filing in
PPD, and the anticipated timing of such activities; our belief in
the potential profile and benefit of zuranolone in the treatment of
depression; our belief that the data from our clinical programs
support the potential of zuranolone in the treatment of depression;
our plan to request priority review for our NDA; our goal of making
zuranolone available as a new treatment option in the treatment of
depression; the potential for approval of zuranolone in the
treatment of depression; and other statements as to our mission and
goals. 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 complete the NDA submission for zuranolone in MDD and to
make the associated filing in PPD, and we may not be able to
complete such activities 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, despite prior
discussions, and may decide not to accept the NDA for filing; even
if the FDA accepts the NDA for filing, the FDA may find that the
data included in the NDA are not sufficient for approval and may
not approve the NDA; 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; the FDA may not grant priority review
for our NDA; the FDA may not meet expected review timelines for our
NDA; other decisions or actions of the FDA or other regulatory
agencies may affect our efforts with respect to zuranolone and our
plans, progress or results; we may experience negative results in
the ongoing SKYLARK Study in PPD that negatively affect our ability
to file the associated NDA for approval of zuranolone in PPD;
results of ongoing or future studies may impact our ability to
obtain approval of zuranolone or impair the potential profile of
zuranolone; unexpected concerns may arise from additional data,
analysis or results from any of our completed studies; we may
encounter 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;
the need to align with our collaborators may hamper or delay our
development and commercialization efforts or increase our costs;
the number of patients with MDD and PPD, the unmet need for
additional treatment options and the potential market for
zuranolone in the treatment of depression, if approved, may be
significantly smaller than we expect; and we may encounter
technical and other unexpected hurdles which may delay our timing
or change our plans, increase our costs or otherwise negatively
impact our efforts to gain approval of zuranolone and to make it
available as a treatment option for depression or to accomplish
other aspects of our mission and goals; as well as those risks more
fully discussed in the section entitled "Risk Factors" in our most
recent annual/quarterly report with the Securities and Exchange
Commission (SEC), as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings with the SEC. 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.
References:
- SAMHSA. 2020 NSDUH Detailed Tables.
https://www.samhsa.gov/data/report/2020-nsduh-detailed-tables.
Published October 2021
- “Depression.” World Health Organization, World Health
Organization,
https://www.who.int/news-room/fact-sheets/detail/depression.
- Bauman BL, Ko JY, Cox S, D’Angelo Mph DV, Warner L, Folger S,
Tevendale HD, Coy KC, Harrison L, Barfield WD. Vital Signs:
Postpartum Depressive Symptoms and Provider Discussions About
Perinatal Depression—United States. Morb Mortal Wkly Rep. 2020;
69(19):575-581.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220429005707/en/
SAGE MEDIA CONTACT: Becky Kern (914) 772-2310
Becky.Kern@sagerx.com
BIOGEN MEDIA CONTACT: Ashleigh Koss Tel: +1 908-205-2572
public.affairs@biogen.com
SAGE INVESTOR CONTACT: Helen Rubinstein (315) 382-3979
Helen.Rubinstein@sagerx.com
BIOGEN INVESTOR CONTACT: Mike Hencke +1 781 464 2442
IR@biogen.com
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