Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc.
(Nasdaq: SAGE) announced the U.S. Food and Drug Administration
(FDA) has accepted the filing of a New Drug Application (NDA) for
zuranolone in the treatment of major depressive disorder (MDD) and
postpartum depression (PPD). Zuranolone is an investigational drug
being evaluated as a 14-day, rapid-acting, once-daily, oral
treatment in adults with MDD and PPD. The application has been
granted priority review and the FDA has assigned a Prescription
Drug User Fee Act (PDUFA) action date of August 5, 2023.
“We see potential for zuranolone, if approved, to be a
meaningful new option that can help address the serious unmet need
faced by the diverse populations struggling with MDD and PPD,” said
Priya Singhal, M.D., M.P.H., Executive Vice President, Head of
Development and Interim Head of Research and Global Safety and
Regulatory Sciences at Biogen. “The FDA filing acceptance and
granting of priority review are important milestones in the mission
Biogen and our collaboration partner Sage share to advance the
understanding and treatment of depression.”
Depression is one of the leading contributors to disability
worldwide.1 It is estimated that more than 21 million adults in the
U.S. experienced at least one major depressive episode in 2020,
with nearly 14 million people diagnosed with major depressive
disorder,2 and an estimated 500,000 cases of PPD annually.3
Symptoms of MDD and PPD have been shown to have an impact on a
person’s overall quality of life, functioning and well-being. In
2018, the incremental economic burden of MDD was an estimated $326
billion in the U.S. alone.4
The zuranolone NDA includes data from the LANDSCAPE and NEST
clinical development programs as well as a Phase 2 study of
zuranolone completed by Shionogi in Japan in adults with MDD. The
LANDSCAPE program includes five studies of zuranolone in adults
with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL). The
NEST program includes two studies of zuranolone in adult women with
PPD (ROBIN and SKYLARK).
“We feel a tremendous responsibility to patients with MDD and
PPD to deliver a potential new treatment option, which is so
desperately needed. Most current approved therapies may take weeks
or months to work. We are committed to advancing treatments that
could help physicians and patients by addressing depression
symptoms quickly,” said Laura Gault, M.D., Ph.D., Chief Medical
Officer at Sage. “We believe zuranolone, if approved, could offer a
new way for physicians to support patients.”
Zuranolone, a neuroactive steroid, has a novel mechanism of
action as a positive allosteric modulator of GABA-A receptors. In
people with depression, it is thought to work by rapidly
rebalancing dysregulated neuronal networks to help reset brain
function. Zuranolone targets brain networks responsible for
functions such as mood, arousal, behavior, and cognition.
Priority Review is granted by the FDA to applications for
medicines that, if approved, would provide significant improvements
in the effectiveness or safety of the treatment, diagnosis, or
prevention of serious conditions.
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 in 2020, more than 21 million adults in the U.S.
experienced at least one major depressive episode with nearly 14
million people diagnosed with major depressive disorder.2 There
were approximately 190 million cases of MDD worldwide in 2020.5
About Postpartum Depression (PPD)Postpartum
depression (PPD) is one of the most common medical complications
during and after pregnancy.6 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
500,000 women annually.3
About ZURANOLONEZuranolone (SAGE-217/BIIB125)
is a once-daily, 14-day, investigational drug in development for
the treatment of major depressive disorder (MDD) and postpartum
depression (PPD). Zuranolone is an 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 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). The
NEST program includes two placebo-controlled studies of zuranolone
in women with PPD (ROBIN and SKYLARK). Additionally, Shionogi
completed a Phase 2 study of zuranolone in Japan in people with
MDD.
About BiogenAs 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 developed the first approved treatment to address a
defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
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 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.
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.
Sage Therapeutics Safe Harbor
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: the potential profile and benefit of
zuranolone in the treatment of MDD and PPD; our belief that the
data from our clinical programs support the potential for approval
of zuranolone in the treatment of MDD and PPD and the potential
benefit of zuranolone, if approved, as a new treatment option in
the treatment of MDD and PPD; our expectations regarding the PDUFA
date for our NDA; our estimates as to the number of people with MDD
and PPD and the need for new treatment options; and other
statements as to our mission, goals and plans. 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: the
FDA may find that the data included in our NDA for zuranolone are
not sufficient for approval and may not approve the NDA or may
grant a more narrow or limited approval than we are seeking; 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 meet expected review timelines for our NDA or there may
be other delays in such timelines; an Advisory Committee of the
FDA, if convened, may not recommend approval of our NDA or may
recommend a more narrow approval than we are seeking; other
decisions or actions of the FDA may affect our efforts with respect
to zuranolone and our plans, progress or results; 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 or use that negatively impact
further development or that require additional nonclinical and
clinical work which may not yield positive results; the number of
patients with MDD and PPD, the unmet need for additional treatment
options and the potential profile and market for zuranolone in the
treatment of MDD and PPD, 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 MDD and PPD 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 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.
References:
- GBD 2017 Disease and Injury Incidence and Prevalence
Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 354 diseases and
injuries for 195 countries and territories, 1990-2017: a systematic
analysis for the Global Burden of Disease Study 2017. Lancet.
2018;392(10159):1789-1858.
- SAMHSA: 2020 NSDUH Detailed Tables.
- Bauman BL, et al. Morbidity and Mortality Weekly
Report, 2020;69(19):575-581.
- Greenberg PE, Fournier AA, Sisitsky T, et al. The economic
burden of adults with major depressive disorder in the United
States (2010 and 2018). Pharmacoeconomics. 2021;39(6):653-665.
- Santomauro DF, Mantilla Herrera AM, Shadid J, et al. Global
prevalence and burden of depressive and anxiety disorders in 204
countries and territories in 2020 due to the COVID-19 pandemic.
Lancet. 2021;398(10312):1700-1712.
- “ACOG Committee Opinion No. 757: Screening for Perinatal
Depression.” Obstetrics and gynecology vol. 132, 5 (2018):
e208-e212. Doi:10.1907/AOG.0000000000002927.
MEDIA CONTACTS: |
INVESTOR CONTACTS: |
Biogen |
Biogen |
Jack Cox |
Mike Hencke |
+ 1 210 544 7920 |
+1 781 464 2442 |
public.affairs@biogen.com |
IR@biogen.com |
|
|
Sage |
Sage |
Kathryn Ritzinger |
Helen Rubinstein |
+1 646 872-2912 |
+1 315 382-3979 |
Kathryn.Ritzinger@sagerx.com |
Helen.Rubinstein@sagerx.com |
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