Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) today announced that the companies will host a joint investor
webcast to discuss the planned commercialization approach and
opportunity for their investigational product, zuranolone, on
Tuesday, December 6 at 8:00 a.m. ET.
Zuranolone is being evaluated as a potential rapid-acting,
once-daily, oral two-week treatment for major depressive disorder
(MDD) and postpartum depression (PPD). The webcast will cover the
unmet medical need in MDD, review clinical data generated with
zuranolone to date and provide more detail on the potential
commercialization plans and opportunity in MDD, if zuranolone is
approved.
Webcast Information
A live webcast of the presentation can be accessed on the
investor page of Sage's website at investor.sagerx.com, where it
will be available for up to 30 days, and the investor page of
Biogen’s website at investors.biogen.com.
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 developed the
first and only 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
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.
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 for approval and
commercialization of zuranolone and the potential commercial
opportunity for zuranolone, if approved. 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 our rolling new drug application (NDA) submission for
zuranolone in MDD and PPD and we may not be able to complete the
submission on the timeline 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 in MDD or
PPD, or both; 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; even if our NDA is successfully filed
and accepted, the FDA may not grant priority review or 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, results and expected
timelines; we may encounter adverse events from ongoing studies or
future use of zuranolone or unexpected concerns from additional
analysis of results of completed studies that negatively impact the
potential for approval of zuranolone or the potential commercial
opportunity; even if the NDA for zuranolone is approved, other
decisions or actions of the FDA, such as decisions related to the
scope and content of the approved label, may affect the commercial
opportunity for zuranolone and our plans; even if zuranolone is
approved, the unmet need for new treatment options in MDD and PPD,
the number of patients with those disorders and related patient
segment estimates and the market for zuranolone in those
indications may be significantly smaller than we expect;
zuranolone, if approved in MDD and PPD, may not achieve market
acceptance for a number of reasons, including if the profile of
zuranolone in clinical practice does not meet expectations or if
competitive products meet treatment needs, or if we encounter
reimbursement-related or other market-related issues that impact
the success of our commercialization; we may never be able to
generate meaningful revenues from sales of zuranolone, if approved,
or to generate revenues at levels we expect; and we may encounter
technical and other unexpected hurdles in the development and
manufacture of our product candidates or the commercialization of
any marketed product which may delay our timing or change our
plans, increase our costs or otherwise negatively impact our
business; as well as those risks more fully discussed in the
section entitled "Risk Factors" in our most recent quarterly
report, 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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version on businesswire.com: https://www.businesswire.com/news/home/20221121005978/en/
Sage Investors Helen Rubinstein 315-382-3979
helen.rubinstein@sagerx.com
Sage Media Matthew Henson 917-930-7147
matthew.henson@sagerx.com
Biogen Investors Mike Hencke 781-464-2442
IR@biogen.com
Biogen Media Jack Cox 210-544-7920
public.affairs@biogen.com
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