Sage Therapeutics & Shionogi & Co., Ltd., Enter Strategic Collaboration to Develop & Commercialize SAGE-217 for MDD & Other I...
June 13 2018 - 8:01PM
Business Wire
Collaboration intended to accelerate
development of SAGE-217 in key Asian markets and supports Sage’s
mission to bring transformational medicines to patients around the
world
Collaboration supports Shionogi’s vision of
creating a more vigorous society by exploring the potential to
provide relief from the psychological uncertainty of depression
with a novel treatment paradigm
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, and Shionogi
& Co., Ltd., today announced they have entered into a strategic
collaboration for the clinical development and commercialization of
SAGE-217 for the treatment of major depressive disorder (MDD) and
other indications in Japan, Taiwan and South Korea. Sage received
Breakthrough Therapy Designation from the U.S. Food and Drug
Administration (FDA) for SAGE-217 in MDD in February 2018, and
recently announced an expedited development plan for SAGE-217 in
the U.S. with a pivotal Phase 3 placebo-controlled trial in
patients with MDD expected to commence this year, and an ongoing
placebo-controlled trial in women with PPD, now also designated a
pivotal trial. The goal of the collaboration is to accelerate
development of a potentially groundbreaking medicine to patients in
key Asian markets.
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Under the terms of the agreement, Shionogi will be responsible
for all clinical development, regulatory filings and
commercialization of SAGE-217 for MDD, and potentially other
indications, in Japan, Taiwan and South Korea. Shionogi will make
an upfront payment to Sage of $90 million, and Sage will be
eligible to receive additional development and commercial
milestones of up to $485 million. Sage will receive tiered
royalties on sales of SAGE-217 in Japan, Taiwan and South Korea, if
development efforts are successful, with tiers averaging in the
greater than 20 percent range, subject to other terms of the
agreement. Shionogi has also granted Sage certain rights to
co-promote SAGE-217 in Japan across all indications. Sage maintains
exclusive rights to develop and commercialize SAGE-217 outside of
Japan, Taiwan and South Korea.
"We are pleased to collaborate with Shionogi, a company that
shares our excitement at the opportunity to work together to
accelerate development and broaden geographic access to a
potentially paradigm-shifting treatment for depression,” said Jeff
Jonas, M.D., chief executive officer of Sage. “Shionogi is a
well-regarded commercial leader in mood disorders in the Asian
market. By working together, we believe we can expand the global
footprint for SAGE-217 alongside our ongoing efforts in the U.S.
and E.U. As we have always said, our goal is to build a
fully-integrated, multi-national biopharmaceutical company and this
collaboration moves us another step closer to achieving the
goal.”
“This collaboration, if successful, will enable us to move one
step closer in realizing a more vigorous society in which patients
in need are provided the potential for relief from the
psychological uncertainty of depression allowing the possibility of
fulfillment of one’s innate ability. In addition, the compound will
allow us to build up and strenghthen the psychiatry presence that
we have built through Cymbalta and Intuniv,” said Dr. Isao
Teshirogi, President and Chief Executive Officer, Shionogi &
Co., Ltd.
About SAGE-217SAGE-217 is a next generation positive
allosteric modulator that has been optimized for selectivity to
synaptic and extrasynaptic GABAA receptors and a pharmacokinetic
profile intended for daily oral dosing. The GABA system is the
major inhibitory signaling pathway of the brain and CNS, and
contributes significantly to regulating CNS function. SAGE-217 is
currently being developed for MDD and certain other mood and
movement disorders.
Sage received Breakthrough Therapy Designation from the FDA for
SAGE-217 in MDD in February 2018. The Breakthrough Therapy
Designation is intended to offer a potentially expedited
development path and review in the U.S. for promising drug
candidates, which includes increased interaction and guidance from
the FDA. This regulatory decision was based primarily on the
positive results from the Phase 2, placebo-controlled trial of
SAGE-217 in 89 adult patients with moderate to severe MDD. In the
trial, SAGE-217 met the primary endpoint with a statistically
significant mean reduction in the Hamilton Rating Scale for
Depression (HAM-D) 17-item total score from baseline at Day 15 in
the SAGE-217 group, compared to placebo (p<0.0001).
Statistically significant improvements were observed in the HAM-D
score compared to placebo by the morning following the first dose
through Week 4 and the effects of SAGE-217 remained numerically
greater than placebo through the end of follow-up at Week 6.
SAGE-217 was generally well-tolerated. The most common adverse
events in the SAGE-217 group were headache, dizziness, nausea, and
somnolence.
About Sage TherapeuticsSage Therapeutics is a
clinical-stage biopharmaceutical company committed to developing
novel medicines to transform the lives of patients with
life-altering CNS disorders. Sage has a portfolio of novel product
candidates targeting critical CNS receptor systems, GABAA and NMDA.
Sage's lead program, a proprietary IV formulation of brexanolone
(SAGE-547), has completed Phase 3 clinical development for
postpartum depression and a New Drug Application is currently under
review with the U.S. Food and Drug Administration. Sage is
developing its next generation modulators, including SAGE-217 and
SAGE-718, in various CNS disorders. For more information, please
visit www.sagerx.com.
About Shionogi & Co., Ltd.Shionogi & Co., Ltd. is
a major research-driven pharmaceutical company dedicated to
bringing benefits to patients based on its corporate philosophy of
“supplying the best possible medicine to protect the health and
wellbeing of the patients we serve.” Shionogi’s research and
development currently targets two therapeutic areas: infectious
diseases, and pain/CNS disorders. For over 50 years, Shionogi has
developed and commercialized innovative oral and parenteral
anti-infectives. In addition, Shionogi is engaged in new research
areas, such as obesity/geriatric metabolic diseases and
oncology/immunology. Contributing to the health and QOL of patients
around the world through development in these therapeutic areas is
Shionogi’s primary goal. For more details, please
visit www.shionogi.co.jp/en/.
Forward-Looking StatementsVarious statements in this
release are “forward-looking" statements, including without
limitation, statements as to: the potential for expedited
development of SAGE-217 in MDD and PPD; the timing of planned
clinical activities related to SAGE-217; the potential of SAGE-217
to be a paradigm shift in the treatment of depression; the
potential for successful development and commercialization of
SAGE-217 in the U.S. and in the Shionogi markets; and expectations
for future milestones and royalties under the collaboration. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties which could cause actual results to differ materially
from those contemplated in these forward-looking statements,
including the risks that: expedited development and review of
SAGE-217 may not be achieved in any market; regulatory authorities
in the U.S. or in the Shionogi markets may decide that the design
or results of the SAGE-217 clinical program are not sufficient for
regulatory approval in MDD, PPD or any other indication;
development of SAGE-217 may not be successful in any indication;
success in non-clinical studies or in earlier stage clinical trials
may not be repeated or observed in ongoing or future studies which
may not support further development or be sufficient to gain
regulatory approval to market the product; adverse events may be
encountered at any stage of development that negatively impact
further development; and even if development efforts are successful
there may be events that limit market potential or trigger
reductions in milestones or royalties. Other risks and
uncertainties include, but are not limited to, issues related to:
adverse outcome of important litigation; domestic and foreign
healthcare reforms and changes of laws and regulations; general
industry and market conditions; changes in interest rates and
currency exchange rates; manufacturing and marketing risks, which
include, but are not limited to, inability to build production
capacity to meet demand and unavailability of raw materials; entry
of competitive products; and other technical and other unexpected
hurdles in the development and manufacture of SAGE-217 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 either company’s other filings with the
Securities and Exchange Commission. In addition, any
forward-looking statements represent the companies views only as of
today, and should not be relied upon as representing their views as
of any subsequent date. The companies explicitly disclaim any
obligation to update any forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20180613006173/en/
Sage Therapeutics:Investors:Paul Cox,
617-299-8377paul.cox@sagerx.comorMedia:Maureen L. Suda,
585-355-1134maureen.suda@sagerx.comorShionogi & Co.,
Ltd:Corporate Communications Department, +81-6-6209-7885
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