Sage Therapeutics and Shionogi & Co., Ltd., Enter Strategic Collaboration to Develop and Commercialize SAGE-217 for MDD and Other Indications in Japan, Taiwan and South Korea
Business Wire
June 13, 2018 [about 9:30 p.m. EST]
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--
Sage Therapeutics ( 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 Therapeutics
Sage 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 Sage Therapeutics
Sage 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/.
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