Sage Therapeutics Forges $575 Million Deal With Shionogi to Market Depression Drug in Parts of Asia

Days after the U.S. Food and Drug Administration (FDA) provided an expedited path forward for SAGE Therapeutics’ depression treatment SAGE-217, the company snagged a deal worth $575 million from Japanese pharma firm Shionogi & Co., Ltd., to market the treatment in parts of Asia.

To secure the marketing rights to the as-of-yet unapproved treatment for major depressive disorder (MDD) and postpartum depression (PPD), Shionogi provided Cambridge, Mass.-based Sage with $90 million in an upfront payment and a potential $485 million in additional development and commercial milestones.

The deal with Shionogi, announced late Wednesday, has pleased investors. Shares of Sage are up more than 2 percent in premarket trading to $173.

Earlier this week SAGE-217 got a significant shot in the arm from U.S. regulatory authorities. The FDA has requested a short-term Phase III trial for MDD patients to evaluate two weeks of dosing at 20 mg and 30 mg in 450 MDD patients. There will be a four-week follow-up of patients. The trial is expected to launch later this year and if all goes well, Sage could file a New Drug Application for SAGE-217. Sage received Breakthrough Therapy Designation from the FDA for SAGE-217 in MDD in February 2018. Not only does it have a path forward in treating MDD, the FDA has designated the company’s ongoing placebo-controlled PPD trial a “pivotal trial.” Topline date from the pivotal PPD trial is expected in the fourth quarter of 2018. If SAGE-217 is approved it would be the first FDA short-course drug approved by the U.S. Food and Drug Administration for severe PPD.

One day after Sage shared the FDA’s announcement, Shionogi pounced on securing rights for parts of Asia. Shionogi plans to market the therapeutic in Japan, Taiwan and South Korea. In addition to the financial part of the deal, Shionogi 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.

Sage Chief Executive Officer Jeff Jonas praised the deal with Shionogi as a way to accelerate development and “broaden geographic access” to a treatment that has been referred to as a game changer in depression.

“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,” Jonas said in a statement.

Shionogi CEO Isao Teshirogi noted that if SAGE-217 can be approved for commercialization in those parts of Asia, it will provide additional therapeutic support for depression patients. Teshirogi said SAGE-217 has the potential to allow those patients to fulfill their “innate ability.” Teshirogi added that the addition of SAGE-217 to the company’s offerings will allow Shionogi “to build up and strengthen the psychiatry presence that we have built through Cymbalta and Intuniv.”