Pharma BD Deal Intelligence

Sumitomo Dainippon Pharma Co., Ltd. / Otsuka Pharmaceutical Co., Ltd.

2021 · Co-Development · $270M · Complete

Outcome grade pending — assessed 5 years post-close.

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The coverage arc

Apr 16, 2020 NEJM — Koblan et al. Phase 2 ulotaront Bullish

In a four-week, double-blind, placebo-controlled Phase 2 trial of 245 patients with acute exacerbation of schizophrenia, ulotaront (SEP-363856) at 50 or 75 mg…

Oct 14, 2021 BioWorld Neutral

Otsuka has agreed to pay Sunovion $270 million upfront, plus undisclosed development and commercial milestones and profit splits, for a worldwide collaboration…

Sep 26, 2024 FDA Neutral

The U.S. Food and Drug Administration today approved Cobenfy (xanomeline and trospium chloride), a first-in-class oral medication for the treatment of…

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On September 30, 2021, Sunovion and its parent Sumitomo Dainippon Pharma entered a worldwide development and commercialization collaboration with Otsuka covering four psychiatry/neurology compounds: ulotaront (SEP-363856), a Phase 3 TAAR1/5-HT1A agonist for schizophrenia; SEP-4199 (bipolar I depression); SEP-378614; and SEP-380135. Otsuka paid Sunovion $270M upfront and the partners shared development costs and profits in designated regions, with up to $620M in development milestones plus sales milestones (total disclosed value ~$890M+). In July 2023 the Phase 3 DIAMOND 1 and DIAMOND 2 schizophrenia trials missed their primary endpoints, which the companies attributed to a high placebo response. On March 15, 2024 the parties amended the agreement: Otsuka took exclusive worldwide rights to develop, manufacture and commercialize ulotaront and SEP-380135 (with Otsuka bearing study costs from January 2024 and paying up to ~$30M in milestones plus royalties, no upfront), while SEP-4199 and SEP-378614 were excluded as Sumitomo refocused on oncology and regenerative medicine. Otsuka has since relaunched a Phase 3 schizophrenia study (NCT06894212) and continues ulotaront programs in major depressive disorder and generalized anxiety disorder.

Key facts

Related deals — scored

DealYearValueOutcome
Sumitomo Dainippon Pharma Co., Ltd. / Otsuka Pharmaceutical Co., Ltd. (this deal)2021$270M
Sumitomo Dainippon Pharma Co., Ltd. / Cynapsus Therapeutics Inc.2016$624M28
Sumitomo Dainippon Pharma Co., Ltd. / Tolero Pharmaceuticals, Inc.2016$780M24
Sumitomo Dainippon Pharma Co., Ltd. / Roivant Sciences Ltd. (Sumitovant five-Vant deal)2019$3.0B
Novartis AG / Advanced Accelerator Applications S.A.2017$3.9B98
Allergan plc / Merck & Co., Inc. (CGRP receptor antagonist program)2015$250M91
Cephalon Inc. / Laboratoire L. Lafon S.A. (Group Lafon)2000$450M89

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