Otsuka: Sumitomo Dainippon Pharma and Otsuka Announce Global Collaboration and License Agreement for Four Compounds in Psychiatry and Neurology

For immediate release

September 30, 2021

Company Name

Otsuka Holdings Co., Ltd.

Representing

Tatsuo Higuchi

President and Deputy Director, Chief Executive Officer

Code number

4578 First Section, Tokyo Stock Exchange

Surveys

Yuji kogure

Director, Investor Relations Department

Sumitomo Dainippon Pharma and Otsuka Announce Global Collaboration and License

Agreement for four compounds of psychiatry and neurology

Sumitomo Dainippon Pharma Co., Ltd. (Headquarters: Osaka, Japan; Representative Director, President and CEO: Hiroshi

Nomura; Securities Code: 4506, First Section of TSE), its American subsidiary Sunovion Pharmaceuticals Inc. and Otsuka

Pharmaceutical Co., Ltd. (Headquarters: Tokyo, Japan; Representative Director, President and CEO: Makoto Inoue) announces today that we have signed a collaboration and license agreement for the global joint development and commercialization of the four The following new candidate compounds (hereinafter referred to as the “four compounds”) currently under development in the field of psychiatry and neurology by Sumitomo Dainippon Pharma and Sunovion.

Development code (generic name)

Indication (current stage of development and geography)

SEP-363856 (ulotaront)

Schizophrenia (Phase 3 in the United States, Phase 2/3 in Japan and China)

SEP-4199

Bipolar Depression I (Phase 3 in US, Prepare for Phase 3 in Japan)

SEP-378614

TBD (Phase 1 in US)

SEP-380135

TBD (Phase 1 in US)

Under the terms and conditions of this agreement, Sunovion grants Otsuka the rights to jointly develop and market the four compounds worldwide. The Sumitomo Dainippon Pharma Group (Sumitomo Dainippon Pharma, Sunovion, Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. and Sumitomo Pharmaceuticals Asia Pacific Pte. Ltd.) and Otsuka will continue the joint development of these compounds. Regarding marketing, the Sumitomo Dainippon Pharma Group will record sales in each of the following countries and regions: United States, Canada, Japan and Asia (China, Taiwan, Singapore, Thailand, Vietnam and Malaysia) and, Sumitomo Dainippon Pharma Group and Otsuka plan to co-promote the four compounds together in principle. In addition, Otsuka will see sales in 41 other countries and regions, including countries in Europe. (The parties will discuss other regions in the future.)

Sunovion and Otsuka will share the expenses and profits related to clinical studies, applications for approval and commercialization in each of these countries and regions under the agreement. Further indications for ulotaront and indications for SEP-378614 and SEP-380135 will be determined after future consultations between the Sumitomo Dainippon Pharma group and Otsuka.

Upon completion of this agreement, Otsuka will make an upfront lump sum payment of $ 270 million (approximately JPY 30 billion) to Sunovion. Going forward, Otsuka will make development milestone payments for all four compounds of $ 620 million (approximately JPY 69 billion), and potentially more depending on the number of additional indications obtained for them. Potentially, sales milestone payments will also be made by Otsuka.

“We are happy to have signed this agreement with Otsuka, which has a broad global reach and important neuropsychiatry

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skill. We will work together to develop and market pharmaceuticals of value to more patients around the world faster and more reliably, in the hope that these new drugs will develop, ”said Hiroshi Nomura, President and CEO General of Sumitomo Dainippon Pharma. “Sumitomo Dainippon Pharma Aims To Achieve Sustained Growth Through Global Collaboration In Anticipation Of Loss Of Atypical Antipsychotic Agent Latuda®exclusivity in the United States and other future changes in the business environment. This collaboration is a major step forward in this initiative. ”

“Otsuka is committed to delivering novel antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capacity and external collaborations, starting with the launch of antipsychotics in the United States in 2002,” said Makoto Inoue, president and deputy director of Otsuka. “We are advancing in new areas such as the development of drugs to treat agitation associated with Alzheimer’s-type dementia and the deployment of the world’s first digital drug. Through this agreement, we are confident that companies will be able to provide even more value to patients through the experience and networks that we have cultivated over many years around the world. ”

The consolidated activity forecasts for the 2021 financial year announced by Otsuka Holdings on August 6, 2021 will not be modified.

Reference

About ulotaront (SEP-363856)

Ulotaront (SEP-363856) is an amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity, jointly developed by Sunovion and PsychoGenics Inc, which is a small molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receivers. Sunovion discovered ulotaront in collaboration with PsychoGenics using its in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. The results of the phase 2 study confirmed efficacy in treating both positive and negative symptoms of schizophrenia while demonstrating a side effect profile with notable similarities to placebo with regard to extrapyramidal symptoms, weight gain, lipid and glycemic disorders and elevation of prolactin. The full results of the study have been published in the New England Journal of Medicine (NEJM) in April 2020.

The agent is currently in phase 3 studies for schizophrenia in the United States and in phase 2/3 global clinical studies in Japan and China, with further indications under study. The United States Food and Drug Administration (FDA) granted breakthrough therapy designation to ulotaront for the treatment of schizophrenia in May 2019.

About SEP-4199

SEP-4199 is an oral small molecule agent with a non-racemic enantiomeric ratio of amisulpride developed by Sunovion. Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific and that increasing the R-amisulpride / S-amisulpride ratio increases the potency of 5-HT serotonin.7 dopamine D receptors2 receivers. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to increase serotonin 5-HT levels7 activity to improve the effectiveness of antidepressants and produce reduced levels of D2 receptor occupation appropriate for the treatment of bipolar depression. In September 2021, Sunovion launched a global Phase 3 clinical study, which is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study for the treatment of bipolar I depression in the United States. Japan will join this global clinical phase 3 study.

About SEP-378614

SEP-378614, jointly discovered by Sunovion and PsychoGenics, is a small molecule oral agent that acts on the central nervous system. Sunovion discovered SEP-378614 in collaboration with PsychoGenics using its in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. The results of preclinical studies suggest that it may have rapid-onset and long-lasting antidepressant-like activity and improve neuroplasticity.

Agent is in Phase 1 studies in the United States

About SEP-380135

SEP-380135, jointly developed by Sunovion and PsychoGenics, is a small molecule oral agent that acts on the central nervous system. Sunovion discovered SEP-380135 in collaboration with PsychoGenics using its in vivo phenotypic SmartCube®

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platform and associated artificial intelligence algorithms. The results of the preclinical study suggest its efficacy against a number of behavioral and psychological symptoms of dementia, including agitation / aggression, psychomotor hyperactivity, depression, and social interaction deficits.

Agent is in Phase 1 studies in the United States

About neuropsychiatric disorders

Neuropsychiatric disorders are among the most complex and difficult to treat. Brain disorders are often associated with significant and often debilitating effects on patients, affecting loved ones and society in general. Almost one in six people worldwide live with a neurological disorder1, approximately 29 million people worldwide live with bipolar disorder2, and about 20 million people worldwide live with schizophrenia3.

Source:

1World Health Organization (WHO) Neurological Disorders: Public Health Challenges 2006.

[Internet] Available at: https://www.who.int/mental_health/neurology/neurological_disorders_report_web.pdf. Accessed February 2021.

2 World Health Organization. Global Burden of Disease Report 2004.

[Internet] Available at: http://www.who.int. Accessed March 29, 2013 (To access: Health topics, Global burden of disease, Global burden

disease: 2004 update).

3 World Health Organization. Mental disorders.

[Internet] Available at: https://www.who.int/news-room/fact-sheets/detail/mental-disorders. Accessed April 2021.

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Disclaimer

Otsuka Holdings Co. Ltd. published this content on September 30, 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on September 30, 2021 06:31:07 AM UTC.


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