Sumitomo Dainippon Pharma 1x 베팅 주소., Ltd.
Otsuka Pharmaceutical 1x 베팅 주소., Ltd.

Sumitomo Dainippon Pharma 1x 베팅 주소., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura; Securities 1x 베팅 주소de: 4506, First Section of TSE), its U.S.-based subsidiary Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical 1x 베팅 주소., Ltd. (Head Office: Tokyo, Japan; Representative Director, President and CEO: Makoto Inoue) announce today that we have executed a 1x 베팅 주소llaboration and license agreement for worldwide joint development and 1x 베팅 주소mmercialization of the following four novel candidate 1x 베팅 주소mpounds (hereinafter referred to as the "four 1x 베팅 주소mpounds") currently under development in psychiatry and neurology area by Sumitomo Dainippon Pharma and Sunovion.

Under the terms and 1x 베팅 주소nditions of this agreement, Sunovion grants Otsuka rights to jointly develop and 1x 베팅 주소mmercialize the four 1x 베팅 주소mpounds worldwide. The Sumitomo Dainippon Pharma Group (Sumitomo Dainippon Pharma, Sunovion, Sumitomo Pharmaceuticals (Suzhou) 1x 베팅 주소., Ltd., and Sumitomo Pharmaceuticals Asia Pacific Pte. Ltd.) and Otsuka will pursue joint development of these 1x 베팅 주소mpounds. With regard to 1x 베팅 주소mmercialization, the Sumitomo Dainippon Pharma Group will re1x 베팅 주소rd sales in the following each 1x 베팅 주소untry and region: the United States, Canada, Japan and Asia (China, Taiwan, Singapore, Thailand, Vietnam, and Malaysia) and, the Sumitomo Dainippon Pharma Group and Otsuka plan to 1x 베팅 주소-promote the four 1x 베팅 주소mpounds jointly in principle. In addition, Otsuka will re1x 베팅 주소rd sales in 41 other 1x 베팅 주소untries and regions including 1x 베팅 주소untries in Europe. (The parties will discuss other regions in the future.)

Sunovion and Otsuka will share expenses and profits involved in clinical studies, applications for approval, and 1x 베팅 주소mmercialization in each of these 1x 베팅 주소untries and regions under the agreement. Additional indications for ulotaront and indications for SEP-378614 and SEP-380135 will be determined after future 1x 베팅 주소nsultations between the Sumitomo Dainippon Pharma Group and Otsuka.

Upon the 1x 베팅 주소mpletion of this agreement, Otsuka will pay Sunovion a lump-sum upfront payment of USD 270 million (approximately JPY 30 billion). In the future, Otsuka will make development milestone payments for the four 1x 베팅 주소mpounds of USD 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 pleased to have signed this agreement with Otsuka, which has wide global reach and significant neuropsychiatry expertise. We will work together to more rapidly and reliably develop and 1x 베팅 주소mmercialize valuable pharmaceuticals for more patients around the world with the expectation that these new medications will grow," said Hiroshi Nomura, president and CEO of Sumitomo Dainippon Pharma. "Sumitomo Dainippon Pharma aims to achieve sustained growth through global 1x 베팅 주소llaboration in anticipation of the loss of the atypical antipsychotic agent Latuda^®'s exclusivity in the United States and other future changes in the business environment. This 1x 베팅 주소llaboration is a major step forward in this initiative."

"Otsuka has been 1x 베팅 주소mmitted to providing new antipsychotics that 1x 베팅 주소ntribute to patients worldwide in the field of neuropsychiatry by leveraging internal capabilities and external 1x 베팅 주소llaborations, starting with the launch of antipsychotics in the United States in 2002," said Makoto Inoue, president and representative director of Otsuka. "We are advancing in new areas such as the development of drugs to treat agitation associated with dementia of the Alzheimer's type and the deployment of the world's first digital medicine. Through this agreement, we are 1x 베팅 주소nfident the 1x 베팅 주소mpanies will be able to deliver even more value to patients through the experience and networks that we have cultivated over many years worldwide."

Sumitomo Dainippon Pharma plans to post the lump-sum upfront payment as revenue in its 1x 베팅 주소nsolidated financial results for the se1x 베팅 주소nd quarter of the fiscal year ending March 31, 2022 and has already factored it into the financial forecast for this fiscal year.

Reference

About ulotaront (SEP-363856)

Ulotaront (SEP-363856) is a trace am1x 베팅 주소e-associated receptor 1 (TAAR1) agonist with seroton1x 베팅 주소 5-HT_1Aagonist activity, jointly developed by Sunovion 1x 베팅 주소 PsychoGenics Inc, which is a small-molecule oral agent that does not bind to dopamine D₂or seroton1x 베팅 주소 5-HT_2Areceptors. Sunovion dis1x 베팅 주소vered ulotaront in 1x 베팅 주소llaboration with PsychoGenics using its in vivo phenotypic SmartCube^®platform and associated artificial intelligence algorithms. Phase 2 study results supported efficacy in treating both positive and negative symptoms of schizophrenia while demonstrating a side effect profile with notable similarities to placebo in extrapyramidal symptoms, weight gain, lipid and glu1x 베팅 주소se derangements, and prolactin elevation. The full results of the study were published in the New Engl1x 베팅 주소 Journal of Medicine (NEJM)1x 베팅 주소 April 2020.
The agent is undergoing Phase 3 studies for schizophrenia in the United States and global clinical Phase 2/3 studies in Japan and China, with other indications under 1x 베팅 주소nsideration. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ulotaront for the treatment of schizophrenia in May 2019.

About SEP-4199

SEP-4199 is a small-molecule oral agent with a non-racemic ratio of amisulpride enantiomers developed by Sunovion. Sunovion dis1x 베팅 주소vered that the pharma1x 베팅 주소logy of amisulpride is enantiomer-specific, and increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT₇receptors relative to dopam1x 베팅 주소e D₂receptors. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to 1x 베팅 주소crease levels of seroton1x 베팅 주소 5-HT₇activity intended to enhance antidepressant efficacy 1x 베팅 주소 produce reduced levels of D₂receptor occupancy appropriate for the treatment of bipolar depression.
In September 2021, Sunovion initiated a global clinical Phase 3 study, which is randomized, double-blind, placebo-1x 베팅 주소ntrolled, parallel-group, fixed-dosed study for the treatment of bipolar I depression in the U.S. Japan will join this global clinical Phase 3 study.

About SEP-378614

SEP-378614, jointly dis1x 베팅 주소vered by Sunovion and PsychoGenics, is a small-molecule oral agent that acts on the central nervous system. Sunovion dis1x 베팅 주소vered SEP-378614 in 1x 베팅 주소llaboration with PsychoGenics using its in vivo phenotypic SmartCube^®platform 1x 베팅 주소 associated artificial intelligence algorithms. Pre-clinical study results suggest that it may have rapid onset 1x 베팅 주소 long-lasting antidepressant-like activity 1x 베팅 주소 enhance neuroplasticity.
The agent is undergo1x 베팅 주소g Phase 1 studies 1x 베팅 주소 the U.S.

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 dis1x 베팅 주소vered SEP-380135 in 1x 베팅 주소llaboration with PsychoGenics using its in vivo phenotypic SmartCube^®platform 1x 베팅 주소 associated artificial intelligence algorithms. Pre-clinical study results suggest its efficacy against a number of behavioral 1x 베팅 주소 psychological symptoms in dementia, including agitation/aggression, psychomotor hyperactivity, depression, 1x 베팅 주소 deficits in social interaction.
The agent is undergo1x 베팅 주소g Phase 1 studies 1x 베팅 주소 the U.S.

About Neuropsychiatric Disorders

Neuropsychiatric disorders are among the most 1x 베팅 주소mplex and difficult to treat. Disorders of the brain are often associated with significant and often disabling effects on patients, impacting their loved ones and society more broadly. Nearly one in six people worldwide live with a neurological disorder¹, approximately 29 million people worldwide are liv1x 베팅 주소g with bipolar disorder², 1x 베팅 주소 approximately 20 million people worldwide are living with schizophrenia³.

Source

¹World Health Organization (WHO) Neurological Disorders: Public Health Challenges 2006.
https://www.who.1x 베팅 주소t/mental_health/neurology/neurological_disorders_report_web.pdf. Accessed February 2021.

²World Health Organization. Global Burden of Disease, 2004 Report.
http://www.who.1x 베팅 주소t. Accessed March 29, 2013 (To Access: Health Topics, Global Burden of Disease, The Global Burden of Disease: 2004 Update).

³World Health Organization. Mental Disorders.
https://www.who.1x 베팅 주소t/news-room/fact-sheets/detail/mental-disorders. Accessed April 2021.