Sumitomo Da1x 베팅 주소ippon Pharma Co., Ltd.
1x 베팅 주소 Pharmaceutical Co., Ltd.

Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President 1x 베팅 주소 CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE), its U.S.-based subsidiary Sunovion Pharmaceuticals Inc. 1x 베팅 주소 Otsuka Pharmaceutical Co., Ltd. (Head Office: Tokyo, Japan; Representative Director, President 1x 베팅 주소 CEO: Makoto Inoue) announce today that we have executed a collaboration 1x 베팅 주소 license agreement for worldwide joint development 1x 베팅 주소 commercialization of the following four novel c1x 베팅 주소idate compounds (hereinafter referred to as the "four compounds") currently under development in psychiatry 1x 베팅 주소 neurology area by Sumitomo Dainippon Pharma 1x 베팅 주소 Sunovion.

Under the terms 1x 베팅 주소 conditions of this agreement, Sunovion grants Otsuka rights to jointly develop 1x 베팅 주소 commercialize the four compounds worldwide. The Sumitomo Dainippon Pharma Group (Sumitomo Dainippon Pharma, Sunovion, Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., 1x 베팅 주소 Sumitomo Pharmaceuticals Asia Pacific Pte. Ltd.) 1x 베팅 주소 Otsuka will pursue joint development of these compounds. With regard to commercialization, the Sumitomo Dainippon Pharma Group will record sales in the following each country 1x 베팅 주소 region: the United States, Canada, Japan 1x 베팅 주소 Asia (China, Taiwan, Singapore, Thail1x 베팅 주소, Vietnam, 1x 베팅 주소 Malaysia) 1x 베팅 주소, the Sumitomo Dainippon Pharma Group 1x 베팅 주소 Otsuka plan to co-promote the four compounds jointly in principle. In addition, Otsuka will record sales in 41 other countries 1x 베팅 주소 regions including countries in Europe. (The parties will discuss other regions in the future.)

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

Upon the completion 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 compounds of USD 620 million (approximately JPY 69 billion), 1x 베팅 주소 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 1x 베팅 주소 significant neuropsychiatry expertise. We will work together to more rapidly 1x 베팅 주소 reliably develop 1x 베팅 주소 commercialize valuable pharmaceuticals for more patients around the world with the expectation that these new medications will grow," said Hiroshi Nomura, president 1x 베팅 주소 CEO of Sumitomo Dainippon Pharma. "Sumitomo Dainippon Pharma aims to achieve sustained growth through global collaboration in anticipation of the loss of the atypical antipsychotic agent Latuda^®'s exclusivity in the United States 1x 베팅 주소 other future changes in the business environment. This collaboration is a major step forward in this initiative."

"Otsuka has been committed to providing new antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capabilities 1x 베팅 주소 external collaborations, starting with the launch of antipsychotics in the United States in 2002," said Makoto Inoue, president 1x 베팅 주소 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 1x 베팅 주소 the deployment of the world's first digital medicine. Through this agreement, we are confident the companies will be able to deliver even more value to patients through the experience 1x 베팅 주소 networks that we have cultivated over many years worldwide."

Sumitomo Dainippon Pharma plans to post the lump-sum upfront payment as revenue in its consolidated financial results for the second quarter of the fiscal year ending March 31, 2022 1x 베팅 주소 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 discovered ulotaront 1x 베팅 주소 collaboration with PsychoGenics us1x 베팅 주소g its 1x 베팅 주소 vivo phenotypic SmartCube^®platform 1x 베팅 주소 associated artificial intelligence algorithms. Phase 2 study results supported efficacy in treating both positive 1x 베팅 주소 negative symptoms of schizophrenia while demonstrating a side effect profile with notable similarities to placebo in extrapyramidal symptoms, weight gain, lipid 1x 베팅 주소 glucose derangements, 1x 베팅 주소 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 1x 베팅 주소 global clinical Phase 2/3 studies in Japan 1x 베팅 주소 China, with other indications under consideration. The U.S. Food 1x 베팅 주소 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 discovered that the pharmacology of amisulpride is enantiomer-specific, 1x 베팅 주소 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 r1x 베팅 주소omized, double-blind, placebo-controlled, 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 discovered by Sunovion 1x 베팅 주소 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 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 1x 베팅 주소 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^®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 complex 1x 베팅 주소 difficult to treat. Disorders of the brain are often associated with significant 1x 베팅 주소 often disabling effects on patients, impacting their loved ones 1x 베팅 주소 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.