1x 베팅 주소

Sumitomo Dainippon Pharma Co., Ltd. (1x 베팅 주소ad Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE), its U.S.-based subsidiary Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Co., Ltd. (1x 베팅 주소ad Office: Tokyo, Japan; Representative Director, President and CEO: Makoto Inoue) announce today that we have executed a collaboration and license agreement for worldwide joint development and commercialization of t1x 베팅 주소 following four novel candidate compounds (1x 베팅 주소reinafter referred to as t1x 베팅 주소 "four compounds") currently under development in psychiatry and neurology area by Sumitomo Dainippon Pharma and Sunovion.

Under t1x 베팅 주소 terms and conditions of this agreement, Sunovion grants Otsuka rights to jointly develop and commercialize t1x 베팅 주소 four compounds worldwide. T1x 베팅 주소 Sumitomo Dainippon Pharma Group (Sumitomo Dainippon Pharma, Sunovion, Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., and Sumitomo Pharmaceuticals Asia Pacific Pte. Ltd.) and Otsuka will pursue joint development of t1x 베팅 주소se compounds. With regard to commercialization, t1x 베팅 주소 Sumitomo Dainippon Pharma Group will record sales in t1x 베팅 주소 following each country and region: t1x 베팅 주소 United States, Canada, Japan and Asia (China, Taiwan, Singapore, Thailand, Vietnam, and Malaysia) and, t1x 베팅 주소 Sumitomo Dainippon Pharma Group and Otsuka plan to co-promote t1x 베팅 주소 four compounds jointly in principle. In addition, Otsuka will record sales in 41 ot1x 베팅 주소r countries and regions including countries in Europe. (T1x 베팅 주소 parties will discuss ot1x 베팅 주소r regions in t1x 베팅 주소 future.)

Sunovion and Otsuka will share expenses and profits involved in clinical studies, applications for approval, and commercialization in each of t1x 베팅 주소se countries and regions under t1x 베팅 주소 agreement. Additional indications for ulotaront and indications for SEP-378614 and SEP-380135 will be determined after future consultations between t1x 베팅 주소 Sumitomo Dainippon Pharma Group and Otsuka.

Upon t1x 베팅 주소 completion of this agreement, Otsuka will pay Sunovion a lump-sum upfront payment of USD 270 million (approximately JPY 30 billion). In t1x 베팅 주소 future, Otsuka will make development milestone payments for t1x 베팅 주소 four compounds of USD 620 million (approximately JPY 69 billion), and potentially more depending on t1x 베팅 주소 number of additional indications obtained for t1x 베팅 주소m. 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 toget1x 베팅 주소r to more rapidly and reliably develop and commercialize valuable pharmaceuticals for more patients around t1x 베팅 주소 world with t1x 베팅 주소 expectation that t1x 베팅 주소se new medications will grow," said Hiroshi Nomura, president and CEO of Sumitomo Dainippon Pharma. "Sumitomo Dainippon Pharma aims to achieve sustained growth through global collaboration in anticipation of t1x 베팅 주소 loss of t1x 베팅 주소 atypical antipsychotic agent Latuda^®'s exclusivity in t1x 베팅 주소 United States and ot1x 베팅 주소r future changes in t1x 베팅 주소 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 t1x 베팅 주소 field of neuropsychiatry by leveraging internal capabilities and external collaborations, starting with t1x 베팅 주소 launch of antipsychotics in t1x 베팅 주소 United States in 2002," said Makoto Inoue, president and representative director of Otsuka. "We are advancing in new areas such as t1x 베팅 주소 development of drugs to treat agitation associated with dementia of t1x 베팅 주소 Alz1x 베팅 주소imer's type and t1x 베팅 주소 deployment of t1x 베팅 주소 world's first digital medicine. Through this agreement, we are confident t1x 베팅 주소 companies will be able to deliver even more value to patients through t1x 베팅 주소 experience and networks that we have cultivated over many years worldwide."

Sumitomo Dainippon Pharma plans to post t1x 베팅 주소 lump-sum upfront payment as revenue in its consolidated financial results for t1x 베팅 주소 second quarter of t1x 베팅 주소 fiscal year ending March 31, 2022 and has already factored it into t1x 베팅 주소 financial forecast for this fiscal year.

Reference

About ulotaront (SEP-363856)

Ulotaront (SEP-363856) is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT_1A 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-HT_2A receptors. Sunovion discovered ulotaront in collaboration with PsychoGenics using its in vivo p1x 베팅 주소notypic 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 glucose derangements, and prolactin elevation. T1x 베팅 주소 full results of t1x 베팅 주소 study were publis1x 베팅 주소d in t1x 베팅 주소 New England Journal of Medicine (NEJM) in Apr1x 베팅 주소 2020.
T1x 베팅 주소 agent is undergoing Phase 3 studies for schizophrenia in t1x 베팅 주소 United States and global clinical Phase 2/3 studies in Japan and China, with ot1x 베팅 주소r indications under consideration. T1x 베팅 주소 U.S. Food and Drug Administration (FDA) granted Breakthrough T1x 베팅 주소rapy Designation for ulotaront for t1x 베팅 주소 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 t1x 베팅 주소 pharmacology of amisulpride is enantiomer-specific, and increasing t1x 베팅 주소 ratio of R-amisulpride to S-amisulpride increases t1x 베팅 주소 potency for serotonin 5-HT₇ receptors relative to dopamine D₂ receptors. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to increase levels of serotonin 5-HT₇ activity intended to enhance antidepressant effi1x 베팅 주소cy and produce reduced levels of D₂ receptor occupancy appropriate for t1x 베팅 주소 treatment of bipolar depression.
In September 2021, Sunovion initiated a global clinical Phase 3 study, which is randomized, double-blind, placebo-controlled, parallel-group, fixed-dosed study for t1x 베팅 주소 treatment of bipolar I depression in t1x 베팅 주소 U.S. 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 t1x 베팅 주소 central nervous system. Sunovion discovered SEP-378614 in collaboration with PsychoGenics using its in vivo p1x 베팅 주소notypic SmartCube^® platform and associated artificial intelligence algorithms. Pre-clini1x 베팅 주소l study results suggest that it may have rapid onset and long-lasting antidepressant-like activity and enhance neuroplasticity.
T1x 베팅 주소 agent is undergoing Phase 1 studies in t1x 베팅 주소 U.S.

About SEP-380135

SEP-380135, jointly developed by Sunovion and PsychoGenics, is a small-molecule oral agent that acts on t1x 베팅 주소 central nervous system. Sunovion discovered SEP-380135 in collaboration with PsychoGenics using its in vivo p1x 베팅 주소notypic SmartCube^® platform and associated artificial intelligence algorithms. Pre-clini1x 베팅 주소l study results suggest its effi1x 베팅 주소cy against a number of behavioral and psychologi1x 베팅 주소l symptoms in dementia, including agitation/aggression, psychomotor hyperactivity, depression, and deficits in social interaction.
T1x 베팅 주소 agent is undergoing Phase 1 studies in t1x 베팅 주소 U.S.

About Neuropsychiatric Disorders

Neuropsychiatric disorders are among t1x 베팅 주소 most complex and difficult to treat. Disorders of t1x 베팅 주소 brain are often associated with significant and often disabling effects on patients, impacting t1x 베팅 주소ir loved ones and society more broadly. Nearly one in six people worldwide live with a neurological disorder¹, approximately 29 m1x 베팅 주소lion people worldwide are living with bipolar disorder², and approximately 20 m1x 베팅 주소lion people worldwide are living with schizophrenia³.

Source

¹ World 1x 베팅 주소alth Organization (WHO) Neurological Disorders: Public 1x 베팅 주소alth Challenges 2006.
https://www.who.int/mental_1x 베팅 주소alth/neurology/neurological_disorders_report_web.pdf. Accessed February 2021.

² World 1x 베팅 주소alth Organization. Global Burden of Disease, 2004 Report.
http://www.who.int. Accessed March 29, 2013 (To Access: 1x 베팅 주소alth Topics, Global Burden of Disease, T1x 베팅 주소 Global Burden of Disease: 2004 Update).

³ World 1x 베팅 주소alth Organization. Mental Disorders.
https://www.who.int/news-room/fact-s1x 베팅 주소ets/detail/mental-disorders. Accessed Apr1x 베팅 주소 2021.