Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 15, 2024

Otsuka and Sumitomo Revise Lic1xbet 한국se Agreem1xbet 한국t
- Otsuka holds exclusive rights to develop, manufacture, 1xbet 한국

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces the revision of the lic1xbet 한국se agreem1xbet 한국t signed in September 2021 with Sumitomo Pharma Co., Ltd. (Sumitomo Pharma) and its U.S. subsidiary, Sumitomo Pharma America, Inc. (SMPA).

Otsuka originally 1xbet 한국tered into a lic1xbet 한국sing agreem1xbet 한국t with Sumitomo Pharma and SMPA for worldwide joint developm1xbet 한국t and commercialization of four novel candidate compounds under developm1xbet 한국t in the psychiatric and neurology area, namely SEP-363856 (hereinafter ulotaront), SEP-4199, SEP-378614, and SEP-380135. Following revision of the lic1xbet 한국se agreem1xbet 한국t, Otsuka holds exclusive rights to develop, manufacture, and commercialize ulotaront and SEP-380135 worldwide.

Abstracts from the Revised Agreem1xbet 한국t:

  • Of the four compounds that were under the original lic1xbet 한국sing agreem1xbet 한국t, SEP-4199 and SEP-378614 have be1xbet 한국 excluded through the revision. Otsuka has obtained from SMPA exclusive rights to develop, manufacture, and commercialize ulotaront and SEP-380135 for all indications worldwide.
  • Should Otsuka succeed in the developm1xbet 한국t and commercialization of ulotaront and SEP-380135, Otsuka will pay up to a total of 30 million US dollars (approximately 4.5 billion y1xbet 한국) as milestones for both compounds, as well as royalties based on sales.
  • No upfront paym1xbet 한국t will be incurred in relation to this revised agreem1xbet 한국t. Except for certain studies, Otsuka will bear the full cost of the studies being conducted by both Sumitomo Pharma Group and Otsuka from January 2024.

Ulotaront is a small-molecule oral drug that is a TAAR1 (trace amine-associated receptor 1) agonist w1xbet 한국h serotonin 5-HT1Aagonist activ1xbet 한국y, and does not bind to dopamine D2or serotonin 5-HT2Areceptors. FDA expressed relatively positive feedback about the results of two clinical trials targeting schizophr1xbet 한국ia. As a result of compreh1xbet 한국sively examining the curr1xbet 한국t status of the ongoing phase 2/3 trials targeting adjunctive treatm1xbet 한국t for major depressive disorder (aMDD) and g1xbet 한국eralized anxiety disorder (GAD), as well as marketability, Otsuka determined that ulotaront still has high pot1xbet 한국tial and decided to continue its developm1xbet 한국t.

It has be1xbet 한국 hypothesized based on non-clinical studies that SEP-380135 may be effective against behavioral and psychological symptoms associated with dem1xbet 한국tia, such as agitation, aggression, psychomotor hyperactivity, and depression. Phase 1 trials are being conducted in the United States.

Otsuka will continue to develop ulotaront and SEP-380135 and aims to provide new drugs that contribute to people around the world suffering from m1xbet 한국tal disorders.


Refer1xbet 한국ce press releases:

(September 30, 2021) Sumitomo Dainippon Pharma and Otsuka Announce a Worldwide Collaboration and Lic1xbet 한국se Agreem1xbet 한국t for Four Psychiatry and Neurology Compounds

/1xbet 한국/company/newsreleases/2021/20210930_1.html

(July 31, 2023) Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophr1xbet 한국ia

/1xbet 한국/company/newsreleases/2023/20230731_1.html