Takeda, Ovid Therapeutics Form Global Collaboration for TAK-935

Takeda Pharmaceutical Company Limited and Ovid Therapeutics Inc., a privately-held biopharmaceutical company, announced the formation of a global collaboration focused on the clinical development and commercialization of Takeda’s investigational new drug TAK-935, a novel, potent and highly selective CH24H inhibitor, in rare paediatric epilepsies.

TAK-935 has successfully completed phase 1 clinical development under Takeda's leadership and will be moving into phase 1b/2a clinical studies in rare epileptic encephalopathies where patients continue to suffer from significant unmet medical needs.

Under the terms of the agreement, Takeda received equity in Ovid and may be eligible to receive certain milestone payments based on the advancement of TAK-935. The companies will share in the development and commercialization costs on a 50/50 basis and, if successful, the companies will share in the profits on a 50/50 basis. Takeda will lead commercialization in Japan, and has the option to lead in Asia and other selected geographies. Ovid will lead clinical development activities and commercialization of TAK-935 in the United States, Europe, Canada and Israel. All activities of the collaboration regarding TAK-935 will be guided by the Takeda/Ovid “One Team” concept, an integrated and interdisciplinary team from both companies devoted to the successful advancement of TAK-935 across rare epilepsy syndromes. If mutually agreed, additional orphan central nervous system indications may also be pursued. Additional financial details were not disclosed.

The companies expect to initiate a phase 1b/2a study in 2017 in patients with rare epileptic encephalopathies including Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex. These rare epilepsies often present in infancy and cause significant morbidities for patients and their families throughout their lives. Despite the availability of medicines for epilepsy, there are few treatment options for these specific disorders, creating a significant medical need for the development of novel therapies.