Sunovion pens $890M Otsuka pact for a clutch of neuropsychiatric drugs

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Sunovion, owned by Japan’s Sumitomo Dainippon Pharma, has signed a near $1 billion upfront/biobucks mix deal with fellow Japanese native Otsuka Pharmaceutical.

The pact sees Otsuka pay $270 million upfront with $620 million in biobucks for a development/sale deal for four compounds: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135.

In line with Otsuka’s historic interests, they are focused on “serious neuropsychiatric disorders.” The four clinical-stage assets span early- to late-stage development. The compounds represent a “scientifically unique approach to treating symptoms that are not adequately addressed by current therapeutic options and/or for which existing treatments have an unsatisfactory safety and tolerability profile,” the company said.

Ulotaront (SEP-363856), the furthest along of the four and with an FDA breakthrough tag to boot, is in a phase 3 test and works as a trace amine-associated receptor 1 agonist with 5-HT1A agonist activity in schizophrenia, with “additional indications under consideration.”

Also in phase 3 (started just this month) is non-racemic amisulpride (SEP-4199), tested as a treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).

SEP-378614 and SEP-380135, meanwhile, are further back in the trial pathway, both in phase 1, with the former being trialed in treatment-resistant depression and the latter focused on agitation in Alzheimer’s disease.

“Sunovion, with our parent company Sumitomo Dainippon Pharma, is proud to collaborate with Otsuka in a shared mission to contribute towards improved lives and better health globally,” said Antony Loebel, M.D., president and CEO of Sunovion.

“Otsuka’s recognition of the significant value of these assets reflects the innovative discovery and development efforts at Sunovion over the past decade, as well as our neuropsychiatry commercialization expertise and capabilities. We look forward to working with Otsuka colleagues as we advance novel compounds to treat patients with serious neuropsychiatric conditions.”

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“Otsuka has been committed to providing new antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capabilities and external collaborations, starting with the launch of antipsychotics in the U.S. in 2002,” added 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 confident the companies will be able to deliver even more value to patients through the experience and networks that we have cultivated over many years worldwide.”