News Feature | November 7, 2014

Takeda, Intra-Cellular Therapies Terminate PDE1 Inhibitors Collaboration

By Cyndi Root

Takeda Pharmaceutical Company and Intra-Cellular Therapies have agreed to terminate their partnership on Intra-Cellular’s ITI-214 and related PDE 1 inhibitors. The two companies announced the termination of the collaboration that began in 2011 in a press release, stating that the compounds will return to Intra-Cellular’s provenance. Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, said, “We are grateful for Takeda’s substantial efforts in advancing this program into clinical development. This provides us with the opportunity to unify our PDE1 platform, and we look forward to continuing the development of ITI-214 and our other PDE1 inhibitors.”

Takeda and Intra-Cellular Therapies Agreement

Takeda had licensed the development and commercialization rights to the compounds from Intra-Cellular Therapies. The termination agreement calls for Takeda to return all rights to Intra-Cellular in a transitioning process that Takeda is responsible for, and Takeda will not participate in any further development activities. Intra-Cellular Therapies plans to development the PDE1 inhibitors for central nervous system, cardiovascular, and other disorders.

PDE1 Inhibitors

PDE1 inhibitors are orally available, investigational drugs that show promise in the treatment of schizophrenia, Alzheimer's disease, and other neuropsychiatric disorders, as well as Attention Deficit Hyperactivity Disorder (ADHD) and Parkinson's disease. The compounds are selective for the PDE1 subfamily vs. other PDE subfamilies, and they do not display off-target behaviors, such as action on enzymes, receptors, or ion channels.

About Intra-Cellular Therapies

Intra-Cellular Therapies focuses on novel drugs for neuropsychiatric and neurodegenerative diseases and other disorders of the central nervous system. The company is developing ITI-007 for schizophrenia, dementia, and bipolar disorder. The agent targets multiple brain systems and is highly dose-adjustable, giving physicians more discretion in prescribing. The candidate acts as a 5-HT2A serotonin receptor antagonist, a dopamine receptor modulator, and an inhibitor of serotonin transporters.

The combination of action methods may help patients with agitation, aggression, and sleep disturbances. Phase 1 and 2 clinical trials showed improved sleep maintenance, antipsychotic efficacy, and improved symptoms, such as impaired social function. The company reports a low rate of cardiovascular abnormalities, metabolic abnormalities, or motor impairments, as well as adverse effects that commonly cause psychiatric patients to stop taking their medications.