TOKYO and NEW YORK - Osaka-based Takeda Pharmaceutical Co. and New York-based Intra-Cellular Therapies announced March 3 a global co-development deal for selective phosphodiesterase type 1 inhibitors discovered by Intra-Cellular for treatment of cognitive impairment associated with schizophrenia.

Under the terms of the agreement, Takeda will pay an upfront cash payment and an additional $500 million after achieving certain development milestones. ITI also will receive up to $250 million after certain sales-based milestones and tiered royalty payments based on net sales of developed products by Takeda. Takeda will be solely responsible for development, manufacture and commercialization of the PDE1 inhibitors. ITI retains the option to co-promote with Takeda in the United States.

Takeda has a medium-range business plan to reinforce its presence in the neural disorder treatment area, and as part of that plan, the company entered into the agreement, Takeda spokesman Hisashi Tokinoya told PharmAsia News.

"This is a highly competitive market but there's a strong unmet need," Tokinoya said, explaining that Takeda struck the deal because ITI's product, now in preclinical development, is believed to have limited side effects. The U.S. firm's PDE1 inhibitors are orally available, and they can treat a variety of psychiatric and neurological disorders, Takeda said in its news release.

Intra-Cellular Therapies CEO Sharon Mates said the deal was competitive and there were "several groups interested in this asset."

When asked why Takeda was the right company to partner with, the CEO said that Takeda's "zealousness to take this program forward with us" was one of the reasons the Japanese company was chosen for the collaborative effort.

In addition to schizophrenia, Takeda obtains the right to develop the compounds for other indications and hopes to develop them for dementia, Parkinson's disease, Alzheimer's disease and attention deficit hyperactive disorder. They also potentially can be applied for improving motor dysfunction associated with these disorders, according to Takeda.

Mates said she initially had not planned on partnering so early, but that after discussing the program at several scientific meetings, it became apparent that there was a lot of interest and "we could move the program forward faster with a partner."

Compound Would Be First Drug To Address Cognition In Schizophrenia

Presently there is not a product on the market that addresses "cognition in schizophrenia," Mates said, noting that ITI's compound is novel because it addresses "deficits not by hitting the dopamine receptor directly but by hitting downstream from the D1 receptor."

Neither company would discuss timelines or details on the clinical development program, but Mates did say there were clearly defined endpoints for positive symptoms associated with schizophrenia such as hallucination. For cognition, there are several scales and "batteries of tests that one can use in defining cognitive endpoints."

"I don't think in schizophrenia the biggest challenges are the endpoints of clinical design," the CEO said. "Certainly for positive symptoms and negative symptoms and cognition as well, I think one can live with the realm that we have to deal with for the development of these drugs."

ITI has several other compounds in its pipeline, the most advanced of which is ITI-007, part of another group of compounds for schizophrenia, and in clinical studies. ITI-009 is an Alzheimer's disease candidate. The company recently discovered a new gene believed to be active in Alzheimer's disease called GSAP (gama secretase activating protein), and is looking at molecules to prevent production of beta amyloid in its development program. Mates said the company has started to talk to possible partners about its '009 program.

"The mission of the company is not to partner everything," she said. "I think we are looking on a regional basis with '007, so with certain territories we might want to bring the drug to market on our own or partner with people. We are really weighing our different options."

Roughly 1% of the global population is believed to suffer from schizophrenia. Some estimates put Japan's patient population at 890,000, out of its total population of 128 million. The United States has about 1.74 million people with schizophrenia, and Europe has 2.12 million people with the disease. In 2009, global drug sales to treat schizophrenia amounted to roughly $230 million.

In Japan, Dainippon-Sumitomo Pharma and Otsuka Pharmaceutical are among the major manufacturers of schizophrenia drugs.

-Jessica Merrill (j.merrill@elsevier.com) and Toshio Aritake (pharmasia@elsevier.com)

Takeda, Intra-Cellular Ink Global Co-Development Deal For PDE1 Inhibitors For Schizophrenia

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