From L to R: Otsuka North America CEO Kabir Nath, Otsuka Pharmaceutical Development & Commercialization CEO William Carson and StartUp Health’s Logan Plaster

Japanese pharmaceutical company Otsuka’s best known effort in mental health has probably been the development of anti-psychotic drug Abilify, which was brought to the U.S. market through a partnership with Bristol-Myers Squibb.

More recently though, the company’s efforts in the space have characterized by partnerships with innovative startup companies.

A fireside chat at the StartUp Health Festival in San Francisco featuring Otsuka Pharmaceutical Development & Commercialization CEO William Carson and Otsuka North America CEO Kabir Nath provided some insight in how the company thinks about driving innovation to tackle the significant problems associated with mental health.

Last year, Otsuka signed an expanded 5-year collaboration with digital medicine company Proteus Digital Health to continue their efforts to work together on therapeutics tackling mental health.

One of the major results of the partnership thusfar has been Abilify MyCite, a digital sensor inside a pill which which records medication adherence. Carson spoke about the company’s lessons in merging the pace of digital medicine development with the rigorous clinical validation necessary to build and market a regulated product.

“The cadence in Silicon Valley versus the pharmaceutical cadence is night and day,” Carson said. “As an organization we had to work hard to make sure we were on the same page.”

Federal regulators initially sent the MyCite application back, seeking more data across different patient populations, before its eventual approval in 2017. That setback, according to Carson, was actually a boon in some ways as the company seeks future digital medicine development.

“As you know we had to do some human factor studies, the FDA was very interested in seeing how patients with MDD, schizophrenia, bipolar disorder could utilize the system,” Carson said. “One thing that stands out to me was in the number of patients which we did those studies in, the amount of data that Otsuka collected was more than all the data we’ve ever had in all of our clinical trials.”

Nath said that the company is “clear” on the idea that digital medicines can play a huge role in giving patients more awareness and control over their health and medication. Which is not to say the road ahead is easy.

“With MyCite we’re trying to change patients, physicians and payers and many of us know that doing any one of those things is really hard,” Nath said. “But we truly believe in the potential of this and in the space of mental health we need new tools and solutions that move just beyond the pill.”

Another recent deal has been with a collaboration with startup Click Therapeutics to develop treatments for those major depressive disorders. Under the terms of the deal, Otsuka will fully fund the development of Click’s mobile application digital therapeutic and commercial milestones payments to the tune of up to $300 million, in addition to royalties based on global sales.

Still, the Otsuka leaders were candid about the difficulties in helping to drive development of digital therapeutics meant to replace or enhance drugs in a traditional pharma ecosystem.

“Even though I firmly believe in 10 years time or whenever it is, we will largely be selling solutions will which include pills and vials, but also potentially a range of other things, it’s still going to take some time to escape that dominant paradigm,” Nath said.

Picture: Kevin Truong, MedCity News