Otsuka, Click Therapeutics partner to create therapy for mental illness (Verdict Medical Devices):

“Otsuka Pharmaceutical’s US division Otsuka America has partnered with Click Therapeutics to develop and commercialise a prescription digital therapeutic for treating Major Depressive Disorder (MDD).

Click Therapeutics offers software as prescription medical treatments for people with unmet medical needs.

Under the partnership, Click Therapeutics will contribute through its expertise in discovering and validating a software application as well as its commercial deployment.

Otsuka will work with its expertise in the development and commercialisation of approved prescription therapies for patients with serious mental illnesses.

Otsuka Pharmaceutical North American pharmaceutical business president and CEO Kabir Nath said “Our goal is to deliver evidence-based cognitive therapies to a broader population of patients with MDD than is currently feasible, due to the challenges of a shortage of mental health professionals and limited time for them to conduct cognitive therapy.”

The Partnership:

Otsuka and Click Therapeutics Collaborate to Develop and Commercialize Digital Therapeutics for Patients with Major Depressive Disorder (press release):

Otsuka has agreed to commit capital to fully fund development of Click’s novel mobile application ‘CT-152’ for MDD, and to commercialize this application world-wide upon achievement of regulatory approvals. Otsuka will pay Click up to $10 million in upfront and regulatory milestone payments, along with an estimated $20 million in development funding. An additional $272 million in commercial milestone payments are contingent upon regulatory approvals. In addition, Click will receive tiered, double-digit royalties on global sales of the software and the digital therapeutic applications that result … The intent is that the app will be classified as Software as a Medical Device (SaMD) and will fall under the FDA regulatory framework that supports innovation and commercialization of digital tools while protecting patient health.

The Partnership in Context: