Otsuka, Click Therapeutics to collaborate on prescription digital therapeutic for patients with depression

Otsuka and Click Therapeutics signed a collaboration agreement to develop and commercialise a prescription digital therapeutic "to address unmet medical needs…and to improve outcomes" for patients with major depressive disorder (MDD), the companies announced Thursday. Under the deal, worth as much as more than $302 million, Otsuka has agreed to fully fund the development of Click's CT-152 mobile application for MDD, and to market the app worldwide upon achievement of regulatory approvals.

Kabir Nath, chief executive at Otsuka's North American pharmaceutical division, remarked that "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." Click CEO David Benshoof Klein said "this collaboration symbolises the growing recognition that digital therapeutics are a new category of treatment with the potential to become a routine treatment option." He noted that "this recognition is also shared by regulators helping to build new pre-market review programmes uniquely suited for digital therapeutics."

According to the companies, the partnership will "leverage Click's ability to discover and validate a software application and deploy it commercially, with Otsuka's expertise in developing approved prescription therapies for patients with serious mental illnesses." They added that "digital therapeutics align naturally with psychiatry and have significant potential to transform mental healthcare."

The agreement calls for Otsuka to pay Click up to $10 million in upfront and regulatory milestone payments, along with around $20 million to fund development, while a further $272 million in commercial milestone payments are dependent upon regulatory approvals. Click will also receive tiered, double-digit royalties on global sales of the software and the digital therapeutic applications that result, the companies added.

In 2017, the FDA released policy documents aimed at modernising the oversight of digital health tools. Prior to that, it unveiled the Digital Health Innovation Action Plan, which outlined efforts by the FDA to ensure timely access to safe and effective digital health products, including increasing the number and expertise of digital health staff at the agency.


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