A year after snagging an FDA nod for its Proteus-partnered digital schizophrenia pill, Otsuka is teaming up with Click Therapeutics on a digital treatment for major depression in a deal potentially worth $305 million.
Otsuka will “commit capital to fully fund” the development of Click’s mobile application, dubbed CT-152, for major depressive disorder (MDD) and to market the app worldwide, the companies said. Specifically, Otsuka will hand over “up to $10 million” in an upfront fee and regulatory milestones and about $20 million in development funding, with another $272 million in commercial milestones up for grabs.
“CT-152 is a software application (app) that will leverage evidence-based cognitive therapy principles and Click’s patient engagement platform to treat patients either independently or in conjunction with prescribed pharmacotherapies,” the companies said in a statement.
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“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,” said Kabir Nath, president and CEO of Otsuka North America Pharmaceutical Business Division at the pharma company’s U.S. subsidiary, in the statement. “We are proud to be one of the few pharmaceutical companies that continues to invest in developing medicinal and digital products for the treatment of mental illnesses, and we are doing so by breaking down barriers and collaborating with leading therapeutic technology companies, such as Click, which share our vision.”
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New York-based Click raised $17 million last July to advance its online platform of “prescription digital therapeutics.” In addition to its depression treatment, Click is also working on digital therapies for insomnia, acute coronary syndrome, chronic pain and smoking cessation.
Its lead product, Clickotine, is a phone app designed to help people stop smoking using input from Magellan Health, a behavioral healthcare company. The app offers services such as live coaching, access to nicotine replacement therapy and personalized messages to keep users on track.
The Click collaboration comes nearly three months after Otsuka and Proteus Digital Health expanded their partnership for another five years. Otsuka paid Proteus $88 million to help fund a portfolio of new digital medicines focused on mental health, including continuing commercial work for their digital pill, a sensor-enabled version of the drug Abilify, that was approved by the FDA late last year.
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That treatment, Abilify MyCite, didn’t have the smoothest road to approval—the FDA knocked it back in 2016 with a complete response letter asking for more data showing the targeted patient population can use digital pills safely and effectively. But it eventually earned approval in November 2017 for schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.