Otsuka Pharmaceutical and Click Therapeutics, a New York-based developer of software as prescription medical treatments, have signed a collaboration agreement, worth up to $302 million, to develop and commercialize a prescription digital therapeutic for treating major depressive disorder (MDD).

This collaboration will combine Click’s ability to discover and validate a software application and deploy it commercially with Otsuka’s expertise in developing and commercializing pharmaceuticals for treating mental illness.

Under the agreement, Otsuka has agreed to commit capital to fully fund development of Click’s mobile application, CT-152, for MDD, and to commercialize this application worldwide 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.

CT-152 is a software application (app) that is being designed to use evidence-based cognitive therapy principles and Click’s patient-engagement platform to treat patients either independently or in conjunction with prescribed pharmacotherapies. The companies say that the intent is that the app will be classified as Software as a Medical Device (SaMD) and will fall under the US Food and Drug Administration’s regulatory framework for digital technologies.

Otsuka previously partnered with Proteus Digital Health, a Redwoods Shores, California-based digital healthcare company, to bring another digital therapeutic to market. In 2017, the FDA approved Otsuka’s and Proteus’ Abilify MyCite (aripiprazole tablets with a sensor), a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with Proteus’ digital ingestion tracking system, for treating schizophrenia, bipolar disorder, and depression. The sensor technology and patch are made by Proteus Digital Health. Abilify, as a tablet without the tracking system, was approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was permitted for marketing by the FDA in 2012.

Abilify MyCite works through an ingestible sensor embedded in the pill that records the amount of the medication that was taken. The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phones.

Source: Otsuka Pharmaceutical