Akili and Shionogi pair up to bring digital therapies to Japan and Taiwan in $125M deal

Akili's tablet-based Project: EVO video game for ADHD was submitted to the FDA for review after meeting its primary endpoint in a randomized trial in Dec. 2017. (Akili)

Akili Interactive is teaming up with Osaka-based Shionogi to help bring the first prescription digital therapeutics to Japan and Taiwan, through an international R&D and commercialization platform.

Delivered through immersive video games, Akili’s lead treatment for pediatric attention deficit hyperactivity disorder is currently being reviewed by the FDA. Its second potential therapy has completed a feasibility study in cognitive dysfunction and related symptoms in children with autism spectrum disorder.

Under the agreement, Shionogi will handle future regulatory filings and maintain exclusive rights to the clinical development, sales and marketing of the two therapies—in exchange for $20 million upfront, plus up to an additional $105 million in milestone-based payments. Shionogi will also contribute to development costs, and has committed to an equity investment in the former Fierce 15 winner.

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Meanwhile, Akili will build out a new global access platform that will encompass development and distribution activities—as well as provide an independent prescription and patient support system designed for digital therapeutics. Akili will also maintain patient data collection and storage.

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“It is critical to Akili that we do everything in our power to maximize long-term growth of our medicines to patients in need, and we could not have found a better partner to work with us to deliver an entirely new treatment model in these territories as we grow our international capabilities,” said Akili CEO Eddie Martucci in a statement.

The Boston-based Akili raised an additional $13 million last August, bringing its 2018 series C fundraising total up to $68 million, as it awaits a clearance decision from the FDA for what could become the first prescription video game and the first digital medicine for children with ADHD.

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