Treatment for ADHD and autism dosed by an action video game is under review by the US FDA and has already found a distributor for Japan and Taiwan
A truly novel treatment for ADHD and autism has been the subject of the alliance between Akili Interactive and Shionogi. Digital medicine delivers treatment in the form of a video game to treat cognitive disorders. Shionogi will fund and oversee development and commercialisation of the new treatment in Japan and Taiwan.
The partnership leverages each party’s distinct expertise to build a novel commercial model and launch the new class of treatment to patients.
Japanese Shionogi is a traditional pharmaceutical company focused on infectious diseases and pain/CNS disorders. The company will provide upfront payments to Akili totalling US$20 million and up to a further $105 million upon development and commercial milestones.
In addition, Akili will receive substantial royalties on sales of the products in Japan and Taiwan.
Shionogi will also be responsible for regulatory filings and will receive exclusive rights to the clinical development, sales and marketing in Japan and Taiwan, which will represent the first such nationwide commitment to digital therapeutics in these territories.
Akili will maintain exclusive global rights to develop and commercialise AKL-T01 and AKL-T02 in all territories outside of Japan and Taiwan.
Eddie Martucci, CEO of Akili, said: “Over their 140-year history, Shionogi has been a model of innovation while placing the highest value on patient care. This agreement is indicative of their continued commitment to push the boundaries of medicine and be on the leading edge of next-generation therapeutics.”
Akili is a US digital medicine company independently affiliated with digital medicine pioneer, PureTech. Headquarted in Boston, Akili creates prescription treatments for people living with cognitive dysfunction and brain-related conditions.
As the supplier, Akili will build and maintain control of a newly created Global Access Platform. This service will include all global product development activities, distribution, technical support services.
Akili will also be responsible for data collection and storage in compliance with local laws and regulation related to privacy and the management of personal health information.
The agreement is for Akili’s digital medicines, AKL-T01 and AKL-T02, in Japan and Taiwan. AKL-T01 is currently under review by the US FDA as a potential digital treatment for children with ADHD. AKL-T02 is currently in late-stage development as a potential digital treatment for cognitive dysfunction and related symptoms in children with Autism Spectrum Disorder (ASD).
The digital treatments are delivered through immersive action video game experiences.
Under the terms of the agreement, the Global Access Platform, including its regional platform covering the Japanese and Taiwanese markets, will serve as an independent prescription and patient support system designed specifically for digital therapeutics.
Dr Isao Teshirogi, President and CEO of Shionogi, said: “ADHD and autism have a significant impact on children and their families in Japan and Taiwan, yet there remains a significant gap in treatment options and access to today’s medicines."
Teshirogi added: "Akili is a clear leader in digital medicine, and their digital treatment systems represent game-changing solutions to treating these disorders and we look forward to working with them to lead the development of the first digital medicine in Japan and Asia while bringing new hope to children affected by cognitive dysfunction.”