Akili and Shionogi Announce Strategic Partnership to Develop and Commercialize Digital Therapeutics in Key Asian Markets

Akili to Create First-of-its-kind International Digital Medicine
Development and Commercial Platform

Shionogi to Oversee Clinical Development, Sales and Marketing for
ADHD and Autism Spectrum Disorder Digital Therapeutics in Japan and
Taiwan

Upfront and potential milestone payments for Japan and Taiwan
commercialization valued up to $125 million

BOSTON & OSAKA, Japan–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/ADHD?src=hash” target=”_blank”gt;#ADHDlt;/agt;–Akili Interactive (“Akili”), a leading digital medicine company creating
prescription treatments for people living with cognitive dysfunction and
brain-related conditions, and Shionogi & Co., Ltd. (“Shionogi”), a major
research-driven pharmaceutical company focused in two therapeutic areas:
infectious diseases, and pain/CNS disorders, today announced they have
entered into a strategic partnership for the commercialization of
Akili’s digital medicines, AKL-T01 and AKL-T02, in Japan and Taiwan.
AKL-T01 is currently under review with the U.S. Food and Drug
Administration (FDA) as a potential digital treatment for children with
attention-deficit/hyperactivity disorder (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.

The partnership leverages each party’s distinct expertise to build a
novel commercial model and launch the new class of treatment to
patients. Under the terms of the agreement, Shionogi will be responsible
for regulatory filings and has exclusive rights to the clinical
development, sales and marketing of AKL-T01 and AKL-T02 in Japan and
Taiwan, which will represent the first such nationwide commitment to
digital therapeutics in these territories. Akili will build and maintain
control of a newly created Global Access Platform – an R&D and
commercial platform including 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 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.

Shionogi makes upfront payments to Akili totaling $20 million and Akili
will be eligible to receive development and commercial milestones of up
to $105 million. In addition, Akili will receive substantial royalties
on sales of the products in Japan and Taiwan. Shionogi will also help
fund development costs and commits to a future equity investment in
Akili. Akili will maintain exclusive global rights to develop and
commercialize AKL-T01 and AKL-T02 in all territories outside of Japan
and Taiwan.

“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,”
said Eddie Martucci, Ph.D., CEO of Akili. “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.”

“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. 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,” said Dr. Isao Teshirogi, President
and Chief Executive Officer, Shionogi & Co., Ltd.

About AKL-T01 in Attention-Deficit/Hyperactivity Disorder (ADHD)
AKL-T01,
is an investigational digital medicine being evaluated as a potential
prescription treatment for children with ADHD. AKL-T01 is designed to
deploy sensory and motor stimuli to target and activate the prefrontal
cortex, the area of the brain known to play a key role in cognitive
function. The investigational medicine is not delivered through a pill,
but rather through a proprietary and captivating video game experience
on a smart phone or tablet. Building on multiple published clinical
trials, a multi-center, randomized, double-blind, active-controlled pivotal
study of AKL-T01
in pediatric ADHD has recently been completed. This
is the first study of its kind, evaluating a potential new digital
medicine as you would a drug to treat disease. AKL-T01 is currently
under regulatory review in the U.S. to ensure it meets strict standards
for efficacy, safety, and manufacturing before being prescribed by
physicians to treat pediatric ADHD patients.

About AKL-T02 in Autism Spectrum Disorder (ASD)
AKL-T02 is
an investigational digital treatment for attention-related function and
symptoms in children with ASD. Building on the specific and simultaneous
sensory and motor stimuli of AKL-T01, Akili worked with experts in the
ASD community to modify AKL-T02 to be suitable for ASD patients. AKL-T02
has been tested in a small, active-controlled study in children with ASD
patients who also have significant attention issues. This feasibility
study evaluated the impact of the digital treatment on attention
abilities and parent reported behavioral symptoms of attention and
executive function. Plans are now underway now for a larger clinical
trial.

About Shionogi
Shionogi & Co., Ltd. is a major
research-driven pharmaceutical company dedicated to bringing benefits to
patients based on its corporate philosophy of “supplying the best
possible medicine to protect the health and wellbeing of the patients we
serve.” Shionogi’s research and development currently target two
therapeutic areas: infectious diseases, and pain/CNS disorders. For over
50 years, Shionogi has developed and commercialized innovative oral and
parenteral anti-infectives. In addition, Shionogi is engaged in new
research areas, such as obesity/geriatric metabolic disease and
oncology/immunology. Contributing to the health and quality of life of
patients around the world through development in these therapeutic areas
is Shionogi’s primary goal. For more details, please visit www.shionogi.co.jp/en/.
For more information on Shionogi Inc., the U.S.–based subsidiary of
Shionogi & Co., Ltd., headquartered in Florham Park, NJ, USA, please
visit www.shionogi.com.
For more information on Shionogi Ltd., the UK-based subsidiary of
Shionogi & Co. Ltd., headquartered in London, England, please visit www.shionogi.eu.

About Akili
Akili is a leading digital medicine company
combining scientific and clinical rigor with the ingenuity of the tech
industry to reinvent medicine. Akili is pioneering the development of
prescription digital treatments with direct therapeutic activity,
delivered not through a pill but through a high-quality action video
game experience. Akili is advancing a broad pipeline of programs to
treat cognitive deficiency and improve symptoms associated with medical
conditions across neurology and psychiatry, including ADHD, MDD, ASD and
various inflammatory diseases. Akili is also developing complementary
and integrated clinical monitors and measurement-based care
applications. The Company was co-founded by PureTech
Health
(PRTC.L) and is a founding member of the Digital
Therapeutics Alliance
. For more information on Akili, please visit: www.akiliinteractive.com.

Forward Looking Statement
This press release contains
statements that are or may be forward-looking statements, including
statements that relate to the company’s future prospects, developments
and strategies. The forward-looking statements are based on current
expectations and are subject to known and unknown risks and
uncertainties that could cause actual results, performance and
achievements to differ materially from current expectations. These
statements are not guarantees of future performance and undue reliance
should not be placed on them. These forward-looking statements are based
on assumptions regarding the present and future business strategies of
the company and the environment in which it will operate in the future.
Each forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements, neither
the company nor any other party intends to, and expressly disclaims any
obligation to, update or revise these forward-looking statements,
whether as a result of new information, future events or otherwise.

Contacts

Akili Interactive
Julie DiCarlo
[email protected]
1-800-862-7807

Shionogi & Co., Ltd
Corporate Communications Department
Shionogi
& Co., Ltd.
Telephone: +81-6-6209-7885

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