CureApp, Inc. and Sawai Group Holdings Co., Ltd. enter into a development and marketing license agreement for a DTx*1 solution in the NASH field
With the conclusion of this agreement, the Sawai Group obtains exclusive rights concerning the development and marketing of the app indicated for the treatment of NASH.
Under this agreement, the Company is set to receive up to 10.5 billion yen in total in the form of a lump sum contractual payment, and as additional payments for milestones reached based on future clinical development progress and sales targets. After launch, the Company plans to introduce the app at medical institutions via its proprietary app prescription service (APS).
*1 Abbreviation of Digital Therapeutics. Software-driven therapeutics.
NASH is known to exacerbate liver cirrhosis and liver cancer, and a future increase in liver cancers caused by NASH is a matter of pressing concern. NASH primarily develops in obese patients, and there is thought to be some two million NASH patients in Japan today (with a further 10 million people prime candidates to develop the condition in the future)*2. However, currently, the main focus is on daily lifestyle guidance, including diet and exercise therapy for weight loss.
Further, even if outpatients get the proper guidance, a strict diet and exercise regimen has proved difficult for patients to maintain through their own efforts. To this end, app-based solutions are hoped to provide a promising treatment solution for NASH based on the anticipated effect of having the app notify patients of a daily behavior therapy regimen that is tailored to their needs while providing a visual guide as to the patient’s status, maximizing the effect of behavior therapy without placing undue burden on the patient or medical practitioners.
In addition, the realization of a weight-loss therapy through cognitive and behavioral improvements on the part of the patient is not only expected to help prevent liver cirrhosis and liver cancer caused by NASH, but also to contribute to reducing healthcare costs in Japan.
Single-site clinical research on the app began in October 2016 between the Company and the University of Tokyo Hospital, before joint clinical research efforts expanded to encompass multiple sites in April 2018. Research has shown that this cognitive behavioral therapy app has a clear effect on reducing weight and improving hepatic fibrosis. Looking ahead, we will proceed with Phase III clinical trials based on the data accumulated from the preceding trials.
*2 Journal of Japanese Society of Gastroenterology 2011；108：1161―1169（https://www.jstage.jst.go.jp/article/nisshoshi/108/7/108_7_1161/_article/-char/ja）
About CureApp, Inc.
CureApp. Inc. is a MedTech venture that conducts research and development into the creation of medical device programs, which apply advanced software technology and medical evidence to treat illnesses, with the intent of manufacturing and distributing them. The Company is hard at work developing “therapeutic apps*” - apps used to treat illnesses - in order to become the first in Japan to establish a new healthcare service centered on “producing a therapeutic effect to treat illnesses using an app”. In August 2020, we received pharmaceutical approval for a DTx treating nicotine dependency – a first for a DTx solution in Japan. This app later included in insurance coverage in December of the same year. Following this, we were the first company in the world to receive pharmaceutical approval in the hypertension field in April 2022.
CureApp’s business activities
In addition to the above, we provide mobile health programs for private companies through our “ascure Smoking Cessation Program” and “Specific Health Guidance ascure Smoking Cessation Program”, which leverages the knowledge garnered in the development of these digital therapeutics®︎ for medical institutions. These programs have been implemented at over 230 companies and health insurance societies. Looking ahead, we will look to sequentially rolling out this “Japanese-developed digital health solution” worldwide based on the model established in Japan.
About Sawai Group Holdings Co., Ltd.
Sawai Group Holdings Co., Ltd. is a pure holding company established in April 2021 in conjunction with the transition of Sawai Pharmaceutical Co., Ltd. to a holding company structure.
Sawai Pharmaceutical, our core company, manufactures and sells generic pharmaceuticals. With our corporate philosophy of “Always putting healthier lives first,” we will strive to contribute to the health of as many people as possible as a healthcare company.
CureApp, Inc. company profile
Representative Director and President: Kohta Satake
Head Office Address: Kodenma-Cho YS building 4th floor 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan, 103-0001
Business activities: Development of Software as a Medical Device (SaMD), mobile health-related services
URL：http://cureapp.co.jp/en/