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Osaka (Japan), July 01, 2024 - Maruho Co., Ltd. ("Maruho"; Head Office: Osaka, Japan, President and CEO, Atsushi Sugita) announces that it has entered into a worldwide collaborative development and commercialization agreement (the "Agreement") with Sibel Health Inc. ("Sibel Health", Head Office: Chicago, Illinois (USA); CEO, Steve Xu MD). The agreement includes co-development and future distribution rights for an innovative, prescription-only digital health technology, which is currently under development by Sibel Health (hereinafter referred to as "the product") for the measurement and suppression of scratching associated with itch.

Under the terms of the agreement, Sibel Health grants Maruho co-development rights for the product, and an exclusive license for distribution and marketing in the USA, Europe, Japan, China, Hong Kong, Macao, Taiwan, South Korea and the 10 ASEAN^*1 member states on the condition that future commercial targets are satisfied. In addition to an upfront payment, Maruho will make payments based on future development milestones.

The product consists of an advanced wearable sensor (ADAM^TM), mobile software, and a cloud backend. It is currently marketed by Sibel Health under the product name "Discovery" as a digital health technology for clinical trials and research to measure scratching objectively. Sibel Health is currently in the process of applying for additional approvals as a medical device in the USA and Europe. As part of this effort, Maruho will work with Sibel Health to add novel features to Sibel's existing "Discovery" product to develop a new Digital Therapeutic^*2 with the ability to measure and suppress scratching to treat unmet medical needs related to itch, such as atopic dermatitis. This is an addition to Maruho's existing efforts to provide value through pharmaceuticals and applications. ^*3

Maruho and Sibel Health will work to bring smiles to the faces of patients suffering from itching by combining Maruho's expertise in dermatology with Sibel Health's extensive know-how in digital health and wearable sensor technology.

NoteThe information contained in this news release in regard to pharmaceutical and developmental products is not intended for the purpose of promotion, advertising or medical advice.

1. The 10 ASEAN member statesSingapore, Malaysia, Thailand, Philippines, Vietnam, Indonesia, Brunei, Cambodia, Laos, and Myanmar

2. Digital TherapeuticsDigital Therapeutics is software that uses digital technology, such as smartphones and applications, to support or implement medical treatments, such as disease prevention, diagnosis, and treatment. It requires a license under the Pharmaceutical Affairs Law and is used either alone or in combination with pharmaceuticals and medical devices. It is expected to be effective in treating diseases and symptoms that are difficult to manage or intervene with conventional drugs.

3. App to Make Your Itches Visible "Itch Tracker"https://www.maruho.co.jp/kanja/app/itchtracker/index.html (Japanese)

About DiscoverySibel's Discovery product consists of the ADAM^TM wearable sensor, mobile software and a cloud backend, and is a tool for clinical trials and research to measure scratching. When used, the device is attached to the back of the hand and captures the motion and acoustic signatures of scratching. The collected data is analyzed using AI algorithms to detect scratching in real time as well as sleep parameters. For more information about the ADAM Sensor and the Discovery product, please visit https://sibelhealth.com/clinical-trials-and-research/

About SibelSibel Health is an award-winning digital health company with a mission to deliver Better Health Data for All®. Based in Chicago with an international office in Seoul, the company's FDA-cleared ANNE® platform includes advanced wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform. The company's Discovery platform is used by the world's leading pharmaceutical companies for continuous data collection in the home setting for clinical trials.
For more information, please visit www.sibelhealth.com and follow them on LinkedIn.

About MaruhoMaruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,566 employees (as of the end of September 2023), and net sales were approximately 85.71 billion yen in its fiscal year ended September 30, 2023. With the mission "More smiles, brighter life for you.", Maruho aims to help realize a society where everyone can live with a smile.
For more information, please visit https://www.maruho.co.jp/english/