Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced an agreement with SoftBank Corp. (“SoftBank”) to develop a Japanese-language digital therapeutic for the treatment of sleep/wake disorders for the Japanese market.
In the United States, Pear is marketing Somryst®, the only FDA-authorized prescription digital therapeutic for the treatment of chronic insomnia. In Japan, SoftBank is a leading communication and information technology service provider. This strategic initiative is a part of Pear’s strategy to commercialize digital therapeutics in international markets. Pursuant to the agreement, Pear will develop digital therapeutic applications for the treatment of sleep/wake disorders for the Japanese market and SoftBank will investigate the Japanese market potential for those applications, and SoftBank has an option to negotiate an exclusive license for Pear’s digital therapeutics for sleep/wake disorders in Japan.
As sleep problems constitute a global epidemic that threatens health and quality of life for up to 45% of the world’s population1, there is a large opportunity for digital therapeutics globally to address patient unmet needs. Most sleep disorders are preventable or treatable, yet less than one-third of sufferers seek professional help.2 Of all adults in Japan, 20% are chronically sleep deprived and 15% feel excessively sleepy during the day, according to the Japanese Association of Preventive Medicine for Adult Disease.3
“Our agreement with SoftBank supports our mission to bring digital treatment options to patients outside of the United States. The Japanese market has a large unmet need in treating people with sleep disorders,” said Corey McCann, M.D., Ph.D., President and CEO of Pear. “This opportunity fits squarely in our strategy to bring our PDTs to patients around the globe.”
“Under our ‘Beyond Carrier’ strategy, SoftBank drives digital transformation in various industry sectors to resolve social issues and we believe that digital therapeutics can help solve healthcare issues in Japan by treating people with sleep disorders,” said Eric Gan, Executive Vice President at SoftBank Corp.
About Pear Therapeutics
Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.
About SoftBank Corp.
Guided by the SoftBank Group’s corporate philosophy, “Information Revolution – Happiness for everyone,” SoftBank Corp. (TOKYO: 9434) provides telecommunications services and combines them with advanced technologies to develop and operate new businesses in Japan and globally. In the year ended March 2021, SoftBank Corp. registered 5.2 trillion yen of revenue, 970.8 billion of operating income, and had 335 group companies (255 subsidiaries and 80 affiliates), both in Japan and abroad. SoftBank Corp. has 56 million mobile and broadband subscribers in Japan, and through its group companies Yahoo Corporation, PayPay Corporation and LINE Corporation, 80 million online media users, 45 million smartphone payment users and 88 million communication app users, respectively (as of February 3, 2022). With this strong business foundation and compelling number of customer touchpoints, SoftBank Corp. is expanding into non-telecom fields in line with its “Beyond Carrier” growth strategy while further growing its telecom business. Also, by fully harnessing the power of 5G, AI, IoT, Digital Twin, Non-Terrestrial Network (NTN) solutions, including High Altitude Platform Station (HAPS)-based stratospheric telecommunications, and other key technologies, SoftBank Corp. aims to realize the “Implementation of Digitalization into Society.” In recognition of its ESG initiatives, SoftBank Corp. was selected for inclusion in the Dow Jones Sustainability Indices, FTSE4Good, 2022 Constituent MSCI Japan ESG Select Leaders Index and other leading global ESG investments indices. To learn more, please visit https://www.softbank.jp/en/
Somryst Indications for Use and Important Safety Information
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.
Safety Information and Warnings
Somryst is not for everyone. Please use your clinical judgement to determine whether Somryst is right for your patient.
- Somryst is not for emergency use. Please instruct patients to dial 911 or to go to the nearest emergency room in the event of a medical emergency.
- Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
- Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
- Somryst is not meant to be a substitution for any treatment medication.
- Somryst contains sensitive medical information. Please instruct patients to protect their information by password-protecting their smartphone and tablet, ensuring no one else may access their device.
- Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:
- Long-haul truck drivers
- Long-distance bus drivers
- Air traffic controllers
- Operators of heavy machinery
- Some assembly line jobs
- The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.
Note: In the early stages of treatment, increased daytime sleepiness may be expected, but is usually temporary. Please instruct the patient to consult with their Health Care Provider if these experiences do not go away over a few weeks, as it may indicate that they have another sleep disorder or medical condition other than insomnia. Please instruct the patient that if they have trouble staying awake while performing potentially dangerous tasks (like driving) at any point in the treatment, to avoid these dangerous tasks or stop following the sleep restriction component of the therapy. This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.
Forward-Looking Statements from Pear Therapeutics
Certain statements and projections in this press release may be considered forward-looking statements within the meaning of the federal securities laws. Forward looking statements generally relate to future events or involving, or future performance of, Pear. For example, statements that digital therapeutics can benefit both SoftBank’s customers as well as the broader Japanese population are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “aim”, “estimate”, “anticipate”, “believe”, or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Pear and its management are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) delay or reluctance by patients and/or providers to adopt, request or use Pear’s products, (ii) the possibility that Pear may be adversely affected by other economic, business, regulatory, and/or competitive factors; (iii) the evolution of the markets in which Pear competes; (iv) the impact of the COVID-19 pandemic on Pear’s business; (v) changes in applicable laws or regulations; and (vi) other risks and uncertainties set forth in Pear’s future filings with the SEC. These filings will identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
Readers are cautioned not to put undue reliance on forward-looking statements, and Pear assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Pear gives no assurance that Pear will achieve its expectations. The inclusion of any statement in this communication does not constitute an admission by Pear or any other person that the events or circumstances described in such statement are material.
- Léger D; Bayon V; Societal costs of insomnia. Sleep Medicine Reviews, Dec2010; 14(6): 379-389. ISSN: 1087-0792 PMID: 20359916
- Wade AG, Zisapel N, Lemoine P. Prolonged-release melatonin for the treatment of insomnia: targeting quality of sleep and morning alertness. Ageing Health 2008; 4 (1): 11-12
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