BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc. today announced a deal with Sandoz, a division of Novartis, to commercialize its two lead products, reSET® and reSET-O™. In addition to an upfront payment, the deal includes research and development funding, commercial milestones, and a profit split on net sales of both therapeutics.
reSET was cleared by the FDA in September 2017 for the treatment of patients with Substance Use Disorder, making it the first prescription digital therapeutic cleared with claims to improve clinical outcomes in a disease. reSET-O, a potential prescription digital therapeutic for treating Opioid Use Disorder, was granted Expedited Access Pathway designation in October 2017 and is currently under review by the FDA.
“After a competitive evaluation process among potential partners, Sandoz emerged as the best fit to commercialize reSET and reSET-O,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Sandoz has a demonstrated record of successful commercial execution both in the U.S. and globally, has extensive expertise working with clinicians and patients, and will provide a dedicated sales force to market both reSET and reSET-O. We believe they are well-positioned to ensure that these innovative products are available to patients in dire need of more effective treatment options.”
Sandoz will assume responsibility for the global commercial launch of reSET, and reSET-O, including ensuring market access, reimbursement from payors, and providing a dedicated sales force. Pear will continue to develop both digital therapeutics and will also support patient services through its digital hub service.
reSET is a 12-week, FDA-cleared prescription digital therapeutic to be used in conjunction with standard outpatient treatment for Substance Use Disorder (SUD) related to stimulants, cannabis, cocaine, and alcohol. The therapy combines patient-facing interventions and assessments via a mobile device, with clinician-facing dashboards and data analytics. reSET has been clinically proven to increase abstinence from a patient’s substances of abuse during treatment and to increase patient retention in the outpatient treatment program. reSET provides access to self-reported substance use, triggers, cravings and outcomes to the patient’s medical provider.
reSET® is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET® is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.
It is intended to:
- increase abstinence from a patient’s substances of abuse during therapy, and
- increase retention in the outpatient treatment program.
Important Safety Information:
Do not use reSET® to communicate any urgent, critical, or emergent information to your provider. reSET® does not have any features that send alerts or warnings to your provider. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.
reSET® is not intended to be used as a stand-alone therapy for SUD and does not replace care by a licensed medical practitioner.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.
reSET-O is a potential prescription digital therapeutic for the treatment of patients with Opioid Use Disorder (OUD), who are enrolled in outpatient treatment and on buprenorphine opioid replacement therapy. Clinical trials for reSET-O have demonstrated improved abstinence and increased retention when used in combination with standard of care and buprenorphine. reSET-O is currently under review by the FDA.
About Pear Therapeutics
Pear Therapeutics is the leader in FDA-cleared prescription digital therapeutics. The company’s approach is to integrate clinically-validated software applications with previously approved pharmaceuticals and treatment paradigms to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear’s lead product, reSET®, is an FDA-cleared 12-week prescription-only therapeutic for Substance Use Disorder (SUD) to be used as an adjunct to standard, outpatient treatment. Pear’s product development pipeline includes reSET-O™ for opioid use disorder (OUD) and additional prescription digital therapeutics in schizophrenia (THRIVE™), combat post-traumatic stress disorder (reCALL™), general anxiety disorder (reVIVE™), pain, major depressive disorder, and insomnia, for which Pear intends to obtain FDA clearance. For more details, please see www.peartherapeutics.com.