- Deal includes reSET®, cleared by FDA for treatment of patients with Substance Use Disorder, and reSET-O™, potential treatment pending FDA clearance for patients with Opioid Use Disorder treated with buprenorphine
- Combines Sandoz expertise in launching / commercializing treatments with Pear's expertise in developing prescription digital therapeutics
- Sandoz and Novartis continue to embrace emerging digital technologies to enhance R&D and deliver better outcomes for patients
Holzkirchen, April 18, 2018 – Sandoz, a Novartis division, announced today that it has entered into a collaboration with Pear Therapeutics to commercialize and continued development of novel prescription digital therapeutics designed to effectively treat disease and improve clinical outcomes for patients.
The collaboration brings together Sandoz expertise in launching and commercializing treatments with Pear's leading experience in digital therapeutics design and implementation.
Sandoz and Pear will work together to bring reSET®* to patients with Substance Use Disorder and, if cleared by FDA, reSET-O™* to patients with Opioid Use Disorder who are currently receiving buprenorphine, to better address the full burden of their illnesses. Pear’s flagship digital therapeutic, reSET,was cleared by the FDA in September 2017 to help treat Substance Use Disorder.
“The opioid crisis is taking a devastating and growing toll on our communities and we all have a role to play in helping find solutions that work for patients, families and communities,” said Richard Francis, CEO, Sandoz. “Our agreement with Pear and its expertise in developing prescription digital therapeutics fits with our strategy to be a part of the solution to the issues plaguing people battling addiction, including opioids.”
Pear's prescription digital therapeutics aim to be designed to deliver clinically proven treatments, such as cognitive behavioral therapy, to patients through mobile and desktop applications. Once cleared by FDA, these digital therapeutics may be prescribed as monotherapies or alongside drug therapies and have the potential to be developed to treat a range of diseases.
Substance Use Disorder (SUD) is a chronic, relapsing disease caused by the recurrent use of alcohol or drugs – or both. For people with SUD, treatment has typically meant resource intensive face-to-face interactions in a specialized setting, and inconsistent quality in treatment and limited accessibility has led to poor treatment outcomes, including low rates of abstinence and high dropout rates.
This collaboration is part of the Sandoz and Novartis strategic effort to work with innovative digital health leaders to drive the next wave of medical innovation. Sandoz and Novartis are collaborating to develop technologies to monitor patient data in real-time, detect day-to-day behavioral and biological changes in condition, improve patient adherence, and ultimately enhance treatment outcomes by helping patients to better understand and control their own healthcare.
Pear is a leader in developing prescription digital therapeutics, developing the first FDA-cleared mobile medical application with both a safety and efficacy label to help treat patients with Substance Use Disorder in September 2017. Novartis invested in Pear's Series A and in its Series B rounds of financing.
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.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people's lives. We contribute to society's ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.
For further information, contact:
Novartis Media Relations
Central media line: +41 61 324 2200
Sandoz US Communications
+1 609 627 5287
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: [email protected]
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