Deal includes reSET®, cleared by FDA for treatment of patients with Substance Use Disorder, and reSET-O(TM), 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(TM)* 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.
Indication: 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.
Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "to develop," "potential," "pending," "growing," "strategy," "aim," "may," "will," "investigational," "launching," "strategic effort," "next wave," or similar terms, or by express or implied discussions regarding potential launches, marketing clearances, new indications or labeling for reSET, reSET-O, or the other products described in this press release, or regarding potential future revenues from such products or the collaboration with and investment in Pear Therapeutics. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that reSET, reSET-O, or the other products described in this press release will be launched, or submitted or cleared for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the collaboration with and investment in Pear Therapeutics will achieve any or all of its intended goals and objectives, or be commercially successful. Nor can there be any guarantee that reSET, reSET-O, or the other products described in this press release will be commercially successful in the future. In particular, our expectations regarding such products, and the collaboration with and investment in Pear Therapeutics, could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional competing versions of such products; our ability to obtain or maintain proprietary intellectual property protection; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz or Pear Therapeutics from marketing its products; general political, economic and industry conditions; safety, quality or production issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
* reSET® and reSET-O(TM) are trademarks of Pear Therapeutics.
About Sandoz 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.