Novartis and Pear Therapeutics to Develop Digital Therapeutics for Patients with Schizophrenia and Multiple Sclerosis

NovartisNovartis has entered into a collaboration with Pear Therapeutics to develop novel prescription digital therapeutics, software applications designed to effectively treat disease and improve clinical outcomes for patients. The collaboration brings together Novartis expertise in biomedical research and clinical development with Pear's leading experience in digital therapeutics design and implementation.

Novartis and Pear will work together towards developing new treatments for patients with schizophrenia and multiple sclerosis to better address the full burden of their illnesses. Pear's prescription digital therapeutics are designed to deliver clinically-proven treatments[1],[2], such as cognitive behavioral therapy, to patients through mobile and desktop applications. Once approved, they may be prescribed alongside drug therapies and have the potential to be developed to treat a range of diseases.

"Psychiatric and neurodegenerative diseases place a heavy physical, mental and economic burden on patients and their families," said Jay Bradner, M.D., President of the Novartis Institutes for Biomedical Research. "With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need."

Novartis will work with Pear to advance clinical development of their THRIVE(TM) digital therapeutic for patients with schizophrenia. THRIVE(TM) has demonstrated potential usability, retention and preliminary efficacy in patients with schizophrenia in early clinical studies.[3],[4],[5]. The companies will also collaborate to design and develop a new therapeutic application to address underserved mental health burden in patients with multiple sclerosis.

"We look forward to working with Novartis, an organization known for excellence in biomedical science, to develop much needed treatments for patients suffering from schizophrenia and multiple sclerosis," said Corey McCann, M.D., Ph.D., President and CEO of Pear. "Novartis shares our vision for prescription digital therapeutics that work alongside drugs to deliver superior patient outcomes. We believe this collaboration further supports the clinical viability of prescription digital therapeutics as an emerging treatment modality and we are poised to execute on that opportunity."

This collaboration is part of Novartis' strategic effort to work with innovative digital health leaders to drive the next wave of medical innovation. Novartis is 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. Pear is a leader in developing prescription digital therapeutics, gaining the first FDA clearance, in September 2017, for a software application with a safety and efficacy label to treat patients. Novartis invested in Pear's Series B round of financing announced in January 2018.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world.

1. Butler AC1, Chapman JE, Forman EM, Beck AT. (2005) The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clinical Psychological Review https://www.ncbi.nlm.nih.gov/pubmed/21348158
2. Psychotherapy: Three approaches evaluated. (2004) https://www.ncbi.nlm.nih.gov/pubmed/16199119
3. Ben-Zeev, D., Brenner, C. J., Begale, M., Duffecy, J., Mohr, D. C., & Mueser, K. T. (2014). Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone Intervention for Schizophrenia. Schizophrenia Bulletin, 40(6), 1244-1253.
4. Ben-Zeev, D., Kaiser, S. M., Brenner, C. J., Begale, M., Duffecy, J., & Mohr, D. C. (2013). Development and Usability Testing of FOCUS: A Smartphone System for Self-Management of Schizophrenia. Psychiatric Rehabilitation Journal, 36(4), 289-296.
5. Ben-Zeev, D., Scherer, E. A., Gottlieb, J. D., Rotondi, A. J., Brunette, M. F., Achtyes, E. D., et al. (2016). mHealth for Schizophrenia: Patient Engagement With a Mobile Phone Intervention Following Hospital Discharge. JMIR Mental Health, 3(3), e34.

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