Novartis and Pear Therapeutics to develop digital therapeutics for patients with schizophrenia and multiple sclerosis

• Novartis and Pear Therapeutics to collaborate on prescription software applications aimed to treat patients with schizophrenia and multiple sclerosis
   
• Collaboration combines Novartis' leadership in biomedical research and clinical development with Pear's expertise in digital therapeutics
   
• Novartis continues to embrace emerging digital technologies to enhance R&D and deliver better outcomes for patients

Basel March 1, 2018 - Novartis 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.

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," "to collaborate," "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for THRIVE or the other investigational or approved 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 THRIVE or the other investigational or approved products described in this press release will be submitted or approved 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 THRIVE or the other investigational or approved 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; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; potential or actual data security and data privacy issues; safety, quality or production issues, 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.

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. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact [email protected]

References
[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.

# # #

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: [email protected]

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: [email protected]