Press Release: Novartis: Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O(TM) to Treat Opioid Use Disorder

Novartis International AG / Sandoz Inc. and Pear Therapeutics Obtain FDA

Clearance for reSET-O(TM) to Treat Opioid Use Disorder. Processed and

transmitted by West Corporation. The issuer is solely responsible for

the content of this announcement.

-- reSET-OTM is the first FDA-cleared Prescription Digital Therapeutic (PDT)

for patients with Opioid Use Disorder

-- Pear Therapeutics is leading the development of a new therapeutic class

with two FDA-authorized PDTs and a robust pipeline of therapeutics across

disease areas

-- Sandoz will lead U.S. commercial launch, anticipated in coming days in Q4

-- As part of broader Novartis digital revolution, Sandoz aims to increase

patient engagement and improve access to treatment through digital

solutions

HOLZKIRCHEN, December 10, 2018 - Sandoz Inc., a division of Novartis,

and Pear Therapeutics

https://peartherapeutics.com/pear-therapeutics-raises-20-million-to-launch-a-family-of-prescription-digital-therapies-treating-disorders-of-the-brain/

, Inc., the leader in prescription digital therapeutics, today announced

that the U.S. Food and Drug Administration (FDA) has granted clearance

for reSET-O(TM).

reSET-O is intended to increase retention of patients with Opioid Use

Disorder (OUD) in outpatient treatment by providing cognitive behavioral

therapy (CBT), as an adjunct to outpatient treatment that includes

transmucosal buprenorphine (medication-assisted-treatment, or MAT) and

contingency management, for patients 18 years or older who are currently

under the supervision of a clinician. reSET-O is indicated as a

prescription-only mobile medical application.

"Digital technologies and data science have incredible potential to

unlock the next chapter of medical innovation and to help individuals

finally take control of their own health in a meaningful way," said

Richard Francis, CEO, Sandoz. "New digital therapeutics such as reSET-O

also have the potential to fundamentally change how patients interact

with their therapies and thus improve patient outcomes. At Sandoz, we

are proud to be a joint pioneer in this exciting new field."

Under the terms of a commercial deal announced

https://peartherapeutics.com/pear-therapeutics-sandoz-announce-deal-commercialize-prescription-digital-therapeutics/

in April 2018, Sandoz will lead marketing and commercialization of

reSET-O and reSET(R), Pear's PDT for the treatment of Substance Use

Disorder. Sandoz launched reSET in November 2018 and plans to launch

reSET-O in the coming days in the U.S.

reSET-O is a 12-week interval PDT for OUD. reSET-O is modeled on the

Community Reinforcement Approach (CRA) and engineered to deliver CBT for

patients with OUD. reSET-O delivers CRA therapy as a series of

interactive therapy lessons. Each therapy lesson is comprised of a

cognitive behavioral therapy component and skill-building exercises.

Therapy lesson content is delivered primarily via text or audio, and may

include videos, animations, and graphics.

reSET-O is intended as an adjunct to standard of care for patients with

OUD. It is limited to persons with a valid prescription from their

licensed provider. reSET-O supports clinician-patient communication

between visits, by providing a means for patients to self-report

cravings and triggers, and buprenorphine use/non-use. reSET-O reinforces

the importance of using buprenorphine for treatment of OUD.

"Nearly 50,000 drug overdose deaths involving opioids, including

prescription pain medications and heroin, took place in the U.S. in

2017," said Corey McCann, M.D., Ph.D., President and CEO of Pear

Therapeutics. "There is an urgent need for new and innovative

therapeutics to address this public health epidemic. This groundbreaking

decision by the FDA ushers in a new standard for treating patients with

Opioid Use Disorder and it signals a new path for therapeutic software

to be used in conjunction with pharmacotherapy to improve efficacy."

More than 80 percent of patients with OUD do not receive or seek out

care[i] and only 13 percent of outpatient facilities in the U.S. offer

MAT, such as buprenorphine[ii]. reSET-O could have the potential to

dramatically impact this gap in treatment, by delivering multi-modal

therapy in combination with MAT in a way that is designed to be more

effective, convenient, and easy to access for patients and clinicians.

reSET-O helps to offer standardized and enhanced care for OUD, providing

particular benefit in geographies where access to care is currently

inconsistent or unavailable.

To support the FDA submission of reSET-O, a National Institute on Drug

Abuse-sponsored clinical trial evaluated the therapeutic in 170 patients

with OUD over 12 weeks. Patients were randomized to receive either

treatment-as-usual (TAU), which consisted of standard clinician

interactions in conjunction with buprenorphine, or reSET-O with standard

clinician interactions in conjunction with buprenorphine. At the end of

the study, patients randomized to reSET-O CBT, when used with outpatient

treatment and contingency management, significantly improved retention

among patients with buprenorphine plus contingency management treatment

experience[iii]. Treatment dropout during the 12-week intervention was

reduced in the test group compared to the TAU group. This reduction in

treatment dropout was significant.

High attrition and relapse rates represent a significant problem to

providing care to patients with OUD. Therefore, it is important to

retain patients in treatment. Retention in treatment is a

well-established indicator of successful treatment outcomes for OUD

patients[iv]. The finding that reSET-O significantly improved patient

retention rates supports the efficacy of reSET-O in increasing retention

of patients with OUD in outpatient treatment.

About Opioid Use Disorder

Every day, approximately 115 Americans die after overdosing on

opioids[v]. The misuse of and addiction to opioids-including

prescription pain relievers, heroin, and synthetic opioids-is a serious

national crisis that affects public health as well as social and

economic welfare. The Centers for Disease Control and Prevention

estimates that the total "economic burden" of prescription opioid misuse

alone in the United States is $78.5 billion a year, including the costs

of healthcare, lost productivity, addiction treatment, and criminal

justice involvement.

reSET-O(TM) Indications for Use

reSET-O(TM) is intended to increase retention of patients with Opioid

Use Disorder (OUD) in outpatient treatment by providing cognitive

behavioral therapy, as an adjunct to outpatient treatment that includes

transmucosal buprenorphine and contingency management, for patients 18

years or older who are currently under the supervision of a clinician.

reSET-O is indicated as a prescription-only Mobile Medical Application.

This Press Release does not include all the information needed to use

reSET-O safely and effectively. Please see the Clinician Brief Summary

Instructions for reSET-O for more information at Clinician Brief Summary

Instructions for reSET-O:

https://www.resetforrecovery.com/reset-O_ClinicianBriefSummary.pdf

About reSET-O(TM)

The reSET-O(TM) prescription mobile medical application is a 12-week

(84-day) software application. It is limited to persons with a valid

prescription from their licensed provider. reSET-O is intended to be

used to increase retention of patients with Opioid Use Disorder in

outpatient treatment by providing cognitive behavioral therapy, as an

adjunct to outpatient treatment that includes transmucosal buprenorphine

and contingency management to patients currently under clinician care.

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 "pipeline," "to lead," "launch," "anticipated," "aims," "will,"

"groundbreaking," "could," "potential," "pioneer," "growing," "may," or

similar terms, or by express or implied discussions regarding potential

launches, marketing clearances and authorizations, new indications or

labeling for reSET-O, reSET, 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 is no 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. Neither can there be any guarantee that reSET-O will be

successfully launched in the U.S., in the expected time frame, or at

all. Nor can there be any guarantee that reSET-O, reSET 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

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December 10, 2018 15:42 ET (20:42 GMT)