Press Release: Novartis: Sandoz and Pear Therapeutics Announce US Launch of reSET-OTM to Help Treat Opioid Use Disorder

Novartis International AG / Sandoz and Pear Therapeutics Announce US

Launch of reSET-OTM to Help Treat Opioid Use Disorder. Processed and

transmitted by West Corporation. The issuer is solely responsible for

the content of this announcement.

-- reSET-O(TM)* is the first US FDA-cleared prescription digital therapeutic

for patients with Opioid Use Disorder

-- Cleared by the FDA in December, reSET-O is available immediately

-- As part of a broader focus on digital healthcare solutions at Novartis,

Sandoz aims to increase patient engagement and improve access to

treatment through digital solutions

HOLZKIRCHEN, January 7, 2018 - Sandoz Inc., a Novartis division, and

Pear Therapeutics, Inc., announced today the US commercial launch of

reSET-O(TM) for patients with Opioid Use Disorder (OUD). reSET-O,

cleared by the US Food and Drug Administration (FDA) in December, is

immediately available.

The reSET-O prescription digital therapeutic (PDT) is a 12-week

cognitive behavioral therapy intended to be used in addition to

outpatient treatment. It includes transmucosal buprenorphine, a commonly

used medication to treat opioid addiction, and contingency management

designed to provide incentives to reinforce positive behaviors. reSET-O

is available by prescription only for patients 18 years or older under

the care of a clinician.

"The launch of reSET-O provides an important technology-based treatment

option for patients with Opioid Use Disorder and may fundamentally

change how they interact with their therapies," said Richard Francis,

CEO, Sandoz. "At Sandoz, we are proud and excited to push the frontiers

of medical innovation."

"Addiction is a chronic and relapsing disease that requires constant

support, monitoring and access to treatment," said Corey McCann, M.D.,

Ph.D, President and CEO of Pear Therapeutics. "We believe prescription

digital therapeutics can transform the way clinicians treat addiction by

providing a way for patients to access treatment when and where it's

needed. reSET-O has been clinically proven to increase the likelihood

that a patient will remain in treatment, while also providing a way for

patients to access treatment anytime, anywhere, under clinician

supervision."

The efficacy of reSET-O was evaluated in a pivotal, randomized trial of

170 patients seeking treatment for OUD, who received supervised

buprenorphine treatment paired with a behavior therapy program, either

with or without the addition of the Therapeutic Education System (TES),

which had equivalent content to reSET-O. The clinical trial showed that

reSET-O therapeutic content had an overall retention rate of 82.4

percent through the end of 12 weeks of treatment compared with 68.4

percent overall retention rate for patients who did not use reSET-O.

reSET-O also serves as a training, monitoring and reminder tool for

healthcare providers by leveraging the Clinician Dashboard. The

dashboard helps clinicians gain deeper insights into their patients'

progress toward recovery, including patient-reported buprenorphine

adherence to allow for more transparency during in-person therapy

sessions.

When a healthcare provider prescribes reSET-O, the patient is contacted

by a patient care specialist and is provided with an access code. The

patient then downloads and installs reSET-O on their smartphone or

tablet and enters the access code to unlock treatment. After that, the

patient can begin working and learning with reSET-O by completing

lessons, answering quiz questions, reporting medication usage and

reporting substance use, cravings and triggers. All the while, the

patient continues to see the clinician in therapy sessions and progress

on reSET-O is tracked via the Clinician Dashboard.

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 prescription digital therapeutics for the

treatment of Substance Use Disorder and Opioid Use Disorder,

respectively. Sandoz launched reSET in November 2018 and now has made

reSET-O available to patients in the U.S.

High attrition and relapse rates represent a significant obstacle 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(i). The study data demonstrate that reSET-O significantly

improved OUD patient retention rates in outpatient treatment.

For more information about reSET-O, go to www.resetforrecovery.com. To

help patients get started with reSET-O, call 1-833-MY-RESET

(1-833-697-3738) Monday-Friday, 8am-6pm ET or go to

www.resetconnect.com.

About Opioid Use Disorder

Every day, approximately 115 Americans die after overdosing on

opioids(ii). 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.

Limitation for Use:

reSET-O has not been shown to decrease illicit drug use or improve

abstinence in patients with OUD.

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

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

Summary Instructions for reSET-O:

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

more information.

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 "launch," "aims," "will," "may," "believe," "can," "could,"

"potential," "pioneering," "growing," 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. 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. You should not place undue reliance on these 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 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.

About Sandoz

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