Dive Brief:

• Novartis' Sandoz division is stepping back from a co-promotion agreement to market Pear Therapeutics' prescription digital therapeutics (PDTs) for treating substance and opioid abuse, known as reSET and reSET-O.
• Pear already has a standalone structure capable of handling sole marketing for the PDTs, the companies said in a Tuesday statement.
• Sandoz said the decision is tied to an organizational and leadership change, which "has resulted in a reinforced focus on and capital allocation for Sandoz core business."

Dive Insight:

Pear and Sandoz launched reSET, the first PDT authorized by FDA, in November last year. They won FDA clearance for reSET-O, for opioid use disorder, the following month.

Sandoz spokeswoman Leslie Pott emphasized that the company remains committed to PDTs. The Swiss drugmaker is "an active member" of the Digital Therapeutics Alliance, and the Novartis Institutes for BioMedical Research will continue a separate collaboration with Pear focused on treating schizophrenia and helping patients handle the mental health burden of multiple sclerosis.

The company will also work with Pear on a transition period to ensure continued access to reSET and reSET-O. "Pear is now well-suited to continue to bring these important digital therapeutics to patients, HCPs, and payers," Sandoz said in its Oct. 15 release.

The Pear PDTs work in conjunction with outpatient care. With a smartphone or tablet, patients can use the app to get cognitive behavioral therapy lessons, track progress in battling their dependence, and report cravings, triggers and substance use. ReSET-O also includes reminders to take buprenorphine, a medication used to treat addiction.

Patients get rewards such as a gift card for completing lessons or getting a negative drug test. Therapists, in turn, can use the information shared by patients to better tailor their treatments.

Sandoz is stepping back from this set of Pear PDTs as new CEO Richard Saynor refocuses the Novartis unit. The company in March announced that Richard Francis would step down from the post because he couldn’t commit to a "multi-year journey" to transform Sandoz and make it more autonomous. Novartis announced Saynor as his replacement in April.

Pear, a pilot participant in FDA's Digital Health Software Precertification Program, in July filed a 510(k) submission for a PDT aiming to treat adults with chronic insomnia and symptoms of depression.