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Wednesday, October 16, 2019

With new leadership, Sandoz breaks up with digital therapeutics outfit Pear

Looks like Novartis’ Sandoz unit — under new leadership — has severed ties with Pear Therapeutics, dissolving the partnership that was inked in 2018.
Last year, Sandoz and Pear collaborated on and launched reSET, an FDA-approved digital therapeutic designed to deliver cognitive behavioral therapy over 12 weeks to patients with substance abuse disorder (SUD) who are in outpatient treatment under the supervision of a doctor. The Swiss drugmaker also invested in Pear’s Series B round of financing announced in January 2018.
The future of Novartis’ generics unit Sandoz is uncertain — as price erosion in the United States fuels speculation that Novartis chief Vas Narasimhan might prefer to spin it off to sharpen focus on developing new treatments.
In March, Sandoz CEO Richard Francis abruptly tendered his resignation, suggesting he couldn’t commit to the ‘multi-year’ transformation that Sandoz was embarking on. Francis was replaced by Richard Saynor, SVP classic & established products, commercial & digital platforms at GSK — although he was with Sandoz prior to that stint.
The “decision to transition commercialization responsibilities for reSET and reSET-O is part of Sandoz transformation and subsequent leadership change, which has resulted in a reinforced focus on and capital allocation for Sandoz core business,” the company said in a statement on Tuesday.
Prescription digital therapeutics — such as reSET and Abilify Mycite, the first digital pill that carries an embedded sensor to track if patients are taking their medication properly — are validated in randomized clinical trials to demonstrate safety and efficacy.
The FDA approved reSET in 2017, on the basis of a NIDA-sponsored trial involving 399 patients with SUD. Patients were randomized to receive standard treatment — comprising intensive face-to-face counseling — or reduced amount of face-to-face counseling plus the digital therapeutic. Patients on the digital therapeutic more than doubled the rate of abstinence compared to standard face-to-face counseling. Pear Therapeutics is also developing digital therapeutics for a host of other disorders including schizophrenia, PTSD and general anxiety disorder. In December 2018, the FDA approved reSET-O, for the opioid use disorder.
Digital therapeutics is an umbrella term that includes technology such as wearable devices, mobile apps and telemedicine platforms — which is typically driven by software to prevent, manage, or treat disorders, independently or in concert with medication and/or medical devices. These tools are largely designed to address chronic diseases such as diabetes, heart or respiratory disorders, by targeting behaviors such as diet, exercise, and lifestyle that have a significant impact on the incidence and management of disease.
Although the rapid penetration of smartphones and tablets and lower healthcare costs have driven the growth of the global digital therapeutics market, privacy concerns could temper the pace of adoption. Still, the size of the global digital therapeutics market is expected to hit about $7.83 billion by 2025, from $1.75 billion in 2017 — according to Allied Market Research estimates.
Under new leadership, Novartis’ Sandoz unit breaks up with digital therapeutics outfit Pear

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