Sumitomo Dainippon Pharma Co. in Japan and US-based behavioural health firm BehaVR have signed definitive agreements to develop and market general wellness products and prescription digital therapeutics for the treatment of major mental health disorders.

WHAT IT'S ABOUT

Sumitomo Dainippon Pharma is engaged in the research and development of new pharmaceutical products in the areas of psychiatry and neurology, oncology and cell therapy. BehaVR, meanwhile, creates prescription DTx backed by decades of neuroscience and cognitive and evidence-based protocols. 

The companies initially collaborated in June last year. They jointly developed a wellness product for those experiencing "stressful, fearful and overwhelming" feelings in a social setting.

Under their recently signed deals, Sumitomo will fund the development and commercialisation of three novel virtual reality-based therapies for the treatment of social anxiety disorder, generalised anxiety disorder and major depressive disorder.

It pledged to pay BehaVR $5 million in upfront payments; up to $18 million in development milestone and R&D support payments, on top of commercial and operational support fees; and up to $140 million in milestone payments conditional upon commercial success. Moreover, BehaVR will receive tiered royalties from the global sales of the DTx products.

These organisations will also seek US FDA approvals for the digital therapies which they intend to be classified as software as a medical device.

WHY IT MATTERS

It is evident that the ongoing COVID-19 pandemic has exacerbated mental health concerns, especially depression and anxiety. Both illnesses are major contributors to the overall global burden of disease and the spike in substance abuse. 

Sumitomo Dainippon Pharma and BehaVR have underscored the need for novel approaches to address these issues. The companies said they believe that the VR medium will transform access to care and power the next-generation delivery of anxiety and depression treatment for patients. 

MARKET SNAPSHOT

This October, Scotland started providing its adult population free access to Big Health's DTx for anxiety and insomnia via the NHS. They are entitled to receive cognitive behavioural therapy through the Daylight and Sleepio apps.

In July this year, Happify Health launched its first prescribed DTx for depression and anxiety. The app-based therapy called Ensemble assists patients in building new skills and habits to manage their cognition by using cognitive behavioural therapy, mindfulness and other techniques delivered through sequenced modules. 

Otsuka Pharmaceutical and Click Therapeutics has also launched this year a remote clinical trial for a depression DTx platform.

Meanwhile, in Japan, startup CureApp has developed a hypertension DTx app to assist people in maintaining lifestyle improvements as part of their treatment. Recently, it disclosed the results of a landmark clinical trial for the said app, revealing its effectiveness in reducing the risks of heart diseases.

ON THE RECORD

"There is inadequate access to high-quality mental health therapists in every country across the world. Our goal is to deliver high-impact digital VR therapies that are evidence-based to a broad global population of patients that continue to struggle with SAD, GAD, and MDD," said Hiroyuki Baba, senior executive officer at Sumitomo Dainippon Pharma.  

"We are thrilled to deepen our relationship to jointly increase our impact on health via clinically validated, FDA-cleared [VR]-based digital therapies. Sumitomo Dainippon Pharma's clinical and commercial expertise in this space will advance our joint objective of successfully scaling effective treatment options for anxiety and depression," said BehaVR founder and CEO Aaron Gani.