The two companies will develop prescription digital therapeutics to treat social anxiety, generalised anxiety disorder, and major depressive disorder


BehaVR develops digital therapeutics. (Credit: Jan Vašek from Pixabay.)

Japan-based Sumitomo Dainippon Pharma has teamed up with BehaVR to jointly develop and market prescription digital therapeutics and general wellness products for various mental disorders.

The mental disorders include social anxiety disorder (SAD), generalized anxiety disorder (GAD), and major depressive disorder (MDD).

Based in Tennessee, US, BehaVR is engaged in developing treatments for anxiety-related disorders, using the neurological power of VR.

Under the terms of the collaboration, the Japanese drugmaker will fund the development of novel VR therapies and commercialise them worldwide, upon receiving regulatory approvals.

BehaVR will receive an upfront payment of $5m, along with up to $18m in development milestone and R&D support payments.

Also, the digital therapeutics firm will receive additional payments of up to $140m, contingent on achieving commercial milestones, in addition to tiered royalties on sales.

Sumitomo Dainippon Pharma senior executive officer Hiroyuki Baba said: “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.

“We are excited and proud to be pioneering the use of this fast-moving new medium of Virtual Reality to develop treatments for anxiety and depression-related mental illnesses.

“I could not be more pleased with this extension to our important partnership with BehaVR, who share our vision of the impact that these new products will make.”

Prescription digital therapeutics are clinically validated software-based interventions designed to prevent, manage, or treat a medical disorder, said the US-based firm.

BehaVR will combine its design and product development capabilities with Sumitomo Dainippon’s expertise in developing prescription therapeutics for central nervous system-related disorders.

The two companies will pursue FDA approval for three products, designed to treat patients with social anxiety, generalised anxiety or major depressive disorder.

Also, the companies aim to achieve Software as a Medical Device (SaMD) classification for their three products, in order to include them in the FDA regulatory framework.

Furthermore, the current partnership builds on an initial collaboration between Sumitomo Dainippon’s US subsidiary Sunovion Pharmaceuticals and BehaVR, initiated in June 2020.

BehaVR founder and CEO Aaron Gani said: “In my opinion, Sumitomo Dainippon Pharma is one of the most forward-thinking and innovative pharmaceutical companies in the world today.

“We are thrilled to deepen our relationship to jointly increase our impact on health via clinically validated, FDA-cleared Virtual Reality-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.”