Orexo has acquired the exclusive US rights to vorvida, a digital therapy for the treatment of Alcohol Use Disorder (AUD), from GAIA.
This news follows an earlier agreement with GAIA in August 2019, for the exclusive global commercial rights to OXD01, a new digital therapy being developed for the treatment of Opioid Use Disorder (OUD).
Under the terms of the new agreement, Orexo will be responsible for the regulatory approval and commercialization of vorvida in the US, whilst GAIA will be entitled to an upfront payment, milestone payments as well as royalties. Orexo and GAIA will initiate a dialog with the FDA about the regulatory pathway, the outcome of which will decide the launch timing and requirement for additional investments in the development of vorvida for the US market.
A fully automated digital therapy
Vorvida (Orexo project no. OXD02) is a fully automated digital therapy developed by GAIA based on its proprietary artificial intelligence (AI)-expert system, broca. Vorvida is scientifically proven to reduce troublesome drinking patterns in adults with AUD. In a randomized controlled trial involving 608 adults with problematic alcohol intake, researchers found that participants in the intervention group with vorvida significantly reduced their daily alcohol consumption over three and six months, with significant effect sizes. Additionally, in comparison to the control group, vorvida users reported fewer days of binge drinking and drunkenness while stating high acceptance and utility rates of vorvida at the same time. Vorvida has already been launched successfully in Germany and Switzerland in 2019 by GAIA.
“We are delighted to extend our partnership with GAIA and proud that Orexo may also be able to address alcohol dependency, another major addiction crisis. We see a significant unmet need in the treatment of alcohol use disorder and are impressed by the clinical effects that vorvida can deliver for patients. As a company, we are making a commitment to the digital therapy space by building up a portfolio of products which I expect to turn into a sizeable business for Orexo in the medium term. As we will invest to enhance our capabilities in the digital space we will of course leverage our successful commercial infrastructure to make our digital therapies a success in the United States,” says Nikolaj Sørensen, CEO and President of Orexo AB.
Further strengthens the alliance with GAIA
The licensing of vorvida further strengthens the alliance with GAIA, states the company. adding a second digital therapy to the group’s pipeline. Orexo intends to continue to broaden investments in digital therapies with a focus on digital products for addiction and adjacent disease spaces that have proven clinical efficacy from well-run patient trials and are demonstrating tangible value to patients, health care professionals and payors alike. For Orexo, it is important the digital therapies independently offer attractive commercial potential where Orexo can leverage its existing commercial infrastructure.
Photo of Nikolaj Sørensen: Jenny Öhman