Orexo has acquired the exclusive US rights to GAIA AG´s (GAIA) deprexis, a digital therapy to help patients manage their symptoms of depression.
The announcement follows two earlier agreements with GAIA where Orexo acquired the exclusive US commercial rights to vorvida which has been proven to reduce risky drinking patterns in adults with alcohol use disorder (AUD), and also the exclusive global commercial rights to OXD01, a new digital therapy being developed for the treatment of opioid use disorder (OUD).
The COVID-19 crisis and the actions taken to control the pandemic is expected to result in a significant rise in mental illness such as depression and substance abuse, states Orexo in its press release. The recent emergency use authorization policy for digital health devices for treating Psychiatric disorders published by the US Food and Drug Administration (FDA) will allow Orexo to accelerate the launch of its three digital therapies, in 2020, in order to help society to address some of the negative consequences of the COVID-19 pandemic, it states.
“The COVID-19 pandemic and resulting isolation and economic distress is likely to trigger a wave of mental health issues such as depression and substance abuse. With deprexis, vorvida and OXD01 Orexo can offer a range of products which could provide patients with access to quality medical devices whilst maintaining social distancing requirements. The agreement today marks our third deal with GAIA and reflects our belief in the important role of digital therapeutics, which continue to generate compelling clinical data to support their use across a range of medical conditions, including depression. During this unprecedented time with COVID-19 we have seen accelerated adoption of digital therapeutics and are focused on advancing deprexis towards a launch during the summer,” says Nikolaj Sørensen, President and CEO at Orexo AB.
Expects to launch deprexis in the US during the summer of 2020
Under the terms of the agreement, GAIA is entitled to an upfront payment and royalties will be paid based on net sales from January 1, 2022 onwards. Deprexis has already been classified by the FDA and Orexo expects to launch deprexis in the US during the summer of 2020. The annual net sales potential of deprexis are estimated to exceed the market potential of vorvida (USD 120 m – USD 200 m) and OXD01 (USD 150 m – USD 225 m). Deprexis has been launched in multiple countries across the world.
The investments related to the deal and the opportunity to accelerate the launch of all Orexo’s digital therapies will impact Orexo’s cash flow with approximately SEK 115 million in the second quarter and result in an increased OPEX for 2020. The company will provide further detail on additional investment required to support the expected launch of the three digital therapies, in its Q2 Interim Report, that will be published on July 16, 2020.
Almost tailor-made for the US
Deprexis is a fully automated digital therapy developed by GAIA based on its artificial intelligence (AI)-expert system, broca. Deprexis provides the user with tailored therapeutic support by simulating effective, up-to-date and personalized cognitive behavioral therapy interventions.
“Even before COVID-19, we believed that deprexis is almost tailor-made for the US: A proven effective, fully-automated digital depression treatment, accessible on any connected device 24/7 and available in 10 languages, including Spanish, French and Chinese. With Orexo we now have the right partner in the US to offer a digital depression treatment, with significant clinical data to support its use. Providers, payors and employers will soon be able to support the ones in need with this top-of-class solution. We are very pleased that Orexo was willing to extend our existing partnership and join us in our constant fight against the massive global burden of diseases such as depression,” says Mario Weiss, CEO and Founder of GAIA.
Photo of Nikolaj Sørensen: Orexo