Orexo and GAIA Expand Partnership to Commercialize Vorvida®, a Digital Therapeutic for Alcohol Use Disorder in the U.S.

2019Year11Month27Day, VCBeat (WeChat ID:vcbeat) According to foreign media reports, Swedish pharmaceutical companyOrexoAnnounces Partnership with Digital Health CompanyGAIA AG（GAIA) signed an agreement to obtain its alcohol use disorder (AUD) Digital TherapeuticsVorvida®Exclusive distribution rights in the United States. Specific transaction terms have not been disclosed.

Under the terms of the new agreement, Orexo will be responsible for the regulatory approval and commercialization of vorvida® in the United States, while GAIA will be entitled to an upfront payment, milestone payments, and royalties. Furthermore, Orexo and GAIA will engage in discussions with the FDA regarding the regulatory pathway, the outcome of which will determine the timing of vorvida®’s market launch in the U.S. and the need for additional investment.

Orexo, founded in 1995 and headquartered in Uppsala, Sweden, is a leading integrated pharmaceutical company. The company develops novel therapeutics for addictive disorders such as opioid use disorder (OUD) and researches innovative drug delivery technologies to help patients manage substance addiction. Orexo was listed on the Stockholm Stock Exchange in 2005 under the ticker symbol ORX.

Vorvida® is a fully automated digital therapeutic developed by GAIA based on its proprietary AI system, broca®. Scientifically proven to reduce harmful drinking behaviors in patients with alcohol use disorder (AUD), Vorvida® demonstrated significant efficacy in a randomized controlled trial involving 608 AUD patients. Researchers found that the intervention group using Vorvida® significantly reduced their daily alcohol consumption within three to six months. Furthermore, compared to the control group, Vorvida® users reported fewer days of binge drinking and intoxication, indirectly indicating high acceptance and adherence rates. Vorvida® was successfully launched in Germany and Switzerland in 2019.

GAIA is a global leader in the field of digital therapeutics, founded in 2001 and headquartered in Hamburg, Germany. The company’s digital therapeutics span multiple disciplines, including neuroscience, immunology, oncology, and behavioral health. GAIA collaborates with Pfizer, Merck, AbbVie (Abbvie), B. Braun (B.Braun), Ferring Pharmaceuticals (Sweden) (Ferring Pharmaceuticals), H. Lundbeck A/S (Lundbeck) and Servier (France) (Servier) and other international healthcare and pharmaceutical companies to jointly develop digital therapeutics.

In August 2019, Orexo entered into an agreement with GAIA to obtain exclusive global commercial rights to OXD01, a digital therapeutic for the treatment of opioid use disorder (OUD).

The licensing of vorvida® further strengthens the alliance between Orexo and GAIA, adding a second digital therapeutic to Orexo’s product portfolio. Orexo intends to continue expanding its investment in digital therapeutics, focusing on digital products for addiction and adjacent disease areas that have demonstrated clinical efficacy through patient trials, thereby showcasing their value to patients, healthcare professionals, and investors.

Nikolaj Sørensen, CEO and President of Orexo, stated, “We are delighted to expand our collaboration with GAIA and are proud that Orexo is also positioned to address alcohol dependence, another severe addiction crisis. The market for treating alcohol use disorder holds tremendous potential. With vorvida®’s deep commitment to digital therapeutics through its portfolio of products, we anticipate it will become a significant revenue-generating business in the medium term. To this end, we will continue to increase our investments in the digital space, aiming to ensure the success of our digital therapeutics in the United States.”

Dr. Mario Weiss, CEO and Founder of GAIA, stated, “Our first agreement with the Orexo team demonstrated their dedication and the potential of digital therapeutics in the field of addiction. Therefore, collaborating with them to develop vorvida® was a natural progression. Scientific evidence has proven that vorvida® can deliver positive health outcomes for patients, healthcare providers, and investors alike. We firmly believe that Orexo is the most suitable partner to introduce such products to the U.S. market.”

(Compiled by Xiong Hui)