Orexo Secures $73M Funding to Advance Digital Therapeutics for Addiction Treatment

Recently, Orexo announced a collaboration with ApexB.io and Magellan Rx Management to further investigate modia™, a digital therapeutic designed specifically for patients with opioid use disorder (OUD).

Orexo is a leading integrated pharmaceutical company specializing in the development of improved medicines and digital therapeutics. Founded in 1995, it is headquartered in Uppsala, Sweden. The company was listed on the Nasdaq Stockholm Exchange in 2005 under the ticker symbol ORX and later listed in the United States in the form of American Depositary Receipts (ADRs).

The company is developing new drugs and novel delivery technologies for addictive disorders such as opioid use disorder (OUD) to help patients manage drug addiction. Drug addiction is a chronic disease that affects an individual’s brain and behavior; individuals with drug addiction have a higher likelihood of co-occurring mental health disorders, and vice versa.

Since its inception, Orexo has focused on the development of pharmaceutical products, commercializing them in the United States or globally through partnerships. These products are primarily developed in the areas of opioid use disorder and pain management, with an emphasis on creating innovative solutions that address patient needs.

Source: Orexo Official Website

Orexo develops specialty pharmaceutical treatments through its innovative intra-oral delivery technology, featuring a low-risk development process and short time-to-market. To date, four products—ZUBSOLV®, Abstral®, Edluar®, and Diabact®—have been developed and approved in multiple countries worldwide. Among these, Abstral® and Diabact® (divested along with the former subsidiary Kibion) are leading brands in several markets.

26 Years of Corporate Struggle

Since its founding in 1995, Orexo has been in operation for more than two decades. It has evolved from a research-and-development-stage company into a highly profitable, integrated specialty pharmaceutical company with robust operational and financial strength.

Source: Orexo Official Website

$73 Million Raised Across Two Funding Rounds

According to Crunchbase, Orexo raised a total of $73 million in two rounds of financing. Its most recent funding round was an equity offering for its public listing on August 29, 2014.

Source: Crunchbase

Orexo aims to become a leader in the field of addiction treatment. To this end, it is expanding its commercial operations through business development, mergers and acquisitions, and the launch of proprietary pharmaceuticals and digital therapeutics.

Regarding the development of its digital therapeutics business, Orexo established its digital health division, Orexo DTx, in the fourth quarter of 2019. Its mission is to redefine addiction treatment by providing clinically validated digital therapeutics, ensuring more successful patient outcomes and delivering cost-effective solutions for clients. The progression of its digital therapeutics business development is as follows:

Source: Artery Orange

Orexo DTx currently has three products in development: vorvida® for the treatment of alcohol use disorder, deprexis® for the treatment of depression, and modia™ for the treatment of opioid use disorder (OUD). These digital therapeutics will be commercialized globally by Orexo DTx, with the United States as its primary market.

Accelerate Development in Partnership with GAIA

In 2020, in response to the rise in mental health disorders during the COVID-19 pandemic, Orexo accelerated the launch of two digital therapeutics, deprexis® and vorvida®, based on GAIA AG’s proprietary AI software broca®, which simulates interactions between patients and physicians or therapists. Additionally, modia™ is under development, with broader clinical data expected in the second half of 2021.

All three products were developed in collaboration with GAIA AG, a leader in the field of digital therapeutics with over 12 years of R&D experience and more than 20 CE-marked and FDA-compliant products. Its research areas include the central nervous system (CNS), immunology, and oncology.

deprexis®, indicated for depression

deprexis® can control symptoms of mild to severe depression. Nine independent studies on deprexis® have demonstrated its efficacy as a standalone treatment and confirmed that it provides additional benefits when added to existing care plans. One of these studies showed that deprexis® significantly reduces the cost of treating depression for health insurance companies.

vorvida®, indicated for alcohol use disorder

Vorvida is indicated for adult patients with severe alcohol misuse, including alcohol use disorder (AUD). It can be used independently or as an adjunct to conventional pharmacotherapy, without the need for appointments or waiting periods.

Its primary function is conversational, providing users with brief information. Users select the option that is most interesting or best suited to their individual circumstances from a fixed set of predetermined answer choices. Vorvida then responds to this selection by delivering the next piece of information, to which the user can again respond. Furthermore, users may interrupt Vorvida at any time; upon returning, they can resume the program exactly where they left off.

Furthermore, Vorvida is supported by robust clinical evidence demonstrating its efficacy. In a randomized controlled trial involving 608 adults with problematic alcohol consumption, researchers found that participants using vorvida® significantly reduced their daily alcohol intake at both 3 and 6 months. Additionally, compared to the control group, vorvida® users reported fewer days of binge drinking and intoxication, with high levels of acceptance and usability.

modia™, for Opioid Use Disorder (OUD)

modia™ is a digital therapeutic solution specifically designed for patients with opioid use disorder (OUD), providing assistance through cognitive behavioral therapy-based digital interventions.

In February 2021, Orexo will partner with ApexB.io and Magellan Rx Management to further study the use of modia™. The initial customers have agreed to provide participants for the trial, and more customers are expected to join in the future. modia™ is anticipated to be rolled out more broadly across the United States in the second half of 2021.

Leading Digital Therapeutics Technology

Orexo’s digital therapeutics provide patients with therapeutic interventions to prevent, manage, or treat corresponding symptoms, enabling continuous 24/7 treatment within the privacy of their own space. It can be used as a standalone therapy or in combination with conventional medications.

This therapy is developed based on established cognitive behavioral therapy (CBT) techniques and is a goal-oriented psychotherapeutic approach. Its purpose is to provide support and modify the thought or behavior patterns underlying patients' difficulties in treatment.

Source: Orexo Official Website

The characteristics of this therapy are as follows:

100% Mobile and Cloud:Available 24/7 on any mobile device (computer, tablet, smartphone).

Personalized Treatment:Cognitive interventions to modulate brain function and thought processes; providing targeted information and exercises based on continuous assessment of patient needs and emotional status; in-depth collection of individual patient data to facilitate further research and enhance physician-patient interaction.

Wearable Devices：Leverage wearable devices to facilitate further content and user engagement.

Orexo believes that fully automated digital therapeutics can serve as a valuable complement to existing treatment plans, improving patients’ access to care and overall treatment outcomes.

At the innovation challenge on digital therapeutics launched in partnership between Orexo and Lyfebulb, Mikaela Odlander, Director of Digital Therapeutics at Orexo, stated that the COVID-19 pandemic has driven an increase in the global population of patients with substance use disorders. Orexo DTx will continue to advance in this field through the use of digital therapeutics, addressing the unmet needs of these patient populations.

According to information on Orexo’s official website, its goals and strategy for 2020 and beyond are as follows: in the traditional pharmaceutical sector, it will continue to expand and promote its pharmaceutical business and innovate drug products; in the digital therapeutics sector, it will establish new revenue-generating businesses, with an expectation of having three revenue-generating products on the market by 2021.

Going forward, Orexo will continue to explore the field of digital therapeutics.