Orexo Enters Exclusive License and Supply Agreement with Accord Healthcare for ZUBSOLV[® ]in Europe

• The agreement covers 29 countries in Europe
• Orexo will receive double-digit royalties on future net sales
• First launches are expected in H2, 2021

Uppsala, Sweden – December 7, 2020 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) has entered into an exclusive licensing agreement with Accord Healthcare, for the commercialisation of ZUBSOLV^® ((buprenorphine (as hydrochloride) and naloxone (as hydrochloride dihydrate)) sublingual tablet. Licensed in Europe, ZUBSOLV^® is indicated for adults and adolescents over 15 years of age for substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment, and who have agreed to be treated for addiction.[1] ZUBSOLV^® offers an alternative treatment option for patients as it launches across 29 countries in Europe. This agreement brings together the experience of Orexo in the opioid addiction market alongside the commercial reach of Accord Healthcare, who are partnering together with a common aim to ensure that people have more access to treatment options. There are estimated to be 1.3 million high-risk opioid users in Europe,[2] yet treatment rates are low with around 50 percent of people with opioid dependence receiving some form of substitution treatment and this can vary greatly between countries.[3]

Under the terms of the agreement, Orexo will be responsible for product supply and Accord will take responsibility for the commercialisation of ZUBSOLV®. Orexo will receive double-digit royalties on future net sales.

Nikolaj Sørensen, President and CEO of Orexo AB, said: “I am excited about this new partnership with Accord and am looking forward to making ZUBSOLV^® available to patients in Europe suffering from opioid dependence. We have chosen Accord for their strong commitment to the addiction field and their successful track record in both generic and branded markets, which makes them ideally placed to make ZUBSOLV^® successful in the competitive European market.”

Paul Tredwell, VP Speciality Brands, Accord Healthcare, Europe, Middle East, and North Africa (EMENA) said: "ZUBSOLV^® is one of several medicines that we are adding to our growing speciality Central Nervous System franchise. This license agreement reaffirms our commitment to patients with addiction by increasing access to a choice of medicines that can help make a real difference to patient lives."

For further information, please contact:
Orexo AB (publ.)

About Orexo
Develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. The products are commercialized by Orexo in the US or via partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercialize its lead product ZUBSOLV® for treatment of opioid use disorder. Total net sales for 2019 amounted to SEK 844.8 million and the number of employees was 127. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The head office, where research and development is also performed, is situated in Uppsala, Sweden.         

For more information about Orexo please visit, www.orexo.com. You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn and YouTube.

About Accord Healthcare
Headquartered in the United Kingdom (UK), Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. Our approach is agile and inventive, always seeking to improve our products and patients’ access to them. We’re driven to think differently and deliver more for the benefit of patients worldwide. www.accord-healthcare.com

Media Enquiries:
Accord Healthcare

Avril Fudge
PR & Comms Lead EMENA
PR@accord-healthcare.com

The information was submitted for publication at 8 am CET, on December 7, 2020.

^[1] https://www.ema.europa.eu/en/documents/product-information/zubsolv-epar-product-information_en.pdf
^[2] European Monitoring Centre for Drugs and Drug Addiction EMCDDA 2019 (https://www.emcdda.europa.eu) 2019
^[3] EMCDDA – Tackling Opioid Dependence (https://www.emcdda.europa.eu/best-practice/briefings/tackling-opioid-dependence_en) 2019