Uppsala, Sweden – December 13, 2018 – Orexo AB (publ.), the fully integrated specialty pharmaceutical company addressing opioid addiction and pain, today announces that the Company will regain the rights to Zubsolv (buprenorphine and naloxone sublingual tablet) for the treatment of opioid dependence in all territories outside the United States from its current partner, Mundipharma, on April 13, 2019.

Mundipharma has seen Zubsolv successfully approved in Europe through a centralized procedure and has launched the product in selected markets such as Germany and Sweden. Following a portfolio reorganization, they have however determined, for strategic reasons, to exit this partnership.

This offers Orexo the opportunity to assess the best route to maximize the potential of Zubsolv, and to ensure that more patients have access to the treatment. The ambition is to ensure that Orexo will have increased control of the commercialization of the product with any new partner.

Several potential partners have expressed interest in commercializing Zubsolv in specific regions and Orexo will now initiate formal negotiations with several interested parties. Both Mundipharma and Orexo are committed to cooperate closely to ensure a smooth transition.

The need for innovative and affordable treatments remains significant given that more than 30 million people globally suffer from opioid use disorder, of which more than 20 million reside outside the United States.

“I am excited to regain control of Zubsolv outside the United States, and Orexo can now take the lead to ensure that Zubsolv becomes globally available for patients in need. We look forward to working with new partners who are committed to join us in the fight against opioid use disorder and who can ensure patients who suffer from this devastating disease will be offered treatment with Zubsolv.” said Nikolaj Sørensen, President and CEO, Orexo AB.

The change will be associated with limited additional expenses for Orexo during the transition period, but does not affect the company’s previous financial guidance and is not associated with any payments to Mundipharma. The company will provide additional financial guidance for 2019 in the year-end report for 2018.

For further information, please contact:

Orexo AB (publ.)

Nikolaj Sørensen, President and CEO Lena Wange, IR and Communications Manager
Tel: +46 (0)18 780 88 00 Tel: +46 (0)18 780 88 00/ + 46 (0)73 064 16 36
E-mail: ir@orexo.com E-mail: ir@orexo.com

About Orexo

Orexo develops improved pharmaceuticals based on innovative drug delivery technologies. The focus is primarily on opioid dependence and pain but the aim is to address therapeutic areas where our competence and technologies can create value. The products are commercialized by Orexo in the US or via selected partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo sells the product Zubsolv®. Total net sales for 2017 amounted to SEK 643.7 million and the number of employees at year-end was 90. 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.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 7.00 am CET on December 13, 2018.