Zubsolv® ex US - treatment of opioid dependence

Nearly 20 million people are suffering from opioid dependence outside of the US and the problem exists both in developed and less developed countries. Heroin remains the main opioid abused outside of the US, whilst countries continue to monitor for any signs of increased misuse of other opioids including prescription medicines.

As a result of the license agreement with Mundipharma, signed June 30, 2016, a new treatment option will potentially be made available to benefit patients with opioid dependence outside of the US. Mundipharma, through its network of independent associated companies, has a pres- ence in 48 countries worldwide, and takes responsibility for all of the key markets where Zubsolv is not available today. The first important milestone in the collaboration was achieved on October 3, 2016, when a regulatory submission for Zubsolv was filed with the European Medicines Agency (EMA). Approval of Zubsolv for the treatment of opioid dependence in Europe is anticipated by the end of 2017.

OX-CLI - respiratory tract diseases

The OX-CLI project is a Leukotriene C4 (LTC4) synthase inhibitor program. The OX-CLI project is a new chemical entity (NCE) project, and aims to enable development of a novel treatment for respiratory diseases such as asthma and COPD.

AstraZeneca established collaboration with Orexo for OX-CLI in 2013 and has since been responsible for all investments, as well as all research and development activities. As the program has advanced into pre-clinical development with an identified development compound (Candidate Drug), AstraZeneca chose to exercise their option to acquire all rights to the OX-CLI project in Q1, 2016. In accordance with the option agreement, Orexo earned a milestone payment of USD 5 million (SEK 40.8 million) for the rights to OX-CLI.

June 1 2017 AstraZeneca advanced the projects into clinical trials which triggered another milestone amounting to USD 2.5 million. AstraZeneca will continue the drug development without further involvement of Orexo and future milestone payments can be  expected if OX-CLI  meets  defined  development and commercial objectives. In addition to the milestones, Orexo will receive a tiered single digit royalty on future net-revenue associated to sales of products generated from the OX-CLI program.

AstraZeneca´s substance code is named AZD9898.

OX-MPI - treatment of inflammatory related pain or disease

The lead candidate drug in the OX-MPI program, BI1029539, has been identified as a highly selective anti-inflammatory compound targeting microsomal prostaglandin E synthase (mPGES-1).

The OX-MPI program was acquired by Gesynta Pharma AB on September 29, 2017. Gesynta Pharma AB is a recently formed research company located in Stockholm, Sweden, and among the founders are highly reputed executives from the biotech industry and experienced researchers at the Karolinska Institute within the field of arachidonic acid pathways and inflammatory diseases. At the time of the acquisition the project was in preclinical phase and Gesynta Pharma AB will progress the candidate drug into proof-of-concept clinical trials.

Under the terms of the agreement Orexo will receive a tiered double digit share of the future revenues that Gesynta Pharma AB generates from the OX-MPI project.