A Fully Integrated Specialty Pharmaceutical Company: Orexo

Orexo is famous for developing four products-from idea to patients. Orexo's portfolio contains commercial products approved in multiple markets worldwide and projects in different phases of development.It develops improved pharmaceuticals based on innovative drug delivery technologies. Thefocus is primarily on opioid dependence and pain but the company also aims to address other therapeutic areas where its competence and technologies can create value. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercializes the product Zubsolv. Other products are commercialized through partners, including the sale of Zubsolv outside the US.

Why go for Orexo?

Patients’ needs have always been central in development, and they are also is of great importance when the future oral and sublingual formulation technologies are being developed to improve drugs within the therapeutic area of addiction.

Orexo has been able to create a unique track record of developing proprietary innovative products with significant value for patients and societies around the world. Orexo is built on innovations stemming from the interplay between talented researchers and experts with different scientific backgrounds. This innovation legacy still characterizes Orexo in the work of continuing to develop formulation technologies, thus benefiting patients around the world with improved drugs.

Trademark Products

Zubsolv: It is a product for the treatment of opioid dependence. Zubsolv has comparable efficacy and safety as well as the same active components as previously approved buprenorphine/naloxone sublingual formulations. The broad choice of six different strengths offers the potential for finer titration and individualized dosing with potentially fewer tablets compared with existing substitution treatments.

In July 2013, Zubsolv was approved for the maintenance treatment of opioid dependence by the US Food and Drug Administration, FDA, and in August 2015 the product also received approval for induction treatment of the same patient population. In November 2017 the EU-commissioned approved Zubsolv for treatment of opioid dependence in Europe. Zubsolv should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of certified physicians.

Edluar: Edluar is based on Orexo’s sublingual tablet technology and the active substance zolpidem. The product offers treatment for short-term insomnia. Zolpidem is a well-documented substance that has been used in the treatment of insomnia for a long time. The Edluar tablet is placed under the tongue, where it rapidly dissolves and the active ingredient is absorbed through the mucous membrane.

Abstral: Abstral is a rapidly disintegrating sublingual tablet for management of breakthrough cancer pain in patients already being treated with opioids. The product contains the pain-relieving substance fentanyl. Abstral allows doses to be customized according to individual requirements, which is essential for achieving optimal pain relief.

Projects in Pipeline

OX382 (Oral Formulation of Buprenorphine): Orexo is developing a swallowable formulation of buprenorphine (OX382). The aim is to be first-to-market in this new product class and to offer clear benefits over today’s treatment options for certain patient categories and treatment settings.

OX124 (Naloxone Rescue Medication): OX124 is based on a novel and unique technology developed to provide a rapidly acting naloxone rescue medication with a differentiated profile compared to currently marketed products and other products under
development. The project supports Orexo´s ambition to take a broader responsibility within the addiction space.

OX338 (New NSAID Formulation): The aim is to develop a new NSAID formulation which could replace opioids for the acute treatment of moderate to severe pain and with a view to removing the risk to develop an addiction. The project supports Orexo´s ambition to take a broader responsibility within the addiction space.

OX-MPI (Inflammation): 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 project is developed by Orexo´s partner Gesynta Pharma AB which owns the rights to the project.

OX51 (Acute Pain Episodes): OX51 is a new sublingual tablet formulation containing alfentanil. The project has been developed to meet the rapidly growing demand for effective pain relief during short surgical and diagnostic procedures. The project has successfully passed the phase II clinical trial and is available for potential partners, but so far the right match has not been identified.

Meet the Leader

Nikolaj Sørensen, President, and CEO: Nikolaj is Chief Executive Officer of Orexo since February 2013. He has been employed in the company since 2011. He holds a B.Sc. and M.Sc. degree from Copenhagen Business School, Denmark.

He has held several senior management positions both internationally and in Sweden at Pfizer Inc and the Boston Consulting Group (BCG). Nikolaj holds 33,000 shares and stock options/share awards entitling to 411,494 shares.

“A key objective in recent years has been to establish a growing profitable specialty pharmaceutical company, with its own commercial capabilities to bring new products to market.”