Orexo Reaches Non-Binding Settlement With US Department of Justice to Resolve Investigation
On August 31, 2026, Orexo AB, a prominent Swedish pharmaceutical company, announced the establishment of a non-binding agreement in principle aimed at settling a prolonged investigation by the US Department of Justice (DOJ). This inquiry has been in progress since 2020, and the firm is currently finalizing a settlement agreement that could avert further scrutiny.
Under the terms of this agreement, Orexo is expected to pay $4 million in installments over several years, along with a contingent payment linked to 5% of net sales, contingent on meeting specific sales targets during the years 2030-2031. This framework relies on the successful marketing of Orexo's commercial products. The agreement is framed as a Non-Prosecution Agreement (NPA) coupled with a separate civil settlement. Importantly, it does not reflect any admission of wrongdoing by Orexo or its employees.
Nikolaj Sørensen, the President and CEO of Orexo, emphasized the significance of this settlement, stating that the decision is primarily influenced by the overwhelming costs associated with a prolonged investigative process. He noted, "The investigation by the Department of Justice has been ongoing for more than six years. I am pleased that we are close to concluding the investigation. The decision to pursue a settlement is not an admission of any wrongdoing, but is based on the significant costs of a continued process and the need to focus on the continued development of Orexo and its important research."
As a result of these developments, Orexo plans to recognize a provision for the anticipated $4 million liability. The exact ramifications for the company's finances will be disclosed upon the finalization of the settlement agreement with the DOJ. Furthermore, the company has been informed that two former employees based in the US have reached their own agreements in principle to settle civil claims with the DOJ, and Orexo intends to secure insurance coverage to cover the full settlement amount related to those employees.
About Orexo:
Founded in Uppsala, Sweden, Orexo is dedicated to advancing medical treatments for severe diseases while also specializing in the development of life-saving rescue medications. Their flagship technology, AmorphOX®, is a proprietary drug delivery system that enhances the bioavailability and stability of both large and small molecules, thus enabling innovative approaches to medicine administration and manufacturing processes. With a rich history of over 30 years, Orexo boasts a diverse pipeline of clinical and preclinical programs and is committed to collaborating with various partners in research and commercialization. The firm is listed on Nasdaq Stockholm and also trades in the US markets as ADRs. For more information about Orexo and its initiatives, please visit www.orexo.com.
In conclusion, Orexo's commitment to resolve outstanding issues with the DOJ highlights its dedication to transparency and cooperative engagement with regulatory authorities. As the firm gears up to focus on its future research and development, this agreement marks a significant step toward ensuring operational continuity and regulatory compliance.
Under the terms of this agreement, Orexo is expected to pay $4 million in installments over several years, along with a contingent payment linked to 5% of net sales, contingent on meeting specific sales targets during the years 2030-2031. This framework relies on the successful marketing of Orexo's commercial products. The agreement is framed as a Non-Prosecution Agreement (NPA) coupled with a separate civil settlement. Importantly, it does not reflect any admission of wrongdoing by Orexo or its employees.
Nikolaj Sørensen, the President and CEO of Orexo, emphasized the significance of this settlement, stating that the decision is primarily influenced by the overwhelming costs associated with a prolonged investigative process. He noted, "The investigation by the Department of Justice has been ongoing for more than six years. I am pleased that we are close to concluding the investigation. The decision to pursue a settlement is not an admission of any wrongdoing, but is based on the significant costs of a continued process and the need to focus on the continued development of Orexo and its important research."
As a result of these developments, Orexo plans to recognize a provision for the anticipated $4 million liability. The exact ramifications for the company's finances will be disclosed upon the finalization of the settlement agreement with the DOJ. Furthermore, the company has been informed that two former employees based in the US have reached their own agreements in principle to settle civil claims with the DOJ, and Orexo intends to secure insurance coverage to cover the full settlement amount related to those employees.
About Orexo:
Founded in Uppsala, Sweden, Orexo is dedicated to advancing medical treatments for severe diseases while also specializing in the development of life-saving rescue medications. Their flagship technology, AmorphOX®, is a proprietary drug delivery system that enhances the bioavailability and stability of both large and small molecules, thus enabling innovative approaches to medicine administration and manufacturing processes. With a rich history of over 30 years, Orexo boasts a diverse pipeline of clinical and preclinical programs and is committed to collaborating with various partners in research and commercialization. The firm is listed on Nasdaq Stockholm and also trades in the US markets as ADRs. For more information about Orexo and its initiatives, please visit www.orexo.com.
In conclusion, Orexo's commitment to resolve outstanding issues with the DOJ highlights its dedication to transparency and cooperative engagement with regulatory authorities. As the firm gears up to focus on its future research and development, this agreement marks a significant step toward ensuring operational continuity and regulatory compliance.
Topics Health）
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