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Orexo nears resolution of six-year US DOJ investigation

After a six-year legal cloud, Swedish pharmaceutical firm Orexo AB has reached a non-binding agreement in principle to settle an ongoing investigation by the US Department of Justice. The proposed resolution includes a 4 million dollar payment and a Non-Prosecution Agreement, marking a potential end to the 2020 inquiry.

Orexo nears resolution of six-year US DOJ investigation
Photo: Bio & News

Under the terms currently being finalized, Orexo would settle the matter through a Non-Prosecution Agreement and a civil settlement. The structure avoids any admission of wrongdoing by the company or its personnel. Beyond the initial 4 million dollar payment, which will be distributed in installments over several years, the agreement includes a contingent payment provision. This secondary liability is capped at five percent of net sales, triggered only if specific commercial performance thresholds are met during 2030 and 2031.

CEO Nikolaj Sørensen indicated that the decision to settle stems from the mounting costs of the protracted legal process rather than any underlying guilt. The company is now prioritizing its research pipeline and long-term development strategies. Additionally, two former employees have reached their own agreements in principle with the DOJ, for which Orexo intends to pursue insurance coverage. The company expects to record a 4 million dollar provision to account for the anticipated liability as it moves toward a final, binding signature.

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