Orion's collaboration partner Bayer submits application for third indication of darolutamide in the EU

Collaboration and Regulatory Submission - Bayer, Orion's collaboration partner, submitted an application to the European Medicines Agency (EMA) for the use of darolutamide in combination with androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC) [1] - The submission is based on positive results from the Phase III ARANOTE trial, which showed a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT in mHSPC patients [1] Market Approvals and Global Reach - Darolutamide, marketed as Nubeqa™, is already approved for mHSPC in combination with ADT and docetaxel in over 80 markets worldwide [2] - The compound is also approved in more than 85 countries for non-metastatic castration-resistant prostate cancer (nmCRPC) in combination with ADT [2] Company Overview - Orion is a globally operating Finnish pharmaceutical company with a focus on oncology and pain therapy areas [3] - The company develops, manufactures, and markets human and veterinary pharmaceuticals, with a portfolio including proprietary and generic medicines and consumer health products [3] - Orion's net sales in 2023 amounted to EUR 1,190 million, and the company employed approximately 3,600 people at the end of the year [3]