Bayer submits third EU application for darolutamide with Orion

ORION CORPORATION INVESTOR NEWS 14 OCTOBER 2024 at 11.00 EEST

Bayer, in collaboration with Orion, has filed an application with the European Medicines Agency (EMA) for their oral androgen receptor inhibitor (ARi) known as darolutamide. Bayer is pursuing approval to use darolutamide in combination with androgen deprivation therapy (ADT) for patients suffering from metastatic hormone-sensitive prostate cancer (mHSPC).

This application is grounded in the encouraging outcomes from the Phase III ARANOTE trial, which demonstrated that darolutamide combined with ADT considerably decreased the danger of radiological progression or death by 46% when compared to a placebo combined with ADT in mHSPC patients.

Darolutamide already has approval under the brand name Nubeqa™ when used with ADT and docetaxel across more than 80 countries globally for treating mHSPC. Additionally, it is sanctioned in over 85 nations as a combination treatment with ADT for non-metastatic castration-resistant prostate cancer (nmCRPC) patients who are at a high risk of developing metastatic disease. The development of darolutamide is a joint effort by Orion and Bayer.

Orion is a Finnish pharmaceutical company with a global footprint, dedicated to enhancing well-being for more than a century. The company is involved in the development, production, and marketing of human and veterinary medicines, as well as active pharmaceutical ingredients. Orion's diverse product range includes both proprietary and generic medications, along with consumer health products. The primary focus areas of Orion’s pharmaceutical research and development are oncology and pain management. Proprietary products from Orion address conditions such as cancer, neurological diseases, and respiratory illnesses. In 2023, Orion reported net sales of EUR 1,190 million and employed approximately 3,600 people by the end of the year. Orion’s shares are listed on Nasdaq Helsinki.