Bayer's Application for Darolutamide in Europe
Orion Corporation's collaboration partner Bayer has taken a significant step recently by submitting an application to the European Medicines Agency (EMA) for darolutamide. This crucial oral androgen receptor inhibitor is being proposed for use in patients with metastatic hormone-sensitive prostate cancer (mHSPC) when combined with androgen deprivation therapy (ADT).
Positive Results from Phase III Trials
The application highlights the promising outcomes from the pivotal Phase III ARANOTE trial. This significant study revealed that the combination of darolutamide and ADT led to a 46% decrease in the risk of radiological progression or death compared to those treated solely with a placebo and ADT. Such results are pivotal, as they open new avenues for combating mHSPC more effectively.
Diverse Approvals Across the Globe
Darolutamide is not a new entrant in the market. The compound has already been approved in more than 80 countries under the brand name Nubeqa™, where it is used together with ADT and docetaxel for treating mHSPC. Additionally, it boasts approval in over 85 other countries for preventing the progression of non-metastatic castration-resistant prostate cancer (nmCRPC) in high-risk patient groups.
Joint Development and Future Trajectory
The development journey of darolutamide is a testament to the collaborative strength between Orion Corporation and Bayer. Both companies are working diligently to ensure that this innovative treatment reaches the patients who need it the most. With ongoing research and positive initial results, the future looks promising for darolutamide and its potential role in prostate cancer management.
Contact Information
For those interested in learning more about Orion Corporation or their innovative treatments, Tuukka Hirvonen is available for inquiries. As part of Investor Relations, he can be reached at +358 10 426 2721.
About Orion Corporation
Orion Corporation is a well-established Finnish pharmaceutical entity with over a century of experience in enhancing well-being. The company focuses on developing, manufacturing, and marketing both human and veterinary pharmaceuticals, along with active pharmaceutical ingredients. Orion's expansive portfolio includes proprietary and generic medications as well as consumer health products, emphasizing oncology and pain treatment. In the previous fiscal year, Orion recorded net sales of EUR 1,190 million, employing approximately 3,600 staff by year-end. The company's shares, designated as A and B, are traded on Nasdaq Helsinki.
Frequently Asked Questions
What is darolutamide used for?
Darolutamide is primarily used for the treatment of prostate cancer, particularly in metastatic hormone-sensitive cases and high-risk non-metastatic settings.
Who developed darolutamide?
Darolutamide was developed jointly by Bayer and Orion Corporation.
In how many countries is darolutamide approved?
Darolutamide has received approval in over 80 countries globally, under the brand name Nubeqa™.
What were the results of the ARANOTE trial?
The ARANOTE trial demonstrated a 46% reduction in the risk of radiological progression or death for patients using darolutamide with ADT.
How can I contact Orion Corporation?
For inquiries, you can reach Tuukka Hirvonen from Investor Relations at +358 10 426 2721.
