Business & Finance
Orion and Bayer announce completion of phase III trial of darolutamide; primary end point met
25 October 2018 -

Finnish pharmaceutical company Orion Oyj (HEL:ORNBV) and Bayer AG (Xetra:BYN.DE), a German multinational pharmaceutical and life sciences company, announced on Wednesday the completion of the phase III clinical trial (ARAMIS) of darolutamide, the novel oral androgen receptor antagonist for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Reportedly, the primary endpoint of the trial was met, which was that Darolutamide significantly extended metastasis-free survival compared to placebo. Also, the safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.

The full data will be presented at an upcoming scientific meeting. Bayer plans to discuss the data from the ARAMIS trial with health authorities regarding the submission for marketing authorisation application.

Darolutamide has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment in men with nmCRPC.

The ARAMIS trial, which commenced in 2014, evaluated the efficacy and safety of darolutamide in patients with non-metastatic castration-resistant prostate cancer, who are currently being treated with androgen deprivation therapy (ADT) as standard of care and are at risk of developing metastatic disease. In the double-blind, placebo-controlled trial, more than 1,500 patients were randomised to receive 600 mg of darolutamide or matching placebo twice a day. The primary endpoint was metastasis-free survival, defined as time between randomisation and evidence of metastasis or death from any cause.

Darolutamide was developed jointly by Orion and Bayer under a partnership. Bayer has covered the majority of the darolutamide development costs. Under the agreement, Bayer has the right to commercialise darolutamide globally, while Orion has the option of co-promoting the product in Europe. In addition, Orion will manufacture the product for global markets.

Orion is eligible to receive milestone payments from Bayer upon first commercial sale of darolutamide with EUR45m upon first commercial sale in the US; EUR20m upon first commercial sale in the EU and EUR8m upon first commercial sale in Japan.

Besides milestone payments, Orion will also receive tiered royalties on the product sales, which will be approximately 20%, including production revenues. With sales increase, royalties may increase slightly. Orion also has the possibility to receive one-off payments from Bayer if certain sales targets are met.

In addition to the completed ARAMIS trial, Orion and Bayer have an ongoing phase III clinical trial (ARASENS), which evaluates the safety and efficacy of darolutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Expected to be completed in 2022, there are no separate milestone payments related to the ARASENS trial.