Bayer and Orion to develop novel prostate cancer treatment

Bayer has entered into a global agreement with Orion, a Finnish pharmaceutical company, to develop and commercialise the compound ODM-201, an investigational novel oral androgen receptor inhibitor.

ODM-201 is in clinical development for the treatment of patients with prostate cancer. Bayer and Orion plan to start jointly the clinical Phase III programme to further evaluate the efficacy and safety of ODM-201 in patients with non-metastatic castration-resistant prostate cancer (nm-CRPC) in 2014. These patients are at high risk of developing metastatic disease and can be identified due to rapid prostate specific antigen (PSA) increases.

“We see in ODM-201 a potential new treatment for patients with high risk non-metastatic castration-resistant prostate cancer and are looking forward to developing this promising compound,” said Dr Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development. “Bayer’s oncology portfolio currently includes Xofigo which has been shown to prolong life in patients with castration-resistant prostate cancer with symptomatic bone metastases, and no known visceral metastases. From a clinical perspective, ODM-201 has the potential to complement our portfolio in prostate cancer and enables us to deliver new treatment options for patients who desperately need them.”

"Joining forces with Bayer, I believe that we have again achieved a collaboration that represents the best of all worlds," said Dr Reijo Salonen, SVP R&D and chief medical officer for Orion. “Bayer has recently committed to developing therapies in oncology, particularly for prostate cancer. At Orion, we continue our track record of inventing innovative molecules. And most importantly, for patients with prostate cancer, this partnership will bring a medicine that will make an important difference to their lives."

Under the terms of the agreement, Bayer and Orion will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. Bayer will commercialize ODM-201 globally and Orion has the option to co-promote ODM-201 in Europe. Orion will be responsible for the manufacturing of the product. Orion will receive an upfront payment of EUR 50 million and is eligible to receive cash payments from Bayer upon achievement of certain development, tech transfer and commercialization milestones, as well as tiered double-digit royalties on future global net sales. Orion will use the majority of the up-front payment this year against the costs of the Phase III study to be started this year.