Bayer announced Monday a global agreement to develop and commercialise Orion's experimental oral androgen receptor inhibitor ODM-201, which is in clinical studies for the treatment of prostate cancer. Joerg Moeller, head of global development at Bayer, said "we see in ODM-201 a potential new treatment for patients with high risk non-metastatic castration-resistant prostate cancer."
Moeller noted that the company's current oncology portfolio includes Xofigo (radium 223 dichloride), adding "from a clinical perspective, ODM-201 has the potential to complement our portfolio in prostate cancer and enables us to deliver new treatment options." Bayer and Orion indicated that they plan to start a Phase III programme for ODM-201 in patients with non-metastatic castration-resistant prostate cancer in 2014. Mid-stage results demonstrated that 86 percent of patients with progressive metastatic castration-resistant prostate cancer who had not received earlier chemotherapy or Johnson & Johnson's Zytiga (abiraterone) experienced a greater than 50 percent prostate specific antigen decrease at week 12 at the highest dose level given twice daily.
Under the deal, the companies will jointly develop ODM-201, with Bayer contributing "a major share" of the costs. The drugmakers noted that Bayer will market ODM-201 globally, with Orion having an option to co-promote the therapy in Europe, if approved, and will also manufacture the product. Bayer will make an upfront payment of 50 million euros ($68 million), with Orion eligible to receive cash payments linked to certain milestones, as well as tiered double-digit royalties on future global net sales.
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