Germany-based Bayer and Finland-based Orion have signed a global agreement to develop and commercialise the investigational oral androgen receptor inhibitor, ODM-201, for treating prostate cancer patients.
ODM-201 is an investigational androgen receptor inhibitor with unique chemistry that is designed to block the growth of prostate cancer cells.
Under the new global agreement, Bayer is planning to begin a Phase III programme in 2014 jointly with Orion to further assess the safety and efficacy of ODM-201 in patients with non-metastatic castration-resistant prostate cancer.
ODM-201 will be jointly developed by the two companies, with Bayer contributing a major share of the costs of future development.
Bayer will commercialise ODM-201 globally, while Orion has the option to co-promote the product in Europe and will be responsible for manufacturing.
Under the terms of the new agreement, Bayer will make an upfront payment of €50m to Orion. Orion will use the majority of the up-front payment in 2014 against the costs of the Phase III study.
Orion will also be eligible to receive cash payments from Bayer upon achievement of certain development, tech transfer and commercialisation milestones, as well as tiered double-digit royalties on future global net sales.
Safety and efficacy of ODM-201 at three dose levels (100mg, 200mg and 700mg given twice-daily) has been evaluated in a Phase II clinical study in 124 patients with progressive metastatic castration-resistant prostate cancer.
The Phase II study included patients who were treated previously with abiraterone, chemotherapy, or were chemotherapy-naive.
The results demonstrated that ODM-201 had high anticancer activity in all patients and the product was well-tolerated in all patients, including patients who had received chemotherapy and abiraterone.
Image: Micrograph showing a prostate cancer (conventional adenocarcinoma) with perineural invasion. Photo: courtesy of Nephron.