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.
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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.
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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.
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By GlobalDataOrion 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.
