3.6. 2014 BioTurku®

Orion and Bayer enter global agreement for development and commercialization of novel prostate cancer treatment

Orion Corporation has entered into a global partnership with Bayer for the development and commercialization of 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 will start jointly a clinical Phase III program to further evaluate the efficacy and safety of ODM-201 in patients with non-metastatic castration-resistant prostate cancer (nm-CRPC) in 2014.

Under the terms of the agreement, Orion and Bayer will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. Bayer will commercialize ODM-201 globally, Orion has the option to co-promote ODM-201 in Europe and Orion is eligible to receive substantial royalties on the product sales. Orion will be responsible for manufacturing of the product.

Dr. Reijo Salonen, Senior Vice President of R&D at Orion commented:

"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."

Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development commented:

"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. "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."

Under the terms of the agreement, Orion will receive an upfront payment of EUR 50 million and is eligible to receive milestone payments from Bayer upon achievement of certain development, tech transfer and commercialization milestones, as well as substantial royalties on future sales. Orion will use significant part of the upfront payment this year against the costs of the Phase III study to be started this year.

Prostate cancer
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. Hormonal deprivation therapy allows long-lasting and effective control of cancer-related symptoms in advanced stages. Despite effective treatment strategies, in some patients with prostate cancer the disease will progress and become castration-resistant. CRPC is characterized by persistent, high level AR function and resistance to conventional anti-androgens such as bicalutamide. Effective treatment options for castrate-resistant patients are still limited, with the field evolving rapidly.

About ODM-201
ODM-201 is an investigational novel AR inhibitor with unique chemistry that is designed to block the growth of CRPC. ODM-201 binds to AR with high affinity and inhibits receptor function by blocking the nuclear translocation of AR. Unlike other AR inhibitors, ODM-201 does not enter the brain in nonclinical models.