Date: 2014-06-02
Type of information: Development agreement
Compound: ODM-201
Company: Orion Corporation (Finland) Bayer (Germany)
Therapeutic area: Cancer - Oncology
Type agreement: development commercialisation
Action mechanism: ODM-201 is an investigational novel androgen receptor (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.
Disease: prostate cancer
Details: * On June 2, 2014, Orion Corporation has entered into a global partnership with Bayer for the development and commercialization of 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. As a result of the agreement Orion Corporation upgrades the full-year outlook estimate for 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.
Financial terms: Under the terms of the agreement, Orion will receive an upfront payment of € 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. As a result of the agreement Orion Corporation upgrades the full-year outlook estimate for 2014 provided on 4 February 2014. The company estimates that the full-year operating profit will be at similar level to 2013 (operating profit in 2013 was € 268 million).
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