Orion and Bayer expand clinical program for ODM-201

3 June 2016

Finnish drugmaker Orion Corp (Nasdaq OMX: ORNAV) and Germany’s Bayer (BAYN: DE) have agreed to start in 2016 a new Phase III study with oral androgen receptor antagonist ODM-201 (BAY-1841788).

The new Phase III study ARASENS will evaluate the safety and efficacy of the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy.

In 2014, Orion and Bayer entered into a global partnership for the development and commercialization of ODM-201 (BAY-1841788), for which Bayer paid an upfront 50 million euros ($55.6 million at current exchange rates). The companies have expanded the 2014 agreement to include the joint development of ODM-201 (BAY-1841788) for mHSPC. The compound is currently in Phase III study ARAMIS for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). The new trial ARASENS is expected to start the enrolment of patients towards the end of 2016.

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