Bayer Enters Global Collaboration With Loxo For Larotrectinib, LOXO-195

(RTTNews) - Loxo Oncology, Inc. (LOXO) announced a global collaboration with Bayer to develop and commercialize larotrectinib and LOXO-195, Loxo Oncology's franchise of TRK inhibitors for patients with TRK fusion cancers. Both compounds are being investigated in global studies for the treatment of patients with cancers harboring tropomyosin receptor kinase gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth. The first filing for larotrectinib is planned in the U.S. in late 2017 or early 2018, with the EU filing expected in 2018.

Loxo will receive a $400 million upfront payment. The company is eligible for $450 million in milestone payments upon larotrectinib regulatory approvals and first commercial sale events in certain major markets and an additional $200 million in milestone payments upon LOXO-195 regulatory approvals and first commercial sale events in certain major markets.

Loxo Oncology will lead global development activities and U.S. regulatory activities. Bayer will lead ex-U.S. regulatory activities, and worldwide commercial activities.