Bayer exercised option under change-in-control clause in it’s agreement with Loxo Oncology to obtain full licensing rights for the two TRK inhibitor agents.
Bayer has exercised its option, under a change-in-control clause in the collaboration agreement with Loxo Oncology, to obtain the exclusive licensing rights for the global development and commercialization, including the U.S., for larotrectinib (VITRAKVI®) and BAY 2731954 (LOXO-195). Both compounds are being developed globally for the treatment of adult and pediatric patients with advanced solid tumors harboring NTRK gene fusions. The option was triggered by the acquisition of Loxo Oncology by Eli Lilly and Company which became effective today.
Bayer is dedicated to improving the lives of cancer patients, and precision oncology is a promising area that has the potential to redefine the way cancer patients are treated. Our partnership with Loxo Oncology was an important milestone and with the opportunity to exercise our option on larotrectinib and BAY 2731954, we are taking the next step in our efforts to advance the future of cancer care and strengthen our leadership in this field. With the first-ever approved TRK inhibitor, larotrectinib, and BAY 2731954 progressing through clinical development, we have two very promising compounds in our precision oncology portfolio and we are committed to expanding this portfolio by bringing forward highly differentiated and promising additional projects
said Robert LaCaze,
Member of the Executive Committee
of Bayer’s Pharmaceuticals Division
and Head of the Oncology Strategic Business Unit at Bayer.
In November 2017, Bayer and Loxo Oncology entered into a global collaboration for the joint development and commercialization of the TRK inhibitors larotrectinib and BAY 2731954 (LOXO-195). Following the change of control, Bayer will be solely responsible for the global development and commercialization of both larotrectinib and BAY 2731954. Bayer is already leading ex-US regulatory activities, and worldwide commercial activities. When the new exclusive licensing arrangement takes effect, the co-promotion in the U.S. will be converted into an exclusive commercialization by Bayer and the sharing of commercial costs and profits on a 50/50 basis for the U.S. market will be replaced by royalties to be paid by Bayer. Bayer will continue to pay royalties on future net sales outside the U.S
In addition, in connection with Bayer’s exercise of the option, certain licenses granted by Loxo to Bayer will become exclusive following anti-trust clearance in the US.