Bayer In Agreement To Develop Therapies Targeting Genetic Cancer Drivers

Bayer and Loxo Oncology to develop and commercialize two therapies that selectively target genetic drivers of cancer.

Bayer has entered into an exclusive global collaboration with Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Conn. for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195.

Both compounds are being investigated in global studies for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

Larotrectinib is an investigational oral, selective TRK inhibitor. LOXO-195 is an investigational next-generation, selective TRK inhibitor capable of addressing potential mechanisms of acquired resistance that may emerge in patients receiving larotrectinib or multikinase inhibitors with anti-TRK activity.

Larotrectinib is currently the only selective TRK inhibitor in clinical development with the comprised clinical data set showing an overall response rate of 75 percent, confirmed by an independent review committee, regardless of tumor type and age.

The most common treatment-emergent adverse events, regardless of relationship to larotrectinib, included fatigue, dizziness, nausea, and anemia, all largely grade 1/2 events. The first filing for larotrectinib is planned in the U.S. in late 2017 or early 2018, with the EU filing expected in 2018.

Under the terms of the agreement, Loxo Oncology will receive an upfront payment of $400 million and 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 milestones payments upon LOXO-195 regulatory approvals and first commercial sale events in certain major markets.

Bayer and Loxo Oncology will jointly develop the two products, larotrectinib and LOXO-195, and share development costs on a 50/50 basis. Bayer will lead ex-U.S. regulatory activities, and worldwide commercial activities.

In the U.S., where Bayer and Loxo Oncology will co-promote the products, the parties will share commercial costs and profits on a 50/50 basis. Loxo Oncology will remain responsible for the filing in the U.S.

Bayer will pay Loxo Oncology tiered double-digit percentage royalties on future net sales outside of the U.S., and U.S. and ex-U.S. sales milestones totaling $500 million.

(Source: Bayer AG)