Bayer, Loxo in $1.55-Billion Oncology Pact

Bayer has signed an agreement with Loxo Oncology, a Stamford, Connecticut-based biopharmaceutical company, to develop Loxo’s larotrectinib (LOXO-101) and LOXO-195 for treating patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions in a deal worth up to $1.55 billion. TRK gene fusions are genetic alterations across a range of tumors that result in uncontrolled TRK signaling and tumor growth, according to Loxo.

Larotrectinib is an oral, potent, and selective TRK inhibitor. LOXO-195 is a selective TRK inhibitor designed to address potential mechanisms of acquired resistance that may emerge in patients receiving larotrectinib or multikinase inhibitors with anti-TRK activity. The first filing for larotrectinib is planned in the US in late 2017 or early 2018, with the filing in the European Union expected in 2018.

Under the agreement, Loxo 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. Loxo is also eligible for an additional $200 million in milestone payments upon LOXO-195 regulatory approvals and first commercial sale events in certain major markets. Bayer will pay Loxo tiered double-digit percentage royalties on future net sales outside of the US and US and ex-US sales milestones totaling $500 million.

Bayer and Loxo will jointly develop the two products and share development costs on a 50/50 basis. Bayer will lead ex-US regulatory activities and worldwide commercial activities. Loxo will remain responsible for the filing in the US.

Source: Loxo Oncology


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