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Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.
On Nov. 14, 2017, Bayer announced that it has entered into an exclusive global collaboration with Loxo Oncology, a US biopharmaceutical company, to develop and commercialize larotrectinib and LOXO-195, investigational anti-cancer drugs. Both compounds are being studied for treating cancers in patients who are 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.
Under the agreement, Bayer will pay Loxo Oncology a $400-million upfront payment. Loxo Oncology is also eligible to receive $450 million in milestone payments upon larotrectinib regulatory approvals and first-commercial sale events in certain major markets, as well as an additional $200 million in milestones payments upon LOXO-195 regulatory approvals and first-commercial sale events in certain major markets.
The two companies will jointly develop the two compounds and share development costs on a 50/50 basis. Bayer will lead regulatory activities outside the United States and worldwide commercial activities. The two companies will co-promote the products in the US, where they will share commercial costs and profits on a 50/50 basis. Loxo Oncology will remain responsible for regulatory filing in the US. In addition, Bayer will pay Loxo Oncology tiered double-digit percentage royalties on future net sales outside of the US, and US and ex-US sales milestones totaling $500 million.
Larotrectinib is an investigational oral, selective TRK inhibitor. The first filing for this drug is planned in the US in late 2017 or early 2018, with filing in the European Union expected in 2018. LOXO-195 is an investigational next-generation, selective TRK inhibitor. It is capable of addressing potential acquired-resistance mechanisms that may emerge in patients receiving larotrectinib or multikinase inhibitors with anti-TRK activity. Neither drug is approved by FDA, the European Medicines Agency, or any other health authority.