Bayer said Friday that it will obtain exclusive global licensing rights for the TRK inhibitors Vitrakvi (larotrectinib) and BAY 2731954, also known as LOXO-195, after exercising an option triggered by the completion of Eli Lilly's $8-billion takeover of Loxo Oncology.
"Our partnership with Loxo Oncology was an important milestone and with the opportunity to exercise our option on [Vitrakvi] 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," said Robert LaCaze, head of Bayer's oncology strategic business unit. Bayer noted that it exercised its option on the drugs under a change-in-control clause in the agreement with Loxo.
Vitrakvi garnered FDA approval last November to treat adult and paediatric patients with tumours harbouring an NTRK gene fusion without a known acquired resistance mutation. A marketing application for the drug was submitted to the European Medicines Agency in August, with Bayer targeting peak sales for the therapy of more than 750 million euros ($845 million). Meanwhile, a Phase I/II trial of BAY 2731954, which is designed for patients with cancers that have acquired resistance to initial TRK therapy, was initiated in 2017.
According to Bayer, it was already leading regulatory activities for the drugs outside the US, as well as global commercial activities. Once the new licensing deal takes effect, the co-promotion in the US will be converted into exclusive commercialisation by Bayer, while the equal sharing of commercial costs and profits for the US market will be replaced by royalties to be paid by Bayer. The company added that it will continue to pay royalties on future net sales outside the US.
Commenting on the news, a Bayer spokesperson indicated that financial terms, such as the initially agreed upfront payments to Loxo, as well as payments for development milestones, remain unaffected. For related analysis, see ViewPoints: Eli Lilly suddenly needs a little more value from Loxo acquisition.
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