Bayer to commercialize TRK inhibitor as Roche creates competition

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/ Aflred Georg Sonsalla)
(Image: Getty/ Aflred Georg Sonsalla)

Related tags: Roche, Bayer, License, development, Commercialization, Loxo Oncology, solid tumor

Bayer exercises its option to obtain exclusive licensing rights for the global development and commercialization of Loxo Oncology’s solid tumor drugs.

Through the optioning, Bayer will have exclusive rights to Vitrakvi (larotrectinib) and BAY 2731954 (LOXO-195), which together according to Leerink Partners have projected sales of $1.75bn (€1.54bn).

Eli Lilly’s $8bn acquisition of Loxo Oncology​ became effective as of February 15, 2019 – shortly after, Bayer chose to exercise its option. The original collaboration agreement was established in November 2017 for the two companies to co-commercialize and share commercial costs and profits of developed therapies, including the option for Bayer acquire the assets.

Bayer will now have full commercialization and development rights, though it will have to pay royalties on future net sales outside the US to Loxo.

Eli Lilly chose to focus the deal on Loxo’s potential first-in-class oral RET inhibitor, LOXO-292, which the company expects to launch in 2020 after it was granted a breakthrough designation by the US Food and Drug Administration (FDA).

Competition in TRK inhibitor space

Vitrakvi, a TRK inhibitor compound, is indicated for the treatment of solid tumors caused by NTRK gene fusions.

Robert LaCase, head of the oncology strategic business unit at Bayer, said, "With the first-ever approved TRK inhibitor with activity against TRKA, TRKB and TRKC, Vitrakvi, and BAY 2731954 progressing through clinical development, we have two compounds in our precision oncology portfolio and we are committed to expanding this portfolio by bringing forward highly differentiated and promising additional projects,” ​he further explained.

However, Roche announced February 19, 2019, that its TRK inhibitor, entrectinib, has been given priority review by the FDA. Roche acquired the drug after its $1.7bn acquisition of Ignyta.

While the data that enabled Roche’s drug to be given priority review shows a tumor shrinking rate of 57.4% across 10 tumor types, it cannot currently be compared to that of Bayer’s Vitrakvi that shows a tumor response rate of 81% because of the drugs’ study protocols.

Related topics: Regulatory & Safety, Regulations

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