Roivant to develop investigational therapy aimed at type 2 diabetes

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Roivant Sciences has signed a development and license agreement for imeglimin, Poxel’s type 2 diabetes investigational oral therapy.

The partnership enables Roivant to add an innovative late-stage development program to its pipeline and Poxel gains a strategic development and licensing agreement for imeglimin beyond the company’s partnership with Sumitomo Dainippon Pharma.

Poxel is entitled to receive an upfront payment of $35 million and Roivant will invest $15 million in Poxel through a subscription to 1,431,399 newly-issued ordinary shares at €8.5 per share.

Poxel is also entitled to receive potential future development and regulatory milestone payments and sales-based payments of up to $600 million subject to the successful clinical development and commercialisation of imeglimin.

After launch Poxel will be entitled to double-digit royalties on net sales. Roivant will be responsible for development and commercialisation costs and Poxel will contribute $25 million to the development program.

Imeglimin has completed Phase 1 and Phase 2 development in 18 clinical studies involving over 1,200 subjects with type 2 diabetes in the U.S., Europe, and Japan, and met its primary and secondary endpoints, including a statistically significant decrease of HbA1c and fasting plasma glucose versus placebo, with a favourable side effect profile.