Roivant Sciences, a Basel, Switzerland globally-headquartered biopharmaceutical company, and Poxel SA, a Lyon, France-based biopharmaceutical company developing treatments for metabolic disorders, have signed a development and license agreement for imeglimin, Poxel’s investigational oral therapy for treating Type II diabetes.

This partnership enables Roivant to add a late-stage development program to its pipeline and gives Poxel a development and licensing agreement for imeglimin beyond the company’s partnership with Sumitomo Dainippon Pharma, an Osaka, Japan-headquartered pharmaceutical company. The agreement is expected to bring the drug to the US, Europe, and all other countries not covered by Poxel’s existing agreement in east and southeast Asia.

Under the agreement, 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 EUR 8.5 per share ($10.5). Poxel is 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 commercialization of imeglimin. Furthermore, after launch, Poxel will be entitled to double-digit royalties on net sales. Roivant will be responsible for development and commercialization costs and Poxel will contribute $25 million to the development program. The parties will decide on a potential co-promotion prior to commercialization.

Activities in 2018 to support initiation of the Phase III program will include differentiation studies to confirm imeglimin’s potential in sensitive patient populations, such as those with chronic kidney disease, as well as manufacturing of the drug product for use in the Phase III program. The goal is to initiate the Phase III program in the US and Europe in 2019. Imeglimin has completed Phase I and Phase II development in 18 clinical studies involving over 1,200 subjects with Type II diabetes in the US, Europe, and Japan, and met its primary and secondary endpoints, according to Poxel.

Source: Roivant Sciences