Poxel finds U.S., European partner for imeglimin

Poxel S.A. (Euronext:POXEL) added €0.65 (10%) to €6.87 on Monday after granting Roivant Sciences GmbH (Basel, Switzerland) rights to late-stage Type II diabetes candidate imeglimin (PXL008). Poxel will receive an upfront payment of $35 million and is eligible for up to $600 million in development, regulatory and sales-based milestones, plus double-digit royalties. Concurrently, Roivant will invest €12.2 million ($14.9 million) in Poxel through the purchase of 1.4 million new shares at €8.50. The price is a 37% premium to Poxel's close of €6.22 before the deal was announced

Poxel will contribute $25 million to imeglimin's development program, and Roivant will be responsible for development and commercialization. The companies may add co-promotion rights.

Roivant gains rights to imeglimin in the U.S., Europe and all other countries outside of Poxel's partnership with Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506). The pharma has rights to the candidate in Japan, China, South Korea, Taiwan and nine Southeast Asian countries under a 2017 deal (see BioCentury Extra, Oct. 30, 2017).

Poxel and Sumitomo are evaluating imeglimin in the Japanese Phase III TIMES I trial to treat Type II diabetes. An NDA submission to Japan's Ministry of Health, Labour and Welfare (MHLW) is expected in 2020.

This year, Poxel and Roivant intend to evaluate imeglimin to treat sensitive patient populations, including those with chronic kidney disease (CKD), in preparation for a Phase III program slated to begin next year in the U.S. and Europe.

Imeglimin is an inhibitor of mitochondrial permeability transition pore (mPTP) opening.