Biopharmaceutical company POXEL SA (Euronext:POXEL - FR0012432516) said on Friday that its partner, Sumitomo Dainippon Pharma, plans to launch TWYMEEG (Imeglimin hydrochloride) 500mg tablets for the treatment of type 2 diabetes in Japan on 16 September 2021.

TWYMEEG, which is Poxel's first product to reach commercialization and Japan is the first country where it has been approved, has received a milestone payment of EUR13.2m from Sumitomo in July for the approval of TWYMEEG.

Under a license agreement with Sumitomo, Poxel is entitled to receive escalating double-digit royalties on TWYMEEG's net sales and sales-based payments of up to approximately EUR200m in accordance with sales goals.

In October 2017, Poxel and Sumitomo entered into a strategic partnership for the development and commercialization of TWYMEEG in Japan, China, South Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore, Myanmar, Cambodia and Lao.

Imeglimin is the first agent in a new chemical class of tetrahydrotriazine-containing molecules. It is thought that TWYMEEG shows a glucose lowering effect by both a pancreatic action that promotes glucose concentration-dependent insulin secretion and an extra-pancreatic action that improves glucose metabolism in the liver and skeletal muscle through an action on mitochondria, added the company.

The product launch follows the approval by the Japanese regulatory agency based on the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) programme managed by Poxel and Sumitomo. The programme included three pivotal trials to evaluate TWYMEEG's efficacy and safety in over 1,100 patients. The medicine met its primary endpoints and objectives, exhibiting favourable safety and tolerability profile.