Poxel S.A. announced with its partner, Sumitomo Dainippon Pharma, that the product launch of TWYMEEG® (Imeglimin hydrochloride), 500mg tablets for the treatment of type 2 diabetes in Japan, is planned for September 16, 2021. TWYMEEG is Poxel's first product to reach commercialization and Japan is the first country where the product has been approved. Poxel has received a milestone payment of JPY 1.75 billion (EUR 13.2 million, USD 15.8 million) from Sumitomo in July for the approval of TWYMEEG.

Additionally, as part of the license agreement with Sumitomo, Poxel is entitled to receive escalating double-digit royalties on net sales (based on Poxel's current forecast) and sales-based payments of up to JPY 26.5 billion (approximately EUR 200 million, USD 230 million) in accordance with sales goals. TWYMEEG is a drug with a unique dual mechanism of action for the treatment of type 2 diabetes across the continuum of the current treatment paradigm. It has been approved as a monotherapy and as an add-on treatment to other glucose lowering therapy regimens.

The product launch follows the approval by the Japanese regulatory agency in June of this year, which was based on positive results from various preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by Poxel and Sumitomo. The program included three pivotal trials to evaluate TWYMEEG's efficacy and safety in over 1,100 patients. TWYMEEG met its primary endpoints and objectives, exhibiting a favorable safety and tolerability profile.