Saturday, September 11, 2021
POXEL SA, a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders, today announced with its partner, Sumitomo Dainippon Pharma, that the product launch of TWYMEEG®1 (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 JPY1.75 billion (EUR13.2 million, USD15.8 million)2 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 JPY26.5 billion (approximately EUR200 million, USD230 million)3 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 and nine other Southeast Asian countries (Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore, Republic of the Union of Myanmar, Kingdom of Cambodia and Lao People's Democratic Republic).
TWYMEEG is a first-in-class 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.
“We are immensely proud to have brought TWYMEEG to patients in Japan through our fruitful partnership with Sumitomo, a global leader in the diabetes field. This launch speaks volumes to our ability to develop and commercialize innovative drugs for metabolic diseases,” said Thomas Kuhn, CEO of Poxel. “Harnessing the momentum of this achievement, we will continue increasing our focus on rare metabolic disease programs to complement our NASH pipeline, accelerating and expanding upon our existing platforms and proven capabilities. Our mission of bringing innovative therapeutics to patients living with metabolic diseases remains unchanged and our recent achievements underscore our ability to deliver on our goals.”