By: IPP Bureau
Last updated : August 03, 2021 7:04 pm
The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies
POXEL , a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders including type 2 diabetes and non-alcoholic steatohepatitis (NASH), and Sumitomo Dainippon Pharma has announced that a new drug application for TWYMEEG Tablets 500mg3, for the treatment of type 2 diabetes, has been approved in Japan.
The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by Poxel and Sumitomo Dainippon Pharma, which included three pivotal trials to evaluate TWYMEEG’s efficacy and safety in over 1,100 patients. In all three trials, TWYMEEG met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.
"The TWYMEEG approval in Japan represents a major milestone for Poxel and the culmination of several years of clinical development work. This approval is a strong validation of our R&D capabilities and the international footprint that we have established. Our vision as a company is focused on developing and commercializing innovative drugs for metabolic diseases,” said Thomas Kuhn, CEO, Poxel.
“Going forward, we’ll continue to support Sumitomo Dainippon Pharma in establishing TWYMEEG as a key treatment for type 2 diabetes in Japan, and in other countries where Sumitomo Dainippon Pharma has the rights to the product,” added Kuhn.
The approval triggers a JPY1.75 billion (approximately EUR13.3 million, US $15.9 million) milestone payment to Poxel. Furthermore, after product launch, Poxel is entitled to receive escalating double-digit royalties on net sales and sales-based payments of up to JPY26.5 billion (approximately EUR200 million, USD230 million) in accordance with sales goals.
“We believe TWYMEEG is an important addition to our existing diabetes franchise through its differentiated dual mechanism of action and favorable efficacy and safety profile. This approval of TWYMEEG allows us to provide patients with type 2 diabetes the opportunity for greater flexibility in their treatment regimens,” said Koichi Kozuki, Executive Officer, Drug Development Division of Sumitomo Dainippon Pharma.
“We are committed to delivering new therapeutic options to help patients manage their disease,” added Kozuki.