Sumitomo Dainippon Pharma Co., Ltd (Osaka, Japan) and POXEL SA (Lyon, France), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes, announced the signing of a strategic partnership for the development and commercialization of Imeglimin, an investigational therapeutic agent for type 2 diabetes, in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.
The partnership enables Sumitomo Dainippon Pharma to add an innovative late-stage development product to its well established diabetes drug franchise in the fast-growing diabetes market in Japan. Poxel also gains a leading pharmaceutical partner for Imeglimin with an extensive track record in late-stage development and commercialization in Asia. Diabetes is a fast-growing market in Asia and Japan is the second largest single market for type 2 diabetes.
“This is a major milestone for Poxel and for the development of Imeglimin and we are extremely pleased to announce this strategic collaboration with Sumitomo Dainippon Pharma. Given Imeglimin’s unique profile and novel mechanism of action, which we believe is well-suited for Asian patients, it has the potential to be a very important new oral therapy for the treatment of type 2 diabetes. With their very long and successful history of commercializing diabetes products and as a leader in this region with a dedicated franchise, Sumitomo Dainippon Pharma will be an excellent partner for Imeglimin in Asia,” said Thomas Kuhn, CEO of Poxel.
“In-licensing new products is part of a strategy to strengthen the domestic revenue base. Diabetes is one of our focus therapeutic areas for sales and marketing and we have a diverse type 2 diabetes product line with different mechanisms of action,” said Masayo Tada, Representative Director, President and CEO of Sumitomo Dainippon Pharma. “We see an opportunity to further strengthen our product line by developing Imeglimin as a candidate compound for treatment of type 2 diabetes with a new mechanism of action. Our hope is that the development and launch of Imeglimin will provide type 2 diabetes patients not only in Japan, but in other Asian countries, a treatment option to help them manage their disease.”
Poxel recently met with the Pharmaceuticals and Medical Devices Agency (“PMDA”) in Japan for the Imeglimin end of Phase 2 meeting to discuss the Phase 3 program plans and the data package required for a Japanese New Drug Application (“JNDA”) submission. Based on constructive interactions and feedback from the PMDA, the Phase 3 program in Japan will include three pivotal studies with approximately 1,100 patients and is on track to be initiated by the end of 2017.
Imeglimin has demonstrated in preclinical studies the potential to address the mitochondrial dysfunction which is believed to be at the core of type 2 diabetes pathophysiology. Imeglimin is an orally available drug candidate that has been shown in clinical studies to demonstrate glucose lowering benefits by simultaneously targeting all three key organs which play an important role in the treatment of type 2 diabetes: the liver, muscles and the pancreas. Imeglimin has completed Phase 1 and Phase 2 development in over 1,200 subjects in the U.S., EU and Japan.