Dainippon will retain Japanese rights to the drug and co-promote the compound with Eisai in major countries.
AS-3201 is designed to improve the symptoms of diabetic neuropathy, a common complication of diabetes, by suppressing the accumulation of sorbitol within cells through strongly inhibiting aldose reductase.
It is estimated that the population with diabetic neuropathy is 3.6 million in the US, 2.6 million in the five major European countries and 1.7 million in Japan.
Dainippon Pharmaceutical has been developing AS-3201 on its own as a global strategic product, aiming at an early application for approval. The company is currently conducting phase III clinical trials in the US and Canada, and phase II trials in Japan in collaboration with Kyorin Pharmaceutical.
In close coordination with Dainippon Pharmaceutical, Eisai will continue the development currently being conducted by Dainippon Pharmaceutical and plans to submit marketing applications in the US and other countries.