Updated on 2 May 2016
Japanese firms Chugai Pharmaceutical Co Ltd and TWO CELLS Co Ltd have signed a licensing agreement to develop gMSC1, a regenerative cellular medicine for chondrogenesis in the knee.
gMSC1 is a tissue-engineered medical product currently developed by TWO CELLS and was created for the purpose of regenerative chondrogenesis using synovium-derived mesenchymal stem cell (MSC).
Under the license agreement, Chugai will obtain joint development and exclusive distribution rights of gMSC1 in Japan, and also, reserve preferential negotiating rights for overseas. In return for this license agreement, TWO CELLS will receive an upfront fee, milestone and royalty payments from Chugai.
This agreement obligates TWO CELLS to conduct clinical studies intended to obtain the initial approval in Japan, and manufacture and supply gMSC1. Meanwhile, Chugai will take advantage of its clinical development experience, and proceed with clinical development in cooperation with TWO CELLS. At the same time, Chugai shall be responsible for filing regulatory approval, marketing and clinical studies after the initial approval.
"We are pleased to conclude this license agreement with TWO CELLS on gMSC1, an innovative regenerative cellular medicine for chondrogenesis in the knee," said Tatsuro Kosaka, President and COO of Chugai. "Chugai strongly believes that this product contributes to the treatment of diseases attributable to traumatic knee cartilage injuries."