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."
"We have been engaging in the developments of regenerative cellular medicine with strong will that TWO CELLS contributes to the treatment of many patients suffering from insusceptible disease, by using expanded mesenchymal stem cell (MSC) cultured with our serum free medium," said Ko-ichiro Tsuji, president & CEO of TWO CELLS. "The regenerative cellular medicine gMSC1 was developed under collaboration with Osaka University and Hiroshima University, with a slogan that Hiroshima will be one of the hubs for regenerative cellular medicine in the world, and it is the first allograft stem cell product developed from Hiroshima."
In June 2012, Chugai and TWO CELLS had previously concluded an agreement on Chugai's acquisition of new stocks issued by TWO CELLS, and an agreement for preferential negotiating rights on tissue-engineered medical products for chondrogenesis using synovium-derived MSC which has been developed by TWO CELLS. Also, in June 2014, Chugai and TWO CELLS concluded another agreement on Chugai's acquisition of new stocks issued by TWO CELLS, and amendment of the agreement for preferential negotiating rights, and have been preparing for the domestic development of tissue-engineered medical products for chondrogenesis in the knee.
This license agreement will enable Chugai and TWO CELLS to make a head start in materializing regenerative medicine for chondrogenesis in the knee using allogeneic synovium-derived MSC.
