The Waltham, Mass.-based company’s Neocart implant is designed to repair knee cartilage damage. The product is made using a patient’s own cells, harvested from the surface of the patient’s femur.
“This transformative collaboration for Histogenics is a clear validation of the value Neocart potentially provides to the physicians and patients who suffer from painful cartilage defects and related loss of function. Medinet is one of the leaders of the burgeoning regenerative medicine sector in Japan, with strong capabilities in development and manufacturing of cell therapy products. We believe their recent initiatives to further develop their therapeutic capabilities with the addition of innovative products such as Neocart will provide a rapid entry into the Japanese market,” president & CEO Adam Gridley said in prepared remarks.
“Our ability to leverage our long clinical and translational medicine history in the U.S. in markets such as Japan was a first step in bringing Neocart to other regions, and we look forward to expanding our global presence more broadly in 2018 into other potential territories in Asia and Europe.”
The Japan Pharmaceuticals and Medical Devices Agency has recommended that Histogenics conduct a one-year, 30-patient trial with Japanese patients, comparing Neocart to microfracture. Data from that trial, plus data from Histogenics’ Phase III trial in the U.S., would be enough to apply for full marketing authorization in Japan, the regulatory body said.
The cartilage repair market in Japan is the second largest market in the world, after the U.S., according to Histogenics.
“This licensing deal has been realized based on our longtime close relationship with Histogenics. I am excited about and proud of, the big challenge to enter into the regenerative medical product market with Neocart in collaboration with the excellent team of Histogenics,” Medinet CEO Yoshiji Kimura said. “We believe this restorative cell therapy will contribute to better treatment by the physicians and quality life, of the patients with knee cartilage defects in Japan.”