Histogenics (HSGX) entered into an agreement with MEDINET to develop and commercialize NeoCart® cell therapy in Japan. Terms include a US $10MM upfront payment to HSGX, with ~$77MM in potential milestones and future royalty payments. The activity supports HSGX's plans to expand its territories in Asia and Europe in 2018.
NeoCart is an autologous cell therapy for the treatment of knee cartilage defects that would be regulated as a Regenerative Medical Product in Japan. HSGX will manufacture the product in the U.S. and supply the implant to MEDINET, which brings established regional capabilities in development and manufacturing of cell therapies.
MEDINET will run a 30-patient, 1-year clinical trial in Japanese patients, comparing NeoCart to microfracture; enrollment is slated to start in 2H18. Data from this and from a 245-patient U.S. Phase III clinical trial will be submitted to apply for Marketing and Manufacturing Authorization in Japan. Commercialization could commence in 2021.
In its observations on the Japan cartilage repair market, HSGX cites the potential for at least 10,000 NeoCart treatments per year. Results of a 1H17 regional survey of 80 orthopaedic surgeons revealed:
- ~60% of patients with knee cartilage defects are either not treated, or are treated solely for temporary pain relief
- ~60% to 70% of patients with knee cartilage defects that are left untreated will likely progress to knee osteoarthritis
- >85% of responding surgeons reported dissatisfaction with current options to treat knee cartilage defects
- ~80% of surgeons consider early improvement in pain and function to be important, and more than half would prescribe NeoCart based on published data
Sources: Histogenics Corporation; ORTHOWORLD Inc.