Japan Update

Monday, 17 October 2016

Regeneus Ltd (ASX: RGS), a clinical-stage regenerative medicine company, announced today that it was on track to complete its first significant manufacturing and development collaboration with a Japanese partner for its Progenza stem cell technology in Japan. The company had disclosed that it anticipated completing the collaboration before the end of the first quarter in FY17 but unexpected delays in the sign off process has impacted completion. The company is confident of completing and announcing the collaboration shortly.

The company has just completed a week of presentations and business meetings in Japan where it presented at FIRM’s Regenerative Medicine Crossroad conference in Tokyo and attended BioJapan in Yokohama. FIRM, the Forum for Innovative Regenerative Medicine, is the peak industry body in Japan.

“We were very encouraged by the quality of the parties interested in our technologies and clinical assets and hope to convert this interest into partnering opportunities for Japan” said Regeneus CEO, John Martin. “Japan is clearly leading the world in the regenerative medicine space. Almost all the major transactions in our market over the last 18 months have involved a Japanese company. The rapid emergence of this market activity in Japan has been driven by a strategic change to the regulatory environment in late 2014. The new laws, designed to enhance the development of the regenerative medicine market, allow for a significantly shorter approval process for patient access and commercialisation of new cell therapies,” said Mr Martin.

The market in Japan for regenerative medicine is projected to grow to US$12.7bn by 2030 according to the Japanese government.

Since the change in regulatory environment, Regeneus has targeted the Japanese market for its Progenza allogeneic stem cell therapy for osteoarthritis. The company plans to conduct a Phase 2 trial for Progenza for OA in Japan. Regeneus is in active discussions with potential Japanese manufacturing, clinical development and marketing partners for Progenza.