Regeneus (ASX:RGS) has entered into a strategic collaboration and licensing agreement for the manufacture, clinical development and commercialisation of Progenza in the Japanese market.
Progenza is a patented off-the-shelf stem cell technology developed for the treatment of knee osteoarthritis and other inflammatory conditions.
Regeneus has entered the agreement with Asahi Glass Co (TYO:5201), a world-leading manufacturer of glass, chemicals, high-tech materials and biopharmaceuticals.
Under the agreement, Regeneus will received US$16.5 million from Asahi Glass in exchange for exclusive manufacturing rights in Japan and a 50% interest in Regeneus Japan.
Asahi Glass will be responsible for funding the manufacture of Progenza for the proposed Phase 2 trial for osteoarthritis in Japan under specific conditions.
The market in Japan for regenerative medicines is projected to grow to US$12.7billion by 2030 according to the Japanese government.
John Martin, CEO, commented:
"As a leading manufacturer of biopharmaceutical products in Japan with recent acquisitions of manufacturing capability in Europe and the U.S, Asahi Glass is well placed to expand into the fast growing market for manufacturing regenerative medicine products."
Terms of agreement
As per the agreement, Regeneus is to receive US$16.5 million comprised of $5.5 million upfront and US$11 million in specified milestone payments.
This will see Regeneus and Asahi Glass establish a 50/50 joint venture for exclusive clinical development and commercialisation of Progenza for osteoarthritis and all inflammatory conditions for the Japanese market.
Regeneus will also be entitled, through its 50% interest in the joint venture, to its share of upfront licence fees, milestone payments and royalties from any sub licensing.
Regeneus is an emerging leader in cell based medicines for both humans and animals.
It is a clinical-stage regenerative medicine company with a focus on osteoarthritis and other musculoskeletal disorders, oncology (cancer) and dermatology diseases.
Over the last 12 months, Progenza has been evaluated as a treatment for knee osteoarthritis in a Phase 1 trial conducted in Sydney.
A safety review of both treatment cohorts found there were no safety or tolerability concerns with Progenza.
All patients are being followed for 12 months and the study results will be made available in the second quarter of 2017.