Regeneus (ASX:RGS), a clinical-stage regenerative medicine company, has entered into a strategic collaboration and licensing agreement with AGC Asahi Glass (AGC) (TYO:5201), a world-leading manufacturer of glass, chemicals, high-tech materials and biopharmaceuticals, for the manufacture, clinical development and commercialisation of Progenza, a patented off-the-shelf stem cell technology platform, for the Japanese market.
Under the terms of the agreement, Regeneus has granted AGC exclusive rights to manufacture Progenza in Japan and a 50 per cent interest in Regeneus Japan, which has the exclusive rights for the clinical development and commercialisation of Progenza in Japan for osteoarthritis and all therapeutic applications.
Regeneus will receive US$16.5 million from AGC, with US$5.5 million as an upfront payment and the remaining US$11 million in specific development and approval milestone payments.
The company will also be entitled, through its 50 per cent interest in the joint venture, to a share of upfront licence fees, milestone payments and royalties from sub-licensing the development and commercialisation of Progenza for osteoarthritis and all other clinical indications in Japan.
AGC will be responsible for funding the manufacture of Progenza for the proposed Phase 2 trial for osteoarthritis in Japan under specific conditions.
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 company said study results will be made available in the second quarter of 2017.
The joint venture will take over the current partnering discussions for the clinical development and commercialisation of Progenza for knee osteoarthritis and other inflammatory disorders in Japan. The parties will collaborate to manufacture Progenza for the proposed Phase 2 trial in Japan and regulatory engagement. AGC will be responsible for the costs associated with the manufacture of the trial product under certain conditions.
John Martin, CEO of Regeneus, said: “We are excited to announce our collaboration with AGC. AGC is a world-class technology driven multinational company headquartered in Tokyo with a clear vision and strategic priority to grow its life science business. This makes AGC an ideal fit for us to manufacture and jointly develop and commercialise Progenza stem cell technology in Japan through clinical marketing partners. As a leading manufacturer of biopharmaceutical products in Japan with recent acquisitions of manufacturing capability in Europe and the USA, AGC is well placed to expand into the fast growing market for manufacturing regenerative medicine products. We look forward to having Progenza manufactured by AGC in Japan and the value AGC will bring to accelerate clinical development of Progenza through its extensive relationships with Japanese pharmaceutical companies, regulators and local market knowledge."