Australian regenerative medicine company, Regeneus (ASX: RGS), has announced that Kyocera has signed a licence agreement to develop and commercialise Progenza for knee osteoarthritis in Japan.
Progenza OA (knee osteoarthritis) has completed a phase one study that met safety and efficacy endpoints.
The company said the study demonstrated that a single injection of Progenza OA into the knee was safe, tolerable and showed significant, rapid and sustained reductions in knee pain for osteoarthritis patients.
The newly announced licence and collaboration agreement follows the signing of a memorandum of understanding (MOU) in March 2020.
Under the agreement, Regeneus grants a licence enabling Kyocera to exclusively develop and commercialise Progenza OA, including technology transfer and joint research on the treatment for Japan.
Kyocera also has right of first refusal for other indications inside and outside of Japan. Regeneus retains the rights to license indications other than knee osteoarthritis with other parties in Japan.
Regeneus will receive US$19 million in upfront and milestone payments from Kyocera. The payments consist of US$9 million upfront payment and US$10 million in regulatory and development milestone payments.
The company said it will also receive single to high double-digit royalties on all future Progenza OA product sales in Japan based on future reimbursement prices.
Kyocera will be responsible for product development, manufacturing and regulatory activities in Japan.
“This agreement with Kyocera is an exciting development for Regeneus and is an endorsement of our Progenza platform technology. It provides a clear commercialisation pathway for Progenza and is a significant market given osteoarthritis potentially affects more than 25.6 million people in Japan alone5,” said Regeneus CEO Leo Lee.
“We look forward to working with Kyocera to take Progenza OA through the commercialisation process.”