"Ono Pharmaceutical Co., Ltd., one of the largest pharmaceutical companies in Japan, announced that it has entered into a basic agreement with Seikagaku Corporation related to co-development and marketing collaboration on Gel-One under development by Seikagaku for the treatment of osteoarthritis in Japan. The companies will further discuss to sign a definitive agreement on Gel-One.
In Japan, three phase III clinical studies are underway, a study for osteoarthritis of the knee, a study for osteoarthritis of the hip, and a long-term safety study for both joints. The companies are committed to facilitating these clinical studies as quickly as possible to obtain an approval for manufacturing and marketing authorization for the product at an earlier date.
Gel-One is an intra-articular injection whose main ingredient is a cross-linked hyaluronate, utilizing Seikagaku’s unique cross-linking technology. Since Gel-One remains in the joint for a long period of time, a single injection of Gel-One is expected to provide long-term pain relief. The product has been available in overseas markets since 2012 as Gel-one (US) and HyLink (Taiwan and Italy) indicated for osteoarthritis of the knee. Additionally, whereas the indication for Gel-One in overseas markets is the knee joint, in Japan, Seikagaku will concurrently conduct a study of Gel-One for osteoarthritis of the hip alongside the knee study with the aim of expanding the target patient population.
Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery.