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Product / Company Performance

Seikagaku and Ono Announce Positive Study Results -

Seikagaku and Ono Pharmaceuticals obtained positive topline results from a Phase III confirmatory study of ONO-5704/SI-613 in the treatment of knee osteoarthritis (OA). The combination of hyaluronic acid (HA) and an NSAID addresses pain and inflammation through a 3-injection regimen. Ono and Seikagaku formed a preliminary collaboration to co-develop and market the product in 2Q17, which became a definitive agreement later in the year. Two other Phase III studies are underway with the HA/NSAID formulation, including a study of OA in the shoulder, elbow, hip and ankle and a long-term study in OA patients to evaluate safety. This randomized, double-blind, placebo-controlled, parallel-group comparative study involved 440 patients with knee OA. ONO-5704/SI-613 demonstrated a statistically significant improvement in knee pain scores vs. placebo at 12 weeks after the initial injection, with no major safety concerns observed in the ONO-5704/SI-613 group. Ono and Seikagaku plan to file for manufacturing and marketing approval in 1H20, after evaluation of data from all three studies. (Seikagaku Corp., 2/19/19)