On 12 May, Seikagaku and Ono Pharmaceutical reached a basic agreement to co-develop and market SI-613 for the treatment of osteoarthritis (OA) in Japan, a partnership that could take the pipeline candidate beyond the Japanese market.
SI-613 is an intra-articular (IA) formulation of hyaluronic acid (HA) and a nonsteroidal anti-inflammatory drug (NSAID) that have been joined using Seikagaku’s proprietary technology. OA is a slowly progressive joint disease and a major cause of disability and pain amongst the elderly, second only to cardiovascular disease. NSAIDs are the most widely used second-line therapy for OA; however, oral NSAIDs are associated with a plethora of adverse events (AEs) and are often contraindicated for use in elderly. SI-613 has the potential to combine the localized anti-inflammatory benefits of NSAIDs with the joint-improving effects of HA, without the AEs associated with long-term systemic exposure to NSAIDs.
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In Japan, IA injections of HA are the preferred treatment option for OA, with the therapy highly rated by orthopedic surgeons. Therefore, SI-613 is a natural fit for the Japanese market, and GlobalData anticipates that SI-613 will enjoy commercial success upon its licensure. That being said, Seikagaku is a small company that lacks commercialization experience; therefore, a successful strategic partnership could greatly improve the commercial outlook of its IA injection. Ono Pharmaceutical’s experience has the potential to provide the missing link to the large-scale marketing of SI-613 in Japan, and globally.
The OA market is undergoing a long-overdue facelift, with novel analgesics—including anti-nerve growth factors (anti-NGFs) and disease-modifying OA drugs (DMOADs), such as TissueGene’s Invossa— forecast to enter the Japanese market in approximately six years. These products could potentially pose a threat to the long-term success of SI-613. Invossa is likely to be world’s first cell-based therapy for OA, and has been licensed to Mitsubishi Tanabe for development and marketing in Japan. As an IA injection with disease-modifying capabilities, Invossa has the potential to cast a hefty shadow over SI-613 when launched in Japan.
Nevertheless, SI-613 has successfully completed Phase II trials in Japan, and a Phase III study was initiated in February 2017 to verify the efficacy and safety of SI-613 in knee, ankle, elbow, and shoulder OA patients. Based on the review process by the Pharmaceuticals and Medical Devices Agency (PDMA), GlobalData estimates that the earliest SI-613 could gain approval in Japan is 2020, three years before Invossa.
With such a wide profile of OA patients, SI-613 has the potential to infiltrate untouched segments of the marketplace, as there are currently no drugs approved specifically for ankle, elbow, or shoulder OA patients, marking a substantial opportunity for Seikagaku and Ono Pharmaceutical.
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