Nordic Pharma Group gets ex-Japan rights to Nippon Kayaku's on Spanidin

Privately-held France-headquartered Nordic Pharma Group (Nordic) has signed a licensing agreement for exclusive rights to development and commercialize Japanese firm Nippon Kayaku’s (NK: 4272: JP) Spanidin (gusperimus) in selected territories outside of Japan, including Europe.

Spanidin is an immunosuppressive agent developed and commercialized in Japan by NK in acute and accelerated rejection crisis after renal transplantation. The product has obtained promising results and orphan medicinal product status in Europe for the treatment of Wegener's granulomatosis. WG is a form of primary systemic vasculitis, with granulomatous inflammation involving the respiratory tract together with a necrotising vasculitis affecting small to medium sized vessels. The drug was approved by Japanese regulators at the end of 1993.

Under the deal, financial terms of which were not disclosed, Nordic will design and execute the global clinical development of Spanidin, which includes a pivotal, comparative Phase III study for patients suffering from WG relapse. Nordic will also be responsible for the regulatory filing and commercialization of the product in the relevant countries. NK will ensure production of the active ingredient until registration and beyond.