PARIS, December 22, 2010 /PRNewswire/ -- Nippon Kayaku (NK) and the Nordic Pharma Group (Nordic) have signed a licensing agreement under which NK grants exclusive rights to NORDIC for the development and commercialisation of Spanidin(R) (gusperimus) in selected territories outside of Japan, including Europe.
Spanidin(R) is an immunosuppressive agent developed and commercialised 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).
Under this agreement, Nordic will design and execute the global clinical development of Spanidin(R), which includes a pivotal, comparative Phase III study for these patients suffering from WG relapse. Nordic will also be responsible for the regulatory filing and commercialisation of the product in the relevant countries. NK will ensure production of the active ingredient until registration and beyond.
Spanidin(R) has the potential to offer a treatment for relapsing WG patients, who currently have no approved drug to cure their disease.
With this new agreement, Nordic is actively pursuing its strategy to bring innovative drugs to the market in specialized therapeutic areas that have specific, unmet medical needs.