Firm will carry out Phase III study in Wegener granulomatosis.
Nordic Pharma has negotiated exclusive rights to develop and commercialize Nippon Kayaku’s Spanidin® (gusperimus) immunosuppressant in Europe and certain other territories outside Japan. The drug has been available in Japan since the 1990s for use in acute and accelerated rejection crisis after renal transplantation.
Orphan medicinal product status has been granted in Europe for the treatment of Wegener granulomatosis (WG). Under terms of the licensing deal Nordic will design and carry out global clinical development of Spanidin, including a pivotal Phase III study in patients suffering from WG relapse. The firm will also be responsible for the regulatory filing and commercializing the product in its designated territories. It points out there is no currently approved therapy for treating relapsing WG.
Nippon Kyaku has previously had a shot at achieving marketing approval for Spanidin in Europe for the treatment of WG. However, the firm withdrew its Marketing Authorization Application in 2008.