Treanda endamustine regulatory update

Teva said FDA granted Orphan Drug exclusivity for Treanda bendamustine through October 2015 for indolent B cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. With the pediatric exclusivity, Treanda has exclusivity in the indication through April 2016. Treanda already has Orphan Drug exclusivity and pediatric exclusivity for chronic lymphocytic leukemia (CLL) until Sept. 20, 2015. Cephalon Corp., which Teva acquired, markets Treanda in the U.S. for the indications.

Astellas granted rights to bendamustine to Cephalon in North America, to Mundipharma in Europe and to SymBio in Japan, China, Korea, Taiwan and Singapore. Cephalon granted exclusive rights to bendamustine in Canada to H. Lundbeck, while SymBio granted exclusive rights to the product in Japan, South Korea and Singapore to Eisai and in Taiwan to InnoPharmax. Eisai markets the product in Japan as Treakisym to treat low-grade B cell NHL and mantle cell lymphoma (MCL) and as Symbenda in Singapore to treat low-grade NHL. Mundipharma markets it as Ribomustin in Germany to treat CLL, NHL and multiple myeloma (MM). ...