Eagle Pharmaceuticals, Inc. has licensed rights to SymBio Pharmaceuticals Limited under Eagle’s intellectual property to develop, market and sell Eagle’s bendamustine hydrochloride (bendamustine HCl) ready-to-dilute (RTD) and rapid infusion (RI) injection products in Japan.

SymBio will be responsible for securing regulatory approval of the RTD and RI injection products using the licensed technology in Japan with a target for approval of a product in 2020.

SymBio currently markets TREAKISYM in Japan, a lyophilized powder formulation of bendamustine HCl indicated for chronic lymphocytic leukemia (CLL); relapsed or refractory low-grade Hodgkin’s lymphoma (NHL); mantle cell lymphoma (MCL); and as a first line treatment of low-grade NHL and MCL.

According to SymBio, 12-month sales ended June 30, 2017 in Japan for TREAKISYM were $52 million, due to the approval of first line treatment for NHL and MCL in December 2016. SymBio has estimated that sales of TREAKISYM are estimated to grow to $90 million in 2018.

A 50 ml RI or rapid infusion presentation of bendamustine hydrochloride injection is currently marketed in the U.S. by Teva Pharmaceutical Industries, Ltd. as BENDEKA (bendamustine HCl) Injection.

BENDEKA currently has a 97 per cent market share of the bendamustine market, and Teva has forecasted the North American market for bendamustine to be approximately $600 - $660 million in sales in 2017. BENDEKA’s low volume infusion and short infusion time represents an important benefit to both patients and healthcare providers.