On March 30, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that its marketing partner SymBio Pharmaceuticals Limited ("SymBio") has completed patient enrollment in a clinical trial for TREAKISYM rapid infusion ("RI"), a liquid bendamustine injection with a 10-minute administration time, in Japan (Press release, Eagle Pharmaceuticals, MAR 30, 2020, View Source [SID1234555980]). The study’s primary objective is to confirm the safety of the RI product. SymBio expects to obtain regulatory approval in the second half of 2022.
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SymBio intends to submit a New Drug Application ("NDA") for the RI product for all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). As previously disclosed, SymBio filed an NDA for its TREAKISYM ready-to-dilute ("RTD") product in October 2019.
In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of TREAKISYM in Japan. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI injection products using the licensed technology in Japan.
Pursuant to the terms of the license with SymBio, Eagle received a $12.5 million upfront milestone payment in 2017, and is entitled to additional milestone payments, including $5 million upon approval of an NDA for either TREAKISYM RTD or RI, and other amounts upon achievement of cumulative sales thresholds. Eagle will also receive royalties on future net sales of the licensed bendamustine products.
According to SymBio, sales in Japan for TREAKISYM were $78 million in 2019.
"SymBio continues to make excellent progress in advancing TREAKISYM RTD and RI for approval in Japan as evidenced by the completion of enrollment of the safety study for the RI product. With anticipated future approvals for both the TREAKISYM RTD and RI products, we look forward to SymBio’s successful commercialization in Japan, allowing patients to benefit from these products’ key advantages," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.