Eagle Pharmaceuticals’ Japanese Licensing Partner SymBio Announces its Submission of a New Drug Application for TREAKISYM® Ready-To-Dilute Formulation

On October 7, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that its marketing partner SymBio Pharmaceuticals Limited ("SymBio") has submitted a New Drug Application ("NDA") for TREAKISYM ready-to-dilute ("RTD") liquid formulation in Japan (Press release, Eagle Pharmaceuticals, OCT 7, 2019, View Source [SID1234540084]). The NDA covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). SymBio expects to launch the TREAKISYM RTD product in the first quarter of 2021, after obtaining marketing authorization.

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In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and rapid infusion ("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 the NDA, 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 2018 and $77 million through June 30, 2019.

"We are pleased that SymBio has made great progress in advancing TREAKISYM toward regulatory approval in Japan. We look forward to SymBio’s future approval and successful commercialization of bendamustine HCI in Japan, enabling patients there to benefit from TREAKISYM’s key advantages," stated Scott Tarriff, Chief Executive Officer.