Benzinga | Sep 23, 2020 06:51AM EDT

Eagle Pharmaceuticals' Japanese Licensing Partner, SymBio, Receives Approval Of TREAKISYM Ready-To-Dilute Formulation, With Launch Expected In January 2021; Eagle To Receive $5M Milestone Payment

- Eagle to receive $5 million milestone payment -

- RTD and Rapid Infusion ("RI") formulations could generate $10 million - $25 million annually for Eagle -

Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that its marketing partner, SymBio Pharmaceuticals Limited ("SymBio"), has received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. The approval covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin's lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). Approval for the additional indication of r/r DLBCL is currently under review by the PMDA, which will create another large market opportunity beyond the current indications. As a result of the approval of TREAKISYM, Eagle will receive a $5 million milestone payment.

With this approval, SymBio will convert its current lyophilized formulation of TREAKISYM to the new RTD liquid formulation upon launch in January 2021.

In addition, SymBio is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation and will seek approval in the second half of 2022. Upon approval of the RI formulation, SymBio intends to convert from the RTD product to the new 50 ml liquid version licensed from Eagle. The RTD and RI liquid formulations bring key benefits to patients and healthcare providers in Japan by eliminating the need for manual reconstitution and significantly reducing preparation time.

"We are pleased that SymBio has received regulatory approval for TREAKISYM in Japan. SymBio is an innovator, and we look forward to their successful commercialization of the ready-to-dilute bendamustine product, enabling patients in Japan to benefit from TREAKISYM's key advantages. This approval represents another significant extension of the durability of this important franchise and the successful execution of our business development activities to bring value for Eagle and our shareholders," stated Scott Tarriff, Chief Executive Officer.

According to SymBio, sales in Japan for its current TREAKISYM product totaled $84.8 million in the twelve months ended June 30, 2020. Together, milestones and royalty payments for the RTD and RI formulations could generate from $10 million to $25 million annually for Eagle.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of TREAKISYM in Japan utilizing Eagle's proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

The $5 million milestone payment due upon approval of TREAKISYM RTD is in addition to a $12.5 million upfront milestone payment Eagle received upon execution of the agreement with SymBio. Eagle is entitled to royalties on future net sales and an additional milestone payment upon achievement of a cumulative sales threshold.