On May 10, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that TREAKISYM RI (50ml) liquid formulation has been filed with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, MAY 10, 2021, View Source [SID1234584740]).

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The application is based on the results of clinical studies investigating the safety and pharmacokinetics of TREAKISYMRTD administered by 10-minute intravenous infusion.

"We are pleased that the RI application has been submitted ahead of schedule, which will enable patients and providers alike to reap the benefits of this formulation. We believe we can get close to peak income of $20-$25 million as early as next year from the RTD and RI products. This is an important extension of the bendamustine franchise, and we value the relationship with Symbio," stated Scott Tarriff, Chief Executive Officer.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name 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.

TREAKISYM RI has the advantage of reducing infusion time to 10 minutes (from the current 60 minutes), eliminating the need for manual reconstitution and significantly reducing preparation time, benefitting both patients and healthcare providers.