WOODCLIFF LAKE, NJ, USA I May 20, 2015 I Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its novel ready-to-use bivalirudin product (“RTU bivalirudin”).

This product is a stable liquid intravenous formulation of bivalirudin, the same active ingredient as in The Medicine Company’s Angiomax® (bivalirudin). U.S. sales of Angiomax were approximately $600M for the twelve months ended December 31, 2014.

This 505(b)(2) NDA requests FDA approval of Eagle’s RTU bivalirudin product for the treatment of patients: (1) undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). RTU bivalirudin is intended for use with aspirin.

“Our RTU bivalirudin product contains the same active ingredient and is dosed as an IV solution at the same dose and rate as Angiomax,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “Furthermore, our liquid formulation will allow for immediate administration, with no reconstitution nor initial dilution required, reducing work flow and the risk of dosing errors. We believe these attributes of our formulation can be clinically significant in critical care situations. We look forward to continuing to work closely with the FDA through the review process.”

Eagle’s intellectual property pertaining to RTU bivalirudin includes two issued patents and an additional patent pending at the U.S. Patent and Trademark Office.

About Eagle Pharmaceuticals, Inc.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA’s 505(b)(2) regulatory pathway. Additional information is available on the company’s website at www.eagleus.com.

SOURCE: Eagle Pharmaceuticals