July 8, 2014
Eagle Pharmaceuticals Inc. (“Eagle” or “the Company”) announced today that the United States Food and Drug Administration (“FDA”) has granted orphan drug designation to bendamustine hydrochloride (“HCl”), a ready-to-dilute concentrate solution for injection that will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride (“saline”) or a saline / dextrose mixture, for the treatment of chronic lymphocytic leukemia (“CLL”) and indolent B-cell non-Hodgkin’s lymphoma (“NHL”).
Pursuant to the orphan drug designation, Eagle is eligible to receive tax incentives and Prescription Drug User Fee Act (“PDUFA”) fee savings, and believes it may receive seven years of marketing exclusivity.
“We are pleased to have received orphan drug designation from the FDA as we advance the development pathway of bendamustine hydrochloride. We received tentative approval for our bendamustine hydrochloride ready-to-dilute (500mL) product on July 2nd, 2014. We believe the shorter infusion time afforded by this 50mL product will greatly benefit patients and healthcare providers alike in the treatment of CLL and NHL,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals Inc. “In the interim, we continue to advance the clinical trial for this low-volume, short infusion time bendamustine product.”
The currently marketed bendamustine HCI product, Treanda, which is manufactured by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., is a lyophilized powder requiring reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for CLL and 60 minutes for NHL.
Eagle is currently engaged in litigation defending a patent claim filed by Teva Pharmaceuticals in connection with our tentatively approved New Drug Application. The U.S. Patent and Trademark Office has issued patent 8,609,707 for Eagle’s unique formulation of Bendamustine Hydrochloride Injection.
Eagle Pharmaceuticals Inc. is a specialty pharmaceutical company focused on developing and commercializing injectable products utilizing the FDA’s 505(b)(2) regulatory pathway. The Company develops products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. For further information: http://www.eagleus.com