Eagle Pharma Says FDA Grants Orphan Drug Status For Bendamustine HCL

(RTTNews) - Eagle Pharmaceuticals Inc. (EGRX) said the United States Food and Drug Administration has granted orphan drug designation to bendamustine hydrochloride, a ready-to-dilute concentrate solution for injection.

The injection will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride or a saline / dextrose mixture, for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma.

Following the orphan drug designation, Eagle is eligible to receive tax incentives and Prescription Drug User Fee Act fee savings. It may receive seven years of marketing exclusivity.

The currently marketed bendamustine HCI product, Treanda, is a lyophilized powder requiring reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for chronic lymphocytic leukemia and 60 minutes for non-Hodgkin's lymphoma.

Treanda is manufactured by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.

Eagle is currently engaged in litigation defending a patent claim filed by Teva Pharmaceuticals in connection with the 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.

EGRX, which closed up around 2 percent on Monday at $14.42, gained about 2 percent in pre-market activity.