FDA grants orphan drug status to Eagle’s bendamustine HCl to treat CLL and NHL

Bendamustine hydrochloride is 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.

Pursuant to the orphan drug designation, the company 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.

Eagle Pharmaceuticals president and chief executive officer Scott Tarriff said the company is happy to have received orphan drug designation from the FDA as it advances the development pathway of bendamustine hydrochloride.

"We received tentative approval for our bendamustine hydrochloride ready-to-dilute (500mL) product on July 2nd, 2014," Tarriff said.

"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.

"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 is Treanda and it is manufactured by Cephalon, a subsidiary of Teva Pharmaceutical Industries.

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 CLL and 60 minutes for NHL.

Currently, the company is engaged in litigation defending a patent claim filed by Teva Pharmaceuticals in connection with its tentatively approved NDA.

The US Patent and Trademark Office has issued patent 8,609,707 for the company’s unique formulation of Bendamustine Hydrochloride Injection.