WOODCLIFF LAKE, N.J.–May 19, 2015–Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. Patent No. 9,034,908, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes (the “rapid infusion” product). The patent issued today expires in March 2033.
The U.S. Food and Drug Administration (“FDA”) recently accepted for filing Eagle’s New Drug Application (NDA) for the rapid infusion bendamustine product. This NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The Prescription Drug User Fee Act (PDUFA) goal date for a decision on this NDA by the FDA is December 13, 2015.
“Today’s patent issuance further strengthens our intellectual property for our rapid infusion bendamustine product, and we anticipate additional patent issuances going forward,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “We look forward to the PDUFA date for the rapid infusion bendamustine product in December, and if approved we believe the additional milestone and royalty payments will expedite our ability to deliver long term, sustainable growth.”
This product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval.
The NDA for Eagle’s rapid infusion bendamustine product is supported by data from clinical trials completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.
In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.