Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office has granted Patent No. 9,000,021 for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. The patent issued today expires in March 2033.
On February 13, 2015, Eagle submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for bendamustine hydrochloride (HCl) for administration in a 50mL admixture (the “rapid infusion” product) for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Eagle has requested Priority Review of the NDA; 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.
“We take great pride in the issuance of this additional patent, relating to our rapid infusion bendamustine product,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “We will continue to expand our intellectual property surrounding our growing portfolio of products and candidates focused on improving treatment options for patients, and we anticipate additional patent issuances in 2015.”
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.
