FDA Denies Eagle's Request For 7-Yrs Of Orphan Drug Exclusivity For BENDEKA

(RTTNews) - Eagle Pharmaceuticals Inc. (EGRX) said that the U.S. Food and Drug Administration has denied Eagle's request for seven years of orphan drug exclusivity in the U.S., for BENDEKA(bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride. BENDEKA was approved in December 2015 for the treatment of patients with chronic lymphocytic leukemia or CLL and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma or NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

Eagle said it believes that the FDA's decision is incorrect, and that BENDEKA was automatically entitled to orphan drug exclusivity for CLL and indolent B-cell NHL upon the drug's December 2015 approval. The FDA previously granted orphan drug designation for BENDEKA for both indications. Eagle is evaluating all options to challenge the FDA's decision.

In September 2014, DepoMed, Inc. prevailed in litigation in federal district court in the District of Columbia, challenging the FDA's application of this clinical superiority demonstration requirement to its orphan-designated drug product, GRALISETM. DepoMed argued that the requirement violates the Orphan Drug Act, which automatically confers seven years of marketing exclusivity on orphan designated products upon approval. District Judge Ketanji Brown Jackson agreed with DepoMed's position, and ordered the FDA to recognize orphan drug exclusivity for GRALISE without requiring proof of "clinical superiority." While the FDA granted orphan drug exclusivity for GRALISE without a clinical superiority demonstration, it has continued to require the clinical superiority demonstration for other orphan designated drugs, such as BENDEKA.

Eagle believes that the FDA's rejection of orphan drug exclusivity for BENDEKA closely mirrors the decision that Judge Jackson overturned in the DepoMed litigation, and Eagle is evaluating all options to obtain a reversal of the FDA's BENDEKA decision at this time.

Under a February 2015 exclusive license agreement for BENDEKA, a subsidiary of Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution. BENDEKA was launched by Teva in late January 2016. As previously announced, Eagle receives a 20% royalty on Teva's sales of BENDEKA.