FDA Scorns Eagle Pharma's Seven Year Orphan Drug Exclusivity Request for Blood Cancer Drug BENDEKA
March 28, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WOODCLIFF LAKE, N.J. – Shares of Eagle Pharmaceuticals are down about 8 percent this morning after the U.S. Food and Drug Administration rejected the company’s request for seven years of orphan drug exclusivity in the U.S. for its blood cancer drug, Bendeka.
The regulatory agency cited the need for Eagle to demonstrate “clinical superiority” for Bendeka before receiving the seven-year-status orphan drug status. The FDA applies this requirement whenever the agency has previously approved another drug of the same active moiety for the same indication.
Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation typically provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, as well as certain financial incentives that can help support its development.
Eagle said it was disappointed in the FDA’s latest ruling to reject the orphan drug status for Bendeka. In a statement this morning, the company said it believes 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 said it is evaluating all options to challenge the FDA’s decision. Eagle said it believes there is legal precedence to challenge the FDA’s ruling. The company cited a 2014 challenge from DepoMed, Inc. regarding the orphan drug status of its drug Gralise. Eagle said it believes the DepoMed case closely mirrors its own.
“We are disappointed with the agency’s decision regarding orphan drug exclusivity for BENDEKA, which we believe to be incorrect,” Scott Tarriff, president and chief executive officer of Eagle said. “With six Orange Book listed patents extending from 2026 through 2033, and additional pending patent applications, the market protection for Bendeka is likely to be intact for many years. These patents will continue to be in effect beyond the seven years of exclusivity that would have been provided had the orphan drug exclusivity been granted.”
Eagle’s Bendeka was approved in December 2015 for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of 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 rejection of orphan drug status for Bendeka comes 10 days after the FDA rejected Eagle’s blood clotting medication for certain patients undergoing heart surgery, which sent its stock plunging more than 20 percent. In its letter to Eagle, the FDA requested further characterization of bivalirudin-related substances in the drug product known as Kangio. Eagle said it plans to work with the FDA to determine a path forward for the drug.
While Eagle has hit a few stumbling blocks with the FDA this year, news for the company has not been all bad. In February, the company announced the FDA granted Fast Track Designation to its Ryanodex (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke, an investigational new indication for the product. The FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need. Ryanodex is currently indicated for the treatment of malignant hyperthermia.
In December, Eagle won FDA approval for its non-alcohol formula of Docetaxel Injection, for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Docetaxel Injection is the first alcohol-free formulation approved in the U.S., the company said.
Shares of Eagle stock are selling at $35.76 at the time of this writing.