Benzinga | Feb 2, 2021 06:56AM EST

Eagle Pharmaceuticals Receives Additional FDA Questions Regarding Vasopressin; Court Date Set for July 7, 2021 in Vasopressin Trial

-Company Expects It Will Have 180 Days of Exclusivity-

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for its Abbreviated New Drug Application ("ANDA") for vasopressin. Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days. Importantly, Eagle has completed an extensive amount of developmental work and continues to do so for its first-to-file polypeptide, where brand sales of the product are over $700 million annually. In its communication with the Company, FDA restated that it has prioritized Eagle's ANDA, and it is also flagged as a COVID priority.

Eagle believes it can fully respond to the questions raised. There is one additional short duration study that will need to be completed and analyzed. The study will be run either in mid-February or mid-March. Based on similar studies previously run on the Company's vasopressin product, Eagle expects the results will be satisfactory. In addition, the Company expects it will have 180 days of exclusivity.

Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals, stated, "Eagle is aligned with FDA in its desire to approve products that meet all possible safety concerns, especially polypeptides like vasopressin that may be administered to COVID patients. Although this adds some time and cost, we believe all ANDA holders are likely to be held to the same high standards. We will be meeting again with FDA and will respond completely to the CRL shortly."

In other vasopressin news, the patent case against Endo Par Innovation Company, LLC is now scheduled to begin on July 7, 2021. Eagle remains confident about this litigation. Par's asserted patents claim a formulation with a pH of 3.7-3.9. Eagle's proposed ANDA product specifies a pH outside of that range. The Company is confident that its ANDA will be approved in a reasonable timeframe.

"We look forward to being able to continue to show the strength of our positions regarding Endo's patents in court and hope to bring this very important, lower price, high-quality product to market as soon as possible," concluded Tarriff.