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Eagle Pharmaceuticals Reports Positive Outcome From FDA Meeting For RYANODEX For Exertional Heat Stroke NDA Submission


Eagle Pharmaceuticals (“Eagle” or the “Company”) (EGRX) today announced that the U.S. Food and Drug Administration ("FDA") has determined that no additional human safety and efficacy data is required for the submission of Eagle’s New Drug Application (“NDA”) for Ryanodex® for the treatment of exertional heat stroke (“EHS”), an investigational new indication for the product, further confirming that a hybrid development program comprised of clinical data from EHS patients and preclinical data from animal studies constitutes an adequate regulatory pathway for the NDA submission.

Eagle has also reduced its future Ryanodex royalty obligations to its licensing partner from 15% to 3% of net sales in exchange for $15 million in cash.

“We believe there is significant long-term value in our Ryanodex portfolio. Following our positive meeting with the FDA, we have an agreement for an NDA submission for EHS. We anticipate requesting priority review of the application and, if granted by the FDA, being the first to market with a potentially life-saving treatment for EHS as early as next year,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “Furthermore, we believe the continued growth of the currently approved Malignant Hyperthermia indication and our plans to expand the Ryanodex label to include the potential treatment of Ecstasy and Methamphetamine intoxication will allow us to maximize the value of this product. Therefore, we increased our commitment to the portfolio by investing a portion of our cash to purchase substantially all of the royalty obligation owed on Ryanodex. This will allow us to increase the earnings potential of Ryanodex, benefitting shareholders for many years to come,” he added.

“We are pleased that the FDA recognized that our study during the Hajj last September, in combination with results from our ongoing animal studies, will provide adequate safety and efficacy data to complete our NDA submission. And, we are very grateful to the authorities of Saudi Arabia for their assistance in supporting the human study. We expect to complete our NDA filing upon successful conclusion of our animal work,” added Adrian Hepner, Executive Vice President and Chief Medical Officer.

The animal studies to support the NDA are currently underway. Upon successful completion of the animal studies, Eagle anticipates requesting priority review for its NDA submission. If approved, EHS would be the second indication for Ryanodex which is currently approved for the treatment of malignant hyperthermia (“MH") and for the prevention of MH in patients at high risk.

Eagle’s Ryanodex for the treatment of EHS has previously been granted fast track designation and orphan drug designation by the FDA. Eagle is evaluating its option to submit a rolling NDA, as allowed by the fast track designation, which permits completed sections of an NDA to...