April 1, 2014
Eagle Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office has granted Patent No. 8,685,460 for the treatment of heat stroke with Eagle’s dantrolene sodium for injectable suspension (“dantrolene”). The patent issued today expires in 2023. Eagle’s dantrolene formulation for the treatment of Exertional Heat Stroke (EHS) was granted Orphan Drug designation by the Food and Drug Administration on September 25, 2012.
Eagle is currently developing dantrolene in this new EHS indication. The company filed an NDA in January 2014 for Ryanodex® (dantrolene sodium-for injectable suspension) in the treatment of Malignant Hyperthermia (“MH”) which was granted a priority review and has a PDUFA date of July 22, 2014. Ryanodex for the treatment of MH has also received Orphan Drug designation.
EHS is one of the top three causes of sudden death among student athletes and is a leading cause of non-combat death within the U.S. Military. Currently, there are no FDA approved drugs for the treatment of EHS. The current standard of care in treating heat stroke patients is aggressive cooling e.g. through icing and intravenous hydration. It is estimated that there are 30,000 cases of heat stroke every year in the U.S. Scott Tarriff, Eagle’s CEO, said, “This is the fourth patent issued to Eagle regarding Ryanodex. Eagle now has 11 patents owned, licensed or issued covering its pipeline and an additional 10 patents filed with the U.S. patent office.”
About Exertional Heat Stroke
EHS is a state of extreme hyperthermia that occurs when heat generated by exercise in warm climates results in an elevated body temperature (above 104° F) due to failed thermoregulation that occurs when the body produces or absorbs more heat than it dissipates. Extreme temperature elevation and the resulting metabolic crisis can become a medical emergency that can result in disability or death.
Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products utilizing the FDA’s 505(b)-(2) regulatory pathway. The company develops products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products.
Eagle Pharmaceuticals, Inc.
David E. Riggs, 201-326-5300
Chief Financial Officer