News Column

Eagle Pharmaceuticals drug OK'd

July 24, 2014

By Melanie Anzidei, The Record (Hackensack, N.J.)

July 24--Woodcliff Lake-based Eagle Pharmaceuticals Inc. said Wednesday that the Food and Drug Administration has approved its use of the drug Ryanodex, which is used for the treatment of malignant hyperthermia, making the drug the first product to be solely marketed by the company.

Shares of Eagle climbed as much as 4.7 percent to $13.68 Wednesday in intraday trading on the Nasdaq Stock Market before reversing course and falling 3.5 percent to close at $12.61.

Eagle is a specialty pharmaceutical company that develops injectable products for expiring patented drugs. Ryanodex is used for the treatment of malignant hyperthermia (MH), an inherited and sometimes fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals.

According to a news release, Ryanodex is the first significant enhancement to MH treatment options in more than 30 years. Ryanodex, made of dantrolene sodium, can be injected in less than one minute to counter the effects of MH. Previously, the process to administer the antidote could take as long as 15 minutes to 20 minutes.

Eagle has not disclosed its projected annual sales for Ryanodex. Once the drug is available, each 250 milligram vial of Ryanodex will cost $2,300, according to the company. The market for existing dantrolene sodium products is about $20 million.

Eagle went public in February and raised $50.3 million in its initial public offering at a time when biotech companies were prime candidates for IPOs. Eagle, which was founded in 2007, said at the time it planned to use the money from the offering for research and development, to expand U.S. and international sales and marketing efforts, and for working capital and other general corporate purposes.


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Source: Record (Hackensack, NJ)

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