Eagle Pharmaceuticals, Inc. , which went public last month, has as many as six candidates in its pipeline in addition to two approved products. The company, which raised more than $50 million from its initial public offering, intends to use the funds primarily to develop its pipeline.
In keeping with its efforts to expand its product portfolio, Eagle Pharma announced last week that the new drug application for the company’s candidate dantrolene will be reviewed on a priority basis by the U.S. Food and Drug Administration (FDA). A decision from the U.S. regulatory body is expected by Jul 22, 2014 (target date). Eagle Pharma is seeking approval of the candidate for treating patients suffering from malignant hyperthermia. Eagle Pharma stated in its press release that the FDA has conditionally accepted the company’s proposed trade name of Ryanodex to market the drug on approval.
The hyper-metabolic rare disorder is often triggered when genetically susceptible individuals come in contact with certain inhaled anesthetics or succinylcholine (a muscle relaxant) causing symptoms such as high blood pressure, elevated carbon dioxide levels and high fever. The disease should be treated immediately to avoid fatality.
The candidate enjoys an orphan drug designation from the FDA. The designation is granted by the FDA to indications being developed to treat/prevent rare diseases (affecting less than 200,000 people in the U.S.) having significant unmet medical needs. Moreover, the status makes the drug eligible for seven years of marketing exclusivity in the U.S. following approval for the orphan indication. Additionally, this status also provides several other benefits to Eagle Pharma on the candidate’s development costs.
We expect investor focus to remain on the regulatory status of Ryanodex going forward.
Eagle Pharma carries a Zacks Rank #3 (Hold). Better ranked stocks in the medical sector include Shire (SHPG - Free Report) , Questcor Pharmaceuticals, Inc. and Lannett Company, Inc. (LCI - Free Report) .