Eagle’s (EGRX) Non-Alcoholic Docetaxel Gets FDA Approval

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Eagle Pharmaceuticals Inc. EGRX announced that its non-alcoholic formulation of docetaxel injection has been approved in the U.S. for the treatment of patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Shipments of docetaxel injection are expected to begin in Jan 2016.

We note that in Oct 2015, Eagle Pharma entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. to market, sell and distribute the product in the U.S.

The company estimates that annual sales of generic docetaxel to be approximately $75 million.

We remind investors that the docetaxel injection is currently marketed as Taxotere by Sanofi SNY. The drug lost patent exclusivity in 2011.

We note that in Jun 2014, the FDA issued a Drug Safety Communication, warning patients that the currently marketed docetaxel may cause symptoms of alcohol intoxication after treatment. This paved the way for a non-alcoholic docetaxel injection.

Meanwhile, Eagle Pharma continues to progress with its safety and efficacy study on Ryanodex. Earlier this month, the company reported positive results from the study on Ryanodex, which is being evaluated for the treatment of patients with exertional heat stroke.

Ryanodex is currently approved in the U.S. for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.

Eagle Pharma currently carries a Zacks Rank #2 (Buy). A couple of other favorably ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and Achillion Pharmaceuticals, Inc. ACHN, both sporting a Zacks Rank #1 (Strong Buy).

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