Antares licensee BioSante submits NDA for transdermal estrogen product

By Lisa Kerner

Erie, Pa., April 21 - Antares Pharma, Inc. licensee BioSante Pharmaceuticals, Inc.'s New Drug Application for Bio-E-Gel transdermal estradiol gel was accepted for review by the Food and Drug Administration, according to a company news release.

Bio-E-Gel is based on Antares's proprietary Advanced Transdermal Delivery gel system, which delivers hormones and other ingredients across the skin for absorption into the bloodstream.

If approved, Bio-E-Gel will be used in the treatment of moderate-to-severe hot flashes in menopausal women.

Included in the application for the low-dose estradiol product candidate were data from a phase 3 clinical trial, a sunscreen study, a pharmacokinetic study and a transfer study, according to the release.

Antares retains the rights to use the data developed from the FDA trial and can market its own estradiol Advanced Transdermal Delivery gel products in Europe, Japan and other markets.

The U.S. market for estrogen products is estimated to be about $1.4 billion annually.

Antares is a pharmaceutical product development company based in Exton, Pa.

BioSante is a pharmaceutical company based in Lincolnshire, Ill., that develops hormone therapy products.

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