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AIS News Antares ATD(TM) Formulation Enters Phase III Study

EWING, N.J.--(BUSINESS WIRE)--Antares Pharma, Inc. (Amex:AIS) announced that its development partner BioSante Pharmaceuticals has initiated a Phase III safety and efficacy trial of Antares’ transdermal testosterone gel (currently called LibiGel®) for the treatment of FSD. The Phase III trial is scheduled to enroll approximately 360 surgically menopausal women in a double-blind, placebo-controlled six month trial under a protocol and investigational new drug (IND) application reviewed by and on file with the U.S. Food and Drug Administration (FDA). It is currently anticipated that the Phase III safety and efficacy trials, plus one year of safety data, are the essential requirements for submission and approval by the FDA of a new drug application (NDA).

Currently there is no FDA approved pharmaceutical product to treat FSD and if approved this product may help address the unmet medical need. According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Our Advanced Transdermal Delivery (ATD™) formulation of testosterone gel is the second of our formulated products for women's health to enter Phase III clinical trials. The first product, our ATD™ low dose estradiol gel formulation named Elestrin™, recently received FDA approval for the treatment of vasometer symptoms in hormone replacement therapy and will be marketed by Bradley Pharmaceuticals, Inc.

Jack E. Stover, President & CEO of Antares Pharma Inc. said, “We are pleased that our ATD™ testosterone gel has progressed to Phase III clinical trials and we look forward to the possibility of eventual approval of another gel formulation in our ATD platform.” Stover added, “It is important to note that Antares has a similar economic arrangement with this formulation as we have with Elestrin including product marketing rights in major European markets.”

About Antares Pharma

Antares Pharma is a specialized pharma product development company focused on developing patented drug delivery systems and injectable device engineering capabilities. Antares’ current technology platforms include its ATD™ Advanced Transdermal Delivery system, and its related TecTix™ system for topical and transmucosal delivery, its Easy Tec™ oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex™ disposable mini-needle injection device and Valeo™/Vision® reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, Antares’ product pipeline, if approved, will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience. Antares Pharma has corporate headquarters in Princeton Crossroads Corporate Center in Ewing, NJ, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.

Safe Harbor Statement

In addition to historical facts or statements or current conditions, this press release contains forward-looking statements within the meaning of the “Safe Harbor” provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the outcome of the Phase III study mentioned herein. Forward-looking statements provide Antares’ current expectation or forecasts of future events. Antares’ results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares’ ability to execute on its development plans and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in Antares’ quarterly reports filed with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Antares undertakes no obligation to update publicly any forward-looking statement.