Healthcare Industry News:  Transdermal 

Biopharmaceuticals FDA

 News Release - December 18, 2006

Antares Receives First FDA Approval of ATD(TM) Gel Platform

Approval of Elestrin(TM) Triggers Approximately $2.6 Million Payment

EWING, N.J.--(HSMN NewsFeed)--Antares Pharma, Inc. (Amex: AIS ) announced the U.S. Food and Drug Administration (FDA) approved for marketing Elestrin(TM) (formerly Bio-E-Gel®) in the United States. Antares' development partner, BioSante Pharmaceuticals (Amex: BPA ) announced today that Bio-E-Gel will be marketed under the name Elestrin(TM) by Bradley Pharmaceuticals Inc. (NYSE: BDY ) and is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. Elestrin is the first FDA approved product in Antares' Advanced Transdermal Delivery (ATD(TM)) gel platform. Two doses of Elestrin, 0.87 grams per day and 1.7 grams per day, were approved and there are no future post-approval clinical development commitments required by the FDA. Elestrin (0.87 grams per day) is the lowest dose of estradiol currently approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms. Antares currently retains the sole marketing rights of the product for Europe and elsewhere.

On November 8, 2006 Antares announced the signing of a marketing agreement with Bradley Pharmaceuticals. Bradley has announced plans to market Elestrin in the U.S. beginning in 2007 through its Kenwood Therapeutics Division, with at least 49 Kenwood sales representatives targeting estrogen prescribing physicians composed mostly of gynecologists. The agreement with Bradley provides for regulatory and sales based milestone payments of potentially more than $13 million to Antares. The FDA approval of Elestrin has triggered a $2.6 million payment to Antares of which $1.75 million is expected to be paid to Antares within 14 weeks of approval and the remainder within one year of approval. In addition, Antares will receive royalties on sales of Elestrin as well as sales-based milestone payments when marketed by Bradley.

Jack Stover, President & CEO commented, "FDA approval of Antares Pharma's formulation of estradiol ATD gel is a significant milestone since Elestrin is Antares' first pharmaceutical product in our ATD gel platform to be approved by the FDA for marketing. Additionally it may be another important revenue contributor in the near future." Stover added, "We are pleased that the lowest dose of Elestrin approved is currently the lowest dose available, which may provide a distinct marketing advantage."

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(TM) Advanced Transdermal Delivery system, and its related TecTix(TM) system for topical and transmucosal delivery, its Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM)/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 receipt of regulatory and sales based milestones of potentially $13 million. 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.


Source: Antares Pharma

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