Antares Pharma's (OTCBB: ANTR / Amex: AIS as of September 23, 2004) North American Licensee BioSante Pharmaceuticals, Inc. Announces Positive Results of Phase II Study of LibiGel(TM), Topical Testosterone Gel Antares Pharma Says Study Shows LibiGel(TM) Significantly Increases Sexual Activity in Surgically Menopausal Women Suffering From Female Sexual Dysfunction (FSD) EXTON, Pa., Sept. 22 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (OTC:ANTR) (BULLETIN BOARD: ANTR) (AMEX:AISAMEX:effectiveAMEX:SeptemberAMEX:23AMEX:2004), an evolving specialty pharmaceutical company with headquarters in Exton, Pennsylvania, announced today that its topical testosterone gel North American licensee, BioSante Pharmaceuticals, Inc. (AMEX:BPA) reported that its placebo-controlled Phase II study showed treatment with LibiGel(TM) significantly increased satisfying sexual events in surgically menopausal women suffering from female sexual dysfunction (FSD). Today's announcement follows yesterday's decision by the Food and Drug Administration to grant Procter & Gamble fast track status for its formulation of Intrinsa(TM), an investigational female testosterone patch, based upon data for its two Phase III trials. LibiGel(TM) utilizes Antares Pharma's propriety advanced transdermal delivery (ATD(TM)) gel technology designed to allow delivery of hormones and other products across the skin. The LibiGel(TM) study was a double-blind placebo controlled study in 46 surgically menopausal women. The effective dose of LibiGel(TM) produced testosterone blood levels within the normal physiological range for pre-menopausal women and the safety profile was similar to that of the placebo product. By incorporating Antares Pharma's ATD(TM) gel technology, LibiGel(TM) is quickly absorbed through the skin after application on the arms, shoulders or abdomen, evenly delivering testosterone to the bloodstream in a non-invasive and painless manner. Although generally characterized as a male hormone, testosterone is also present in women, and its deficiency has been found to decrease libido (sex drive). Additional information on the study will be presented at the October 30, 2004 Annual Meeting of Sexual Health in Women in Atlanta. Phase III studies are expected to start in early 2005. Antares Pharma will receive milestone payments at certain stages of development and royalties from end sales of LibiGel(TM) in North America. Additionally, Antares Pharma has rights to the clinical data generated for further licensing of testosterone for the treatment of FSD in other territories, including Europe and Japan. Jack E. Stover, President and CEO of Antares Pharma, stated, "Credible estimates of the U.S. market for female sexual dysfunction range between $1 billion and $4 billion. We think the market potential in Europe could be as large as the U.S. market, and we also believe the Japanese market will prove to be significant. We are very encouraged by the positive results of BioSante's clinical study." Mr. Stover added, "Recently, Proctor & Gamble was given fast track status by the FDA for Intrinsa(TM), its transdermal patch containing testosterone for FSD. We believe that this further validates the importance of this unmet medical need. We further believe that gel technology may prove more attractive to patients than transdermal patches." A study published in the Journal of American Medical Association reported that 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical. About Antares Pharma Antares Pharma is an emerging specialty pharmaceutical company leveraging its experience in drug delivery systems to enhance product performance of established and developing drugs. The Company's current technology platforms include transdermal (Advanced Transdermal Delivery ATD(TM)) gels, disposable mini-needle injection systems (Vibex(TM)), reusable needle-free injection systems (VISION(R) and Valeo(TM)), and fast-melt oral (Easy Tec(TM)) tablets. The Company currently has active partnering programs with several pharmaceutical and distribution companies for a number of indications and applications, including diabetes, growth disorders, obesity, female sexual dysfunction and other hormone therapy. Antares Pharma currently distributes its needle-free injector systems in more than 20 countries and markets the same technology for use with human growth hormone through licensees in most major regions of the world. Licensees also market an ibuprofen gel using Antares Pharma's ATD(TM) technology in several major European countries. In addition, Antares Pharma is undertaking development or is conducting research on several product opportunities that will form the basis of its specialty pharma program. Antares Pharma's corporate headquarters is in Exton, Pennsylvania, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ materially and which are identified from time to time in the Company's reports filed with the U.S. Securities and Exchange Commission. Antares Pharma claims the protection of the Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. For more information, visit Antares Pharma's web site at http://www.antarespharma.com/. Information included on the Company's website is not incorporated herein by reference or otherwise. DATASOURCE: Antares Pharma, Inc. CONTACT: Jack E. Stover, President and CEO, +1-610-458-6200, or Lawrence M. Christian, CFO and Vice President - Finance, +1-610-458-6200, both of Antares Pharma; or Ira Weingarten or Steve Chizzik, Equity Communications, +1-805-897-1880, for Antares Pharma Web site: http://www.antarespharma.com/

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