BPA Biosante Pharmaceuticals

Antares Pharma's Licensee Reaches Important Milestone Antares Pharma's North American Licensee, BioSante Pharmaceuticals, Inc., Completes Enrollment in Pivotal Phase III Clinical Trial for Estradiol Gel EXTON, Pa., Jan. 19 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (AMEX:AIS) announced today that its North American licensee, BioSante Pharmaceuticals, Inc. (AMEX:BPA), has completed enrollment of more than 450 women in a pivotal Phase III clinical trial for its transdermal bioidentical estradiol gel, Bio-E-Gel(TM). The clinical trial will evaluate the safety and efficacy of Bio-E-Gel(TM) for the treatment of moderate-to-severe hot flashes in menopausal women. Hot flashes occur in up to 85% of menopausal women. BioSante further announced that they expect to complete the trial by the end of Q1 2005 and plan to file an NDA with the U.S. Food and Drug Administration (FDA) in mid-2005. Bio-E-Gel(TM) utilizes Antares Pharma's proprietary Advanced Transdermal Delivery (ATD(TM)) gel technology designed to allow delivery of hormones and other products across the skin. Antares Pharma's ATD(TM) gel technology allows active pharmaceutical ingredients to be quickly absorbed through the skin following application to the arms, shoulders or abdomen, evenly delivering pharmaceuticals to the bloodstream in a non-invasive and painless manner. Estrogen products are currently approved for the treatment of menopausal symptoms, including hot flashes and vaginal atrophy. The current U.S. market for estrogen products is estimated at $2.0 billion. While Antares Pharma has licensed its estradiol gel in its patented ATD(TM) system to BioSante for North America and certain other territories, Antares Pharma retains all rights to utilize and reference the data obtained from clinical trials in order to develop, market and license its own estradiol ATD(TM) gel products in Europe, Japan and other important markets. Additionally, Antares Pharma expects to receive milestone payments at certain stages of development and royalties on end sales of Bio-E-Gel(TM) in North America. Jack E. Stover, President and CEO of Antares Pharma, said, "We are pleased with the progress BioSante has reported, and we look forward to the completion of the Phase III trial and submission of an NDA in the mid-2005 timeframe. Antares Pharma can now formalize its own plans for regulatory submission and commercialization of estradiol ATD(TM) gel in the rest of the world." About Antares Pharma Antares Pharma is a specialty pharma company focused on the growing lifestyle products sector and committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new products and devices. 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 Steve Chizzik or Ira Weingarten of Equity Communications, +1-805-897-1880, for Antares Pharma Web site: http://www.antarespharma.com/

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