88% Decrease in Hot Flashes and the Lowest Effective Dose is Established, According to the Results Reported
EXTON, Pa., Sept. 30 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (AMEX:AIS) announced today that its North American licensee, BioSante Pharmaceuticals, Inc. (AMEX:BPA) has presented a full report of the results of its Phase III clinical study data on Bio-E-Gel(TM) (bio-identical estradiol gel) at the North American Menopause Society (NAMS) annual meeting in San Diego, CA. The study results showed three doses of Bio-E-Gel(TM) that significantly decrease the number of hot flashes in menopausal women and identified the lowest effective dose in order to implement estrogen therapy.
The Phase III trial was a 12-week, randomized, double-blind, placebo- controlled study of 484 symptomatic menopausal women using three dosage levels of Bio-E-Gel(TM) in order to establish safety and efficacy of Bio-E-Gel(TM) for the treatment of hot flashes, which are known to occur in up to 85% of menopausal women. Results showed that the most effective dose decreased the number of hot flashes by 88% from 12.9 per day at baseline to 1.6 after treatment (p<0.0001). The decrease was also significant versus placebo, with a mean decrease of 11.3 hot flashes per day with Bio-E-Gel(TM) versus a decrease of 6.1 with placebo (p<0.0001). Bio-E-Gel(TM) also produced low estradiol blood levels and had a safety profile similar to that observed in the placebo group. Notably, there was minimal application site irritation reported, a side effect known to be associated with transdermal patches.
Bio-E-Gel(TM) utilizes Antares Pharma's proprietary Advanced Transdermal Delivery (ATD(TM)) gel system designed to allow delivery of hormones and other active ingredients across the skin. Antares Pharma's ATD(TM) gel system allows active 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. The current U.S. market for estrogen products is estimated at approximately $1.4 billion in annual sales, and the European market for estrogen products is estimated to be equally substantial to the U.S. Market.
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 contractually agreed milestone payments at certain stages of development and royalties on end sales of Bio-E-Gel(TM) in North America upon commercialization.
Jack E. Stover, President and CEO of Antares Pharma, said, "We believe the study results demonstrate that Bio-E-Gel(TM) is a significant improvement to the low dose estrogen therapy currently available in the U.S. and elsewhere. Additionally, with the positive results of the Phase III trial we now look forward to the submission of a New Drug Application with the FDA in the fourth quarter and proceeding with Antares Pharma's regulatory submissions and commercialization of its estradiol ATD(TM) gel product in important markets throughout the rest of the world. In summary, we believe that the progress demonstrated by Bio-E-Gel(TM) is an important milestone for the Antares ATD(TM) system." About Antares Pharma Antares Pharma is a specialized pharma product development company with patented drug delivery systems and injectable device engineering capabilities. The Company's current technology platforms include its ATD(TM) (Advanced Transdermal Delivery) system, Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms (Vibex(TM) disposable mini-needle injection device and Valeo(TM) and Vision(R) 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 products and devices. The Company believes its product pipeline addresses unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience.
The Company has active 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. Its needle-free injector system is distributed in more than 30 countries for the administration of insulin and is marketed for use with human growth hormone through licensees in most major regions of the world. Licensees also market an ibuprofen gel in several major European countries. In addition, Antares Pharma is undertaking development or is conducting research on several product opportunities that it expects will form the basis of its specialized pharma program.
Antares Pharma has corporate headquarters 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/ and its needle-free product website, http://www.mediject.com/. Information included on the Company's websites 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, Inc.; or Steve Chizzik or Ira Weingarten, both of Equity Communications for Antares Pharma, Inc., +1-805-897-1880 Web site: http://www.antarespharma.com/ http://www.mediject.com/
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