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BPA Biosante Pharmaceuticals

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Share Name Share Symbol Market Type
Biosante Pharmaceuticals AMEX:BPA AMEX Ordinary Share
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ADDING AND REPLACING NDA Filed by Antares Pharma Licensee for Transdermal Estradiol Gel (Bio-E-Gel(TM))

17/02/2006 4:34pm

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Add after "www.antarespharma.com" in the contact information of the release (dated Feb. 16, 2006): -0- *T Equity Communications Steve Chizzik, 973-912-0980 *T The corrected release reads: NDA FILED BY ANTARES PHARMA LICENSEE FOR TRANSDERMAL ESTRADIOL GEL (BIO-E-GEL(TM)) Antares Pharma, Inc. (Amex:AIS) announced today that its licensee BioSante Pharmaceuticals, Inc. (Amex:BPA),has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Bio-E-Gel(TM) (a product based on Antares' proprietary ATD(TM) gel technology) to treat moderate-to-severe hot flashes in menopausal women. Across the low, mid, and high doses tested in the Phase III trial, it was reported that there was a clear dose response in the reduction in the number and severity of hot flashes. The NDA is seeking approval for all three doses. Results of the Phase III study also reported that beginning in Week 5, the low dose showed a highly significant decrease in the number of and severity of hot flashes versus placebo, therefore suggesting identification of the lowest effective dose. This significant response was also maintained through Week 12. Importantly, over 80 percent of women who used Bio-E-Gel(TM) reported "moderate" or "great" results. It was also reported that there were no significant differences in the safety profile of any doses when compared to placebo other than for predictable estrogen effects such as breast tenderness. Bio-E-Gel(TM) utilizes Antares Pharma's proprietary (ATD(TM)) Advanced Transdermal Delivery gel system designed to allow delivery of hormones and other active ingredients across the skin. This system allows active ingredients to be absorbed quickly following application. The current U.S. market for estrogen products is estimated at approximately $1.4 billion in annual sales and the European market is estimated to be equally substantial. While Antares has licensed its ATD(TM) estradiol gel to BioSante for North America and certain other territories, Antares retains rights to market its own estradiol ATD(TM) gel products in Europe, Japan, and other important markets and has the rights to utilize the data developed from the FDA trials to do so. "We are pleased that the NDA for Bio-E-Gel(TM) has been submitted and especially pleased that the three doses tested in Phase III are being submitted for approval," Jack E. Stover, President and CEO reported. "We look forward to receiving data from the studies to embark on our own filings. Additionally, it is welcome news to know, that if approved, Bio-E-Gel(TM) may be the lowest effective dose of estrogen available on the market to treat hot flashes," concluded Mr. Stover. About Antares Pharma Antares Pharma is a specialized pharma product development company with patented drug delivery systems and injectable device engineering capabilities. Antares' current technology platforms include its ATD(TM) Advanced Transdermal Delivery system, 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(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 pharmaceutical products and injectable devices. Overall, Antares' product pipeline 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 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.

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