Antares Pharma's Licensee Reaches Important Milestone
January 19 2005 - 9:25AM
PR Newswire (US)
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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