Biosante Pharma (AMEX:BPA)
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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/