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New Data Highlights Key Advantages of Antares Pharma's ATD(TM)
Gel Technology When Compared to Transdermal Patches
EXTON, Pa., Nov. 4 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (AMEX:AIS),
a specialty pharmaceutical company that develops and licenses drug delivery
technology for the next generation lifestyle products sector, said today that
new Phase II data on LibiGel(TM), a gel formulation of testosterone, being
developed by BioSante Pharmaceuticals, Inc. (AMEX:BPA) highlighted key
advantages of Antares Pharma's Advanced Transdermal Delivery (ATD(TM)) gel
technology when compared with a transdermal testosterone patch delivery system.
Phase II data on LibiGel(TM), as reported by Antares Pharma's licensee,
BioSante, indicated minimal application site irritation in contrast to previous
trials with a transdermal testosterone patch delivery system in which
approximately 30 percent of subjects reported such reactions. Additionally,
LibiGel(TM) produced testosterone blood levels within the normal range for
pre-menopausal women and had a safety profile similar to that observed in the
placebo group with no serious adverse effects observed.
"Antares Pharma believes its proprietary ATD(TM) gel technology offers
compelling advantages compared with transdermal patches, such as Intrinsa(R),
and that these advantages include not only the lack of irritation associated
with occlusion and response to adhesives but also cost, efficiency of delivery
and cosmetic elegance," according to Antares Pharma's President and CEO, Jack
E. Stover. Stover also added, "We believe that the data emerging from clinical
trials of LibiGel(TM), while still early, confirm our expectations that
LibiGel(TM) will compare favorably on all important dimensions."
BioSante recently announced new Phase II clinical data on LibiGel(TM) that was
presented before the International Society for the Study of Women's Sexual
Health (ISSWSH) Annual Meeting in Atlanta on October 30, 2004. Pursuant to its
agreement with BioSante, Antares Pharma expects to receive milestone payments
from BioSante at certain stages of development and royalties from end sales of
LibiGel(TM) in North America. Importantly, also pursuant to this agreement,
Antares Pharma has rights to the clinical data generated by BioSante to
independently submit for regulatory approval and marketing the testosterone gel
for the treatment of female sexual dysfunction in other territories, including
Europe and Japan.
Antares Pharma believes its proprietary ATD(TM) single and combination gels are
safe, patient friendly, easy to use and highly attractive new methods of drug
delivery. Antares Pharma's ATD(TM) gels utilize a combination of permeation
enhancers and further bolster a pharmaceutical agent's ability to penetrate the
skin. This new generation of product leads to a sustained plasma profile of
the active agent without the irritation and cosmetic concerns often associated
with patches. Presently, Antares Pharma markets, through its licensees, an
ibuprofen gel for localized pain relief in 11 countries throughout the world
and is currently evaluating entering markets in North America. In addition to
its testosterone gel for women that has been licensed to BioSante in North
America and other territories, Antares Pharma has also licensed to BioSante, in
North America and other territories, an estradiol gel to treat hot flashes and
vaginal atrophy (known as Bio-E-Gel(TM) in the U.S.) and a combination
estradiol and progestin gel for hormone therapy that has also been licensed to
Solvay Pharmaceuticals, B.V. Additionally, Antares Pharma is developing its
own ATD(TM) oxybutynin gel for overactive bladder disorder, as well as other
products.
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 its transdermal
Advanced Transdermal Delivery (ATD(TM)) gels, fast-melt (Easy Tec(TM)) oral
tablet technology, disposable mini-needle injection systems (Vibex(TM)), and
reusable needle-free injection systems (VISION(R) and Valeo(TM)). 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
Web site: http://www.antarespharma.com/