New Data Highlights Key Advantages of Antares Pharma's ATD(TM) Gel Technology When Compared to Transdermal Patches
November 04 2004 - 9:15AM
PR Newswire (US)
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/
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