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Antares Pharma's (OTCBB: ANTR / Amex: AIS as of September 23,
2004) North American Licensee BioSante Pharmaceuticals, Inc. Announces Positive
Results of Phase II Study of LibiGel(TM), Topical Testosterone Gel
Antares Pharma Says Study Shows LibiGel(TM) Significantly Increases Sexual
Activity in Surgically Menopausal Women Suffering From Female Sexual
Dysfunction (FSD)
EXTON, Pa., Sept. 22 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (OTC:ANTR)
(BULLETIN BOARD: ANTR) (AMEX:AISAMEX:effectiveAMEX:SeptemberAMEX:23AMEX:2004),
an evolving specialty pharmaceutical company with headquarters in Exton,
Pennsylvania, announced today that its topical testosterone gel North American
licensee, BioSante Pharmaceuticals, Inc. (AMEX:BPA) reported that its
placebo-controlled Phase II study showed treatment with LibiGel(TM)
significantly increased satisfying sexual events in surgically menopausal women
suffering from female sexual dysfunction (FSD).
Today's announcement follows yesterday's decision by the Food and Drug
Administration to grant Procter & Gamble fast track status for its formulation
of Intrinsa(TM), an investigational female testosterone patch, based upon data
for its two Phase III trials.
LibiGel(TM) utilizes Antares Pharma's propriety advanced transdermal delivery
(ATD(TM)) gel technology designed to allow delivery of hormones and other
products across the skin. The LibiGel(TM) study was a double-blind placebo
controlled study in 46 surgically menopausal women. The effective dose of
LibiGel(TM) produced testosterone blood levels within the normal physiological
range for pre-menopausal women and the safety profile was similar to that of
the placebo product.
By incorporating Antares Pharma's ATD(TM) gel technology, LibiGel(TM) is
quickly absorbed through the skin after application on the arms, shoulders or
abdomen, evenly delivering testosterone to the bloodstream in a non-invasive
and painless manner. Although generally characterized as a male hormone,
testosterone is also present in women, and its deficiency has been found to
decrease libido (sex drive). Additional information on the study will be
presented at the October 30, 2004 Annual Meeting of Sexual Health in Women in
Atlanta. Phase III studies are expected to start in early 2005.
Antares Pharma will receive milestone payments at certain stages of development
and royalties from end sales of LibiGel(TM) in North America. Additionally,
Antares Pharma has rights to the clinical data generated for further licensing
of testosterone for the treatment of FSD in other territories, including Europe
and Japan.
Jack E. Stover, President and CEO of Antares Pharma, stated, "Credible
estimates of the U.S. market for female sexual dysfunction range between $1
billion and $4 billion. We think the market potential in Europe could be as
large as the U.S. market, and we also believe the Japanese market will prove to
be significant. We are very encouraged by the positive results of BioSante's
clinical study." Mr. Stover added, "Recently, Proctor & Gamble was given fast
track status by the FDA for Intrinsa(TM), its transdermal patch containing
testosterone for FSD. We believe that this further validates the importance of
this unmet medical need. We further believe that gel technology may prove more
attractive to patients than transdermal patches."
A study published in the Journal of American Medical Association reported that
43 percent of American women (about 40 million) experience some degree of
impaired sexual function. Among the more than 1,400 women surveyed, 32 percent
lacked interest in sex and 26 percent could not experience orgasm. The majority
of women with FSD are postmenopausal, experiencing FSD due to hormonal changes
following menopause, whether natural or surgical.
About Antares Pharma
Antares Pharma is an emerging specialty pharmaceutical company leveraging its
experience in drug delivery systems to enhance product performance of
established and developing drugs. 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 Ira Weingarten or Steve Chizzik, Equity Communications,
+1-805-897-1880, for Antares Pharma
Web site: http://www.antarespharma.com/