Antares Pharma Partner Completes Phase II Clinical Trials for
Testosterone Transdermal Gel in Female Sexual Dysfunction
EXTON, Pa., June 29 /PRNewswire-FirstCall/ -- Antares Pharma Inc. (OTC:ANTR)
(BULLETIN BOARD: ANTR) said today that its U.S. licensee, BioSante
Pharmaceuticals, Inc. (AMEX:BPA) completed Phase II clinical trials of
LibiGel(TM) (transdermal testosterone gel) for the treatment of female sexual
dysfunction (FSD). Antares will receive a royalty on U.S. sales of LibiGel by
BioSante. In addition, Antares will have the opportunity to independently
submit the product for regulatory approval in Europe and Japan - based
primarily on clinical data generated by BioSante.
According to Roger G. Harrison, Ph.D., Antares' president and chief executive
officer, "Credible estimates of the U.S. market for female sexual dysfunction
in the U.S. range between $1 billion and $4 billion, and we think the market
potential in Europe is also likely to be greater than $1 billion." Dr. Harrison pointed out, "Procter and Gamble's (NYSE:PG) recent completion of
two large Phase III trials of Intrinsa, its female testosterone patch, will
help to establish clinical precedence and regulatory requirements for similar
products. Moreover, P&G announced its intention to spend $100 million to
advertise Intrinsa, an effort that should be more than sufficient to create
consumer awareness of female sexual dysfunction as a treatable disorder.
"While we have no doubt this advertising campaign and early market entry will
establish Proctor and Gamble as the market leader," Dr. Harrison said, "we
believe the elegance of our gel product will make it quite competitive with the
P&G patch and provide an excellent opportunity for Antares and its partners." Commenting upon the Phase II results announced on June 23rd by BioSante, Dr. Harrison said he was "very encouraged to learn that the trial had been
completed earlier than anticipated, and that the data appears to be excellent." About Antares Pharma Antares Pharma develops specialty pharmaceutical products, including
needle-free and mini-needle injector systems, transdermal gel technologies, and
fast-melt oral tablet technology. These delivery systems are designed to
improve both the efficiency of drug therapies and the patient's quality of
life. The Company currently distributes its needle-free injector systems in
more than 20 countries. In addition, Antares Pharma conducts research and
development with transdermal gel products and currently has several products in
clinical evaluation with partners in the U.S. and Europe. The Company is also
conducting ongoing research to create new products that combine various
elements of the Company's technology portfolio. Antares Pharma has established
collaborations with 13 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 has
corporate headquarters in Exton, Pennsylvania, with manufacturing and research
facilities in Minneapolis, Minnesota, and research facilities in 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 about Antares Pharma, visit the Company's web site at
http://www.antarespharma.com/.
Information included on Antares Pharma's website is not incorporated herein by
reference or otherwise. DATASOURCE: Antares Pharma Inc.
CONTACT: Dr. Roger Harrison, CEO and President, Antares Pharma, +1-610-458-6200, or Lawrence M. Christian, CFO and Vice President - Finance, Antares Pharma, +1-610-458-6200, or Ira Weingarten or Steve Chizzik, Equity Communications, +1-805-897-1880, for Antares Pharma Web site: http://www.antarespharma.com/
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