Antares and Population Council Initiate Phase 1
Clinical Study with Innovative Low-dose Contraceptive
EWING, NJ and NEW YORK, NY (30 May 2007) — Antares Pharma, Inc. (AMEX:AIS)
and the Population Council have initiated a Phase 1 (safety) clinical trial
in 12 healthy, postmenopausal women using Antares's advanced transdermal
delivery system (ATD)™ gel to deliver Nestorone® and estradiol, a natural estrogen hormone.
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The Population Council and Antares Pharma,
Inc., are developing a contraceptive gel that can be absorbed
through the skin of the arm, leg, or abdomen.
Photo credit: Karen Tweedy-Holmes/Population
Council |
Current research in the United States from the National Survey of Family
Growth has revealed that 31 percent of women discontinue use of reversible contraceptives
for method-related reasons within six months of starting use, and 44 percent do so
within 12 months. This high rate of method-related discontinuation suggests
considerable dissatisfaction with available methods. Furthermore, these
statistics indicate that even with the recent advent of novel hormonal
contraceptive delivery systems there is still a need for more options to
prevent unintended pregnancies. The need is heightened in the developing
world, where dissatisfaction with methods is compounded by access, cost, and sociocultural issues. Additionally, there are concerns about the
potential for side effects; hence the need for safer options using a natural
estrogen such as estradiol.
There will be two separate treatment
periods in the study. In the first period there will be a single administration of two
different doses of Nestorone concurrently
with estradiol, and in the second treatment period the most effective
combined dose of Nestorone and estradiol will be tested as a once-daily
dosing for ten consecutive days. The primary objectives of the study include determining the pharmacokinetic profile of the Nestorone component
of the Nestorone/estradiol combination ATD gel delivered transdermally and
determining the necessary Nestorone dose to achieve the appropriate
therapeutic levels for effective contraception. Secondary objectives include
determining the profile of estradiol needed to reach estrogen replacement
levels and to maintain regular bleeding patterns, and evaluating local skin
irritation and tolerability of the Nestorone/estradiol combination ATD gel.
Worldwide contraception product sales in 2005 were $3.6 billion, with
projections of approximately $4.5 billion by 2010, as reported by Thomson
Pharma®.
An innovative gel formulation that can deliver Nestorone in combination
with estradiol has been developed using Antares's advanced transdermal
delivery system. The gel is invisible, designed for rapid systemic
absorption through the skin after application on arms, shoulder, or abdomen
and lasts for approximately a 24-hour period of time. The formulation is not
known to cause irritation or occlusion of the skin after application. All excipients and permeation enhancers used in the formulation are compendial,
therefore no specific toxicity studies are required. Development of a
contraceptive product at this time builds on the substantial experience
gained during Antares's development of hormone replacement therapy technology
and products.
About Antares Pharma
Antares Pharma is a specialized pharma product development company focused
on developing patented drug delivery systems and injectable device
engineering capabilities. Antares's current technology platforms include its ATD Advanced Transdermal Delivery system, and its related TecTix™ system for
topical and transmucosal delivery, its Easy Tec™ oral fast-melt technology,
and subcutaneous injection technology platforms including both Vibex™
disposable mini-needle injection device and Valeo™/Vision® reusable
needle-free injection devices. Antares Pharma is committed to leveraging its
multiple drug delivery platforms to add value to existing drugs and to
create new pharmaceutical products and injectable devices. Overall, Antares's product pipeline, if approved, will address unmet medical needs by reducing
side effect profiles, improving safety, increasing effectiveness, and
improving patient compliance and convenience. Antares Pharma has corporate
headquarters in Princeton Crossroads Corporate Center in Ewing, New Jersey, with
subsidiaries performing research, development, manufacturing, and product
commercialization activities in Minneapolis, Minnesota, and Basel,
Switzerland.
About the Population Council
The Population Council is an international, nonprofit, nongovernmental
research organization that seeks to improve the well-being and reproductive
health of current and future generations around the world and to help
achieve a humane, equitable, and sustainable balance between people and
resources. The Council conducts biomedical, social science, and public
health research and helps build research capacities in developing countries.
Established in 1952, the Council is governed by an international board of
trustees. Its New York headquarters supports a global network of regional
and country offices.
Safe Harbor Statement
In addition to historical facts or statements or current conditions, this
press release contains forward-looking statements within the meaning of the
"Safe Harbor" provisions of the Private Securities Litigation Reform Act of
1995, including statements regarding the timing of product sales, market
estimates, and market potential. Forward-looking statements provide Antares's
current expectation or forecasts of future events. Antares's results could
differ materially from those reflected in these forward-looking statements
due to decisions of regulatory authorities, Antares's ability to execute on
its development plans, and general financial, economic, regulatory, and
political conditions affecting the pharmaceutical industry generally. For a
discussion of these and other risks and uncertainties that may affect the
forward-looking statements, please see the risk factors in Antares's 10Qs,
10Ks, and other filings made with the Securities and Exchange Commission.
Given these risks and uncertainties, any or all of these forward-looking
statements may prove to be incorrect. Antares undertakes no obligation to
update publicly any forward-looking statement.
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Media contacts
Population Council
Melissa May, APR: +1 212 339 0525; mmay@popcouncil.org
Diane M. Rubino: +1 212 339 0617; drubino@popcouncil.org
Antares Pharma, Inc., Ewing, New
Jersey
Stephanie M. Baldwin: +1 609 359 3020;
sbaldwin@antarespharma.com
