Acrux (ASX:ACR)
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Annual Worldwide Sales of Hormonal Contraceptives Exceed US$4 Billion
Acrux (ASX: ACR), the Australian company with patient-preferred
technology for delivering drugs across the skin, today announced an
agreement with the New York-based Population Council, Inc. The
agreement enables Acrux to progress toward commercialisation of a
unique contraceptive spray, containing the new-generation
contraceptive drug Nestorone(R).
Under the agreement, Acrux has a worldwide licence from the
Population Council to intellectual property covering the use of
Nestorone(R) with Acrux's patented metered-dose skin spray delivery
technology (MDTS(R)). Acrux will develop and commercialise
Nestorone(R) MDTS(R) and has the right to sub-license to commercial
partners. In addition to commercial distribution of the product, Acrux
(or its sub-licensees) will make Nestorone(R) MDTS(R) available at
reduced prices to public sector organisations providing human
reproductive health products to disadvantaged people.
Results of a Phase 1 clinical trial, conducted by Acrux last year
under a development agreement with the Population Council, showed that
a once-daily application of Nestorone(R) MDTS(R) provides the level of
Nestorone(R) in the blood known to be effective for contraception. A
Phase 2 trial, scheduled to start in the second half of 2006, aims to
demonstrate that Nestorone(R) MDTS(R) controls ovulation. Acrux will
seek commercial partners for the remaining steps in global
commercialisation.
"This exciting product will give women a very attractive new
option for contraception. It combines our unique technology with the
know-how of one of the world's leading developers of reproductive
health products," said Acrux CEO Igor Gonda.
"The target features of Nestorone(R) MDTS(R) are: a convenient
daily spray onto the arm that is more discreet and less irritating to
the skin than a patch, and we believe, will prove to have a better
safety profile than other hormonal contraceptives. Market research has
shown that many women will prefer the ease and convenience of this
method to swallowing pills, taking injections, or wearing patches," he
added.
Gonda also noted that Acrux sees great market potential for
Nestorone(R) MDTS(R) given the fact that annual worldwide sales of
hormonal contraceptives exceed US$4 billion, and sales of transdermal
contraceptive patches in the United States alone are more than US$400
million a year.
Population Council CEO Peter Donaldson said he was pleased with
the progress Acrux had made in the validation of its transdermal spray
technology platform in clinical trials, especially in the area of
women's health. "We are very encouraged by the results obtained so far
with the Nestorone(R) spray. An important part of the Population
Council's mission is to meet the need for reproductive healthcare
products on a global scale, and we believe that Acrux's technology can
be an attractive option for many women around the world."
Acrux has two other products in its women's health portfolio that
are delivered as daily sprays; Evamist(TM) for menopausal symptoms and
Testosterone MDTS(R) for decreased libido. Both are in advanced stages
of development.
About Nestorone(R) MDTS(R)
Nestorone(R), which cannot be taken orally, is a fourth-generation
progestin contraceptive that has no androgenic hormonal effects, and a
good safety profile. MDTS(R) is a small, hand-held, easy-to-use spray
that is designed to provide an easy and convenient means to deliver a
preset dose of a therapeutic drug via the skin. The spray applicator
is placed gently against the forearm and an actuator button is pushed.
A light spray containing a proprietary formulation of Nestorone(R) is
quickly absorbed into the skin. Nestorone(R) is released into the
blood stream on a sustained basis over 24 hours, providing a practical
and convenient once-a-day dosing regimen. The spray is fast-drying,
non-irritating, and invisible after application.
About Acrux www.acrux.com.au
-- Acrux is a specialty pharmaceutical company, developing and
commercialising a range of patented, patient-preferred
healthcare products for global markets, using its innovative
technology to administer drugs through the skin.
-- Acrux's product pipeline includes treatments of hormonal
deficiencies, pain, central nervous system disorders and a
contraceptive. 20 human clinical trials have been completed
with 8 different drugs and the lead product, Evamist(TM), is
nearing the end of a phase 3 trial in the USA.
-- Acrux has licensed USA rights for Evamist(TM) (Estradiol
MDTS(R)) and Testosterone MDTS(R) to VIVUS and AUS/NZ
distribution rights for Testosterone MDTS(R) and Fentanyl
UDTS(TM) to CSL Limited. Acrux has also licensed its
technology to Eli Lilly for veterinary healthcare products.
About the Population Council www.popcouncil.org
-- The Population Council, an international, non-profit,
non-governmental organisation, 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
Population 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.
-- The Population Council has a proven track record in the
successful development of female contraceptive products and
has worked to make them accessible to people in developing
countries. Three of the four major long-acting reversible
contraceptives available today were developed by the
Population Council: the Copper T IUD, Norplant(R), Jadelle(R),
and Mirena(R). (more)
-- More than 50 million Copper T IUDs have been distributed in
over 70 countries.