NEW YORK and MELBOURNE (15 November 2004) — The Population Council, an international research organization, and Acrux Limited (ASX: ACR), an Australian pharmaceutical company that specializes in administering drugs through the skin, announced today the start of the clinical study of a new type of contraceptive for women, the Nestorone® Metered Dose Transdermal System® (MDTS®).
“We hope the development of Nestorone MDTS as a transdermal contraceptive will offer women and couples a new option in meeting their family planning needs with confidence and ease. This first study will provide us with the information necessary before we begin the contraceptive efficacy trial,” said Sandra Arnold, the Population Council’s vice president of corporate affairs.
Acrux CEO and managing director, Dr. Igor Gonda, said, “The commencement of this study in collaboration with the Population Council, a world leader in reproductive health research, is another step toward bringing to market the world’s first contraceptive spray product. Our transdermal spray would be easy to use and would eliminate the need to swallow pills, take injections, or wear patches.”
The Population Council and Acrux have a joint development agreement on the transdermal spray delivery of Nestorone. The patented transdermal delivery system, MDTS, applies a pre-set dose of fast-drying formulation on the skin. This forms an invisible depot within the skin from which the drug is slowly absorbed into the bloodstream. MDTS will deliver the Population Council’s Nestorone, a fourth-generation progestin.
The study is sponsored by FemPharm Pty Ltd., a wholly owned subsidiary of Acrux Ltd. Principal investigators are Professor Ian Fraser of the University of Sydney’s Queen Elizabeth II Research Institute for Mothers and Infants, Sydney, Australia, and Dr. Edith Weisberg, director of research, FPA Health, Ashfield, Australia.
“FemPharm is conducting an initial Phase 1 Proof of Concept pharmacokinetic study in eight healthy women to establish the effective dosage required for fertility control,” said Weisberg. The study will be carried out at the Sydney Centre for Reproductive Health Research and the Woolcock Institute for Medical Research at the Royal Prince Alfred Hospital, Sydney, Australia.
The global contraception market is valued at US$4.4 billion*, representing an increase of 12 percent* over the previous year. (*IMS Health, IMS Midas, MAT Feb 2004)
The Population Council, an international, not-for-profit, nongovernmental organization, 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.
The Population Council has successfully developed contraceptives and worked to make them accessible to people in developing countries. Three of the four major long-lasting reversible contraceptives available today were developed by the Population Council: the Copper T IUD, Norplant®, and Mirena®. More than 50 million Copper T IUDs have been distributed in over 70 countries.
Acrux Limited’s group of companies is engaged in the development and commercialization of a range of patented, patient-preferred healthcare products for global markets.
Acrux has completed 14 human clinical trials with six different drugs using its proprietary drug delivery technology, comprising ACROSS® penetration enhancers, Metered Dose Transdermal System (MDTS) applicators for transdermal administration, and Patchless Patch® delivery method.
Acrux’s portfolio includes treatments of hormonal deficiencies, pain, central nervous system disorders, and urinary incontinence, as well as a contraceptive.
Acrux has licensed USA rights to its two lead products, Estradiol MDTS® and Testosterone MDTS®, to VIVUS and AUS/NZ distribution rights for Testosterone MDTS® to CSL Limited. Acrux has also licensed its technology for commercial development to Eli Lilly for veterinary healthcare products, and to Connetics Australia, a subsidiary of the US company Connetics, for anti-psoriatics and local anesthetics.
Additional media contact: Paula Hannaford, Director, Gavin Anderson & Company
phannaford@gavinanderson.com.au
Telephone: +61 2 9552 4499
Mobile: +61 0413 940 180
Fax +61 2 9552 4899
See Also
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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.
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Media contacts
Melissa May, APR: mmay@popcouncil.org
+1 212 339 0525
Diane Rubino: drubino@popcouncil.org
+1 212 339 0617
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