Acrux, the Australian company with patient-preferred technology for delivering drugs across the skin, entered 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.
Under the agreement, Acrux has a worldwide licence from the Population Council to intellectual property covering the use of Nestorone with Acrux's patented metered-dose skin spray delivery technology (MDTS). Acrux will develop and commercialise Nestorone MDTS and has the right to sub-license to commercial partners, states the company release.
In addition to commercial distribution of the product, Acrux (or its sub-licensees) will make Nestorone MDTS 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 MDTS provides the level of Nestorone 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 MDTS 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.
"Nestorone MDTS is 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 MDTS given the fact that annual worldwide sales of hormonal contraceptives exceed USD 4 billion, and sales of transdermal contraceptive patches in the United States alone are more than USD 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.
Nestorone, which cannot be taken orally, is a fourth-generation progestin contraceptive that has no androgenic hormonal effects, and a good safety profile. MDTS 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.
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.
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.