Contraceptive spray development

March 13, 2007

Contraceptives that are sprayed onto the skin are under development to offer a more convenient alternative method of birth control.

Contraceptives that are sprayed onto the skin are under development to offer a more convenient alternative method of birth control. Organon, human healthcare business unit of Akzo Nobel, has licensed the skin spray technology to biotechnology company, Acrux, with a potential to develop multiple contraceptive products worth $6.7 billion globally each year.

The spray uses a hand-held applicator to deliver a fast-drying formulation to the skin, consisting of an alcohol-based carrier with the API and a skin penetration enhancer. Within a minute, the volatile component evaporates, leaving the spray dry on the skin — the contraceptive component and skin penetration enhancer being absorbed and forming a depot within the outer layer of the skin. The contraceptive then diffuses into the bloodstream over a 24-hour period. Applied daily, the depot is topped up to allow a steady level of contraceptive to be released into the blood.

Under the agreement, Organon has licensed Acrux's technology for use with selected contraceptive compounds. Acrux will be responsible for developing formulations of contraceptive compounds and upon successful completion of this programme; Organon will undertake and fund all clinical trials, regulatory submissions, manufacturing and marketing.

For each contraceptive compound that Organon selects to develop, Acrux may receive payments totalling between $12-16 million as development and regulatory milestones are achieved. Acrux will also earn royalties on worldwide sales of each product.

Acrux is free to develop and commercialize sprays containing other contraceptive compounds, including Nestorone, which it is currently advancing through clinical trials.

Worldwide sales of hormonal contraceptive products in 2006 were approximately $6.7 billion. The availability of a broad range of effective, safe and appealing contraceptive products is viewed as one of the most important issues in contraception. This enables women to choose the method most appropriate to their needs and lifestyle.

www.acrux.com.au