AG900 is a new, low dose, progestin-only contraceptive patch currently in clinical development. The primary indication for this patch will be the prevention of pregnancy in women desiring contraception who are breast-feeding and/or women where estrogen containing contraceptives are contraindicated, inappropriate or unwanted.

The patch contains levonorgestrel (LNG) and is provided in a 28-day regimen. The patch is replaced every 7 days on a continuous basis, with no "patch-free" period.

Agile has signed a Clinical Trial Agreement with the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) for the clinical testing of AG900. The clinical testing will be completed within NICHD’s Contraceptive Clinical Trials Network. Two doses will be included in these studies: (1) approximately 75 µg/day (AG900-12.5), and (2) approximately 40 µg/day (AG900-6.5). The clinical trials under this agreement will determine the safety, efficacy and appropriate dosing of this progestin-only contraceptive patch.

AG900 will be a significant advancement in women’s healthcare and could provide a convenient alternative to progestin-only contraceptive pills. AG900 builds upon Agile’s proprietary technology to create an exciting new option for women who would benefit from progestin-only contraception.”

AG900 could make the lives of breast feeding women easier by eliminating the need to remember to take a pill daily. AG900 can contribute to advancing the contraceptive options for women through NICHD-sponsored clinical trials.

The progestin-only pills (POPs) are predominantly used in breast feeding mothers requiring contraception. These products are not actively promoted and have significant limitations. According IMS data (MAT 3/09) the current POPs market in US is approximately $130 million.

The market for women requiring estrogen free contraception is increasing due to the epidemic of obesity in the US population. According to NHANEs data 30.5% of women between the ages of 20-39 years of age are obese (BMI >30).

The market need for a low dose, progestin only contraceptive patch is very large.