SOURCE: Agile Therapeutics, Inc.

November 18, 2008 08:01 ET

Agile's Lead Product, AG200-15, Moving Into Pivotal Phase 3 Trials

Successful Meeting With FDA Provides Clear Development Path for Innovative Birth Control Method: a Low-Dose, Once-Weekly Contraceptive Patch

PRINCETON, NJ--(Marketwire - November 18, 2008) - Agile Therapeutics, Inc., a late-stage pharmaceutical company specializing in women's health products, announced today that after a successful end-of-Phase 2 meeting with the Food and Drug Administration (FDA), the company is moving forward with its pivotal Phase 3 program to support a NDA filing and marketing approval of AG200-15 with SKINFUSION™ technology. AG200-15 is an innovative, low-dose contraceptive patch that offers women a convenient, once-weekly form of birth control. AG200-15 will fulfill a large unmet need for a more convenient contraceptive alternative to the birth control pill.

New market research, conducted by Agile in 2008 with approximately 1,500 women of reproductive age, highlights that of the 80 percent of women who would consider using the patch these women actually prefer the weekly contraceptive to the pill by a 4-to-1 margin. More than 30 percent of women who use birth control reported dissatisfaction with their current contraceptive methods -- with a lack of convenience cited as a leading reason. In addition, up to 65 percent of women who reported thinking about using contraception said they would discuss AG200-15 with their doctors.

Thomas Rossi, Ph.D., President and Chief Executive Officer of Agile Therapeutics, Inc., said, "We are very excited about the outcome of the end-of-Phase 2 meeting with the FDA. We now have a clear development pathway for AG200-15 for marketing approval. Agile's low-dose contraceptive patch is expected to fill a sizeable need in the $6 billion global ($2.5 billion U.S.) hormonal contraceptive market, opening the way for AG200-15 to become a leading contraceptive product."

During the meeting, the Company obtained FDA review and feedback on AG200-15's results in Phase 1 and 2 clinical studies, along with non-clinical and CMC data. While citing no safety concerns over drug components, levonorgestrel and ethinyl estradiol, the FDA is requiring the customary birth control Phase 3 study design to assess safety and efficacy of AG200-15 along with some additional supporting data for AG200-15's label.

Marie Foegh, M.D., Chief Medical Officer and Vice President, Clinical Research and Development at Agile Therapeutics, said, "We are very comfortable with the FDA's requests and are confident in our ability to have a successful Phase 3 program based upon our Phase 2 results."

About AG200-15, Agile's Low-Dose Contraceptive Patch

AG200-15 with SKINFUSION™ technology is a low-dose, weekly contraceptive patch that is entering Phase 3 development with a clear defined regulatory pathway. SKINFUSION™ technology makes it possible to use the trusted hormone combination of levonorgestrel and ethinyl estradiol in a contraceptive patch. AG200-15 has completed Phase 2 development and met all target endpoints, including providing estrogen dose, ovulation suppression, and side-effect similar to low-dose oral contraceptives. The patch was designed for flexibility and comfort.

About the Contraceptive Patch Market

Ortho EVRA®, the only contraceptive patch available on the market today, suffered major sales declines in 2005, when the FDA revised the product's labeling to warn women about the risks associated with its higher than expected estrogen dose. Prior to this labeling change, Ortho EVRA® had been the most successful contraceptive launch in U.S. history.

About Estrogen

Estrogen is associated with certain common side effects, such as breast tenderness, bloating/weight gain and nausea. These side effects are believed to be related to the level of hormones delivered into the blood stream, particularly with higher levels of estrogen. In some rare cases, high estrogen levels are thought to be linked with serious, cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are desired.

About Agile Therapeutics, Inc.

Agile Therapeutics is a high-growth, late-stage pharmaceutical company specializing in women's health products prescribed by OB/GYNs with an initial focus on developing safer, more convenient methods of hormonal contraception. Agile is privately financed and has raised a total of $35 million in venture funding with experienced and committed healthcare investors, including ProQuest Investments, The Hillman Company, TL Ventures, and Novitas Capital. For more information, please visit www.agiletherapeutics.com.