Agile Therapeutics Abstracts On Lead Product, AG200-15 Accepted By ACOG

Main Category: Pregnancy / Obstetrics
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 10 Dec 2008 - 0:00 PDT

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Agile Therapeutics, Inc., a late-stage pharmaceutical company specializing in women's health products, announced that two abstracts from Phase 2 studies of its lead product, AG200-15 with SKINFUSION(TM) technology, were accepted by the American College of Obstetricians and Gynecologists Annual Clinical Meeting and will be presented in May 2009 at ACOG's annual meeting in Chicago.

AG200-15, a new, innovative, low-dose, weekly contraceptive patch entering Phase 3 clinical trials, represents a significant advancement in the women's healthcare market. As a convenient alternative to oral contraceptives, the patch will fill an unmet need, freeing women from having to remember to take a pill every day. Phase 2 clinical study results will be presented on safety, efficacy and dosage for AG200-15, in which the product met its primary endpoints of ovulation suppression, cycle control and safety and demonstrated estrogen levels comparable with the well-established, low-dose oral contraceptive, Levlen(R).

Thomas Rossi, Ph.D., President and Chief Executive Officer of Agile Therapeutics, Inc., said, "This news represents another major milestone for AG200-15 with our patented SKINFUSION(TM) technology. Having two abstracts accepted for presentation at the premier obstetric-gynecology conference in the country reinforces the importance that this product will have for women as a contraceptive option."

The two abstracts scheduled for poster presentation are: (1) Pharmacokinetics: Contraceptive Patches Containing Levonorgestrel and Ethinyl Estradiol vs. Levlen(R), authored by David F. Archer, M.D., Frank Stanczyk, Ph.D., Arkady Rubin, Ph.D., and Marie Foegh, M.D., DrSc and will be presented on Monday, May 4, and (2) Ovulation Suppression and Cycle Control of Ethinyl Estradiol and Levonorgestrel Combination Patches, authored by Daniel R. Mishell Jr., M.D., David F. Archer, M.D., Arkady Rubin, Ph.D., Marie Foegh, M.D., DrSc, to be presented on Tuesday, May 5.

Marie Foegh, M.D., DrSc, Vice President, Clinical Research and Development at Agile Therapeutics, Inc., commented, "We are very excited to be working closely with leaders in the field of women's reproductive health, including David Archer M.D., Daniel Mishell M.D., and Frank Stancyk Ph.D., and to share positive safety and efficacy data on this important new entry into the contraceptive market."

Daily oral contraceptives and condoms are currently the most popular methods of birth control. In a 500 patient survey, sponsored by Agile, a weekly contraceptive patch was preferred over the pill by a 4-to-1 margin by women desiring contraception. Interest in an alternative to the daily birth control pill was also seen in another Agile-sponsored survey of 1,000 women using or desiring contraception. In that study, more than half of the women surveyed said they would ask their doctor about AG200-15, a low-dose, weekly contraceptive patch, after reading its profile.

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

AG200-15 with SKINFUSION(TM) technology is a low-dose, weekly contraceptive patch that is entering Phase 3 development with a clearly defined regulatory pathway. SKINFUSION(TM) technology makes it possible to utilize the trusted hormone combination of levonorgestrel and ethinyl estradiol in a contraceptive patch. The patch was designed for flexibility and comfort.

About Estrogen

Estrogen is associated with certain side effects, such as breast tenderness, bloating/weight gain, nausea and vomiting. These side effects are believed to be related to the amount of hormones delivered into the bloodstream, particularly with higher levels of estrogen. In some rare cases, high estrogen levels are thought to be linked with serious cardiovascular side effects. Therefore, low doses of estrogen in hormonal contraception are desired. According to FDA product labeling, women using Ortho EVRA(R), the only marketed birth control patch, are exposed to about 60 percent more estrogen than if they were using typical low-dose birth control pills. Increased levels of estrogen may increase the risk of blood clots, which led the FDA to add warnings to Ortho EVRA's labeling.

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. AG200-15, an innovative, weekly, low-dose contraceptive patch has the potential to become a major product in the $5 billion global hormonal contraceptive market (U.S. market $3 billion). AG200-15 is based on Agile's patented, dual delivery system, SKINFUSION(TM) technology, and utilizes the trusted hormonal combination of levonorgestrel and ethinyl estradiol.

The lead product is moving into Phase 3, with a clearly defined regulatory path. Agile is privately financed, with a solid foundation for growth. The Company 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 http://www.agiletherapeutics.com.

LEVLEN(R) is a registered trademark of Berlex Laboratories

Ortho EVRA(R) is a registered trademark of OrthoMcNeil(TM)

Agile Therapeutics, Inc.
http://www.agiletherapeutics.com

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