NICHD/National Institutes of Health (NIH) to Conduct Clinical Study With Agile Therapeutics, Inc.'s Weekly, Progestin-Only, Contraceptive Patch

PRINCETON, NJ--(Marketwire - March 26, 2009) - Agile Therapeutics, Inc., a late-stage pharmaceutical company specializing in women's health products, today announced that it 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). The collaboration agreement is for the clinical study of a progestin-only contraceptive patch, identified by Agile Therapeutics as AG1000, designed to deliver a safer and more convenient method of hormonal contraception for breast feeding mothers and women with contraindications to estrogen. The clinical testing of this first-in-class product will be completed in NICHD's Contraceptive Clinical Trials Network.

Agile Therapeutics' weekly, progestin-only contraceptive patch will be a significant advancement in women's healthcare and could provide a convenient alternative to progestin-only contraceptive pills. The clinical trials under this agreement will determine the safety, efficacy and appropriate dosing of this progestin-only contraceptive patch.

Thomas M. Rossi, Ph.D., Agile's President and Chief Executive Officer, said, "The collaboration agreement announced today with the NICHD allows us to build upon our proprietary SKINFUSION™ technology to create an exciting new option for women who would benefit from progestin-only contraception."

Marie Foegh, M.D., Chief Medical Officer and Vice President, Clinical Research and Development of Agile, said, "The progestin-only patch, applied once-weekly, will be an important option not only for breast-feeding women, but also for women where estrogen containing contraceptives may not be used. AG1000 could make the lives of breast feeding women easier by eliminating the need to remember to take a pill daily. We are very pleased that we can contribute to advancing the contraceptive options for women through NICHD sponsored clinical trials."

About Estrogen

Estrogen may significantly decrease breast milk production. Therefore, estrogen containing contraceptives are not recommended for breast-feeding mothers. Also, in rare cases, estrogen has been linked to serious cardiovascular side effects. Women with past history of cardiovascular events or women with certain cardiovascular risk factors are recommended not to use contraceptives containing estrogen.

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's lead product is AG200-15, an innovative, weekly, low-dose combination 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 also based on Agile's patented SKINFUSION™ technology, and utilizes the trusted hormonal combination of levonorgestrel and ethinyl estradiol. The lead product is moving into Phase 3 clinical development. Agile is privately financed, with a solid foundation for growth and backed by experienced healthcare investors, including ProQuest Investments, The Hillman Company, TL Ventures, and Novitas Capital. For more information, please visit http://www.agiletherapeutics.com.


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