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Frost & Sullivan Recognizes Agile Therapeutics for Its Innovative Weekly Low-Dose Contraceptive Patch
Date:10/16/2009

MOUNTAIN VIEW, Calif., Oct. 16 /PRNewswire/ -- Based on its annual assessment of companies making innovative contributions in healthcare, Frost & Sullivan recognizes Agile Therapeutics, Inc. (Agile) with the 2009 North American Pharmaceuticals & Biotechnology Healthcare Innovation of the Year Award for its outstanding achievements in drug development. Agile's lead product, AG200-15 with SKINFUSION(TM), offers great potential as a convenient contraceptive option. Not only does this once-per-week contraceptive patch offer maximized patient comfort, but it also provides a safe and effective method of birth control.

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Of the estimated 62 million women of reproductive age in the United States, approximately 60 percent are currently using a contraceptive method to prevent pregnancy, according to the National Survey of Family Growth (NSFG). The Centers for Disease Control identifies oral contraceptives as the most popular form of birth control - used by an estimated 11.6 million American women. However, patient compliance is typically characterized as low for oral birth control pills with 19 to 47 percent of patients missing one or more pills per cycle.

"Missed doses result in decreased efficacy and may result in unwanted pregnancies," says Frost & Sullivan Research Analyst Katheryn Symank. "One way to ensure proper patient use is through the use of contraceptives with less frequent or novel dosing, which highlights the strong market opportunity for contraceptives that increase patient convenience."

Agile's AG200-15 utilizes the company's proprietary transdermal drug delivery technology, SKINFUSION(TM), in an innovative low-dose contraceptive patch that administers the proven hormonal combination of levonorgestrel and ethyinyl estradiol, with its established safety profile in oral contraceptives for over 30 years. Agile's transdermal patch combines a patented peripheral and active adhesive system to offer a soft, flexible transdermal patch that looks good and is comfortable to wear for 7 days.

Moreover, AG200-15 with SKINFUSION(TM) technology allows for stable drug delivery and dependable adhesion over 7 days. AG200-15 is a 28 day regimen, with a patch worn once weekly for 3 weeks, with the fourth week off.

AG200-15 promises to be a safe, effective and low dose contraceptive option that will meet a major, unmet market need of convenience (i.e. not needing to take a pill everyday). The only marketed contraceptive patch in the U.S. has an FDA-mandated warning that informs patients of its increased exposure to estrogen. Specifically, patients using that contraceptive patch are exposed to 60 percent more estrogen than typical oral birth control pills.

"As elevated levels of estrogen have been linked to an increased risk of cardiovascular events like venous thromboembolism, the sales of this contraceptive patch have declined noticeably with increased awareness," notes Symank. "In contrast, AG200-15 delivers a low-dose of estrogen, which is less than half the dose of the currently marketed transdermal patch."

In Phase II clinical trials, AG200-15 demonstrated estrogen levels that were equivalent to low dose OCs. In addition to its excellent safety profile, AG200-15 is also designed to be effective in preventing pregnancy. In Phase II clinical trials, AG200-15 was found to suppress ovulation similar to a low-dose OC. Accordingly, this product is moving into Phase III clinical trials.

Agile Therapeutics is also developing a weekly, levonorgestrel (progestin)-only contraceptive patch, AG1000. The company 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 AG1000.

"AG1000 could be a significant advancement in women's healthcare and could provide a convenient alternative to progestin-only contraceptive pills," says Symank. "It builds upon Agile's SKINFUSION(TM) technology to create an exciting new option for women who would benefit from progestin-only contraception, such as for breast-feeding mothers and women who should not use estrogen for contraception."

In recognition of the company's outstanding achievements in contraceptive drug development, Frost & Sullivan is proud to present the 2009 North American Pharmaceuticals & Biotechnology Healthcare Innovation Award in Women's Health to Agile Therapeutics, Inc. Each year, Frost & Sullivan presents the Healthcare Innovation Award to the company that has demonstrated a breakthrough approach or degree of differentiation innovation compared to other market participants.

The company's innovative contribution(s) to healthcare make it possible to envision a new level of care in the diagnosis, treatment, and management of disease, leading to better outcomes and quality-of-life for patients. In addition, the company's innovative efforts may also lead to improvements in the tools that clinicians, diagnosticians, researchers, and healthcare administrators have at their disposal to improve quality and efficiency in the provision of healthcare services.

Frost & Sullivan's Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

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, has the potential to become a major product in the $5 billion global hormonal contraceptive market (U.S. market $3 billion). Agile Therapeutics is also developing a weekly, levonorgestrel (progestin) only contraceptive patch, AG1000. 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 AG1000. 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.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best in class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 35 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.

    Contact:
    Jake Wengroff
    210.247.3806
    jake.wengroff@frost.com

SOURCE Frost & Sullivan


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