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New Studies on Agile Therapeutics, Inc.' Low-Dose Contraceptive Patch to be Presented at the American College of Obstetricians and Gynecologist' Annual Clinical Meeting


4/25/2012 9:53:04 AM

PRINCETON, NJ--(Marketwire - April 25, 2012) -

Agile Therapeutics, a pharmaceutical company focused on developing and commercializing more convenient women's contraceptive products, announced today that three new studies, including Phase III data, using AG200-15, Agile's weekly contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG), will be presented during poster and oral presentations at the American College of Obstetricians and Gynecologists' (The College) 60th Annual Clinical Meeting (ACM). The meeting will take place in San Diego, CA from May 5th to May 9th, 2012.

Information on the studies is as follows:

[Embargoed until 5/7/2012, 12:01 A.M. Eastern Time]
Oral Presentation: The Pharmacokinetic Profile of a Low-Dose Contraceptive Patch is Equivalent at Three Anatomical Sites
Investigators: Dr. Frank Stancyzyk, University of Southern California/ Dr. David Archer, Eastern Virginia Medical School
Date: Monday, May 7th, 2012
Time: 2:10 PM

[Embargoed until 5/7/2012, 12:01 A.M. Eastern Time]
Poster Presentation: Comparative Phase III study of AG200-15, a Low-Dose estrogen and levonorgestrel Contraceptive Patch
Poster Number: 5
Investigator: Dr. Andrew Kaunitz, University of Florida
Date: Monday, May 7th, 2012
Time: 3:00 PM - 4:00 PM

[Embargoed until 5/7/2012, 12:01 A.M. Eastern Time]
Poster Presentation: Adhesiveness and Pharmacokinetics of a Low-Dose Contraceptive Patch under Daily External Stressors
Poster Number: 1
Investigator: Dr. David Archer, Eastern Virginia Medical School
Date: Monday, May 7th, 2012
Time: 3:00 PM - 4:00 PM

Dr. Marie Foegh, Chief Medical Officer and Vice President, Clinical Research and Development of Agile Therapeutics, said, "There is a significant unmet need for more convenient contraceptive options that are safe and easy for patients to use. We are pleased to be presenting important data at The College's 60th ACM. We are working diligently to bring this unique product to market as quickly as we can and have recently submitted our New Drug Application with the U.S. Food and Drug Administration."

About AG200-15
AG200-15, developed by Agile Therapeutics, is a combination hormonal contraceptive patch, which in clinical studies has been shown to deliver a low dose of ethinyl estradiol, as well as a dose of levonorgestrel that is consistent with the efficacy and safety profile of low-dose oral contraceptives. Agile Therapeutics initiated its Phase III clinical trials, NEW CHOICE STUDY and NEW CHOICE II, for AG200-15 in August 2010. The phase III trials, which enrolled more than 2,000 women, will form the basis for the Company's application to the US Food and Drug Administration in 2012.
The AG200-15 patch is applied once weekly for three weeks, followed by a fourth, patch-free week. The patch may be applied to the abdomen, buttocks, or upper torso, is soft and flexible with a cloth-like, silky feel, and is designed to provide excellent adhesion, comfort, and appearance.

About Agile Therapeutics
Agile Therapeutics is a pharmaceutical development company specializing in Women's Healthcare products, with an initial focus on providing women with more options and more convenient methods of hormonal contraception. The company's lead product, AG200-15, is a once-weekly contraceptive patch that recently completed Phase III clinical trials. In addition, Agile is also developing a low dose, progestin-only contraceptive patch, AG890 (formerly AG900). Both AG200-15 and AG890 incorporate proprietary transdermal delivery technology, Skinfusion®, developed by Agile, consisting of an active and peripheral adhesive system that allows stable drug delivery and dependable adhesion over seven days. For more information, please visit http://www.agiletherapeutics.com.


Media Contact:
Chantal Beaudry or Erich Sandoval for Agile Therapeutics
cbeaudry@lazarpartners.com
esandoval@lazarpartners.com
Tel. 212-867-1762


Read at BioSpace.com

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