Agile Therapeutics Announces Issuance Of Key Patents For Its Skinfusion™ Technology In Contraception

Main Category: Sexual Health / STDs
Article Date: 28 Oct 2008 - 11:00 PDT

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Agile Therapeutics, Inc., a late-stage pharmaceutical company specializing in women's health products, announced today that the United States Patent and Trademark Office (USPTO) has issued two patents for its proprietary transdermal delivery technology. The patents (US 7,045,145 and US 7,384,650) for the Company's SKINFUSION™ technology covers the intermediate formulation during manufacturing and the finished product for a transdermal patch containing estrogen and progestin used in contraception. Agile's lead product, AG200-15, is a new, innovative, low-dose, weekly contraceptive patch entering Phase 3 clinical development. The patch will provide women with a convenient alternative to oral contraceptives by avoiding the need to remember to take a pill every day.

The patents represent a key advancement in the development of transdermal delivery systems. SKINFUSION™ technology utilizes Passive Enhancement Chemistry (PEC) in a dual delivery system consisting of an active and peripheral adhesive system that delivers hormones at levels necessary to prevent pregnancy. The Company has filed an additional patent application covering the active adhesive system, which utilizes a unique combination of enhancers to provide balanced delivery of drug over seven days. In addition, patent applications have been filed to protect intellectual property rights in the peripheral adhesive system, which maintains drug stability while improving patch adhesion and comfort.

Thomas Rossi, Ph.D., President and Chief Executive Officer of Agile Therapeutics, Inc., said, "SKINFUSION™ technology is a significant advancement in contraception, providing women with the trusted hormonal combination of levonorgestrel and ethinyl estradiol in a low-dose, weekly contraceptive patch that is comfortable to wear. We expect our patents to protect this important asset for Agile well into the future."

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 a 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. This is much higher than the 30 percent of women who reported dissatisfaction with their current method prior to seeing the Agile patch profile.

Jeffrey Frick, Chief Business Officer of Agile, said, "We are very excited about the potential of our lead product AG200-15 with SKINFUSION™ technology. This patch has the potential to become a preferred method of birth control."

AG200-15 with SKINFUSION™ technology is the first in a portfolio of contraceptive products in Agile's pipeline that are patent protected well beyond 2020. Agile Therapeutics, Inc. has also recently filed three additional patents on unique dosing regimens with transdermal contraceptives. These additional dosing regimens will allow Agile to build a solid franchise based upon its lead product AG200-15.

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 clearly defined regulatory pathway. SKINFUSION™ technology makes it possible to utilize 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 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 level 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 in some women. Therefore, low doses of estrogen in hormonal contraception are desired. According to FDA product labeling, women using Ortho EVRA®, 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 $6 billion global hormonal contraceptive market (U.S. market $2.5 billion). AG200-15 is based on Agile's patented, dual delivery system, SKINFUSION™ 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.

Source
Lisa Rivero
LaVoie Group