Agile Therapeutics Announces Issuance of Key Patents for Its SKINFUSION(TM) Technology in Contraception
Agile's Phase 3 Product Could Become a Preferred Alternative to Daily Oral Contraceptives
PRINCETON, NJ -- (Marketwire) -- 10/28/08 -- Agile Therapeutics, Inc., a late-stagepharmaceutical company specializing in women's health products, announcedtoday that the United States Patent and Trademark Office (USPTO) has issuedtwo patents for its proprietary transdermal delivery technology. Thepatents (US 7,045,145 and US 7,384,650) for the Company's SKINFUSIONtechnology covers the intermediate formulation during manufacturing and thefinished product for a transdermal patch containing estrogen and progestinused in contraception. Agile's lead product, AG200-15, is a new,innovative, low-dose, weekly contraceptive patch entering Phase 3 clinicaldevelopment. The patch will provide women with a convenient alternative tooral contraceptives by avoiding the need to remember to take a pill everyday.
Thomas Rossi, Ph.D., President and Chief Executive Officer of AgileTherapeutics, Inc., said, "SKINFUSION technology is a significantadvancement in contraception, providing women with the trusted hormonalcombination of levonorgestrel and ethinyl estradiol in a low-dose, weeklycontraceptive patch that is comfortable to wear. We expect our patents toprotect this important asset for Agile well into the future."
Daily oral contraceptives and condoms are currently the most popularmethods of birth control. In a 500 patient survey, sponsored by Agile, aweekly contraceptive patch was preferred over the pill by a 4-to-1 marginby women desiring contraception. Interest in an alternative to the dailybirth control pill was also seen in another Agile-sponsored survey of a1,000 women using or desiring contraception. In that study, more than halfof the women surveyed said they would ask their doctor about AG200-15, alow-dose, weekly contraceptive patch, after reading its profile. This ismuch higher than the 30 percent of women who reported dissatisfaction withtheir current method prior to seeing the Agile patch profile.
Jeffrey Frick, Chief Business Officer of Agile, said, "We are very excitedabout the potential of our lead product AG200-15 with SKINFUSIONtechnology. This patch has the potential to become a preferred method ofbirth control."
AG200-15 with SKINFUSION technology is the first in a portfolio ofcontraceptive products in Agile's pipeline that are patent protected wellbeyond 2020. Agile Therapeutics, Inc. has also recently filed threeadditional patents on unique dosing regimens with transdermalcontraceptives. These additional dosing regimens will allow Agile to builda 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 contraceptivepatch that is entering Phase 3 development with a clearly definedregulatory pathway. SKINFUSION technology makes it possible to utilizethe trusted hormone combination of levonorgestrel and ethinyl estradiol ina contraceptive patch. AG200-15 has completed Phase 2 development and metall target endpoints, including providing estrogen dose, ovulationsuppression, and side-effect similar to low-dose oral contraceptives. Thepatch was designed for flexibility and comfort.
About Estrogen
Estrogen is associated with certain side effects, such as breasttenderness, bloating/weight gain, nausea and vomiting. These side effectsare believed to be related to the level of hormones delivered into thebloodstream, particularly with higher levels of estrogen. In some rarecases, high estrogen levels are thought to be linked with seriouscardiovascular side effects in some women. Therefore, low doses ofestrogen in hormonal contraception are desired. According to FDA productlabeling, women using Ortho EVRA®, the only marketed birth control patch,are exposed to about 60 percent more estrogen than if they were usingtypical low-dose birth control pills. Increased levels of estrogen mayincrease the risk of blood clots, which led the FDA to add warnings toOrtho EVRA's labeling.
About Agile Therapeutics, Inc.
Agile Therapeutics is a high-growth, late-stage pharmaceutical companyspecializing in women's health products prescribed by OB/GYNs with aninitial focus on developing safer, more convenient methods of hormonalcontraception. AG200-15, an innovative, weekly, low-dose contraceptivepatch has the potential to become a major product in the $6 billion globalhormonal contraceptive market (U.S. market $2.5 billion). AG200-15 isbased on Agile's patented, dual delivery system, SKINFUSION technology,and utilizes the trusted hormonal combination of levonorgestrel and ethinylestradiol. The lead product is moving into Phase 3, with a clearly definedregulatory path.
Agile is privately financed, with a solid foundation for growth. TheCompany has raised a total of $35 million in venture funding withexperienced and committed healthcare investors, including ProQuestInvestments, The Hillman Company, TL Ventures, and Novitas Capital. Formore information, please visit www.agiletherapeutics.com.
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