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Agile Therapeutics Announces Allowance of Several Patents on Novel Dosing Regimens for Its Pipeline of Follow-On Contraceptive Products

PRINCETON, N.J., July 23, 2015 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (NASDAQ:AGRX), a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today announced that the U.S. Patent and Trademark Office issued Notices of Allowance between July 21 and 23 for four patent applications with claims directed to novel transdermal contraceptive dosing regimens.

The allowances of these patent applications provides the company with an additional proprietary platform for development of new products based on the Company's lead product candidate, Twirla® ethinyl estradiol and levonorgestrel transdermal system (AG200-15), currently in Phase 3 development. The four patent applications are published as US Publication Numbers 20110251163, 20110256210, 20110256211 and 20120021041. The allowed claims, which are available on the U.S. Patent and Trademark Office website, are directed to various novel dosing regimens, each of which employs transdermal delivery of contraceptive doses of ethinyl estradiol and levonorgestrel during a "treatment interval" and transdermal delivery of low dose ethinyl estradiol and low dose levonorgestrel during a "withdrawal interval". The company expects these patents will be relevant to two of the products in the Agile pipeline, AG200-SP and AG200-ER, as well as other new potential regimens.

"The allowance of these patent applications is an important milestone in building our women's health franchise beyond Twirla®. It validates our strategy for providing women additional contraceptive choices and demonstrates our commitment to develop unique follow-on products," said Al Altomari, Chief Executive Officer and President of Agile.

About Agile

Agile Therapeutics is a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products. Our product candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. Our lead product candidate, Twirla®, (ethinyl estradiol and levonorgestrel transdermal system), also known as AG200-15, is a once-weekly prescription contraceptive patch currently in Phase 3 clinical development. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to provide advantages over currently available patches and is intended to optimize patch adherence and patient acceptability. For more information, please visit the company website at www.agiletherapeutics.com. The company may occasionally disseminate material, nonpublic information on the company website.

Forward Looking Statement

Certain information contained in this press release includes "forward-looking statements" related to the Company's intellectual property protection and future product development. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates", "estimates," "expects," "plans," "intends," "may," "could," 'might," "will," "should" or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements are subject to important factors, risks and uncertainties, including, but not limited to, the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; patents may be delayed in issuing or may not ultimately issue at all; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the success, timing and cost of our ongoing and anticipated clinical trials of or our current product candidates or plans for product development and preclinical and clinical trials of future product candidates, including statements regarding the timing of initiation and completion of the trials and development work; the Company's ability to obtain the capital necessary to fund its operations; the Company's ability to generate revenues; the successful implementation of the Company's research and development programs and collaborations; the acceptance by the market of the Company's products; the success of the Company's license agreements; and other factors, including general economic conditions and regulatory developments, not within the Company's control. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. All forward looking statements are subject to risks detailed in our filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

CONTACT: Mary Coleman 609-683-1880Source:Agile Therapeutics