PRINCETON, N.J., June 16, 2016 (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 US Patent 9,364,487 on June 14, 2016. The newly-issued patent includes claims covering the formulation of a progestin-only transdermal patch containing levonorgestrel and is expected to expire in 2032.
The Company continues to explore innovative methods of delivering hormonal contraceptives through its Skinfusion® transdermal delivery system. While the Company does not expect to list the newly issued patent in the FDA’s Orange Book in connection with its lead product candidate, Twirla®, (ethinyl estradiol and levonorgestrel transdermal system), the patent is relevant to the Company’s progestin-only patch R&D program. The Company has eight issued US patents that cover Twirla and that the Company expects will be listed in the Orange Book: US 7,045,145, US 7,384,650, US 8,221,784, US 8,221,785, US 8,246978, US 8,747,888, US 8883196, and US 9050348, the latest of which extend into 2028.
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. 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 clinical trials and anticipated clinical trials of or our current product candidates, including statements regarding the timing of initiation and completion of the trials; 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.