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PRINCETON, N.J., July 17, 2014 /PRNewswire/ -- 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 a Notice of Allowance on July 17, 2014 for additional patent claims covering dosing regimens using the Company's lead product candidate Twirla (ethinyl estradiol and levonorgestrel transdermal system (AG200-15)), currently in Phase 3 development. The allowed patent, which is published as US Patent Application 20140072615, is based on Agile's prior patent, US 7,384,650, covering the formulation for Twirla.
"We believe the allowance of this patent represents another step towards our goal of protecting Twirla, and future product line extensions," said Al Altomari, Chief Executive Officer and President of Agile. "We intend to continue our efforts to expand our intellectual property portfolio protecting our proprietary Skinfusion® transdermal technology."
Agile will submit information regarding this patent to the FDA for inclusion in the FDA's Orange Book if the Company's New Drug Application for Twirla is approved.
The Company has multiple additional patents and applications on file, all relating to further advances in Skinfusion transdermal delivery system.
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, 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.
Forward Looking Statement
Certain information contained in this press release includes "forward-looking statements" related to the Company's intellectual property protection and regulatory filings. 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; the patent 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. These factors could cause actual results and developments to be materially different from those expressed in or implied by such statements. All forward looking statements are subject to risks detailed in the Company's filings with the U.S. Securities and Exchange Commission, including its Registration Statement on Form S-1 and its Final Prospectus. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as the date of this press release. The Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
SOURCE Agile Therapeutics, Inc.