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SOURCE Agile Therapeutics, Inc.
Expands Patent Portfolio for its Contraceptive Patch, Twirla™
PRINCETON, N.J., June 20, 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 patent U.S. 8,747,888 ('888 Patent), was issued by the U.S. Patent and Trademark Office on June 10, 2014. The patent is a continuation of its prior patent US 8,246,978 and is intended to provide additional patent protection covering its contraceptive patch, Twirla™ ethinyl estradiol and levonorgestrel transdermal system.
"The granting of this patent further strengthens the patent protection of our proprietary Skinfusion® transdermal technology used in our contraceptive patch, Twirla currently in Phase 3 clinical development," said Al Altomari, Chief Executive Officer and President of Agile. "The issuance of this patent demonstrates our commitment to protecting our intellectual property in our proprietary transdermal technology and is expected to provide protection into 2028."
Agile will submit the '888 Patent to the FDA in addition to previously submitted patent information on five other issued patents on its propriety Skinfusion transdermal technology. If the Company's New Drug Application for Twirla is approved, the Company intends the '888 Patent to be the sixth patent that will be listed in the FDA Orange Book. The Company has multiple additional patent 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 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.
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