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.
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™, 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.
SOURCE Agile Therapeutics, Inc.