Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare
company, today hosted the Company’s first analyst day in New York
City to showcase its corporate vision and commercial strategy for
the potential launch of Twirla® (AG200-15), its investigational low
dose hormonal contraceptive patch product candidate. In July 2017,
the U.S. Food and Drug Administration (FDA) accepted resubmission
of the Company’s New Drug Application (NDA) for Twirla and assigned
December 26, 2017 as the Prescription Drug User Fee Act (PDUFA)
goal date.
“The U.S. combined hormonal contraceptive market
is currently worth an estimated 3.9 billion dollars,” said Al
Altomari, chairman and chief executive officer, Agile Therapeutics,
Inc. “We are rapidly preparing our commercial organization to
deliver on our vision of answering unmet needs for women who want
to be in control of their contraceptive choice with a non-daily
option. We eagerly await the FDA decision on Twirla by our PDUFA
goal date.”
In addition to Twirla, its lead investigational
product candidate, Agile Therapeutics is continuing to explore ways
to address additional needs in the contraceptive market through its
pipeline. Agile expects to begin planning the clinical
development for its investigational small patch program, including
AG200-SP and AG200-ER in 2018.
Underscoring Agile’s prospective growth and
position to capitalize on the large scale potential of the hormonal
contraceptive market, the Company has been granted 17 United States
patents to date, with counterparts in several important markets
worldwide. Most recently, the U.S. Patent and Trademark
Office issued the Company four new patents with claims directed to
novel transdermal contraceptive dosing regimens. These new patents
provide an expanded proprietary platform not only for the
development of Twirla and Agile’s pipeline, but also for potential
new products utilizing a broad selection of other progestins and
estrogens.
“It’s an exciting time for Agile as we continue
to build and grow our commercial infrastructure for our lead
product candidate and beyond,” said Renee Selman, chief commercial
officer, Agile Therapeutics, Inc. “We are adding the best and
brightest talent in women’s health to support our commercial
efforts and bolster our commercial operations, supply chain and
sales and marketing teams.”
The analyst day presentation was webcast live
and can be accessed on the Investor Relations section of Agile
Therapeutics website at www.agiletherapeutics.com.
For more information, please visit the Company
website at www.agiletherapeutics.com. The Company may occasionally
disseminate material, nonpublic information on the Company
website.
About Agile Therapeutics
Agile Therapeutics is a forward-thinking women's
healthcare company dedicated to fulfilling the unmet health needs
of today's women. Our product candidates are designed to provide
women with contraceptive options that offer freedom from taking a
daily pill, without committing to a longer-acting method. Our lead
product candidate, Twirla®, (ethinyl estradiol and levonorgestrel
transdermal system), also known as AG200-15, is a once-weekly
prescription contraceptive patch that recently completed Phase 3
trials. 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 adhesion and patient wearability. For more
information, please visit the company website
at www.agiletherapeutics.com.
Follow Agile on social
media: @agilether. The company may occasionally
disseminate material, nonpublic information on the company
website.
About Twirla®
Twirla (ethinyl estradiol and levonorgestrel
transdermal system) or AG200-15 is an investigational once-weekly
prescription contraceptive patch. AG200-15 is a combined hormonal
contraceptive (CHC) patch that contains the active ingredients
ethinyl estradiol (EE), a synthetic estrogen, and levonorgestrel
(LNG), a type of progestin, a synthetic steroid hormone. Twirla is
designed to be applied once weekly for three weeks, followed by a
week without a patch.
Forward-Looking Statement
Certain information contained in this press
release includes "forward-looking statements" related to the
Company's clinical trials, regulatory submissions, projected cash
position and potential market opportunity for its product
candidates. 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.
Our forward-looking statements are based on current beliefs and
expectations of our management team that involve risks, potential
changes in circumstances, assumptions and uncertainties. Any or all
of the forward-looking statements may turn out to be wrong, or be
affected by inaccurate assumptions we might make or by known or
unknown risks and uncertainties. Our statements about the results
and conduct of our clinical trial could be affected by the
potential that there are changes in the data or interpretation of
the data by the FDA (for example, the FDA may include additional
pregnancies in its calculation of the Pearl Index, which would
increase the Pearl Index), whether the results will be deemed
satisfactory by the FDA (for example, we describe the results of
the SECURE trial as positive, the FDA may disagree with that
characterization), whether the FDA requires labeling restrictions,
and whether additional studies will be required or other issues
will arise that will negatively impact acceptance, review, and
approval of Twirla by the FDA; our statements about our projected
cash position could be affected by market factors, the inherent
risks in our business, our ability to execute the Company’s
operational and budget plans, the FDA does not approve Twirla, the
FDA’s timeline for review is not completed by the target PDUFA goal
date, our ability to timely complete the qualification and
validation of our commercial manufacturing process, the fact that
our existing cash and cash equivalents will not be sufficient to
fund our current and planned operations through the next 12 months,
which raises substantial doubt about our ability to continue as a
going concern, and which, in turn, may create negative reactions to
the price of our common stock making it more difficult to obtain
financing in the future, and unforeseen events in our clinical and
manufacturing development plans; and our statements about the
potential commercial opportunity could be affected by the potential
that our product does not receive regulatory approval, does not
receive reimbursement by third party payors, potential limitations
of the federal insurance mandate for contraception, delays in our
potential launch as a result of unforeseen product supply and/or
manufacturing constraints or a commercial market for the product
does not develop because of any of the risks inherent in the
commercialization of contraceptive products. 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 Investor RelationsAgile Therapeutics, Inc. E:
mcoleman@agiletherapeutics.com P: 609-683-1880
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