Discussions with FDA on Design of Comparative
Wear Study of Twirla® and Xulane® Completed
Agile Therapeutics, Inc., (Nasdaq: AGRX), a women’s healthcare
company, today announced that on January 9, 2019 it received final
meeting minutes from its December 11, 2018 meeting with the U.S.
Food and Drug Administration’s (“FDA”) Division of Bone,
Reproductive, and Urologic Products (“DBRUP”). The Company
met with DBRUP to discuss the design of a comparative wear study
between Twirla® and Xulane® (the “comparative wear study”) as
suggested by FDA’s Office of New Drugs (“OND”) in its decision on
the Company’s previously announced formal dispute resolution
request.
In its meeting with DBRUP, the Company discussed the specific
design and success criteria of the comparative wear study, which is
intended to demonstrate adequate adhesion via non-inferiority of
Twirla to Xulane, the generic version of the previously marketed
Ortho Evra® contraceptive patch, a product the FDA considers to
have acceptable adhesion. After consultation with DBRUP, the
Company has initiated a crossover wear study in approximately 80
healthy women with a Body Mass Index of less than 35 kg/m2 who will
be randomized to wear either Twirla or Xulane for the first week
and then switched to the patch not initially worn for the second
week. The overall design of this comparative wear study follows the
FDA’s guidance with respect to abbreviated new drug applications,
entitled Assessing Adhesion With Transdermal and Topical Delivery
Systems for ANDAs.
“Now that we have completed our discussions with the FDA, we are
eager to complete the comparative wear study and resubmit our
Twirla new drug application (“NDA”). I can confirm, as we
previously stated, that we expect to complete the study in the
first quarter of 2019 and to resubmit our NDA in the first half of
2019, which gives us the opportunity to receive approval by the end
of 2019,” said Al Altomari, Chairman and Chief Executive Officer of
Agile Therapeutics, Inc.
The FDA has previously informed the Company that in connection
with its review of the Twirla NDA, the FDA plans to bring the
safety and efficacy of Twirla to an Advisory Committee. The
Company also expects that the FDA will conduct a pre-approval
inspection of the Company’s third-party manufacturer’s facility,
which must be successfully completed prior to approval.
The Company believes that its unaudited cash and cash
equivalents as of December 31, 2018, will be sufficient to meet its
projected operating requirements into the second quarter of 2019,
which will include completion of the comparative wear study.
The Company will require additional capital to fund operating needs
for the remainder of the second quarter of 2019 and beyond,
including among other items, preparation for an anticipated
Advisory Committee meeting to discuss safety and efficacy of
Twirla, the completion of its commercial plan for Twirla, which
primarily includes validation of the commercial manufacturing
process and the commercial launch of Twirla, if approved, and
advancing the development of its other potential product
candidates.
About Twirla® (AG200-15)Twirla
(levonorgestrel/ethinyl estradiol transdermal system) or AG200-15
is an investigational low-dose, once-weekly contraceptive patch.
AG200-15 is a combined hormonal contraceptive (CHC) patch that
contains the active ingredients ethinyl estradiol (EE), a type of
estrogen and levonorgestrel (LNG), a type of progestin. Twirla is
designed to be applied once weekly for three weeks, followed by a
week without a patch. The Company has completed its Phase 3
clinical trials of Twirla and is pursuing regulatory approval in
the U.S. Agile received a complete response letter (CRL) from
the FDA in December 2017 relating to the New Drug Application (NDA)
for Twirla. In the CRL, the FDA informed the Company that the
product could not be approved in its present form due to
deficiencies related to, among other things, the in vivo adhesion
properties of Twirla and their potential relationship to the
Company’s Phase 3 clinical trial results. The Company
initiated formal dispute resolution with the FDA in June 2018 in
response to the FDA’s position on Twirla’s in vivo adhesion
properties, and in October 2018, the FDA’s Office of New Drugs
formally denied the Company’s appeal but provided a path forward
for seeking regulatory approval for Twirla, which the Company is in
the process of pursuing.
About Agile Therapeutics, Inc. 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® (levonorgestrel/ethinyl estradiol transdermal
system), also known as AG200-15, is an investigational low-dose,
non-daily, prescription contraceptive. Twirla is based on our
proprietary transdermal patch technology, called Skinfusion®, which
is designed to allow drug delivery through the skin. For more
information, please visit the company website at
www.agiletherapeutics.com. The Company may occasionally disseminate
material, nonpublic information on the Company’s website.
Follow Agile on Linked In and Twitter: @AgileTher.
Xulane® is a registered trademark of Mylan N.V., and Ortho Evra®
is a registered trademark of Johnson & Johnson.
Forward-Looking StatementsCertain information
contained in this press release includes "forward-looking
statements", within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, related to our regulatory submissions and
projected cash position. We may, in some cases use terms such as
"predicts," "believes," "potential," "continue," "anticipates,"
"estimates," "expects," "plans," "intends," "may," "could,"
“might," “likely,” "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, including statements regarding the
fact that our existing cash and cash equivalents likely will not be
sufficient to fund our current and planned operations beyond the
second quarter of 2019, 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, our intention
to complete a comparative wear study of Twirla and Xulane, which
may not yield positive results, and our belief that a reformulation
of Twirla may not be necessary. 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. These forward looking statements are
subject to risks and uncertainties including risks related to our
ability to manage costs and execute on our operational and budget
plans, the FDA requiring us to reformulate Twirla, our ability to
develop a reformulation that will address the FDA’s concerns,
including showing bioequivalence, if necessary, our ability to
successfully complete the comparative wear study as discussed with
DBRUP and that the results of such comparative wear study do not
support a conclusion by the FDA that Twirla has demonstrated
adequate adhesion, and, the potential that we will not complete the
comparative wear study in the timeframe we expect, the potential
that we may be required to conduct an additional Phase 3 trial, the
likelihood that we will require additional correspondence with the
FDA prior to the resubmission of our NDA, our ability to resubmit
and the timing of our resubmission of the NDA for Twirla, FDA
acceptance and approval of the resubmitted NDA, or whether other
issues will arise that will negatively impact acceptance, review,
and approval of Twirla by the FDA, including a determination by the
Advisory Committee that Twirla should not be approved, our ability
to address the deficiencies identified by the FDA in the CRL issued
in December 2017 and in the Type A meeting minutes issued in May
2018, the fact that our existing cash and cash equivalents may not
be sufficient to fund the completion of the development and
regulatory review process for Twirla, our ability to raise capital
when needed to complete the development and regulatory review
process for Twirla, and unforeseen market factors or events in our
clinical and manufacturing development plans and the other risks
set forth in our filings with the U.S. Securities and Exchange
Commission, including our Annual Report on Form 10-K and our
Quarterly Reports on Form 10-Q. For all these reasons, actual
results and developments could be materially different from those
expressed in or implied by our forward-looking statements. 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.
SOURCE: Agile Therapeutics, Inc.
Contact:Investor Relations Agile
Therapeutics609-683-1880
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