Cash Expected to Enable Company to Fund
Operations into Second Quarter 2019
Agile Therapeutics, Inc., (Nasdaq:AGRX), a women’s healthcare
company, today announced several key corporate updates:
- Formal dispute resolution request has been submitted to the FDA
regarding Twirla® (levonorgestrel/ethinyl estradiol transdermal
system), its lead product candidate
- Reducing workforce by approximately 30% and reducing other
planned expenses
- Reductions in workforce and expenses expected to allow existing
cash to fund operations into the second quarter of 2019
Agile has submitted a formal dispute resolution request (FDRR)
with the FDA for Twirla (AG200-15), the Company’s investigational
low-dose, non-daily, combination hormonal contraceptive patch. The
dispute pertains to the determination from the FDA’s reviewing
Division of Bone, Reproductive and Urologic Products (DBRUP), that
concerns surrounding the in vivo adhesion properties of Twirla
prevent its approval and cannot be addressed through the Company’s
proposed patient compliance programs.
The Company anticipates that its FDRR will be reviewed by the
Office of Drug Evaluation III (ODEIII) and has requested a meeting
with the Office Director, which, according to FDA’s guidance,
should occur within thirty days of the request. After the
meeting, the Director should provide a decision within thirty
days.
The formal dispute resolution process exists to encourage open,
prompt discussion of scientific and procedural disputes that arise
during drug development, new drug review, and post-marketing
oversight processes of the FDA. By submitting its FDRR, the
Company is availing itself of the FDA’s established appeal process
whereby disagreements with conclusions reached by a reviewing
Division within the FDA are reviewed above the Division
level. Through this process the Company has the ability to
escalate its appeal to additional levels of FDA management, if
necessary.
“Twirla’s adhesion profile was assessed in the context of a
large Phase 3 trial, the objective of which was to demonstrate
safety and efficacy as the basis for approval of the product.
We continue to believe the objectives of this trial were met, and
that there is no evidence that in vivo adhesion impacted the
clinical outcomes of the trial. On this basis, we believe the
in vivo adhesion data are adequate to support approval without the
need for product reformulation or additional work. We have
also developed multiple innovative approaches to patient compliance
that we believe can further support or enhance the appropriate use
of Twirla if it is approved,” said Al Altomari, Chairman and Chief
Executive Officer, Agile Therapeutics. “We disagree with the
FDA’s conclusions on the adhesion of Twirla and look forward to
having the opportunity to engage with the Office of Drug Evaluation
III on these issues.”
The Company also announced a reduction in its workforce, which
will result in the elimination of the positions of several
employees primarily from the Company’s commercial and clinical
teams, representing approximately thirty percent of its employees.
This workforce reduction, along with other reductions in its
planned operating expenses, is designed to reduce operating
expenses and preserve cash while the Company pursues formal dispute
resolution. The Company now expects that its cash and cash
equivalents as of March 31, 2018, will be sufficient to meet its
operating requirements into the second quarter of 2019.
Mr. Altomari continued, “Due to the ongoing regulatory process
with Twirla and our need to fund the formal dispute resolution
process, we made the difficult decision to reduce our
workforce. I would like to personally express my appreciation
to each of the employees impacted by this decision for their
commitment and contributions to Agile. We are also grateful to
those members of our team that will continue to seek the approval
of Twirla.”
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. Agile received a complete response
letter (CRL) from the FDA on December 21, 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 quality adhesion test
methods, observations identified during the pre-approval inspection
of the manufacturing facility for Twirla, and because of questions
the FDA had on the in vivo adhesion properties of Twirla and their
potential relationship to the Company’s Phase 3 clinical trial
results. As announced on May 18, 2018, Agile met with the FDA
during a Type A meeting on April 16, 2018 to discuss the CRL and
received the official end of review (EOR) minutes on May 15,
2018.
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) or 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.
Forward-Looking StatementCertain information
contained in this press release includes "forward-looking
statements" 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 ability to succeed in formal dispute
resolution with the FDA, which can be lengthy and expensive and the
success of which is not guaranteed and our belief that Twirla’s
adhesion profile is adequate for approval and a reformulation of
Twirla is not 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 to execute on our operational and budget plans,
our ability to either succeed in our formal dispute resolution with
the FDA, or, if we are unsuccessful, our ability to develop a
reformulation that will address the FDA’s concerns, if we are
required to reformulate Twirla, our ability to successfully
complete an additional adhesion study and bioequivalence study, 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, 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, and unforeseen market factors or events in our clinical and
manufacturing development plans and the other risks set forth 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
Agile Therapeutics (NASDAQ:AGRX)
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