Agile Therapeutics, Inc. Provides Regulatory Update on Twirla® (AG200-15) for the Prevention of Pregnancy
18 5월 2018 - 8:30PM
Agile Therapeutics, Inc., (Nasdaq:AGRX), a women’s healthcare
company, today announced the content of the official minutes from
its Type A meeting with the U.S. Food and Drug Administration (FDA)
held on April 16, 2018 to discuss the complete response letter
(CRL) issued by the FDA on December 21, 2017 relating to the New
Drug Application (NDA) for Twirla (AG200-15), the Company’s
investigational low-dose, non-daily, combination hormonal
contraceptive patch. In the CRL, the FDA informed the Company
that the Twirla NDA could not be approved due to deficiencies
related to the manufacturing process and 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.
In the official minutes, the FDA informed the Company that it
continues to have significant concerns regarding the adhesion of
Twirla, which the FDA believes cannot be addressed through the
Company’s proposed patient compliance programs, and that the
Company needed to address the Twirla adhesion properties by
reformulating the transdermal system and conducting a formal
adhesion study with the new formulation. The FDA also informed the
Company that it would need to demonstrate bioequivalence to the
data and information for the original formulation. The FDA
advised the Company that after the Company satisfies the FDA’s
questions on adhesion and adequately bridges to the findings in the
SECURE Phase 3 trial, it anticipates discussing the safety and
efficacy of Twirla at an advisory committee meeting to obtain input
on whether the benefits outweigh the risks. In the absence of
a finding of bioequivalence, the Company would need to conduct a
new Phase 3 study with the new formulation. Finally, the FDA
provided guidance on the path forward for addressing manufacturing
issues related to Twirla, which path is largely based on the
materials the Company had previously submitted in December 2017.
To the extent that the Company reformulates Twirla, it may
create the need for additional manufacturing work and review by the
FDA. “We believe we had a constructive
meeting with the FDA, however, we disagree with the FDA’s
conclusions on the adhesion of Twirla and our patient compliance
programs. We believe we have demonstrated an adhesion profile
for Twirla that supports approval based on extensive data from our
Phase 2 studies, including an extreme conditions trial, and our
three Phase 3 trials. We also believe that we have planned
compliance and education programs that can address the issues
raised by the FDA and will support patient use of the product once
it is approved. While we will continue to evaluate all of our
options on next steps, we expect we will pursue formal dispute
resolution. We will provide an update when we move forward,”
said Al Altomari, Chairman and Chief Executive Officer, Agile
Therapeutics. “In light of the feedback from the FDA, we also are
re-evaluating our business plan to identify ways to extend our
ability to fund the Company’s operations,” concluded Mr. Altomari.
Company to Host Conference Call
Agile Therapeutics will host a conference call on May 18, 2018
at 8:00 a.m. Eastern Time to discuss the Company’s regulatory
update. A question and answer session will follow Agile
Therapeutics’ remarks. To participate on the live call, please dial
(844) 413-1773 (domestic) or (678) 865-8976 (international), and
provide the conference ID number: 5858819.
A live audio webcast of the call will be available via the
“Investor Relations” page of the Agile Therapeutics website,
www.agiletherapeutics.com. Please log on through Agile
Therapeutics’ website approximately 10 minutes prior to the
scheduled start time. A replay of the webcast will be archived on
Agile Therapeutics’ website for 60 days following the call.
About Twirla® (AG200-15)Twirla
(levonorgestrel/ethinyl estradiol 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 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.
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 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.
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 our
ability to adequately and timely respond to the deficiencies in the
CRL issued by the FDA in December 2017 may be affected by whether
any such response will be accepted by the FDA, our ability to
address the FDA’s concerns regarding Twirla raised in the Type A
meeting minutes issued by the FDA in May 2018, our ability to
either succeed in our discussions with the FDA that a reformulation
of Twirla is not necessary, 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
statements about our projected cash position could be affected by
market factors, the inherent risks in our business, our ability to
execute our operational and budget plans, 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 likely will
not be sufficient to fund our current and planned operations beyond
2018, 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; our statements about
the potential commercial opportunity could be affected by potential
labeling restrictions, the potential that our product does not
receive regulatory approval, does not receive reimbursement by
third party payors, 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 our 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.
SOURCE: Agile Therapeutics, Inc.
Contact:Investor Relations Agile
Therapeutics609-683-1880
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