Agile Therapeutics and Afaxys Partner to Expand Access to Twirla® (Levonorgestrel and Ethinyl Estradiol) Transdermal System
11 January 2022 - 12:01AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare
company, today announced a new alliance with Afaxys Pharma, LLC to
promote Twirla® (levonorgestrel and ethinyl estradiol) transdermal
system.
Every year, more than 31 million Americans rely
on community and public health centers to get essential care. This
agreement expands access of Twirla in the U.S. family planning
community and for the patients who rely on healthcare in this
setting. As a trusted expert in community and public health, Afaxys
is a leading provider of innovative contraceptive options, which
will now include Twirla, an effective, low-dose contraceptive
option in a non-daily, non-invasive patch.
“Afaxys and Agile Therapeutics are aligned on a
mutual goal to provide reliable, affordable contraceptive access to
women on their sexual and reproductive health journeys,” said Ronda
Dean, President, CEO & Co-Founder of Afaxys. “We are committed
to community and public health patients and providers, and this
alliance will empower women with one more reliable family planning
option to consider as they work with their physicians to choose the
method of contraception that is right for them.”
“This strategic agreement with Afaxys, a
recognized leader in the public health system, will help ensure
that Twirla is available, accessible and affordable to a much
broader group of patients who can benefit from it,” commented Al
Altomari, Chairman and CEO of Agile Therapeutics. “We look forward
to advancing women’s reproductive health together.”
About Twirla®Twirla®
(levonorgestrel and ethinyl estradiol) transdermal system is a
once-weekly combined hormonal contraceptive (CHC) patch that
contains the active ingredients levonorgestrel (LNG), a type of
progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla
is indicated for use as a method of contraception by women of
reproductive potential with a body mass index (BMI) < 30
kg/m2 for whom a combined hormonal contraceptive is
appropriate. Healthcare providers (HCPs) are encouraged to consider
Twirla’s reduced efficacy in women with a BMI ≥ 25 to <30
kg/m2 before prescribing. Twirla is contraindicated in
women with a BMI ≥ 30 kg/m2. Twirla is also contraindicated in
women over 35 years old who smoke. Cigarette smoking increases the
risk of serious cardiovascular events from CHC use. Twirla is
designed to be applied once weekly for three weeks, followed by a
week without a patch.
Women who would like to learn more about Twirla
as a potential contraceptive option should speak to their doctor or
a healthcare provider.
About Agile
TherapeuticsAgile Therapeutics is a women's
healthcare company dedicated to fulfilling the unmet health needs
of today’s women. Our product and 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 initial product, Twirla®,
(levonorgestrel and ethinyl estradiol) transdermal system, is a
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.
About AfaxysAfaxys, whose name
is derived from a combination of affordable and access, is a
first-of-its-kind socially conscious healthcare company inspired by
the need to solve a public health crisis. The organization uniquely
partners with community and public health, and private industry to
ensure healthcare providers have stable pricing and reliable access
to the products and services they need to care for their
patients.
The Afaxys enterprise comprises a family of
companies that operate under two wholly owned subsidiaries: Afaxys
Pharma, LLC and Afaxys Group Services, LLC (AGS). Afaxys
Pharma provides a broad portfolio of branded and generic
contraceptives to the public healthcare market. AGS is a strategic
sourcing operation that negotiates favorable pricing across a broad
base of products and services through its Group Purchasing
Organization and emapp. For more information about Afaxys visit
www.afaxys.com.
Forward-Looking Statements
Certain 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. 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 our
ongoing and planned manufacturing and commercialization of Twirla®,
the potential market acceptance and uptake of Twirla, including the
increasing demand for Twirla, our placement on the preferred drug
list of the California Medi-Cal formulary, our expansion of access
to Twirla in California, and current and future Medicare coverage
for Twirla,. 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 maintain regulatory
approval of Twirla, the ability of Corium to produce commercial
supply in quantities and quality sufficient to satisfy market
demand for Twirla, our ability to successfully commercialize
Twirla, the accuracy of our estimates of the potential market and
the market demand for Twirla, regulatory and legislative
developments in the United States and foreign countries, our
ability to obtain and maintain intellectual property protection for
Twirla, our strategy, business plans and focus, the effects of the
COVID-19 pandemic on our operations and the operations of third
parties we rely upon as well as on our potential customer base, 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.
Agile Therapeutics Media ContactMatt
RileyHead of Investor Relations & Corporate
Communicationsmriley@agiletherapeutics.com
Afaxys Media ContactStaci
GouveiaDirector, Corporate Communications &
PR843-408-6339staci.gouveia@afaxys.com
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