Agile Therapeutics and Afaxys Partner to Expand Access to Twirla® (Levonorgestrel and Ethinyl Estradiol) Transdermal System

Rhea-AI Summary

Agile Therapeutics (Nasdaq: AGRX) announced a strategic alliance with Afaxys Pharma to promote Twirla^®, a transdermal contraceptive system. This partnership aims to enhance access to Twirla for patients in the U.S. family planning community, benefiting over 31 million Americans who rely on community health centers. Afaxys, a leader in public health, will help ensure Twirla is affordable and widely available. Twirla is indicated for women with a BMI < 30 kg/m² and is designed for weekly use as a non-invasive contraceptive option.

Positive

• Alliance with Afaxys expands Twirla's access in U.S. family planning, targeting a significant patient base.
• Partnership aims to enhance affordability and reliability of contraceptive options for underserved women.

Negative

• Twirla is contraindicated for women with a BMI ≥ 30 kg/m² and those over 35 who smoke, limiting potential market.

PRINCETON, N.J. and CHARLESTON, S.C., Jan. 10, 2022 (GLOBE NEWSWIRE) -- 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 Therapeutics
Agile 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 Afaxys
Afaxys, 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 Contact
Matt Riley
Head of Investor Relations & Corporate Communications
mriley@agiletherapeutics.com

Afaxys Media Contact
Staci Gouveia
Director, Corporate Communications & PR
843-408-6339
staci.gouveia@afaxys.com

FAQ

What is the significance of Agile Therapeutics' partnership with Afaxys Pharma for AGRX?

The partnership enhances access to Twirla in the U.S. family planning sector, aiming to reach millions of women.

When was the Agile Therapeutics and Afaxys Pharma alliance announced?

The alliance was announced on January 10, 2022.

What is Twirla and its target demographic according to the press release?

Twirla is a transdermal contraceptive patch for women with a BMI < 30 kg/m².

How does the partnership impact the availability of Twirla?

The alliance aims to ensure Twirla is affordable and accessible, especially for those relying on public health services.

What type of contraceptive is Twirla and how is it used?

Twirla is a once-weekly combined hormonal contraceptive patch.