Evofem Biosciences Announces Regulatory Submission in Mexico for Its Hormone-Free Contraceptive

Rhea-AI Summary

Evofem Biosciences (NASDAQ: EVFM) announced the submission of its hormone-free contraceptive vaginal gel to the Mexican Regulatory Agency COFEPRIS on November 10, 2021. This submission marks a critical step in expanding access to Femidence™ for women in Mexico and aligns with Evofem's 2020 Global Health Agreement with Adjuvant Capital. If approved, Femidence™ could be available in early 2023. The company aims to provide effective reproductive health solutions for low and middle-income countries.

Positive

• Submission of Femidence™ to COFEPRIS represents opportunity for market expansion.
• Potential for Femidence™ availability in Mexico in early 2023 indicates growth prospects.

Negative

• None.

SAN DIEGO, Nov. 10, 2021 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ: EVFM) today announced that it has submitted the registration for its hormone-free contraceptive vaginal gel to the Mexican Regulatory Agency COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).

"This regulatory submission is the first step toward expanding access to our non-hormonal contraceptive vaginal gel to women outside the United States," said Saundra Pelletier, CEO of Evofem Biosciences. "Access to women's health should not have borders. We look forward to the day when all women, regardless of income or geography, have access to hormone-free birth control that they can use on their terms, only when they need it."

This is the first of several strategic regulatory submissions planned under Evofem's 2020 Global Health Agreement with Adjuvant Capital. The goal is to ensure that safe, effective, high-quality contraceptive and STI-prevention products are made available to women and healthcare providers in low and middle income countries (LMICs) on terms that are commercially viable for Evofem Biosciences.

If approved by COFEPRIS, Femidence™ is expected to be available in Mexico in early 2023 through Evofem Biosciences' to-be-named distributor.

About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (chlamydia and gonorrhea). The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com.

Phexxi^® is a registered trademark of Evofem Biosciences, Inc.

Forward-Looking Statements
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to the anticipated commercialization of Femidence™ in Mexico and timing thereof. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements, or that could impair the value of Evofem Biosciences' assets and business, are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 4, 2021. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com 
Mobile: (917) 673-5775

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SOURCE Evofem Biosciences, Inc.

FAQ

What recent regulatory action has Evofem Biosciences taken regarding Femidence™?

Evofem Biosciences submitted a registration for its hormone-free contraceptive vaginal gel to the Mexican Regulatory Agency COFEPRIS.

When could Femidence™ be available in Mexico?

If approved, Femidence™ is expected to be available in early 2023.

What is the significance of this submission for Evofem Biosciences?

This submission is part of a strategy to expand access to non-hormonal contraceptive options for women in low and middle-income countries.

Under which agreement is Evofem pursuing regulatory submissions?

Evofem is pursuing these submissions under its 2020 Global Health Agreement with Adjuvant Capital.