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.