-- Evofem's Cost to Manufacture PHEXXI will
Decrease by 55% - 60% --
SAN
DIEGO, March 26, 2025 /PRNewswire/ -- Evofem
Biosciences, Inc. (OTCQB: EVFM) (Evofem or the Company) today
announced that it has entered into a License and Supply Agreement
(L&S Agreement) with Windtree Therapeutics, Inc. (NasdaqCM:
WINT), under which Windtree will be Evofem's sourcing partner for
PHEXXI® (lactic acid, citric acid and potassium bitartrate).
This FDA-approved hormone-free contraceptive vaginal gel is applied
0 to 60 minutes before each act of intercourse. It prevents
pregnancy by maintaining the normal vaginal biome which has a
slightly acidic pH that is inhospitable to sperm.
Under the L&S Agreement, Windtree will leverage its
manufacturing contacts to reduce the cost to manufacture PHEXXI.
Evofem expects PHEXXI COGS will decrease by 55% to 60% from current
levels. Furthermore, there will be no cost to Evofem for the tech
transfer to the new manufacturer engaged by Windtree.
"Global expansion of PHEXXI has always been a critical mandate
for Evofem, but a significant hurdle has been high manufacturing
costs which make commercialization cost-prohibitive in many markets
outside of the U.S.," said Saundra
Pelletier, CEO of Evofem. "The meaningful decrease in the
per-box cost of PHEXXI that we expect to achieve with Windtree's
assistance should allow Evofem to take PHEXXI into new,
price-sensitive global markets where there is great need for
non-hormonal contraceptives that women control. Our goal is to
empower women; to have PHEXXI available in all markets around the
world is a big step in that direction."
Jed Latkin, CEO of Windtree,
noted, "Using our extensive contacts across the globe, we have
engaged with a pharmaceutical manufacturer on the plan to produce
PHEXXI at a far lower cost while delivering the same high quality
product that women and their healthcare providers rely on for
hormone-free contraception. We look forward to collaborating with
Evofem and our manufacturing partner as we do the tech transfer and
manufacture the initial batches and validation batches in line with
the FDA requirements."
Evofem maintains ownership of the asset and continues to
commercialize PHEXXI in the United
States through its dedicated sales team and internationally
through strategic partnerships, including its July 2024 license agreement with Emirati
pharmaceutical company Pharma 1 Drug Store, which plans to launch
the hormone-free contraceptive vaginal gel in the UAE following
approval by the Emirates Drug Establishment.
About Evofem Biosciences
Evofem is commercializing innovative products to address
unmet needs in women's sexual and reproductive health. 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.
In July 2024 Evofem broadened its commercial offering
with the acquisition of SOLOSEC® (secnidazole) 2g oral
granules, an FDA-approved oral antibiotic for the treatment of
two sexual health diseases: bacterial vaginosis (BV), a common
vaginal infection, in females 12 years of age and older, and
trichomoniasis, a common sexually transmitted infection (STI), in
people 12 years of age and older. SOLOSEC provides a complete
course of therapy in just one dose.
PHEXXI® and SOLOSEC® are registered trademarks 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.
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 are disclosed in the
Company's SEC filings, including its Annual Report on Form 10-K for
the year ended December 31, 2024 filed with the SEC
on March 24, 2025, and any subsequent filings. 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.
Contact
Amy Raskopf, Chief Business
Development Officer
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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SOURCE Evofem Biosciences, Inc.
