— Pharma 1 anticipates filing UAE
regulatory submission for Phexxi as a hormone-free
contraceptive in Q3 2024 —
— UAE
contraceptive drug market is projected to reach
$185.1 million by 2030 —
SAN
DIEGO, July 23, 2024 /PRNewswire/ -- Women's
health innovator Evofem Biosciences, Inc. (OTCQB: EVFM) and
private Emirati health care company Pharma 1 Drug Store LLC have
signed a License and Supply Agreement for the Middle East rights to Phexxi® (lactic
acid, citric acid, potassium bitartrate), Evofem's FDA-approved
hormone-free contraceptive.
Under the terms of the agreement, Pharma 1 will have the
exclusive commercialization rights for Phexxi in the
Middle East, including the
United Arab Emirates (UAE),
Kuwait, Saudi Arabia, Qatar and certain other countries in the
region. Pharma 1 will be responsible for obtaining and maintaining
any regulatory approvals required to market and sell Phexxi, and
will handle all aspects of distribution, sales and marketing,
pharmacovigilance and all other commercial functions in these
countries.
"This agreement for Phexxi reflects our unwavering
commitment to improve women's health in the member states of the
Gulf Cooperation Council (GCC)," said Abdulwahab Atfah, CEO of
Pharma 1 Drug Store. "We expect to file for regulatory approval of
Phexxi in the UAE in the very near future and look forward to
launching this important product immediately following approval.
Market research indicates a growing demand for hormone-free, on
demand contraception in UAE and the surrounding region. We expect
Phexxi will be extremely well received among OB/GYNs and the women
they serve."
"The Phexxi licensing agreement for the Middle East is an important milestone as we
continue to execute Evofem's strategy to expand and diversify our
revenue stream. We are delighted to partner with Pharma 1, which is
uniquely positioned to launch the product and provide women in the
UAE and surrounding region with access to hormone-free,
non-systemic birth control that they control and use on-demand,
only when needed," said Evofem CEO Saundra
Pelletier.
Since its inception in 2019, Pharma 1 has continued to
successfully execute its mission of offering practical solutions to
fulfill health care needs based on scientific studies and accurate
surveys. The company's success reflects its substantial expertise,
scientific approach, and agility to adapt to the very dynamic and
growing market in the GCC.
Phexxi is the first and only locally-acting contraceptive gel
approved by the FDA. It is applied zero-to-60 minutes before
intercourse using a pre-filled applicator and works, without
hormones, by maintaining the normal vaginal microbiome with a pH
that is naturally inhospitable to sperm as well as certain viral
and bacterial pathogens.
About Evofem Biosciences
Evofem Biosciences, Inc., 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: trichomoniasis, a common
sexually transmitted infection (STI), in people 12 years of age and
older and bacterial vaginosis (BV), a common vaginal infection, in
females 12 years of age and older. SOLOSEC provides a complete
course of therapy in just one dose.
In December 2023, Evofem entered into a Merger Agreement
with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt
intends to acquire Evofem. The parties amended and restated the
Merger Agreement, as amended, in its entirety in July 2024. The companies are targeting a
September 30, 2024, closing.
Follow us on:
LinkedIn:
https://www.linkedin.com/company/evofem
Facebook: http://www.facebook.com/Evofem
X (f/k/a Twitter): https://x.com/Evofem
Phexxi® and SOLOSEC® are
registered trademarks of Evofem Biosciences, Inc.
About Pharma 1
Pharma 1 Drug Store is an Emirati company dedicated to
providing practical solutions, backed by scientific studies
and accurate surveys, that cater to the ever-evolving healthcare
needs of people in the GCC and support development of a healthier
community. Pharma 1 are agents to a growing number of
pharmaceutical companies, with a variety of commercial products and
medications in process with the Ministry of Health. Learn more at
https://pharma1ds.com/.
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 regarding anticipated
regulatory filings and approvals and timing thereof, anticipated
demand for hormone-free, on demand contraception in the territory,
and anticipated timing to close the contemplated Aditxt
transaction. 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, 2023 filed with the SEC
on March 27, 2024, Quarterly Report on Form 10-Q for the three
months ended March 31, 2024 filed with the SEC
on May 12, 2024, 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
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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SOURCE Evofem Biosciences, Inc.