Evofem's PHEXXI Submitted for Marketing Approval in United Arab Emirates by Pharma 1 Drug Store

Rhea-AI Summary

Evofem Biosciences (OTCPK: EVFM) announced that Pharma 1 Drug Store has submitted PHEXXI, their FDA-approved hormone-free contraceptive, for marketing approval in the United Arab Emirates. Pharma 1 plans to place a launch quantity order in July 2025, with commercial launch targeted for Q1 2026. The Emirati healthcare company holds exclusive commercialization rights for PHEXXI in several Middle Eastern countries and will handle all aspects of distribution, sales, marketing, and regulatory compliance. PHEXXI is the first FDA-approved locally-acting contraceptive gel that works by maintaining vaginal pH levels inhospitable to sperm. Market research indicates growing demand for hormone-free contraception in the UAE region, suggesting strong potential for market acceptance.

Positive

• Expansion into new international market with UAE submission represents potential revenue growth
• Launch quantity order expected in July 2025 will provide immediate revenue
• Partnership with established local company (Pharma 1) reduces operational burden and risks
• Market research indicates strong demand for hormone-free contraception in the region

Negative

• Regulatory approval timeline uncertain in UAE market
• Commercial success dependent on third-party partner performance
• Competition from established contraceptive methods in conservative market

— Pharma 1 Will Place Launch Quantity Order for PHEXXI in July 2025 —

— Commercial Launch in UAE Targeted for Q1 2026 —

SAN DIEGO, June 23, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCPK: EVFM) announced today that private Emirati health care company Pharma 1 Drug Store LLC has filed an application with the United Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) seeking approval to commercialize PHEXXI^® (lactic acid, citric acid, and potassium bitartrate) Evofem's FDA-approved hormone-free contraceptive, in the UAE.

"With the submission to MOHAP now complete, we are developing our commercial strategy for PHEXXI in the UAE and look forward to launching this important product as quickly as possible following approval," said Abdulwahab Atfah, CEO of Pharma 1 Drug Store. "Market research indicates a growing demand for hormone-free, on demand contraception in the UAE and the surrounding region. We expect PHEXXI will be extremely well received among OB/GYNs and the women they serve."

"This filing is an important milestone towards the commercialization of PHEXXI outside the U.S.," said Evofem CEO Saundra Pelletier. "We look forward to expanding and diversifying our revenue stream with PHEXXI sales to Pharma 1 for the UAE beginning in July 2025 to support the product launch in the UAE and provide Emirati women with access to hormone-free, non-systemic birth control that they control and use on-demand, only when needed."

Pharma 1 holds the exclusive commercialization rights for PHEXXI in the Middle East, including the UAE, Kuwait, Saudi Arabia, Qatar and certain other countries in the licensed Territory. Pharma 1 is 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.

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 Gulf Cooperation Council (GCC).

PHEXXI is the first and only locally-acting contraceptive gel approved by the U.S. Food and Drug Administration (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 generates revenue from the sale of two FDA-approved products: the hormone-free contraceptive PHEXXI^® (lactic acid, citric acid, and potassium bitartrate) vaginal gel, and SOLOSEC^® (secnidazole) 2 g oral granules, an FDA-approved oral antibiotic indicated for the treatment of bacterial vaginosis (BV) in females 12 years of age and older, and trichomoniasis in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. 

Evofem's commercial team relaunched SOLOSEC in November 2024 and promotes the product alongside PHEXXI to OB/GYNs in the U.S. 2024 marked Evofem's fourth consecutive year of net sales growth. Evofem is entering global markets through strategic partnerships, including its license agreements with Pharma 1 Drug Store LLC under which PHEXXI and SOLOSEC are expected to launch in the United Arab Emirates (UAE) in 2026. Learn more at evofem.com.

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 and Prevention. 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. Words such as, but not limited to, "anticipate," "aim," "believe," "continue," "could," "expect," "intend," "plan," "possible," "potential," "predict," "project," "seek," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to expected timing of the launch quantity order, regulatory approval of PHEXXI in the UAE, and commercial launch, and the level of demand for PHEXXI in the UAE. 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, amended on March 28, 2025, and any subsequent Form 10-Q 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.

FAQ

When will PHEXXI be available in the United Arab Emirates?

PHEXXI is targeted for commercial launch in the UAE in Q1 2026, pending regulatory approval from the UAE Ministry of Health and Prevention.

What is the significance of Evofem's (EVFM) UAE market entry?

This represents PHEXXI's first international market expansion, diversifying revenue streams and providing access to the growing Middle Eastern contraceptive market.

Who will distribute PHEXXI in the UAE?

Pharma 1 Drug Store LLC, a private Emirati healthcare company, holds exclusive commercialization rights for PHEXXI in the UAE and several other Middle Eastern countries.

What makes PHEXXI different from other contraceptives?

PHEXXI is the first FDA-approved locally-acting contraceptive gel that is hormone-free and used on-demand, working by maintaining vaginal pH levels that are inhospitable to sperm.

When will Evofem (EVFM) begin generating revenue from UAE sales?

Evofem expects to begin generating revenue from UAE sales starting July 2025 when Pharma 1 places their launch quantity order.