Favorable Pricing Certificates Issued for Evofem's PHEXX by Emirates Drug Establishment are Launching Step for Commercialization in UAE

Rhea-AI Summary

Evofem Biosciences (OTCID: EVFM) announced that the Emirates Drug Establishment (EDE) issued favorable pricing certificates for PHEXX on Nov 21, 2025, a preliminary administrative step toward UAE regulatory approval.

Pharma 1, Evofem's licensee, holds exclusive commercialization rights for PHEXX and SOLOSEC in six GCC states with potential expansion into 15 MENA countries, and is expected to launch PHEXX in the UAE in 2026, subject to timely EDE marketing approval and other regulatory and commercial conditions. Pharma 1 will manage distribution, sales, marketing, and pharmacovigilance in the licensed territory.

Positive

• EDE issued favorable pricing certificates on Nov 21, 2025
• Pharma 1 holds exclusive rights in 6 GCC states
• Targeted commercial launch of PHEXX in the UAE in 2026

Negative

• UAE launch is subject to EDE marketing approval and other conditions
• Commercial rollout depends on Pharma 1 execution across licensed countries

— PHEXX^® Poised to Become First and Only Hormone-Free Contraceptive Vaginal Gel Approved in UAE —

— 2026 Launch Planned for Hormone-Free Contraceptive in UAE —

SAN DIEGO, Nov. 21, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. ("Evofem" or the "Company") (OTCID: EVFM) announced today that the Emirates Drug Establishment (EDE) has issued favorable pricing certificates for PHEXX® (lactic acid, citric acid, potassium bitartrate), which is a preliminary administrative step toward regulatory approval in the United Arab Emirates (UAE).

"Issuance of these pricing certificates by the EDE is an important step toward expanding and diversifying Evofem's revenue stream through entry into new markets," said Saundra Pelletier, CEO of Evofem. "We eagerly await approval of PHEXX® in the UAE. This will pave the way for Pharma 1 to launch and commercialize PHEXX® in the UAE, giving Emirati women and their healthcare providers access to on-demand, hormone-free contraception, while also facilitating Pharma 1's planned submissions to other countries in the licensed territory."

Evofem's licensee Pharma 1 is expected to launch PHEXX® in the UAE in 2026, subject to timely EDE marketing approval and other regulatory and commercial conditions.

Pharma 1 holds the exclusive commercialization rights for both of Evofem's FDA-approved products — PHEXX® and SOLOSEC® (secnidazole) 2g oral granules— in six Gulf Cooperation Council (GCC) states with potential to expand into 15 other countries in the Middle East and North Africa (MENA).  Both products were submitted to the EDE for marketing approval in 2025, and Pharma 1 is on track to submit the products for marketing approval in other licensed countries following approval in the UAE. In addition to obtaining and maintaining required regulatory approvals, Pharma 1 will handle all aspects of distribution, sales and marketing, pharmacovigilance, and all other commercial functions for PHEXX® and SOLOSEC® in the licensed territory.  

Since its inception in 2019, Pharma 1 has continued to execute its mission of offering practical solutions to fulfill health care needs based on scientific studies and accurate surveys. Pharma 1's success reflects its substantial expertise, scientific approach, and agility to adapt to the very dynamic and growing market in the GCC.

About PHEXX®

PHEXX® (lactic acid, citric acid and potassium bitartrate) 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. Visit phexxi.com to learn more and for important safety information.

About Evofem Biosciences

Evofem Biosciences, Inc. is commercializing two FDA-approved products to address unmet needs in women's sexual and reproductive health: PHEXX® (lactic acid, citric acid and potassium bitartrate) and SOLOSEC® (secnidazole) 2g oral granules.

PHEXX^®, 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," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "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 potential approval of PHEXX® in the UAE and timing thereof, timing of the PHEXX® commercial launch in the UAE and planned regulatory submissions in additional licensed countries. 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 is based on current expectations and assumptions that are subject to risks and uncertainties which could cause actual results to differ materially. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements include, but are not limited to: regulatory approval risks, commercial execution risks, dependence on partners and licensees including Pharma 1 for marketing and distribution, market acceptance in competitive landscape in new markets, and other Risk Factors that 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, as amended on March 28, 2025, and 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. All forward-looking statements speak only as of the date of this release.

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

 

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SOURCE Evofem Biosciences, Inc.

FAQ

What did Evofem (EVFM) announce on Nov 21, 2025 about PHEXX in the UAE?

Evofem said the EDE issued favorable pricing certificates for PHEXX, a preliminary step toward UAE regulatory approval.

When does Evofem expect PHEXX (EVFM) to launch in the UAE?

Pharma 1 is expected to launch PHEXX in 2026, subject to timely EDE marketing approval and other conditions.

Which territories does Pharma 1 hold exclusive commercialization rights for EVFM products?

Pharma 1 holds exclusive commercialization rights for PHEXX and SOLOSEC in 6 GCC states with potential to expand into 15 MENA countries.

What commercial responsibilities will Pharma 1 handle for EVFM products in the licensed territory?

Pharma 1 will handle distribution, sales, marketing, pharmacovigilance, and all other commercial functions for PHEXX and SOLOSEC.

Does the EDE pricing certificate mean immediate UAE approval for PHEXX (EVFM)?

No; the pricing certificates are a preliminary administrative step and approval remains subject to EDE marketing authorization.

How might the UAE launch of PHEXX affect Evofem (EVFM) commercialization strategy?

A UAE launch would enable Pharma 1 to commercialize on-demand, hormone-free contraception locally and support submissions in other licensed countries.