Evofem and Pharma 1 Sign Licensing Agreement for SOLOSEC in the Middle East

Evofem Biosciences Teams Up with Pharma 1 to Accelerate SOLOSEC Access in Middle East, Targeting Mid-2025 UAE Submission

SAN DIEGO, May 21, 2025 /PRNewswire/ — Evofem Biosciences, Inc. (OTCQB: EVFM), a leader in women’s health innovation, has entered into a strategic licensing partnership with UAE-based Pharma 1 Drug Store LLC to expand access to its FDA-approved therapy SOLOSEC® across the Middle East. The agreement grants Pharma 1 exclusive commercialization rights for the single-dose oral treatment targeting bacterial vaginosis (BV) and trichomoniasis—two under-addressed conditions affecting millions in the Gulf region.

Under the terms, Evofem will receive upfront and milestone payments tied to regulatory achievements and sales performance. Once approved, Evofem will supply SOLOSEC to Pharma 1 at cost-plus pricing, leveraging the latter’s regional distribution network. Pharma 1 plans to file for regulatory approval in the UAE this summer, eyeing a mid-2025 submission.

“SOLOSEC addresses a critical gap in sexual health care with its one-dose convenience,” said Pharma 1 CEO Abdulwahab Atfah. “In markets like the UAE, where trust in U.S.-manufactured pharmaceuticals is high, this product offers both clinical and commercial potential.” Atfah emphasized the drug’s alignment with regional needs, noting BV prevalence of 25%–41% among women in the Middle East and North Africa (MENA).

Evofem CEO Saundra Pelletier highlighted the partnership’s strategic value: “Pharma 1’s expertise in navigating MENA’s regulatory landscape makes them an ideal ally to bring SOLOSEC to underserved populations.” The collaboration builds on prior agreements for Evofem’s contraceptive PHEXXI®, now also under Pharma 1’s regional purview.

Market Opportunity and Clinical Impact

With an estimated 1.7 million women in the UAE alone affected by BV and trichomoniasis impacting 4.7% of MENA’s female population, the partnership aims to tackle compliance challenges linked to multi-day therapies. SOLOSEC’s single-dose regimen could reduce treatment abandonment, particularly in regions where stigma around sexual health persists.

Globally, trichomoniasis affects 156 million annually, per the WHO, with 70% of cases asymptomatic. Untreated infections elevate risks of HIV transmission, preterm births, and cervical cancer—issues disproportionately affecting MENA’s growing population.

About SOLOSEC

SOLOSEC® (secnidazole) is a FDA-approved nitroimidazole antibiotic, administered as a one-time oral granule dose. It is indicated for BV and Trichomonas vaginalis infections in patients aged 12+, offering a compliance-friendly alternative to traditional therapies.

Looking Ahead

While regulatory timelines remain subject to UAE health authority reviews, the deal underscores Evofem’s global expansion strategy amid its fourth consecutive year of revenue growth. Pharma 1 will manage regional distribution, marketing, and pharmacovigilance, with potential to extend access to Saudi Arabia, Kuwait, Qatar, and neighboring nations.

Forward-Looking Statements

This release contains forward-looking statements regarding regulatory timelines and market expectations. Actual results may differ due to risks detailed in Evofem’s SEC filings, including its 2024 Annual Report and subsequent disclosures.

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SOURCE Evofem Biosciences, Inc.