Evofem's SOLOSEC Deal Targets Women's Health Crisis in Sub-Saharan Africa

SAN DIEGO, CA – April 27, 2026 – Women’s health innovator Evofem Biosciences is set to expand into Sub-Saharan Africa through a strategic partnership, bringing a single-dose treatment for two widespread and serious infections to a region where millions of women are disproportionately affected. The company announced an exclusive distribution agreement with Clovis Davis Pharmaceuticals to commercialize SOLOSEC® (secnidazole), an oral antibiotic for bacterial vaginosis (BV) and trichomoniasis (Trich).

The deal marks a significant step in addressing a critical public health challenge in a market poised for substantial growth. Clovis Davis will manage the distribution, marketing, and sales of the FDA-approved treatment across the territory. This move is not merely a commercial expansion but a targeted intervention aimed at conditions that, while common, carry severe health risks, including increased susceptibility to HIV and adverse pregnancy outcomes.

“Women everywhere deserve access to effective drugs that treat common sexual health conditions with simple, patient-friendly dosing regimens,” said Saundra Pelletier, Chief Executive Officer of Evofem. “We are delighted that Clovis Davis will distribute SOLOSEC—Evofem’s single-dose oral treatment for BV and Trich—in Africa, greatly increasing its global reach.”

A Silent Epidemic with Severe Consequences

The need for accessible and effective treatments in Sub-Saharan Africa is stark. Bacterial vaginosis, one of the conditions treated by SOLOSEC, is estimated to affect 25% of women in the region, with some studies showing prevalence rates as high as 40% to 50% in certain populations. In Ethiopia alone, this translates to a potential patient pool of nearly 11 million women.

Far from being a simple nuisance, BV is linked to a host of severe health complications. It is a known risk factor for acquiring sexually transmitted infections, including a significantly increased risk of HIV acquisition. For pregnant women, it can lead to preterm birth, low birth weight, and other adverse outcomes.

Similarly, trichomoniasis, a common STI caused by a parasite, is rampant. The World Health Organization (WHO) reports that the African Region accounts for approximately one-third of the 156 million new cases that occur globally each year among people aged 15-49. Like BV, trichomoniasis is associated with increased HIV transmission and can lead to pelvic inflammatory disease and infertility. The standard treatment often involves multi-day courses of antibiotics like metronidazole, where patient adherence can be a significant challenge.

A Strategic Entry into a Growing Market

For Evofem Biosciences, this expansion is a calculated move that aligns with its recent financial turnaround and global growth strategy. After achieving its fifth consecutive year of net sales growth in 2025 and posting a full-year operating income of $3.4 million—a stark improvement from a $7.7 million loss the previous year—the company is leveraging its stronger financial footing to tap into new markets.

The Sub-Saharan African pharmaceutical market, valued at over $25 billion, represents a major opportunity. Evofem has been actively pursuing cost-reduction strategies for its products, aiming to cut manufacturing costs for SOLOSEC by approximately 50%. This initiative is critical for competing in price-sensitive regions where affordable generics currently dominate the landscape.

SOLOSEC’s primary competitive advantage is its single-dose regimen. This convenience is a powerful differentiator against older, multi-dose treatments, offering the promise of improved adherence and better clinical outcomes. By providing a complete course of therapy in one oral dose, the treatment simplifies care for both patients and healthcare providers, a crucial factor in settings with limited healthcare infrastructure and follow-up capabilities.

Beyond the Pill: An Integrated Approach to Care

The partnership goes beyond simple drug distribution. Clovis Davis plans to implement comprehensive women's health initiatives, beginning in Ethiopia and Uganda. A key component of this strategy is the introduction of the OSOM® BVBlue® test, a point-of-care diagnostic that allows for rapid and accurate detection of bacterial vaginosis in clinical settings without the need for complex laboratory infrastructure.

“We believe SOLOSEC will be well received among healthcare providers and patients in our target markets because it delivers a complete treatment for BV and Trich with just one oral dose, enabling patients to quickly resume their normal, daily lives,” said Jeff Reichman, Chief Operating Officer of Clovis Davis. He emphasized the importance of the diagnostic tool, stating it aligns with their commitment "to not only treat, but also to improve early detection and diagnosis of BV in underserved markets."

This integrated "test-and-treat" model is vital for empowering women and improving public health outcomes. Early and accurate diagnosis ensures that patients receive the correct treatment promptly, preventing the progression of the infection and its associated complications. In many parts of Sub-Saharan Africa where syndromic management—treating based on symptoms alone—is common, access to reliable diagnostics represents a significant leap forward in the quality of care.

Navigating the Path to Market Access

Bringing a new drug to market across the diverse continent of Africa involves navigating a complex web of national regulatory bodies. The agreement stipulates that local regulatory filings for SOLOSEC will be based on the comprehensive dossier already approved by the U.S. Food and Drug Administration (FDA). This reliance on a stringent regulatory authority's approval can help streamline the process in many African nations.

However, each country, from South Africa's SAHPRA to Ethiopia's EFDA and Nigeria's NAFDAC, has its own specific requirements, timelines, and procedures. Clovis Davis will be responsible for steering the product through these regulatory pathways to secure marketing authorization across the territory.

This expansion is part of a broader international push for Evofem, which has also made inroads into the Middle East and North Africa (MENA) region. By establishing these global partnerships, the company is diversifying its revenue streams while advancing its core mission of addressing unmet needs in women's sexual and reproductive health worldwide. The introduction of SOLOSEC in Sub-Saharan Africa represents a potentially transformative step in providing women with a modern, effective, and convenient tool to take control of their health.