Evofem Signs Exclusive Deal to Distribute and Commercialize SOLOSEC Across Sub-Saharan Africa
Evofem Biosciences, Inc., a biopharmaceutical company focused on advancing innovative solutions for women’s health, has announced a strategic step to expand global access to its flagship anti-infective therapy. The company has entered into an exclusive distribution agreement with Clovis Davis Pharmaceuticals, LLC to commercialize SOLOSEC® (secnidazole) 2g oral granules across sub-Saharan Africa. This partnership represents a significant milestone in Evofem’s international growth strategy and underscores its commitment to addressing unmet medical needs in underserved regions.
SOLOSEC is an oral antibiotic therapy that has received approval from the U.S. Food and Drug Administration for the treatment of bacterial vaginosis (BV) in females aged 12 years and older, as well as for trichomoniasis, a common sexually transmitted infection (STI), in both males and females aged 12 and above. What distinguishes SOLOSEC from many conventional treatments is its single-dose oral regimen, which offers a simplified and patient-friendly alternative to multi-day antibiotic therapies. This ease of use has the potential to significantly improve treatment adherence and overall clinical outcomes, particularly in regions where healthcare access and follow-up may be limited.
The newly announced agreement grants Clovis Davis exclusive rights to distribute, promote, market, and sell SOLOSEC throughout sub-Saharan Africa, a region where both bacterial vaginosis and trichomoniasis remain highly prevalent and often underdiagnosed. By leveraging Clovis Davis’ regional expertise and distribution capabilities, Evofem aims to ensure that this innovative therapy reaches a broader patient population, including communities that have historically faced barriers to accessing effective healthcare solutions.
Evofem’s Chief Executive Officer, Saundra Pelletier, emphasized the importance of expanding access to effective and convenient treatments for women worldwide. She highlighted that many women continue to face challenges in managing common sexual health conditions due to limited access to healthcare resources, stigma, and complex treatment regimens. By introducing SOLOSEC into African markets, the company seeks to provide a practical and efficient solution that enables women to address these conditions with minimal disruption to their daily lives.
From Clovis Davis’ perspective, the partnership aligns with its broader mission to improve healthcare delivery in emerging markets. Chief Operating Officer Jeff Reichman noted that SOLOSEC’s single-dose format makes it particularly well-suited for regions where adherence to multi-dose regimens can be challenging. The ability to complete treatment in a single administration not only enhances patient convenience but also reduces the risk of incomplete therapy, which can contribute to persistent infections and antimicrobial resistance.
In addition to distributing SOLOSEC, Clovis Davis is taking a more comprehensive approach to women’s health in the region. The company is developing initiatives in countries such as Ethiopia and Uganda that focus on improving early detection and diagnosis of bacterial vaginosis. Central to these efforts is the introduction of the OSOM® BVBlue® test, an FDA-cleared and CLIA-waived point-of-care diagnostic tool that enables rapid and accurate identification of BV in clinical settings. This diagnostic capability is particularly valuable in resource-limited environments where access to laboratory infrastructure may be constrained. By combining effective treatment with accessible diagnostics, Clovis Davis aims to create a more holistic approach to managing women’s health conditions.
The need for such interventions is underscored by the high prevalence of bacterial vaginosis in sub-Saharan Africa. Studies estimate that approximately 25% of women in the region are affected by BV, making it one of the most common gynecological conditions. In Ethiopia alone, where there are an estimated 43.8 million women aged 12 years and older, roughly 10.9 million may be eligible for treatment with SOLOSEC. These figures highlight the substantial public health burden posed by BV and the potential impact of expanding access to effective therapies.
Trichomoniasis also represents a significant global health challenge. Caused by the parasite Trichomonas vaginalis, the infection requires accurate diagnosis and complete treatment of all affected partners to prevent reinfection and transmission. According to the World Health Organization, there were approximately 156 million new cases of trichomoniasis worldwide in 2020 among individuals aged 15 to 49. Notably, about one-third of these infections occurred in the WHO African Region, underscoring the urgent need for improved access to both diagnostic and therapeutic solutions in this part of the world.
The distribution agreement also includes plans to pursue local regulatory approvals for SOLOSEC across the target markets. These filings will be supported by Evofem’s existing regulatory dossier, which has already been reviewed and approved by the FDA. This approach is expected to streamline the approval process in multiple countries, enabling faster access to the therapy for patients in need.
Overall, the collaboration between Evofem Biosciences and Clovis Davis Pharmaceuticals represents a strategic effort to bridge gaps in women’s healthcare across sub-Saharan Africa. By combining an innovative, single-dose treatment with expanded diagnostic capabilities and regional distribution expertise, the partnership aims to improve both the detection and management of common but often overlooked conditions such as bacterial vaginosis and trichomoniasis.
As global health stakeholders increasingly recognize the importance of addressing women’s health disparities, initiatives like this highlight the role of public-private partnerships in driving meaningful change. With a strong focus on accessibility, simplicity, and clinical effectiveness, the introduction of SOLOSEC into sub-Saharan Africa has the potential to significantly enhance the quality of care for millions of women, ultimately contributing to better health outcomes and improved quality of life across the region.
About Evofem Biosciences
Evofem Biosciences, Inc. is commercializing two FDA-approved sexual and reproductive health products:
- PHEXX® (lactic acid, citric acid, and potassium bitartrate)– the first and only hormone-free, on-demand prescription contraceptive vaginal gel. Visit phexx.com to learn more and for important safety information.
- SOLOSEC® (secnidazole) 2 g oral granules– an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. Visit solosec.com to learn more and for important safety information.
PHEXX® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.
About Clovis Davis Pharmaceuticals
Clovis Davis Pharmaceuticals, LLC is dedicated to delivering sustainable global solutions in the production and distribution of pharmaceuticals, radioisotopes, and diagnostic tests, addressing the dynamic challenges of today’s healthcare landscape. Its services are at the forefront of innovation in human and veterinary medicine, offering high-quality, cost-effective, and pioneering tests, treatments, and therapies to meet the diverse needs of healthcare providers and their patients worldwide.
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