Evofem and Pharma 1 Form Partnership to Launch SOLOSEC in the Middle East

Evofem Biosciences Partners with Pharma 1 for SOLOSEC in the Middle East

Evofem Biosciences, a pioneer in women’s health, has announced a significant collaboration with Pharma 1 Drug Store LLC, an Emirati healthcare company, to bring SOLOSEC® (secnidazole) to the Middle East. This strategic agreement marks a crucial step in enhancing sexual health treatment options in the region, particularly for conditions like bacterial vaginosis (BV) and trichomoniasis, which affect numerous women across the Gulf Cooperation Council (GCC) states.

Licensing Details

Under the terms of the agreement, Evofem grants Pharma 1 exclusive rights to market SOLOSEC in the Middle East. The partnership involves an initial payment to Evofem, plus additional compensations based on regulatory milestones and sales performance. Once regulatory approvals are secured, Evofem will supply SOLOSEC at a cost-plus basis, ensuring that Pharma 1 can effectively distribute the product.

Pharma 1's CEO, Abdulwahab Atfah, emphasized the importance of this partnership, stating, "SOLOSEC provides a one-and-done oral solution for BV and trichomoniasis, both prevalent across the GCC. Our goal is to secure regulatory approval in the UAE by mid-2025."

The Need for SOLOSEC in the GCC

The prevalence of BV in the MENA region is notably concerning, with reports indicating that between 25% to 41% of women of reproductive age may be affected. This translates to approximately 1 to 1.7 million women in the UAE alone. Furthermore, trichomoniasis, the most common non-viral sexually transmitted infection worldwide, poses significant health risks, with an estimated 156.3 million cases globally in 2020.

The partnership comes at a critical time as insufficient diagnosis and treatment adherence contribute to the continued spread of these infections. SOLOSEC offers a convenient, effective solution, countering the challenge of compliance linked to multi-day treatment regimens.

Regulatory Pathways and Future Prospects

The exclusive commercialization agreement covers several regional markets, including not only the UAE but also Kuwait, Saudi Arabia, and Qatar. Pharma 1 will oversee obtaining and maintaining all regulatory approvals, sales, distribution, marketing and pharmacovigilance, setting the stage for a thorough market entry strategy.

Evofem’s CEO, Saundra Pelletier, expressed confidence in Pharma 1, highlighting their commitment to women’s health as a key factor in choosing a partner for SOLOSEC’s launch. The plan to expand the relationship beyond their existing product, PHEXXI, is seen as a significant move towards addressing critical health concerns for women in the region.

Understanding Bacterial Vaginosis and Trichomoniasis

Bacterial vaginosis is a prevalent condition that can lead to severe health complications, including an increased susceptibility to STIs and adverse pregnancy outcomes. Recent research even classifies BV as a sexually transmitted infection, emphasizing its increasing impact on women's health. On the other hand, trichomoniasis can go unnoticed as up to 70% of infected individuals may not exhibit symptoms, leading to further transmission among partners.

This new collaboration aims to not only tackle these health issues but also increase awareness around them, fostering better communication about sexual health in the region. The introduction of SOLOSEC reflects a growing recognition of women's health needs in medicine and public health alike.

About SOLOSEC and the Companies Involved

SOLOSEC is an FDA-approved, single-dose oral treatment that simplifies the management of two common infections affecting women's sexual health. Provided by Evofem Biosciences, this innovative treatment is aimed at providing an effective, easy-to-use solution for patients. Meanwhile, Pharma 1 Drug Store is known for its commitment to addressing healthcare demands in the GCC through evidence-based products.

As both companies gear up for the upcoming regulatory submission for SOLOSEC, the anticipated benefits of this partnership could very well revolutionize how sexual health issues are approached across the Middle East.