Women's health innovator Evofem Biosciences, Inc. and private Emirati health care company Pharma 1 Drug Store LLC have signed a License and Supply Agreement for the Middle East rights to SOLOSEC® (secnidazole) 2 g oral granules, Evofem's FDA-approved single-dose oral treatment for two common sexual health conditions.

Consideration to Evofem for the exclusive commercial rights to SOLSOEC in the Territory includes an upfront payment, payments on achievement of certain regulatory milestones, and sales-based milestone payments. Once approved, Evofem will supply SOLOSEC to Pharma 1 for sale in the Territory at cost-plus.  

"SOLOSEC offers a convenient 'one-and-done' oral treatment for two common sexual health conditions, bacterial vaginosis (BV) and trichomoniasis, which affect millions of people in the member states of the Gulf Cooperation Council (GCC)," said Abdulwahab Atfah, CEO of Pharma 1 Drug Store. "We are pleased to secure exclusive commercial rights to SOLOSEC in the Territory and eager to file for regulatory approval of SOLOSEC in the United Arab Emirates (UAE) this summer."

"In addition to its strong brand identity, SOLOSEC  is manufactured in the United States, which holds considerable value in markets where trust in quality, regulatory rigor, and prescriber confidence are key differentiators," added Mr. Atfah.

"We applaud Pharma 1's focus on sexual health, particularly in women, and are excited to expand our strong relationship beyond PHEXXI to now include SOLOSEC,"  said Evofem CEO Saundra Pelletier.  "We are confident that Pharma 1 is the right partner to effectively launch and commercialize SOLOSEC in the UAE and surrounding region."

Studies in the Middle East and North Africa (MENA) region have reported BV prevalence ranging from 25% to 41%. A systematic review and meta-analysis of global BV prevalence among reproductive-aged women in the general population found that one in four women in MENA have BV1. In the UAE alone, this represents between 1.0 million and 1.7 million women.

Despite the availability of anti-infectives approved to treat Trichomonas vaginalis, the parasite that causes trichomoniasis, in 2020 the WHO estimated 156.3 million new cases of trichomoniasis worldwide: 73.7 million in females and 82.6 million in males.3 Undiagnosed infections and lack of compliance with multi-day treatment regimens are critical contributing factors.

A meta-analysis of evidence sourced from 263 international, regional, and national databases found that MENA has a substantial trichomoniasis prevalence, with approximately 4.7% of women in the general population affected by this sexually transmitted infection (STI).2 Trichomoniasis was more common in intermediate- and high-risk populations (17.2% and 10.3%, respectively) and among symptomatic women (13.9%).

Under the terms of the agreement, Pharma 1 will have the exclusive commercialization rights for PHEXXI in the Middle East, including the UAE, Kuwait, Saudi Arabia, Qatar and certain other countries in the region. Pharma 1 will be responsible for obtaining and maintaining any regulatory approvals required to market and sell SOLOSEC, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. 

Source: prnewswire.com