Originally published Evofem Eying Middle East Markets on by https://www.sdbj.com/life-sciences/pharmaceuticals/evofem-eying-middle-east-markets/?utm_source=rss&utm_medium=rss&utm_campaign=evofem-eying-middle-east-markets at San Diego Business Journal
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SAN DIEGO – A new market into the Middle East is being pursued by women’s health innovator Evofem Biosciences, Inc. (OTCID: EVFM) and private Emirati health-care company Pharma 1 Drug Store, LLC. Officials announced that Pharma 1 has filed an application with the United Arab Emirates (UAE) for PHEXXI® (lactic acid, citric acid, and potassium bitartrate), Evofem’s FDA-approved hormone-free contraceptive.
For San Diego-based Evofem, the Phexxi submission is an important milestone in its expansion and diversification strategy, according to CEO Saundra Pelletier.
“We look forward to expanding and diversifying our revenue stream with PHEXXI sales to Pharma 1 to support the product launch and long-term commercial availability in the UAE, and provide Emirati women with access to hormone-free, non-systemic birth control that they control and use on-demand, only when needed,” Pelletier said.
Their regulatory review begins this month following official submission to the Emirati Ministry of Health and Prevention (MOHAP) seeking marketing approval for Phexxi in the UAE, according to company officials, with turnaround-times on filings typically within six months.
Contraceptive Use Increasing in UAE
“We are developing our commercial strategy for Phexxi in the UAE and look forward to launching this important product as quickly as possible following approval,” said Abdulwahab Atfah, CEO of Pharma 1 Drug Store. “Market research indicates a growing demand for hormone-free, on-demand contraception in the UAE and the surrounding region. We expect Phexxi will be extremely well received among OB/GYNs and the women they serve.”
Pharma 1 holds exclusive commercialization rights for Phexxi in the Middle East, including the UAE, Kuwait, Saudi Arabia and Qatar. Pharma 1 is responsible for obtaining and maintaining regulatory approvals required to market and sell Phexxi, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries.
The move puts Phexxi on track to become the first and only hormone-free contraceptive drug product approved in the UAE, according to Amy Raskopf, Evofem’s Chief Business Development Officer. Feedback from medical practitioners in the Mideast has been positive, she said, and gynecologists are already asking Pharma 1’s sales reps about Phexxi by name.
“Use of contraceptives has increased notably in the UAE over the past decade, becoming an essential part of women’s healthcare,” said Raskopf. “Not all women want to take an oral contraceptive every day, filling their bodies with synthetic hormones. The commercial availability of this new non-hormonal product, once approved by MOHAP, is expected to be game-changing for Emirati physicians and women alike.”
Anti-Obesity Meds Connection
There could be another key health boost for local women with expanding hormone-free contraceptive access in connection with popular GLP-1 medications. In the UAE, Raskopf explains, GLP-1s are approved for Type-2 Diabetes and increasingly used off-label for weight loss.
Why does this matter? Women of reproductive age must not become pregnant while on GLP-1s due to the risk of fetal harm, she explains. No matter where they live – San Diego to Dubai — women who are using GLP-1s and who rely on oral contraceptives are at risk for unintended pregnancy, Raskopf said, since GLP-1s make the pill less effective at certain times – specifically in early weeks on the GLP-1 and again for some weeks every time the GLP-1 dose is increased. During these times, these women should also use a hormone-free contraceptive.
With entry into the Mideast market, Raskopf notes that Pharma 1 will be able to leverage its endocrinologist relationships to drive awareness and use of Phexxi among women using GLP-1s.
Since its inception in 2019, Pharma 1 has continued to successfully execute its mission of offering practical solutions to fulfill health-care needs based on scientific studies and accurate surveys. The company’s success reflects its substantial expertise, scientific approach, and agility to adapt to the very dynamic and growing market in the Gulf Cooperation Council (GCC).
Phexxi is the first and only locally acting contraceptive gel approved by the U.S. Food and Drug Administration. It is applied 0-to-60 minutes before intercourse using a pre-filled applicator and works, without hormones, by maintaining the normal vaginal microbiome with a pH that is naturally inhospitable to sperm as well as certain viral and bacterial pathogens.
For San Diego, this move translates to increased technical operations ramping up Phexxi manufacturing to fill the initial stocking order to support the UAE commercial launch, according to company officials. Potential expansion into additional Mideast markets is also pending.
Sales Growth Increasing
Evofem’s leadership has acknowledged that it’s been a rollercoaster of dips and peaks and even celebrity endorsements, especially since the 2020 FDA approval of Phexxi, increasing birth-control options with the hormone-free vaginal pH modulator. The stock price surged, at one point surpassing $8,000 on a split-adjusted basis. Then in 2022, momentum shifted, and Evofem was delisted from the Nasdaq exchange, investors drifting away.
In late 2023, the company entered into an agreement to be acquired by Aditxt Inc. (NASDAQ: ADTX). Through the proposed acquisition of Evofem, Aditxt aims to build a vertical focus on monitoring, prevention, and treatment of conditions impacting women’s lives. The companies are working to complete the merger by Sept. 30, 2025, according to official filings.
In 2024 the company delivered its fourth consecutive year of net sales growth (a 6% increase to $19.4 million for the year ended Dec. 31, 2024, according to official filings).
Also in 2024, Evofem acquired SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved single-dose oral antimicrobial agent for the treatment of two common sexual health infections: trichomoniasis and bacterial vaginosis. Evofem and Pharma 1 signed a SOLOSEC license agreement for the Mideast in late May; preparations to submit that product to the UAE regulatory authorities are underway.
Evofem Biosciences
FOUNDED: 2009
CEO: Saundra Pelletier
HEADQUARTERS: San Diego
EMPLOYEES: 32
BUSINESS: Biotech
WEBSITE: evofem.com
NOTABLE: Evofem’s PHEXXI is the first and only FDA-approved hormone-free contraceptive gel.
LISA PETRILLO
Originally published San Diego Business Journal
