Evofem Biosciences is revolutionizing women’s sexual and reproductive healthcare with a first-in-class innovative hormone-free contraceptive and STI prevention compound in development.
Evofem’s mission is to empower women by providing products that give women the control and flexibility they desire.
Launched in 2020, FDA-approved Phexxi® (lactic acid, citric acid and potassium bitartrate) vaginal gel is a first-in-class hormone-free, on-demand prescription contraception that a woman can control.
Fulfilling a critical unmet need in the contraceptive space, Phexxi provides an FDA-approved localized option designed for women to use at their discretion 0-60 minutes prior to each act of intercourse.
Phexxi is a hormone-free birth control women have been waiting for.
Evofem is Leading a New Era in Women’s Contraception Targeting a Multi-Billion Dollar Market Opportunity
- Phexxi prescriptions grew 69% in the fourth quarter of 2021 from the prior quarter.
- More than 22,600 women started Phexxi in the fourth quarter of 2021 alone.
- Net product sales in the fourth quarter of 2021 more than doubled from the prior quarter.
- The U.S. Department of Labor and Health Resources and Services Administration (HRSA) separately issued updated guidance in January 2022 that is intended to ensure women have access to all FDA-approved contraceptives, including Phexxi, at zero copay under the Affordable Care Act (ACA)
- Advancing multiple partnership discussions for the commercialization of Phexxi in international markets.
- Evaluating Phexxi for two potential new indications with top-line data expected in the second half of 2022
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A Paradigm Shift in Contraception
23M+ women in the U.S. are not using a hormonal contraceptive.2
As the organic movement grows, society is trending in favor of more natural products and solutions. Women’s healthcare is no different. Many women are now opting for a non-hormonal, localized method of birth control.
Because Phexxi is a non-hormonal birth control, it is not associated with side effects like depression, mood swings and irritability. With Phexxi, women do not need to choose between their quality of life or contraception.
Taking hormones may not be right for some women especially for those with certain medical conditions including clotting disorders and most cancers, limiting their birth control options. There are approximately 800,000 new cases of cancer reported annually among women.3 Phexxi uniquely offers hormone-free, non-invasive prescription contraception.
2 Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief. 2018; 327: 1-14.
Granted Fast Track Designation
U.S. Sexually Transmitted Infections (STIs) Market Opportunity
Evofem’s pipeline includes programs developing Phexxi for the prevention of two common STIs and EVO200 to reduce recurrent Bacterial Vaginosis (BV).
Every day, more than 1 million new cases of sexually transmitted infections (STIs) are acquired worldwide among people aged 15-49 years.4Every sexually active woman, no matter what form of contraception she is using, is potentially at risk to contract an STI.
In the United States, the CDC estimates that 4.0 million and 1.6 million new cases of chlamydia and gonorrhea, respectively, occurred in 2018 alone.6 The number of reported cases is lower than the estimated total number because infected people are often unaware of, and do not seek treatment for, their infections. Almost 60% of women infected with chlamydia have no symptoms.7
Chlamydia and gonorrhea have been reported to be responsible for one-third to half of pelvic inflammatory disease (PID) cases. PID can cause serious, long-term problems including infertility, ectopic pregnancy, and chronic pelvic pain.8
In 2020, Evofem initiated EVOGUARD, a confirmatory Phase 3 clinical trial to evaluate the safety and efficacy of EVO100 (the investigational name for Phexxi) for the prevention of urogenital transmission of chlamydia and gonorrhea in women. Top-line study results are expected in the second half of 2022.
The U.S. Food and Drug Administration granted EVO100 (Phexxi) Fast Track designation for the prevention of both chlamydia and gonorrhea. Fast Track designation is designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.
Additionally, the FDA has awarded EVO100 (Phexxi) Qualified Infectious Disease Product (QIDP) designation for the prevention of both chlamydia and gonorrhea in women. A drug that receives QIDP designation may qualify for an additional five years of marketing exclusivity.
EVOGUARD builds on the positive, statistically significant results of the Company’s AMPREVENCE Phase 2b clinical trial. This landmark study met its primary and secondary endpoints, demonstrating a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection compared to placebo.5 The AMPREVENCE manuscript was published in the prestigious peer-reviewed journal American Journal of Obstetrics and Gynecology in 2021.
Assuming FDA approval for these potential new indications, Phexxi is expected to be the first prescription product approved to address this critical large unmet medical need.
4World Health Organization. Sexually transmitted infections (STIs) Fact sheet. http://www.who.int/mediacentre/factsheets/fs110/en/. Updated August 2016. Accessed December 9, 2016.
5Chappell T et al. EVO100 Prevents Chlamydia and Gonorrhea in Women at High-Risk for Infection. Am. J. Obstet Gynecol, 2021. https://doi.org/10.1016/j.ajog.2021.03.005
7Patel, Chirag G et al. “The Proportion of Young Women Tested for Chlamydia Who Had Urogenital Symptoms in Physician Offices.” Sexually transmitted diseases vol. 45,9 (2018): e72-e74. doi:10.1097/OLQ.0000000000000858