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 $2.4B U.S. Market Opportunity
- Phexxi prescriptions grew 47% in the second quarter of 2021 from the prior quarter.
- Aggressively advancing an ACA (Affordable Care Act) strategy to gain a new category for Phexxi as a vaginal pH modulator. This would provide increased access with no out-of-pocket costs for Phexxi across the U.S.
- Advancing multiple partnership discussions for the commercialization of Phexxi in international markets.
- Collaboration with NCODA (National Community Oncology Dispensing Association) as many women with cancer are contraindicated to hormone usage.
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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.
Granted Fast Track Designation
$2.1B Peak U.S. Sexually Transmitted Infections (STIs) Market Opportunity
Evofem is leveraging its proprietary vaginal pH modulator to develop product candidates for the prevention of two common STIs and 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.4
In 2020, Evofem initiated EVOGUARD, a pivotal Phase 3 clinical trial to evaluate the safety and efficacy of EVO100 for the prevention of urogenital transmission of chlamydia and gonorrhea in women. Top-line study results are expected in mid-2022.
The U.S. Food and Drug Administration granted EVO100 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, EVO100 has been designated a Qualified Infectious Disease Product (QIDP) by the FDA for the prevention of 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, EVO100 is expected to be the first prescription product approved for 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