News | September 26, 2018

Survey Reveals High Number Of Sexually Active Women Who Use No Birth Control Method, Supporting The Continued Need For Non-Hormonal Birth Control Innovations Such As Evofem Biosciences' Amphora

On World Contraception Day, these U.S data/statistics support the need for non-hormonal birth control methods with other preventive measures that give women better control over their sexual and reproductive health

Evofem Biosciences, Inc., ("Evofem" or the "Company"), a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, recently announced detailed results of a commissioned Consumer Survey conducted by The Harris Poll. Results from the survey indicate:

  • 24 million1 (55%) of sexually active American women use no birth control method, yet these women have an 85% risk of becoming pregnant within one year2
  • Of those American women who use birth control, about 8 million1 (36%) would prefer non-hormonal birth control
  • 67% of American women do not use condoms for the prevention of pregnancy and sexually transmitted infections (STIs)3, because this method is male partner dependent

On World Contraception Day, these U.S. data/statistics support the continued need for new non-hormonal birth control innovation that protects against pregnancy and may also have other preventive indications, thus giving women better control over their sexual and reproductive health.

“The results of this survey substantiate the need for a non-hormonal, womancontrolled, ‘only when she needs it’ birth control method such as Amphora that would potentially benefit the tens of millions of women who do not wish to become pregnant but do not or cannot use hormones and currently use no form of birth control,” said Saundra Pelletier, Evofem Biosciences' Chief Executive Officer. "I am especially proud to share these results on World Contraception Day, as its mission aligns with ours with regard to improving awareness of birth control methods and enabling women to make informed choices about their sexual and reproductive health.”

Amphora is an investigational first-in-class Multipurpose Vaginal pH Regulator (MVP-R) designed to give a woman authority over some of the most intimate issues of her life and health. This non-hormonal, non-systemic vaginal gel is being developed for woman-controlled birth control as well as prevention of chlamydia and gonorrhea.

“These data should be a call to action for women to gather together on important issues related to sexual and reproductive health. The fact that over 50 percent of sexually active American women use no birth control clearly demonstrates the continued need for innovations in birth control methods including non-hormonal birth control such as Evofem’s Amphora,” said Mary Jane Minkin, M.D., Clinical Professor of Obstetrics, Gynecology and Reproductive Sciences at Yale University School of Medicine. “On World Contraception Day, I am proud that Evofem is committed to revolutionizing women’s health through the development of Amphora and education on safe and effective tools for birth control.”

Evofem expects to report top-line data by year-end 2018 from its second Phase 3 clinical trial of Amphora (L-lactic acid, citric acid, and potassium bitartrate) for the prevention of pregnancy. Assuming positive results, the Company plans to re-submit the Amphora New Drug Application (NDA) in the second quarter of 2019. If approved by the FDA, Evofem will commercialize Amphora in early 2020 as the first and only hormone-free, woman-controlled, only when she needs it birth control method.

About Evofem Biosciences
Evofem Biosciences, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem’s pipeline includes two Multipurpose Vaginal pH Regulator (MVP-R) product candidates. The Company expects to report top-line Phase 3 data on its lead MVP-R drug candidate, Amphora, for prevention of pregnancy by year-end 2018. For more information, visit www.evofem.com.

Survey Methodology
This survey was conducted online within the United States by The Harris Poll on behalf of Evofem Biosciences from August 21-23, 2018 among 1,198 U.S. women ages 18 and older, of whom 650 were between the ages of 18 and 49. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. To learn more about The Harris Poll, please visit: www.harrispollonline.com.

About World Contraception Day
World Contraception Day takes place on September 26th every year. The annual worldwide campaign centers around a vision where every pregnancy is wanted. Launched in 2007, WCD’s mission is to improve awareness of contraception and to enable young people to make informed choices on their sexual and reproductive health. To learn more about WCD, please visit www.your-life.com/wcd.

1Guttmacher Institute (2018). Contraceptive Use in the United States. Accessed September 2018 from https://www.guttmacher.org/fact-sheet/contraceptiveuse-united-states (The baseline for this calculation is 43 million)

2Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Technology: Twentieth Revised Edition. New York NY: Ardent Media, 2011

3CDC (2006). Sexually Transmitted Diseases Treatment Guidelines, 2006. Morbidity and Mortality Weekly Report, 55(RR-11).

SOURCE: Evofem Biosciences, Inc.