Press Releases
SAN DIEGO, Sept. 26, 2018 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ: EVFM) ("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, today announced detailed results of its commissioned Consumer Survey conducted by The Harris Poll, which aligns with previously published data by the Guttmacher Institute1-3 and supports the following statistics:
- 24 million1 (55%) sexually active American women at risk for pregnancy currently 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, such as chlamydia and gonorrhea
On World Contraception Day, these U.S. statistics support the continued need for new woman-controlled, non-hormonal birth control innovations like Amphora. Ideally such methods would protect against pregnancy and also have other preventive indications (such as STI prevention), thus giving women better control over their sexual and reproductive health.
"The results of this survey substantiate the need for a non-hormonal, woman-controlled, 'only when she needs it' birth control method such as Amphora that would, if approved, potentially benefit the 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 on-demand birth control as well as prevention of chlamydia and gonorrhea.
"These statistics 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% of sexually active American women at risk for pregnancy 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, on-demand MVP-R for birth control.
About Evofem Biosciences
Evofem Biosciences, Inc. (NASDAQ: EVFM) 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 proprietary 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 regarding Evofem, please 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. Launched in 2007, WCD's mission is to improve global 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.
Forward-Looking Statements
Statements in this press release about Evofem's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the Company's control. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the Company's filings with the Securities and Exchange Commission (SEC), including its Quarterly Report for the period ended March 31, 2018, as filed with the SEC on Form 10-Q on May 14, 2018, and include but are not limited to the following: objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the Company intends, expects, projects, believes or anticipates will or may occur in the future; risks and uncertainties associated with market conditions; statements about the anticipated results of the Phase 3 clinical trial evaluating Amphora as a contraceptive and the Phase 2b clinical trial of Amphora to prevent urogenital acquisition of Chlamydia trachomatis and Neisseria gonorrhea in women, and any expected completion dates or general timing for these clinical trials; the Company's reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the Company's products; the impact of potential product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the Company's common stock, and the concentration of power in its stock ownership. Forward-looking statements in this press release are made as of the date of this press release, and the Company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Evofem's views as of any date subsequent to the date hereof. We have included certain information from government publications which was obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We have not independently verified market and industry data from any third-party sources.
1 Derived from NCHS Data Brief No. 173_December 2014 and the 2016 US Census Bureau data
2 Trussell 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
3 CDC (2006). Sexually Transmitted Diseases Treatment Guidelines, 2006. Morbidity and Mortality Weekly Report, 55(RR-11).
Amphora® is a registered trademark of Evofem Biosciences, Inc.
Investor Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
O: 858-550-1900 x167
Media Contact
Sophia Ononye
RXMD
evofem@rxmedyn.com
O: (646) 599-8630
M: (917) 557-1909
SOURCE Evofem Biosciences, Inc.
