SAN DIEGO, May 14, 2019 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, announced today that its Chief Executive Officer, Saundra Pelletier, will present at the 2019 RBC Capital Markets Global Healthcare Conference on Wednesday, May 22, 2019 at 10:30 AM EDT. The conference will be held at the InterContinental New York Barclay Hotel in New York, NY.
To access the live and archived webcasts of the presentation, visit the Investors section of the Evofem Biosciences website at www.evofem.com. The webcast will be archived on the Evofem website for 90 days following the event.
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 Biosciences aims to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections ("STIs"). The Company is leveraging its proprietary Multipurpose Vaginal pH Regulator™ (MVP-R) platform to develop Amphora® (L-lactic acid, citric acid and potassium bitartrate) for birth control and prevention of urogenital acquisition of certain STIs. For more information, please visit www.evofem.com.
Amphora is an MVP-R designed to regulate vaginal pH within the normal range of 3.5 to 4.5. This maintains an acidic environment which is inhospitable to sperm as well as certain viral and bacterial pathogens associated with sexually transmitted infections but is integral to the survival of healthy bacteria in the vagina. Amphora met the pre-specified primary endpoint of AMPOWER, the Phase 3 clinical trial evaluating this MVP-R for the prevention of pregnancy in approximately 1,400 women at 112 centers in the United States. Amphora had a favorable safety profile, and was well tolerated. The Company plans to re-submit the Amphora New Drug Application (NDA) in the fourth quarter of 2019.
The Company recently completed patient enrollment in AMPREVENCE, a double-blinded placebo-controlled Phase 2b clinical trial of Amphora to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. This study enrolled approximately 850 women at approximately 50 centers in the United States. Top-line data is expected in the fourth quarter of 2019.
Amphora® is a registered trademark and Multipurpose Vaginal pH Regulator™ is a trademark of Evofem Biosciences, Inc.
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements related to the timing of the planned NDA Amphora resubmission for prevention of pregnancy, potential FDA approval of Amphora, and the potential commercial launch of Amphora, the anticipated results of the Phase 2b clinical trial of Amphora to prevent urogenital acquisition of Chlamydia trachomatis and Neisseria gonorrhea in women, and any expected completion date or general timing for this clinical trial. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of Evofem Biosciences' assets and business are disclosed in the risk factors contained in its Annual Report on Form 10-K filed with the Securities and Exchange Commission and subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. Evofem Biosciences does not undertake any duty to update any forward-looking statement except as required by law.
Evofem Biosciences, Inc.
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SOURCE Evofem Biosciences, Inc.