SAN DIEGO, Nov. 26, 2019 /PRNewswire/ -- Evofem Biosciences,
Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company,
today announced that it has resubmitted its New Drug Application
(NDA) to the U.S. Food and Drug
Administration (FDA) for Amphora®, a Multipurpose Vaginal
pH Regulator (MVP-R™), for the prevention of pregnancy.
"Today's submission represents a significant step forward for
Evofem and for the millions of women who are dissatisfied with
their current contraceptive options and are eagerly awaiting a new
alternative," said Saundra
Pelletier, Evofem Biosciences' Chief Executive Officer. "We
have submitted a comprehensive and compelling package that we
believe addresses the Agency's outstanding questions, and we look
forward to the potential opportunity to provide millions of women
with an innovative new hormone-free, on-demand, prescription
contraceptive option that gives them control over their sexual and
reproductive health."
The Amphora NDA resubmission includes full results from the
Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase
3 trial evaluating the safety and efficacy of Amphora in
approximately 1,400 healthy women aged 18-35 years. The trial was
designed with guidance and input from the FDA to address questions
raised in the Complete Response Letter received by Evofem in
April 2016.
According to the FDA's classification, this application
will be considered a Class 2 resubmission. Under the Prescription
Drug User Fee Act (PDUFA), FDA review of a Class 2
resubmission is expected to be completed within a six-month period
beginning on the date the resubmission is received.
About Amphora
Amphora® (L-lactic acid, citric acid and
potassium bitartrate) is an investigational Multipurpose Vaginal pH
Regulator (MVP-R™) designed to regulate vaginal pH within the
normal range of 3.5 to 4.5, even in the presence of semen, which
normally raises the vaginal pH to 7.0 – 8.0. This maintains an
acidic environment that is inhospitable to sperm, as well as
certain viral and bacterial pathogens associated with sexually
transmitted infections, but it is integral to the survival of
healthy bacteria in the vagina.
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 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's
lead Multipurpose Vaginal pH Regulator (MVP-R™) product candidate,
Amphora®, is in development for multiple potential indications:
prevention of pregnancy, prevention of urogenital transmission
of Chlamydia trachomatis infection (chlamydia) in
women and prevention of urogenital transmission
of Neisseria gonorrhoeae infection (gonorrhea) in
women. For more information regarding Evofem, please visit
www.evofem.com.
Amphora® is a registered trademark and MVP-R™ is a trademark of
Evofem Biosciences, Inc.
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, include, but are not limited to statements
regarding objectives, plans and strategies that address activities,
events or developments that the Company intends, expects, projects,
believes or anticipates will or may occur in the future; and
statements about the anticipated timing and outcome of the
re-submission of the NDA for Amphora for prevention of pregnancy.
These statements are often characterized by terminology such as
"believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "could," "would," "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 Annual Report on Form 10-K and subsequent
filings, and include but are not limited to the following: the
Company's ability to raise the additional funds necessary to
commercialize Amphora as a contraceptive and/or to complete the
development of Amphora to prevent urogenital acquisition of
Chlamydia trachomatis and Neisseria gonorrhea in women; 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.
Contact
Investor Relations
Amy Raskopf
Evofem Biosciences
araskopf@evofem.com
O: (858) 550-1900 x167
M: (917) 673-5775
Media
Cara Miller
Vice President, Public Affairs and Corporate Communications
cmiller@evofem.com
Office: (858) 550-1900 x272
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SOURCE Evofem Biosciences, Inc.