SAN DIEGO, Dec. 18, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage
biopharmaceutical company, today announced that the U.S. Food and
Drug Administration (FDA) acknowledged receipt of the New Drug
Application (NDA) resubmission for Amphora®, a
Multipurpose Vaginal pH Regulator (MVP-R™), for the prevention of
pregnancy. Deemed a Class 2 resubmission by the FDA, the agency has
assigned a six-month review period and a Prescription Drug User Fee
Act (PDUFA) goal date of May 25,
2020.
"Today's acknowledgement brings us one step closer to delivering
the first true contraceptive innovation in decades," said
Saundra Pelletier, Evofem
Biosciences' Chief Executive Officer. "We look forward to
continuing to work closely with the FDA during the review process
and to the potential to offer women a new, non-hormonal
prescription contraceptive option that puts them in control of
their sexual health."
The Amphora NDA resubmission includes full results from the
Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase
3 trial that evaluated the efficacy and safety of Amphora in
approximately 1,400 healthy women ages 18 to 35 years.
The Company is also evaluating the potential use of Amphora for
the prevention of urogenital chlamydia and gonorrhea in women.
Top-line results from the Phase 2b
AMPREVENCE trial, reported in December
2019, demonstrated that the study met both its primary and
secondary endpoints, with a 50% relative risk reduction in
chlamydia infection and a 78% relative risk reduction in gonorrhea
infection compared to placebo.
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 to
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 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, including,
without limitation, 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 most recent Annual Report on Form 10-K and
subsequent filings, and include but are not limited to the
following: whether the FDA approves Amphora as a contraceptive; 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 gonorrhoeae 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
View original content to download
multimedia:http://www.prnewswire.com/news-releases/us-fda-acknowledges-receipt-of-evofem-biosciences-new-drug-application-resubmission-for-amphora-for-the-prevention-of-pregnancy-300976594.html
SOURCE Evofem Biosciences, Inc.