SAN DIEGO, Aug. 29, 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, believes that new data
recently released by the Centers for Disease Control and Prevention
(CDC) on the increasing rates of sexually transmitted diseases
(STDs) in the United States
support the continued need for and clinical development of
Amphora® (L-lactic acid, citric acid, and potassium
bitartrate) vaginal gel for the prevention of Chlamydia
trachomatis and Neisseria gonorrhea in
women.
The CDC reported this week at the National STD Prevention
Conference in Washington that
rates of syphilis, gonorrhea and chlamydia have climbed for the
fourth consecutive year in the United States. Last year,
nearly 2.3 million U.S. cases of these STDs were diagnosed,
according to preliminary data, an increase of over 200,000 cases as
compared with 2016.1
Amphora is being studied as an on-demand vaginal contraceptive
and for the prevention of certain STDs. Evofem is conducting a
Phase 2b double-blinded
placebo-controlled efficacy trial (AMPREVENCE) to evaluate Amphora
for the prevention of urogenital acquisition of Chlamydia
trachomatis (primary endpoint) and Neisseria
gonorrhea (secondary endpoint) in women. This clinical
trial is actively enrolling 844 women at up to 50 centers
in the United States for a
four-month interventional period and subsequent one-month follow-up
period.
Earlier this year, the U.S. Food and Drug Administration (FDA)
granted Fast Track designation for Amphora for the prevention of
urogenital chlamydia in women. Fast Track designation is designed
to facilitate the development and expedite the review of new
therapies to treat serious conditions and fill unmet medical
needs.
"As the prevalence of sexually transmitted diseases continues to
rise, there is an increasing need for preventive measures. We
believe the AMPREVENCE trial will provide data in support of
Amphora's use to prevent these infections in women," said
Kelly Culwell, MD, Chief Medical
Officer of Evofem Biosciences. "With the growing epidemic of STDs,
and chlamydia in particular, we have the potential to address a
significant unmet medical need with a preventative
therapeutic."
The Company expects to report top-line data by year-end 2018
from its confirmatory Phase 3 clinical trial of Amphora for
contraception. Assuming positive results, Evofem expects to
re-submit the Amphora New Drug Application (NDA) in the first half
of 2019 which, if approved by the FDA, would position the Company
to commercialize Amphora as the first and only hormone-free,
on-demand contraceptive drug in early 2020.
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 is leveraging its proprietary Multi-purpose Prevention
Technology vaginal gel to develop product candidates for multiple
indications, including contraception, the prevention of urogenital
transmission of chlamydia and gonorrhea in women, and recurrent
bacterial vaginosis. For more information regarding Evofem, please
visit www.evofem.com.
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.
1Centers for Disease Control and Prevention (2018):
STD Preliminary Data Accessed August
2018.
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
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SOURCE Evofem Biosciences, Inc.