SAN DIEGO, Nov. 1, 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 it will
host a key opinion leader event in New
York City on Thursday, November 15,
2018 from 11:30am to 1:00pm
ET: "New Perspectives in Birth Control -- Non-Hormonal, On
Demand and Woman Controlled."
The event will feature presentations from Bassem Maximos, MD, MPH, FACOG, chairman of the
Department of Surgery and Medical Director at Bay Area Regional
Medical Center, and Patricia Cason,
MS, FNP-BC, Assistant Clinical Professor at the UCLA School of
Nursing.
Bassem Maximos is a practicing
OB/GYN and Fellow of the American College of Obstetricians and
Gynecologists. He is an investigator in AMP002, an ongoing
Phase 3 clinical trial evaluating Amphora (L-lactic acid, citric
acid, and potassium bitartrate) vaginal gel for the prevention of
pregnancy. He is also an investigator in the Phase
2b AMPREVENCE trial, which is
evaluating this Multipurpose Vaginal pH Regulator (MVP-R) for
prevention of chlamydia and gonorrhea in women. Dr. Maximos will
provide his thoughts on Amphora for birth control and offer insight
on both the physician and patient response to Amphora.
Patricia Carson is a nurse
practitioner, published author, and renowned women's reproductive
health thought leader. Ms. Cason has practiced for 35 years in a
wide variety of clinical settings and is an Assistant Clinical
Professor and guest lecturer at the UCLA School of Nursing. As an
editor and author of Contraceptive Technology she just completed
writing chapters on "Sexuality and Contraception" and
"Patient-centered reproductive goals and contraceptive counseling"
for the upcoming 21st edition of Contraceptive Technology. Ms.
Cason will provide insight on the current landscape of birth
control methods and the significant unmet
need.
Additionally, Kelly Culwell, MD,
Evofem's Chief Medical Officer, a practicing OB/GYN with over 18
years specializing in women's health and contraceptive research,
and a former investigator in AMP001, the first Phase 3 clinical
trial of Amphora for contraception, will provide an overview on
scientific principles underlying this MVP-R and the Company's
clinical development program for Amphora.
Evofem expects to report top-line data by year-end 2018 from
this second Phase 3 clinical trial of Amphora for the prevention of
pregnancy. Assuming positive results from AMP002, Evofem plans to
re-submit the Amphora New Drug Application (NDA) in the second
quarter of 2019.
Institutional investors and sell-side analysts may register to
attend the event in person by sending an email to
evofem@troutgroup.com. A live webcast of the presentations will be
available at www.evofem.com in the "Investors" section under
"Events and Presentations".
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 developing proprietary Multipurpose Vaginal pH Regulator
(MVP-R) product candidates for potential 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.
About Amphora
Amphora® (L-lactic acid, citric
acid, and potassium bitartrate) is an investigational non-hormonal
MVP-R gel designed to regulate vaginal pH within the normal range
of 3.5 to 4.5 even in the presence of semen. 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.
Top-line data are expected by year-end 2018 from Evofem's
single-arm, open-label Phase 3 clinical trial (AMP002)
evaluating Amphora for the prevention of pregnancy. AMP002 enrolled
approximately 1,400 women aged 18-35 at risk of pregnancy at 112
centers in the United States; enrollment was complete
in February 2018. The primary endpoint of this study is
pregnancy prevention over seven cycles of use. 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 expects to commercialize Amphora in early 2020 as the
first and only hormone-free, on-demand, woman-controlled MVP-R
birth control.
The Company is actively enrolling a double-blinded
placebo-controlled Phase 2b clinical trial (AMPREVENCE) of
Amphora to prevent urogenital acquisition of Chlamydia
trachomatis (primary endpoint) and Neisseria
gonorrhea (secondary endpoint) in women. This study is
designed to enroll 844 women at approximately 50 centers
in the United States for a four-month interventional
period and subsequent one-month follow-up period.
The CDC recently reported 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
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," "could,"
"would," "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.
1Centers for Disease Control and Prevention (2018):
STD Preliminary Data Accessed August 2018.
Amphora® is a registered trademark of Evofem Biosciences,
Inc.
Investor Contact
Amy
Raskopf
Evofem Biosciences
araskopf@evofem.com
O: (858) 550-1900 x167
M: (917) 673-5775
Media Contact
Libby Holman
RXMD
evofem@rxmedyn.com
O: (646) 599-8630
M: (703) 409-2573
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SOURCE Evofem Biosciences, Inc.