SAN DIEGO, Jan. 3, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today provided insight into
anticipated 2019 milestones and events across its clinical
pipeline. The Company recently reported that its Phase 3 trial
evaluating Amphora® for the prevention of pregnancy met
its primary endpoint, and plans to resubmit the Amphora NDA in the
second quarter of 2019. Additional highlights are
below.
"We made substantial clinical progress in 2018, highlighted by
our successful Phase 3 clinical trial of Amphora for the prevention
of pregnancy, and remain committed to translating this into
increased shareholder value," said Saundra
Pelletier, Chief Executive Officer of Evofem Biosciences.
"We expect 2019 to be a pivotal year for Evofem as we focus on
refiling the Amphora NDA and establishing the commercial
infrastructure to successfully launch this first-in-class
Multipurpose Vaginal pH Regulator™ for hormone-free birth control
in January 2020."
2019 Planned
Objectives:
- Resubmit Amphora NDA the second quarter of 2019.
- Present data from AMPOWER, the recently-completed Phase 3
clinical trial of Amphora for the prevention of pregnancy,
including data on exploratory secondary endpoint of sexual
satisfaction, at an appropriate medical meeting.
- Complete enrollment in AMPREVENCE, the Phase 2b clinical trial of Amphora for the prevention
of urogenital acquisition of Chlamydia trachomatis (primary
endpoint) and Neisseria gonorrhea (secondary endpoint) in
women, in the first half of 2019.
- Report top-line AMPREVENCE data in the fourth quarter of
2019.
- Secure partnership for commercialization of Amphora in at least
one ex-U.S. market.
2018 Recent Highlights:
- Reported positive top-line AMPOWER results which met the Phase
3 study's primary efficacy endpoint. Data demonstrated 86.0%
efficacy (referred to as typical use) and 98.7% efficacy when
Amphora was used as directed per study protocol.
- Announced detailed results of the Consumer Survey, which
revealed that 88% of subjects were not using any birth control
method prior to entering the AMPOWER study. These findings
underscore that currently available contraceptive methods are
insufficient to meet the needs of women.
- Advanced enrollment in the Phase 2b AMPREVENCE trial with over 70% of the planned
844 women enrolled at year-end 2018.
- Hosted Key Opinion Leader event on new perspectives in birth
control, featuring presentations on Amphora's potential, if
approved, to drive change in women's birth control choices.
- Presented data at the 2018 American Society for Reproductive
Medicine (ASRM) Annual Congress from two clinical trials of
Amphora, AMP001 and EVO-002.
- Completed public offering raising net proceeds of $36.4 million.
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 Multipurpose Vaginal pH
Regulator™ (MVP-R) gel to develop product candidates for multiple
indications, including prevention of pregnancy, prevention of
urogenital transmission of chlamydia and gonorrhea in women and the
prevention of recurrent bacterial vaginosis. For more information
regarding Evofem, please visit www.evofem.com.
Amphora® is a registered trademark and Multipurpose
Vaginal pH Regulator™ 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 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.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 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: whether the FDA will approve Amphora as a
contraceptive based on the resubmitted NDA; whether and the degree
to which women choose to use Amphora as a birth control method and
whether and the degree to which physicians prescribe Amphora; the
Company's ability to raise the additional funds necessary to
commercialize Amphora as a contraceptive, if approved, 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 and the extent to which these third parties perform
their respective activities subject to and in compliance with FDA
requirements; 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 and general publications and research,
surveys and studies conducted by third parties. This information
has been obtained from sources believed to be reliable, although
they do not guaranty the accuracy or completeness of such
information. We have not independently verified market and industry
data from any third-party sources.
Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
C: (917) 673-5775
O: (858) 550-1900 x167
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SOURCE Evofem Biosciences, Inc.