SAN DIEGO, Feb. 26, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage
biopharmaceutical company, today announced the appointment of
Lisa Rarick, M.D., F.A.C.O.G., to
its Board of Directors. Dr. Rarick is a board-certified
obstetrician/gynecologist and regulatory affairs expert with 35
years' experience in women's health and 15 years' experience
leading several offices within the U.S. Food and Drug
Administration (FDA).
"Lisa's FDA experience and insights will be invaluable to the
Company as we prepare for the potential U.S. approval and launch of
our innovative, hormone-free contraceptive option, Amphora, and a
period of substantial growth," said Saundra
Pelletier, Chief Executive Officer, Evofem Biosciences. "Her
medical training, regulatory expertise and personal passions all
align perfectly with the Company's mission, and we are thrilled to
welcome her to the Board."
Dr. Rarick began her career at the FDA in 1988 as a Medical
Officer, responsible for the management of products indicated for a
variety of reproductive health conditions, including oral,
transdermal and vaginal contraceptives. She became the Director for
the Division of Reproductive and Urologic Products when it was
formed in 1996, and later held several management roles in the
Center for Drug Evaluation and Research (CDER), including Deputy
Director of the Office of Drug Evaluation II and Associate Director
in the Office of the Center Director.
Her final year at the FDA was spent in the Office of Women's
Health, where she focused on HIV prevention, pregnancy prevention,
pre- and post-pregnancy care and menopausal therapy. She is
currently a reproductive health and regulatory affairs consultant
who has helped numerous companies navigate the development of their
products from early-stage development through FDA approval.
"I am honored to join the Board of such an inspirational,
female-forward Company whose mission is to advance the sexual and
reproductive lives of women," said Dr. Rarick. "I look forward to
working with this experienced leadership team to bring a disruptive
new contraceptive technology to women and supporting the Company's
successful evolution into a commercial-stage organization."
Dr. Rarick received her B.S. and M.D. from the Loma Linda University School of Medicine and
completed her residency training in Obstetrics and Gynecology at
Georgetown University. She has been a
member of the Scientific Advisory Committee for the National
Institute of Child Health and Human Development since 2004 and
served on the Board of Directors for Alliance Partners 360 from
June 2017 – June 2019.
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, Inc.
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
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 Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
M: (917) 673-5775
Media Contact
Cara
Miller
Evofem Biosciences, Inc.
cmiller@evofem.com
O: (858) 550-1900 x272
View original content to download
multimedia:http://www.prnewswire.com/news-releases/evofem-biosciences-appoints-former-fda-division-director-lisa-rarick-md-to-its-board-of-directors-301011514.html
SOURCE Evofem Biosciences, Inc.