Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced that the company’s Chief Scientific
Officer, David Friend, Ph.D., will be presenting in the Keynote
Forum of the Global Pharma & Drug Delivery Summit 2023 to be
held April 24-26, 2023 in Frankfurt, Germany.
Dr. Friend’s talk is scheduled from 9:00 – 9:25
AM CEST on April 24th and is titled: Safety and
Pharmacokinetic Assessment of Ovaprene®, A Once-Monthly Nonhormonal
Vaginal Contraceptive, in Sheep over 9 Months.
About Ovaprene
Ovaprene is an investigational hormone-free
monthly intravaginal contraceptive whose U.S. commercial
rights are under a license agreement with Bayer HealthCare.
Ovaprene is designed to be worn conveniently over multiple weeks
(one menstrual cycle) and prevent pregnancy by releasing a locally
acting, non-hormonal agent which impedes sperm motility, and
physically blocking sperm from entering the cervical canal with its
unique knitted polymer barrier. The novel combination of these
complementary approaches has the potential to produce efficacy
consistent with existing short-acting hormone birth control options
(pills, patches, vaginal ring), without the use of hormones.
Ovaprene has the potential to be the first FDA-approved monthly,
self-administered, hormone-free contraceptive product.
In October 2022, Daré announced FDA approval of
an Investigational Device Exemption (IDE) application allowing Daré
to conduct a single arm, open-label pivotal contraceptive efficacy
study of Ovaprene. The planned pivotal Phase 3 clinical study will
evaluate Ovaprene’s effectiveness as a contraceptive device along
with its safety and usability over a 12-month (13 menstrual cycles)
duration. If successful, Daré expects the study to support a
premarket approval (PMA) submission to the FDA to allow for
marketing approval of Ovaprene in the U.S. The study will be
conducted under a Cooperative Research and Development Agreement
(known as a CRADA) with the U.S. Department of Health and Human
Services, as represented by the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD), part of
the National Institutes of Health (NIH) and within NICHD’s
multi-center Contraceptive Clinical Trials Network. The initiation
of subject recruitment for the pivotal Phase 3 clinical study is
anticipated in mid-2023.
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company
committed to advancing innovative products for women’s health. The
company’s mission is to identify, develop and bring to market a
diverse portfolio of differentiated therapies that prioritize
women's health and well-being, expand treatment options, and
improve outcomes, primarily in the areas of contraception, vaginal
health, reproductive health, menopause, sexual health and
fertility.
Daré’s first FDA-approved product, XACIATO™
(clindamycin phosphate) vaginal gel, 2% is a lincosamide
antibacterial indicated for the treatment of bacterial vaginosis in
female patients 12 years of age and older, which is under a global
license agreement with Organon. XACIATO is a clear, colorless,
viscous gel, to be administered once intravaginally as a single
dose. Daré’s portfolio also includes potential first-in-category
candidates in clinical development: Ovaprene®, a novel,
hormone-free monthly intravaginal contraceptive whose U.S.
commercial rights are under a license agreement with Bayer;
Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to
treat female sexual arousal disorder utilizing the active
ingredient in Viagra®; and DARE-HRT1, a combination bio-identical
estradiol and progesterone intravaginal ring for menopausal hormone
therapy. To learn more about XACIATO, Daré’s full portfolio of
women’s health product candidates, and Daré’s mission to deliver
differentiated therapies for women, please visit
www.darebioscience.com.
Daré may announce material information about its
finances, product and product candidates, clinical trials and other
matters using the Investors section of its website
(http://ir.darebioscience.com), SEC filings, press releases, public
conference calls and webcasts. Daré will use these channels to
distribute material information about the company, and may also use
social media to communicate important information about the
company, its finances, product and product candidates, clinical
trials and other matters. The information Daré posts on its
investor relations website or through social media channels may be
deemed to be material information. Daré encourages investors, the
media, and others interested in the company to review the
information Daré posts in the Investors section of its website and
to follow these Twitter accounts: @SabrinaDareCEO and
@DareBioscience. Any updates to the list of social media channels
the company may use to communicate information will be posted in
the Investors section of Daré’s website.
Forward-Looking Statements
Daré cautions you that all statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements. Forward-looking
statements, in some cases, can be identified by terms such as
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“design,” “intend,” “expect,” “could,” “plan,” “potential,”
“predict,” “seek,” “should,” “would,” “contemplate,” “project,”
“target,” “objective,” or the negative version of these words and
similar expressions. In this press release, forward-looking
statements include, but are not limited to, statements relating to
Ovaprene’s potential effectiveness at preventing pregnancy,
Ovaprene’s potential to be the first FDA-approved monthly,
self-administered, hormone-free contraceptive product, the
potential for FDA approval of Ovaprene based on a single pivotal
contraceptive efficacy study, and anticipated timing of initiation
of subject recruitment for the pivotal study of Ovaprene.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Daré’s actual
results, performance or achievements to be materially different
from future results, performance or achievements expressed or
implied by the forward-looking statements in this press release,
including, without limitation, risks and uncertainties related to:
the risk that positive findings in early clinical and/or
nonclinical studies of a product candidate may not be predictive of
success in subsequent clinical and/or nonclinical studies of that
candidate; Daré’s ability to develop, obtain FDA or foreign
regulatory approval for, and commercialize its product candidates
and to do so on communicated timelines; failure or delay in
starting, conducting and completing clinical trials of a product
candidate; Daré’s ability to design and conduct successful clinical
trials, to enroll a sufficient number of patients, to meet
established clinical endpoints, to avoid undesirable side effects
and other safety concerns, and to demonstrate sufficient safety and
efficacy of its product candidates; Daré’s dependence on third
parties to conduct clinical trials and manufacture and supply
clinical trial material and commercial product; the risk that
development of a product candidate requires more clinical or
nonclinical studies than Daré anticipates, or that the duration of
a study or number of study subjects must be significantly greater
than anticipated; Daré’s ability to raise additional capital when
and as needed to advance its product candidates, execute its
business strategy and continue as a going concern; the loss of, or
inability to attract, key personnel; the effects of the COVID-19
pandemic, macroeconomic conditions such as inflation, rising
interest rates and geopolitical events on Daré’s operations,
financial results and condition, and ability to achieve current
plans and objectives, including the potential impact of the
pandemic on Daré’s ability to timely commence, enroll, conduct and
report results of its clinical trials and on the ability of third
parties on which Daré relies to assist in the conduct of its
business to fulfill their contractual obligations to Daré; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; the risk that
developments by competitors make Daré’s product or product
candidates less competitive or obsolete; difficulties establishing
and sustaining relationships with development and/or commercial
collaborators; failure of Daré’s product or product candidates, if
approved, to gain market acceptance or obtain adequate coverage or
reimbursement from third-party payers; Daré’s ability to retain its
licensed rights to develop and commercialize a product or product
candidate; Daré’s ability to satisfy the monetary obligations and
other requirements in connection with its exclusive, in-license
agreements covering the critical patents and related intellectual
property related to its product and product candidates; Daré’s
ability to adequately protect or enforce its, or its licensor’s,
intellectual property rights; the lack of patent protection for the
active ingredients in certain of Daré’s product candidates which
could expose its products to competition from other formulations
using the same active ingredients; product liability claims;
governmental investigations or actions relating to Daré’s product
or product candidates or the business activities of Daré, its
commercial collaborators or other third parties on which Daré
relies; the impact of pharmaceutical industry regulation and health
care legislation in the United States and internationally; global
trends toward health care cost containment; cyber attacks, security
breaches or similar events that compromise Daré’s technology
systems or those of third parties on which it relies and/or
significantly disrupt Daré’s business; and disputes or other
developments concerning Daré’s intellectual property rights. Daré’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. For a
detailed description of Daré’s risks and uncertainties, you are
encouraged to review its documents filed with the SEC including
Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Daré undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made, except as required by law.
Contacts:Investors on behalf of Daré Bioscience,
Inc.:Lee RothBurns McClellanlroth@burnsmc.com 212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonEvoke Canalejake.robison@evokegroup.com 619.849.5383
Source: Daré Bioscience, Inc.
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