Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, and Health Decisions, Inc., a full-service contract
research organization (CRO) specializing in women’s health clinical
research and diagnostic development, today announced that the
companies have signed a partnership agreement under which Health
Decisions will exclusively provide CRO services within the United
States to support the clinical development of Daré’s innovative
pipeline of novel programs designed specifically to address
persistent unmet needs in the areas of contraception, fertility,
and broader gynecological disorders. Daré and Health Decisions have
successfully worked together on prior Daré clinical studies,
including the post-coital test clinical study of Ovaprene®. The
partnership agreement provides for dedicated resources and new
pricing structures, which, together with Health Decisions’
expertise, site network and relationships with key opinion leaders
and investigators, are expected to accelerate clinical development
of key programs in a capital-efficient manner.
“One of the clear goals of this strategic partnership is to
leverage Health Decisions’ expertise in clinical development of
women’s health products,” said Sabrina Martucci Johnson, President
& CEO of Daré Bioscience. “Health Decisions is the Statistical
and Clinical Coordinating Center for the Contraceptive Clinical
Trials Network of the Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD), a unit of the National
Institutes of Health (NIH), and in this capacity they have
conducted more than 40 clinical trials in contraception, as well as
a number of other therapeutic areas aligned with Daré’s broad and
diverse portfolio of women’s health programs. We believe their deep
domain expertise coupled with their clinical and technical acumen
will enable us to accelerate clinical development activities across
our portfolio. Further, we believe the pricing structure under the
partnership agreement will result in cost savings in our clinical
development expenditures.”
Under the terms of the agreement, Health Decisions will be
Daré’s exclusive provider of CRO services within the United States
for all of Dare’s reproductive health assets for an initial
three-year period, provided that Health Decisions has the
expertise, resources and availability to perform the clinical
research services that Daré requires. This includes the assets that
Daré has or may have in development for pregnancy and delivery,
contraception, infertility, polycystic ovarian syndrome and
endometriosis during that period. In exchange for CRO exclusivity,
Health Decisions will provide a core team of personnel dedicated to
supporting all of Daré’s development programs covered by the
agreement, including Daré’s pivotal clinical study of Ovaprene®, a
hormone-free, monthly contraceptive whose U.S. commercial rights
are under a license agreement with Bayer, and the planned DARE-BV1
Phase 3 study in bacterial vaginosis, with topline data expected in
2020.
“It is an honor for Health Decisions to be selected as a partner
by Daré,” said Dr. Patrick Phillips, Chief Executive Officer of
Health Decisions. “Our like-minded commitment to women’s health has
allowed us to foster an already highly productive relationship, and
we look forward to supporting the acceleration of Daré’s unique
pipeline with even greater efficiency moving forward.”
About Daré Bioscience
Daré Bioscience is a clinical-stage biopharmaceutical company
committed to the advancement of 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 expand
treatment options, improve outcomes and facilitate convenience for
women, primarily in the areas of contraception, vaginal health,
sexual health, and fertility.
Daré’s product portfolio includes potential first-in-category
candidates in clinical development: Ovaprene®, a hormone-free,
monthly contraceptive intravaginal ring 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®;
DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2%
to treat bacterial vaginosis via a single application; and
DARE-HRT1, a combination bio-identical estradiol and progesterone
intravaginal ring for hormone replacement therapy following
menopause. To learn more about Daré’s full portfolio of women’s
health product candidates, and mission to deliver differentiated
therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances,
product candidates, clinical trials and other matters using its
investor relations 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 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 on its investor relations website
(https://darebioscience.gcs-web.com/) 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 on the investor relations page of Daré’s
website mentioned above.
About Health Decisions
Health Decisions is a full-service contract research
organization offering therapeutic, operational and regulatory
excellence for the clinical development of drugs, medical devices
and combination drug/devices in all areas of women’s health as well
as the development of diagnostics. Based on experience and
investigator relationships developed over the past 30 years, Health
Decisions successfully addresses the challenges of developing
assets in areas including reproductive and sexual health,
menopause, pain management, osteoporosis, osteoarthritis,
reproductive psychiatry, and gynecologic oncology. In addition,
Health Decisions conducts studies of diagnostics in women’s health,
oncology and infectious disease. Health Decisions’ headquarters is
in Durham, North Carolina.
For more information, visit www.healthdec.com.
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,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to Daré’s
expectations that its partnership agreement with Health Decisions
will accelerate clinical development of its programs and result in
cost-savings and the anticipated timing for topline data from
Daré’s planned Phase 3 study of DARE-BV1 for the treatment of
bacterial vaginosis. 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, risk and
uncertainties related to: the effects of the COVID-19 pandemic on
Daré’s operations, financial results and condition, and ability to
achieve current plans and objectives; the effects of the COVID-19
pandemic on the ability of third parties on which Daré relies to
assist in the conduct of its business, including its clinical
trials, to fulfill their contractual obligations to Daré; Daré’s
ability to raise additional capital when and as needed to advance
its product candidates and continue as a going concern; Daré’s
ability to develop, obtain regulatory approval for, and
commercialize its product candidates; the failure or delay in
starting, conducting and completing clinical trials or obtaining
FDA or foreign regulatory approval for Daré’s product candidates in
a timely manner; Daré’s ability to conduct and design 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; 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 studies of
that candidate; Daré’s ability to retain its licensed rights to
develop and commercialize a 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 candidates; developments by Daré’s competitors that make
its product candidates less competitive or obsolete; Daré’s
dependence on third parties to conduct clinical trials and
manufacture clinical trial material; 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; the risk of failure associated with product
candidates in preclinical stages of development that may lead
investors to assign them little to no value and make these assets
difficult to fund; 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
McClellan1.212.213.0006lroth@burnsmc.com
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communications1.619.849.5383 jake@canalecomm.com
Media on behalf of Health Decisions, Inc.:Danielle KroftHealth
Decisions1.919.967.1111 x139dkroft@healthdec.com
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