Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s
health innovation, today announced that it entered into a
Cooperative Research and Development Agreement (CRADA) with the
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), part of the National Institutes of Health
(NIH), for the pivotal Phase 3 study of Ovaprene®, an
investigational hormone-free monthly intravaginal contraceptive
currently in clinical development for the prevention of pregnancy.
The agreement will allow Daré to leverage the contraceptive
clinical trial expertise of NICHD while also sharing the costs of
the Phase 3 pivotal study with NICHD. If Ovaprene® is approved by
the U.S. Food and Drug Administration (FDA), it could be the first
monthly non-hormonal contraceptive option for women.
The pivotal Phase 3 study will be supported by
the NICHD’s Contraceptive Development Program (CDP). The CDP
oversees the Contraceptive Clinical Trial Network (CCTN), which was
established in 1996 to conduct studies of investigational
contraceptives, and the Phase 3 study will be conducted within the
CCTN with the NICHD contractor Health Decisions Inc. Daré will be
responsible for providing clinical supplies of Ovaprene® and
coordinating interactions with and preparing and submitting
supportive regulatory documentation to the FDA. Daré and NICHD will
each provide medical oversight for the trial and final data review
and analysis, and will work together to prepare the final report of
the trial results.
Under the CRADA, Daré has also agreed to
contribute $5.5 million toward the total estimated cost to conduct
the pivotal Phase 3 study, which will be payable in four payments.
The first payment is due within 30 days of the effective date of
the CRADA and the final payment is due by April 1, 2023. NICHD will
be responsible for the other costs related to the conduct of the
pivotal study and will manage the payment of expenses to Health
Decisions, the clinical sites, and other parties involved with the
study.
“We are thrilled to continue our work with NICHD
to advance Ovaprene® through this pivotal study,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience, Inc. “Grant
funding previously provided by NICHD supported the conduct of our
pre-pivotal clinical study of Ovaprene. With this CRADA, we have
the opportunity to leverage NICHD’s experience in the design and
execution of contraceptive studies, as well as continued funding to
support the development of Ovaprene. We look forward to
collaborating with NICHD, along with our partner Bayer®, to advance
the development of additional non-hormonal contraceptive options
for women.”
Bayer and Daré entered into an exclusive
licensing agreement for U.S. commercial rights to Ovaprene® in
January 2020. Under the agreement, Daré receives access to Bayer’s
extensive clinical and market capabilities while retaining control
over Ovaprene’s development and regulatory approval process. Bayer
has the right to obtain exclusive rights to commercialize the
product in the U.S. following completion of the pivotal clinical
trial being undertaken by Daré and the NICHD. If Bayer, in its sole
discretion, makes payment to Daré of $20 million, which Daré
intends to apply to reimbursement of its portion of the clinical
study and manufacturing costs, then the exclusive license to
commercialize Ovaprene in the U.S. will become effective. Daré will
also be entitled to receive commercial milestone payments
potentially totaling $310 million, in addition to double digit
tiered royalties on net sales.
“This collaboration between Daré and NICHD marks
an important milestone in Women’s Healthcare Innovation. Women
are at the center of everything we do and we are so pleased to
continue to partner with Daré in support of our mission We’re For
Her to provide women with education and access to contraceptive
options,” said John Berrios, Bayer’s Head of Women’s
Healthcare.
The multi-center, single arm, non-comparative,
pivotal Phase 3 contraceptive study of Ovaprene® will evaluate its
effectiveness as a contraceptive device along with its safety and
usability. Daré plans to file an IDE for Ovaprene in the forth
quarter of 2021 and, pending the FDA’s review and clearance of the
IDE, to initiate the pivotal study of Ovaprene in 2022. If
successful, Daré expects the pivotal study to support marketing
approvals of Ovaprene in the U.S. and other countries.
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
novel, investigational 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®; 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 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 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 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 on
the investor relations page of Daré’s website mentioned above.
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. In this press release, forward-looking
statements include, but are not limited to, statements relating to
the conduct and funding of a Phase 3 pivotal clinical study of
Ovaprene by the NICHD, anticipated timing of submission of the IDE
and commencement of the Phase 3 study, Ovaprene’s potential to
become the first first monthly non-hormonal contraceptive approved
by the FDA, the potential for regulatory approval to market
Ovaprene in the U.S. and other countries based on a single pivotal
study, and potential payments to Daré under its agreement with
Bayer. 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 NICHD’s ability to timely enroll, conduct and report results of
the Phase 3 study of Ovaprene; the NICHD’s ability to terminate the
CRADA for any reason upon 30-days’ notice; Daré’s ability to raise
additional capital when and as needed to advance its product
candidates and continue as a going concern; the effects of the
COVID-19 pandemic 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 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, including its clinical trials, to
fulfill their contractual obligations to Daré, including the NICHD
under the CRADA; 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 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; 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; the risk that developments by
competitors make Daré’s product candidates less competitive or
obsolete; failure of Daré’s product candidates, if approved, to
gain market acceptance or obtain adequate coverage from third-party
payers; 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;
the risks that the license agreement with Bayer may not become
effective and, if it becomes effective, that future payments to
Daré under the agreement may be significantly less than the
anticipated or potential amounts; Daré’s failure to timely
establish or leverage third-party partnerships or collaborations to
commercialize its product candidates, if approved; 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; 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.
Contact
Lisa Walters-Hoffert, Chief Financial Officer
Daré Bioscience, Inc.lwalters@darebioscience.com858.926.7655
Source: Daré Bioscience, Inc.
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