Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today announced that the U.S. Food and Drug
Administration (FDA) accepted for filing the company’s New Drug
Application (NDA) for DARE-BV1 for the treatment of bacterial
vaginosis. The FDA granted this application Priority Review and set
a Prescription Drug User Fee Act (PDUFA) date of December 7, 2021
for the target completion of its review of the NDA. The FDA grants
Priority Review to applications for potential drugs that, if
approved, would provide a significant improvement in the safety or
effectiveness of the treatment of a serious condition.
The NDA is supported by positive results from
the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded,
placebo-controlled clinical trial evaluating DARE-BV1 in women
diagnosed with bacterial vaginosis, a condition that can cause
serious health risks and very disruptive symptoms and is estimated
to affect approximately 21 million women in the United States.
DARE-BV1 is an investigational thermosetting bioadhesive hydrogel
containing clindamycin phosphate 2% designed as a one-time
vaginally-administered treatment for bacterial vaginosis.
"The acceptance of this NDA marks a major
milestone not only for Daré as a company but importantly for the 21
million women impacted by bacterial vaginosis,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience. “It is our
goal to bring to market a product that has the potential to improve
outcomes and convenience for women, as DARE-BV1 demonstrated it has
the potential to do in the Phase 3 study, where a single vaginal
dose of DARE-BV1 achieved clinical cure rates of 70-81%."
The results from the DARE-BVFREE study
demonstrated DARE-BV1’s potential to provide improved clinical cure
rates in a convenient, one-time dose compared to those of currently
branded FDA-approved products indicated for the treatment of
bacterial vaginosis. Patients in the study were evaluated during
three clinic visits: Day 1 (screening and randomization visit), Day
7-14 (assessment visit), and Day 21-30 (test-of-cure visit). The
study met its primary endpoint, demonstrating that as a primary
therapeutic intervention a single vaginal dose of DARE-BV1 was
statistically superior to placebo at Day 21-30 in the modified
intent-to-treat population (70% compared to 36% of subjects
clinically cured). Additionally, DARE-BV1 demonstrated clinical
cure rates of 77% at Day 21-30 and 81% at Day 7-14 in the per
protocol population, compared to 43% and 30% for placebo cream,
respectively. Current FDA-approved products have clinical cure
rates in the range of only 37-68%.
DARE-BV1 has received both Qualified Infectious
Disease Product (QIDP) and Fast Track designations from the FDA for
the treatment of bacterial vaginosis. Under QIDP designation, if
approved, DARE-BV1 will receive five years of additional market
exclusivity on top of the three years available for having
generated new clinical data.
Ongoing strategic discussions and other
activities intended to support a robust market introduction of
DARE-BV1 in 2022, if approved, are underway in parallel with the
regulatory process. The FDA’s target date for the completion of its
review of December 7, 2021 aligns with Daré’s intent to finalize
and announce the commercialization strategy for DARE-BV1 in the
U.S. in 2021. Commercialization arrangements for DARE-BV1 may
include granting pharmaceutical companies with other commercial
products in women's health an out-license to exclusively market,
sell and distribute the product, if approved, in specific
geographies; engaging commercial sales organizations to utilize
their internal sales organizations and other commercial functions
for market access, marketing, distribution, and other related
services; or assembling a hybrid of these potential options to
co-promote the product.
Information about the results from the
DARE-BVFREE Phase 3 clinical study of DARE-BV1 currently can be
found in the company’s most recent investor presentation under
“Presentations, Events & Webcasts" in the Investors section of
the company's website at http://ir.darebioscience.com.
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, hormone-free, monthly contraceptive
whose U.S. commercial rights are under a license
agreement with Bayer; Sildenafil Cream, 3.6%, a proprietary 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 regarding
DARE-BV1’s clinical cure potential for bacterial vaginosis,
DARE-BV1’s potential to provide more effective treatment for
bacterial vaginosis as compared to currently branded FDA-approved
products for the treatment of bacterial vaginosis, DARE-BV1’s
commercial potential, Daré’s ability to finalize and announce a
commercialization strategy for DARE-BV1 in the U.S. in 2021, and
the potential for a robust market introduction of DARE-BV1 in 2022.
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 risk that the FDA, other regulatory authorities or members of
the scientific or medical communities may not accept or agree with
Daré’s interpretation of or conclusions regarding the data from the
DARE-BVFREE clinical study and/or may require additional clinical
or nonclinical studies of DARE-BV1 prior to approving the NDA;
whether and when the NDA for DARE-BV1 pending with the FDA may be
approved, which will depend on a variety of factors, including
making a determination as to whether the product's benefits
outweigh its known risks and determination of the product's
efficacy and, if approved, whether DARE-BV1 will be commercially
successful; decisions by the FDA impacting labeling, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of DARE-BV1; Daré’s failure to
timely establish or leverage third-party partnerships or
collaborations to commercialize its product candidates, if
approved; 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; 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;
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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