Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today reaffirmed its commitment to the commercial
launch of XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal
gel, 2% with collaborator Organon (NYSE: OGN), and announced that
Organon will pay Daré $1.0 million in July 2023.
“We believe Organon’s commercial capabilities
and track record of success in the branded women’s health category
will help ensure a successful introduction of XACIATO in the United
States and, ultimately, that XACIATO reaches the global population
of women suffering from bacterial vaginosis, which is estimated to
impact between 23% to 29% of all women worldwide,” said Sabrina
Martucci Johnson, President and CEO of Daré. “Daré has completed
manufacturing validation activities required to support commercial
launch. To provide for continuity of supply to support a robust
commercial launch, additional manufacturing related activities are
being performed and Organon and Daré are working towards a 2023
U.S. launch as soon as feasible. We are confident that XACIATO will
be well positioned for commercial success given the knowledge and
experience of Organon’s sales team, which is the same sales team
that helped drive the market acceptance and record sales of
NEXPLANON®, coupled with Organon’s payer outreach and provider and
patient-centered initiatives, and we look forward to the launch
later this year.”
Under the amended license agreement between Daré
and Organon for XACIATO, Organon will pay Daré $1.0 million in July
2023 and will pay Daré $1.8 million upon the first commercial sale
of XACIATO. In 2022, Daré received a $10.0 million upfront payment
from Organon when the license agreement became effective. In
addition to the upfront payment and the $2.8 million described
above, Daré is also eligible to receive additional potential future
milestone payments of up to $180.0 million and tiered double-digit
royalties based on net sales.
As Daré previously shared, the New Drug
Application (NDA) for XACIATO was supported by positive results
from the DARE-BVFREE Phase 3 randomized, multi-center,
double-blinded, placebo-controlled clinical trial evaluating
XACIATO (formerly known as DARE-BV1) for the treatment of bacterial
vaginosis (NCT04370548).
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
Daré’s expectations about commercial distribution and sale of
XACIATO, receipt of payments from Organon, and expected timing of
commercial availability of XACIATO in the United States.
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 those expressed or implied by the forward-looking statements
in this press release, including, without limitation: the risks
that none of the milestones under the agreement with Organon may be
achieved and none of potential milestone payments become payable;
the potential for royalty payments to be subject to reductions and
offsets; dependence on Organon to commercialize licensed products
and on other third parties for commercial supplies of licensed
products and components and Daré’s lack of control over the efforts
and resources expended by those third parties; Daré’s ability to
raise additional capital when and as needed to support its
operations, execute its business strategy and continue as a going
concern; general industry conditions and competition; the effects
of 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; 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.com646.930.4406
OR
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonEvoke Canalejake.robison@evokegroup.com619.849.5383
Source: Daré Bioscience, Inc.
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