Daré Bioscience Announces Closing of Global License Agreement with Organon to Commercialize XACIATO™ (clindamycin phosphate vaginal gel, 2%), FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis
June 30 2022 - 8:00AM
Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced that the exclusive license agreement
entered into on March 31, 2022 with Organon (NYSE: OGN), a global
women’s healthcare company, has become fully effective. Under the
agreement, Organon licensed global rights to XACIATO (clindamycin
phosphate vaginal gel, 2%), an FDA-approved medication for the
treatment of bacterial vaginosis in females 12 years of age and
older. XACIATO received both Qualified Infectious Disease Product
(QIDP) and Fast Track designations from the FDA for the treatment
of bacterial vaginosis.
In connection with the closing, Daré will
receive a $10 million upfront payment from Organon. Daré is
eligible to receive potential milestone payments of up to $182.5
million and tiered double-digit royalties based on net
sales. XACIATO is expected to be available commercially in the
U.S. in Q4 2022.
“Bacterial vaginosis is the most common cause of
vaginitis worldwide and is estimated to affect approximately 21
million women in the U.S.,” said Sabrina Martucci Johnson,
President and CEO of Daré. “The Daré team identified bacterial
vaginosis as an area in need of new treatment options. We are
thrilled to be collaborating with Organon, one of the premier
companies in women’s health, as we believe Organon’s commercial
capabilities will ensure that XACIATO reaches the women most
impacted by this condition.”
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,
fertility, and vaginal and sexual health.
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 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 hormone therapy following menopause. 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,” “endeavor” 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 its agreement with
Organon, including 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; general industry
conditions and competition; general economic factors, including
inflation, rising interest rates and currency exchange rate
fluctuations; the impact of the ongoing COVID-19 pandemic; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances; new
products and patents attained by competitors; Daré’s ability to
accurately predict its future financial condition, operating
results and performance; Daré’s or its licensee’s ability to
accurately predict future market conditions; third-party
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; difficulties developing
and sustaining relationships with commercial counterparties;
dependence on the effectiveness of patents owned or licensed by
Daré and other protections for innovative products; and the
exposure of Daré, its commercial counterparties and other third
parties on which it relies to litigation, including patent
litigation, and/or regulatory actions. 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
Roth Burns McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience,
Inc.:Jake RobisonEvoke
Canalejake.robison@evokegroup.com619.849.5383
Source: Daré Bioscience, Inc.
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