Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced the first shipment of XACIATOTM
[pronounced zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2%
in connection with the first commercial sale of the product in the
United States, triggering a $1.8 million milestone payment to Daré
under its global license agreement with Organon.
“This is a major achievement for Daré Bioscience,
proving our ability to accelerate the development of much-needed,
innovative medicines for women,” said Sabrina Martucci Johnson,
President and CEO of Daré Bioscience. “In less than five years
since licensing the technology, we advanced a pivotal clinical
trial, gained U.S. Food and Drug Administration approval, and
ensured supply to support the launch of XACIATO. We look forward to
our continued collaboration with Organon and its established sales
force to offer this important treatment for bacterial vaginosis in
females 12 years or older.”
The New Drug Application 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).
Daré and Organon entered into a global exclusive license
agreement for XACIATO in March 2022. Daré received a $10.0 million
upfront payment after the license agreement became effective and a
$1.0 million payment in July 2023. In addition to the $1.8 million
milestone payment, Daré is eligible to receive potential future
milestone payments of up to $180 million and tiered double-digit
royalties based on net sales.
About Bacterial Vaginosis
Bacterial vaginosis is the most common vaginal condition in
women of reproductive age in the United States. The condition
results from an overgrowth of certain bacteria, which upsets the
balance of the natural vaginal microbiome and can lead to symptoms
of odor or discharge. Bacterial vaginosis may self-resolve in up to
30% of women, but most symptomatic women require treatment. If left
untreated, bacterial vaginosis may lead to serious complications.
Bacterial vaginosis has also been shown to disproportionately
affect non-Hispanic Black and Mexican American women.
About XACIATO
XACIATO is indicated for the treatment of bacterial vaginosis in
females 12 years and older. A single-dose user-filled disposable
applicator delivers 5g of vaginal gel containing 100mg of
clindamycin.
Selected Safety Information
XACIATO is contraindicated in individuals with a history of
hypersensitivity to clindamycin or lincomycin.
Clostridioides difficile-associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents, including
clindamycin, and may range in severity from mild diarrhea to fatal
colitis. Careful medical history is necessary since CDAD has been
reported to occur over 2 months after the administration of
antibacterial agents. If CDAD is suspected or confirmed, ongoing
antibacterial use not directed against C. difficile may need to be
discontinued.
Polyurethane condoms are not recommended during treatment with
XACIATO or for 7 days following treatment. During this time period,
polyurethane condoms may not be reliable for preventing pregnancy
or for protecting against transmission of HIV and other sexually
transmitted diseases. Latex or polyisoprene condoms should be
used.
XACIATO may result in the overgrowth of Candida spp. in the
vagina resulting in vulvovaginal candidiasis, which may require
antifungal treatment.
The most common adverse reactions reported in >2% of patients
and at a higher rate in the XACIATO group than in the placebo group
were vulvovaginal candidiasis and vulvovaginal discomfort.
XACIATO has not been studied in pregnant women. However, based
on the low systemic absorption of XACIATO following the
intravaginal route of administration in nonpregnant women, maternal
use is not likely to result in significant fetal exposure to the
drug.
There are no data on the effect of clindamycin on milk
production. The developmental and health benefits of breastfeeding
should be considered along with the mother's clinical need for
clindamycin and any potential adverse effects on the breastfed
child from clindamycin or from the underlying maternal
condition.
Please see the Prescribing Information, Patient Information, and
Instructions for Use.
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. 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 (FSAD) and/or female sexual
interest/arousal disorder (FSIAD) 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 Bioscience leadership has been named on the Medicine
Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In
2023, Daré's CEO was honored as one of Fierce Pharma’s Most
Influential People in Biopharma for Daré’s contributions to
innovation and advocacy in the women’s health space. Daré
Bioscience placed #1 in the Small Company category of the San Diego
Business Journal’s 2023 Best Places to Work Awards.
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 receipt of payments under Daré’s license
agreement with Organon. 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 milestones under the agreement with Organon may not
be achieved and milestone payments received, if any, may be
significantly less than the potential total amount; the potential
for royalty payments to be subject to reductions and offsets; the
potential for payments under the license agreement with Organon to
become subject to dispute and not received in the amount or on the
timeline anticipated; 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; cybersecurity incidents 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:
Media and Investors on behalf of Daré Bioscience,
Inc:Camilla White / Simona KormanikovaDentons Global
AdvisorsDareBioscience@dentonsglobaladvisors.com /
1.212.466.6450
Source: Daré Bioscience, Inc.
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