Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced a new development program targeted at
treating primary dysmenorrhea by delivering the active
pharmaceutical ingredient diclofenac, a nonsteroidal
anti-inflammatory drug (NSAID), in a novel way. Daré’s new
investigational product, DARE-PDM1, will deliver diclofenac
vaginally via the Company’s proprietary hydrogel technology. A
Phase 1 study of DARE-PDM1 is targeted for 2023. Because there are
currently no FDA-approved vaginal diclofenac treatment options for
primary dysmenorrhea, DARE-PDM1 has the potential to be a
first-in-category product. Following clinical development, Daré
intends to leverage the existing safety and efficacy data for
diclofenac to utilize the U.S. Food and Drug
Administration’s (FDA) 505(b)(2) pathway to obtain marketing
approval of DARE-PDM1 in the U.S.
“Calendar 2022 has been an incredibly successful year for our
portfolio in terms of:1) expanding our portfolio with additional
differentiated product candidates that we believe further our
leadership as an accelerator of innovative products in women’s
health;
2) securing a global commercialization collaboration for our
first FDA-approved product, XACIATO (clindamycin phosphate) vaginal
gel, 2%, a single-dose prescription medication for the treatment of
bacterial vaginosis in females 12 years of age and older, which is
the second commercial collaboration agreement for our portfolio
(the first was entered into with Bayer in 2020 for Ovaprene);
and
3) demonstrating clinical success (such as with DARE-HRT1 and
DARE-VVA1) and advancing regulatory and clinical development to
enable important 2023 milestones (such as the Sildenafil Cream
Phase 2b topline data targeted for 2Q-2023 and Ovaprene pivotal
study recruitment initiation targeted for mid-2023),” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience.
“As a company, we are committed to addressing unmet needs in
women’s health. We believe that we have assembled a robust
portfolio in women’s health and that all of our programs have the
opportunity to be either first-line or first-in-category, or both,”
Johnson added. “It is our belief that prioritizing women’s health
is not only good for the many women lacking effective or convenient
therapeutic choices, but also for a broad set of stakeholders,
because contraception, fertility, and vaginal and sexual health,
our areas of focus, are compelling markets impacting millions of
women and we have seen that innovation in these areas has led to
commercially successful brands. Specifically, we find these market
research statistics compelling: Only approximately 1% of healthcare
research is invested in female-specific conditions beyond oncology,
and women’s health conditions outside of oncology comprise less
than 2% of the current healthcare pipeline. Yet, women’s health
products outside of oncology make up 27% of the total number of
blockbuster products (products that each have over $500 million in
annual sales) and contribute 35% of the total sales dollars
generated by blockbuster products. This is why we believe
investment in women’s health will be efficient and
disproportionately impactful in terms of translating dollars
invested in R&D to ultimate revenue generated, and therefore,
not only good for the 50% of the population to whom these products
are targeted, but also a good business model.”
About Primary Dysmenorrhea and DARE-PDM1
Primary dysmenorrhea is defined as painful menstruation in women
with normal pelvic anatomy, typically described as cramping pain in
the lower abdomen before or during the menstrual period. Primary
dysmenorrhea usually begins during adolescence and is a leading
cause of recurrent short-term school absence in adolescent girls
and a common problem in women of reproductive age. Recent market
research suggests that the global market for dysmenorrhea treatment
is estimated to be valued at USD $11 billion and that the size of
this market is expected to increase to USD $25 billion by the year
2028. According to the American College of Obstetricians and
Gynecologists’ Committee on Adolescent Health Care, dysmenorrhea is
the most common menstrual symptom among adolescent girls and young
women, and most adolescents experiencing dysmenorrhea have primary
dysmenorrhea. Prevalence rates of dysmenorrhea vary but range from
50% to 90%. A prospective study of college students found that 72%
of monitored periods were painful, most commonly during the first
day of menses, and 60% of the women studied reported at least one
episode of severe pain.
“Utilizing the same hydrogel technology found in XACIATO, and
consistent with our portfolio of differentiated and novel product
candidates, we are developing DARE-PDM1 to address a critical unmet
medical need in women’s health,” said Dr. Annie Thurman,
Medical Director of Daré Bioscience. “The most common interventions
for primary dysmenorrhea include oral NSAIDs and hormonal
contraceptives which often can produce undesirable side effects. By
incorporating diclofenac into our proprietary hydrogel for vaginal
administration, we believe we can provide a treatment option that
addresses the pain-related symptoms of the condition while
minimizing side effects commonly seen with use of oral NSAIDs,”
continued Dr. Thurman.
Portfolio Updates Previously Announced in
2022:
XACIATO™ (clindamycin phosphate) vaginal gel, 2%,
FDA-approved for treatment of bacterial vaginosis in females 12
years of age and older
Bacterial vaginosis is the most common cause of vaginitis
worldwide and is estimated to affect approximately 21 million women
in the U.S. The condition results from an overgrowth of bacteria,
which upsets the balance of the natural vaginal microbiome and can
lead to symptoms of odor and discharge.
In June, Daré announced that the exclusive license
agreement entered into in March
2022 with Organon (NYSE: OGN), a global women’s
healthcare company, became fully effective. Under the agreement,
Organon licensed global rights to XACIATO. Under the license
agreement Daré received a $10 million cash payment from Organon
after the license became effective. Daré is eligible to receive
potential milestone payments of up to $182.5 million as well as
tiered double-digit royalties based on net sales. Launch
preparation activities are ongoing and the first commercial sale of
XACIATO is anticipated in the first half of 2023 in the
U.S.
Ovaprene® - investigational hormone-free monthly
intravaginal contraceptive
In October, Daré announced that the FDA approved an
Investigational Device Exemption (IDE) application allowing Daré to
proceed with a single arm, open-label pivotal contraceptive
efficacy study of Ovaprene. The multi-center, single arm,
non-comparative, pivotal Phase 3 study will evaluate Ovaprene’s
effectiveness as a contraceptive device along with its safety and
usability. If successful, Daré expects the pivotal study to support
marketing approvals of Ovaprene in the U.S. and other countries.
The Ovaprene investigator meeting for the pivotal study took place
in December and initiation of recruitment for the study is targeted
for mid-2023.
In January 2020, Daré and Bayer announced an exclusive licensing
agreement for U.S. commercial rights to Ovaprene. Under the
agreement, Daré received an upfront payment and access to Bayer’s
extensive clinical, regulatory, manufacturing and commercial
expertise while retaining control over Ovaprene’s development and
regulatory approval process. Bayer received 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.
If Bayer, in its sole discretion, makes payment to Daré of $20
million, which Daré intends to apply to reimbursement of clinical
study 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.
If Ovaprene is approved by the FDA, it could be the first
monthly non-hormonal contraceptive product for women and a
first-in-category option for women seeking a hormone-free,
self-administered and monthly birth control method.
Sildenafil Cream, 3.6% - investigational treatment for
female sexual arousal disorder
In a joint communication released in November of this year, Daré
and its development partner, Strategic Science and Technologies,
LLC, reported that subject screening for the exploratory Phase 2b
RESPOND clinical study of Sildenafil Cream, 3.6% had completed,
allowing for a topline data announcement target of 2Q-2023. The
Phase 2b RESPOND clinical study is a multi-center, double-blind,
placebo-controlled study to evaluate the efficacy and safety of
Sildenafil Cream, 3.6% in premenopausal patients with female sexual
arousal disorder (FSAD). Approximately 160 to 170 subjects in total
are expected to complete the study for inclusion in the topline
data assessment targeted for 2Q-2023.
Sildenafil Cream is a proprietary topical formulation of
sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being
developed as a first-in-category option for the treatment of FSAD.
FSAD is the inability to reach or maintain a sufficient physical
response to sexual stimulation and, of the various types of female
sexual dysfunction disorders, FSAD is most analogous to erectile
dysfunction (ED) in men. Sildenafil is the active ingredient in a
tablet for oral administration currently marketed under the brand
name Viagra® for the treatment of ED in men. Market research
suggests that 16% of women in the U.S. ages 21 to 60, or
approximately 10 million women, are distressed from experiencing
symptoms associated with FSAD, including lack of or low sexual
arousal, and are actively seeking solutions to improve their
condition. For context on the potential market opportunity for an
FDA-approved treatment for FSAD, the prevalence of complete ED in
men is estimated to be about 5% of men at age 40, increasing to
about 15% at age 70.
If clinical development is successful, Sildenafil Cream, 3.6%
has the potential to be the first FDA-approved FSAD treatment
option.
DARE-HRT1 & DARE-VVA1 Phase 1/2 data
In April, Daré announced the initiation of a Phase 1/2 clinical
study of DARE-HRT1, a novel, investigational intravaginal ring
(IVR) designed to deliver bio-identical 17β-estradiol and
bio-identical progesterone continuously over a 28-day period as
part of a hormone therapy (HT) regimen following menopause. HT is
used to treat the vasomotor symptoms (VMS) and genitourinary
syndrome associated with menopause. Positive efficacy results from
this study were announced in October, including statistically
significant results for improvement in both the vasomotor and
vaginal symptoms of menopause. Daré anticipates that the topline
pharmacokinetics (PK) data from the study will be available and
reported later in the fourth quarter of 2022.
“The levels of estradiol released from both the lower and higher
dose formulations of DARE-HRT1 achieved statistically significant
improvement in VMS as well as the genitourinary symptoms of
menopause, and vaginal pH and maturation index,” said David Friend
PhD, Chief Scientific Officer of Daré Bioscience. “DARE-HRT1 also
had a high level of acceptability in the study, with 100% of
subjects reporting that the IVR was comfortable to wear and no
reports of expulsion during use and over 95% of subjects stated
they would be either somewhat or very likely to use the IVR for a
women’s health condition or unrelated disease if needed.”
The North American Menopause Society’s (NAMS) guidance on
hormone therapy states that dosing estrogen and progestogen in
combination may offer important benefits to women, and NAMS
observed that non-oral routes of administration may offer
advantages over orally administered therapies.
DARE-HRT1 has the potential to be the first FDA-approved monthly
IVR delivering both estrogen and progestogen hormone therapy.
Positive topline results from a Phase 1/2 clinical study of
DARE-VVA1 were also announced this year, in November. The Phase 1/2
study evaluated different doses of DARE-VVA1, a tamoxifen vaginal
insert, in 17 postmenopausal women with vulvar and vaginal atrophy
(VVA). DARE-VVA1 is an investigational, proprietary formulation of
tamoxifen for intravaginal administration with the potential to be
a first-in-category treatment of VVA for women with or at-risk of
hormone receptor-positive (HR+) breast cancer. Tamoxifen is a
well-known and well-characterized selective estrogen receptor
modulator (SERM) that has been prescribed by oncologists for
decades for the treatment of breast cancer. In breast tissue,
tamoxifen acts as an estrogen antagonist. In contrast, in other
tissues such as vaginal tissues, tamoxifen has been reported to
exert an estrogen-like response on vaginal cytology.
The DARE-VVA1 study was a randomized, multi-center,
double-blind, parallel-arm, placebo-controlled, dose-ranging study
that evaluated the safety, tolerability, plasma PK and
pharmacodynamics (PD) of DARE-VVA1. Eligible participants were
randomly allocated to one of five treatment groups (approximately 4
participants per group) that evaluated four dose levels (1 mg, 5
mg, 10 mg, and 20 mg) and a placebo. Following a screening visit,
DARE-VVA1 was self-administered intravaginally once a day for the
first two weeks, and then twice a week for the following six weeks
for a total treatment period of 56 days. Intravaginal
administration of DARE-VVA1 was well tolerated and all treatment
emergent adverse events were mild or moderate and equally
distributed between participants randomized to study drug treatment
versus placebo. DARE-VVA1 demonstrated improvements in vaginal
cytology parameters and self-assessed most bothersome symptoms of
VVA (vaginal dryness or pain with intercourse) that support ongoing
development.
VVA is a common condition in postmenopausal women as well as
women diagnosed with, or with a history of, HR+ breast cancer, who
often report VVA as one of the most unpleasant side effects of
their cancer treatment. The prevalence of VVA in postmenopausal
breast cancer patients is estimated to be between 42 and 70
percent. Products containing estrogen are commonly used to treat
VVA. However, the use of estrogen-containing products for the
treatment of VVA is often contraindicated for HR+ breast cancer
patients and survivors because of the concern that estrogen use
will promote recurrence of disease.
There are currently no FDA-approved products labeled for VVA
treatment for patients with or at risk of recurrence of HR+ breast
cancer.
New Portfolio Candidates – DARE-LBT and
DARE-GML
DARE-LBT - novel hydrogel formulation for delivery of
live biotherapeutics In November, Daré announced it
received a grant of $584,986 to support activities related to
development of a vaginal thermosetting gel formulation that can be
reconstituted at the point of care for the delivery of live
biotherapeutics to support vaginal health, such as for
administration following effective primary infection treatment to
rebalance the vaginal microbiota disrupted by the infection. If
successful, the formulation could be carried forward for further
development as a delivery vehicle with potential to enhance the
availability of novel therapeutics for vaginal health in the United
States and worldwide, including in countries with varying climatic
conditions or where extended storage may be required. There are
currently no FDA approved live biotherapeutics for vaginal
health.
DARE-GML - novel antimicrobial glycerol
monolaurateIn August, Daré announced it entered into a
license agreement with Hennepin Life Sciences LLC under
which Daré acquired the exclusive global rights to develop and
commercialize treatments delivering the novel antimicrobial
glycerol monolaurate (GML) intravaginally for a variety of vaginal
health conditions including bacterial, fungal, and viral
infections. GML is a naturally occurring fatty acid monoester that
has shown broad antimicrobial activity, killing bacteria, fungi,
and viruses, and represents a new class of antimicrobials. GML has
the potential to be a first-in-category multi-target antimicrobial
agent.
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 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 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,” 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 plans and expectations with respect to
Daré’s product candidates, including anticipated timing for
commencement and conduct of clinical trials and clinical trial data
readouts, potential regulatory approval pathways, potential for FDA
approval based on a single pivotal clinical study, and potential to
be first-line and/or first-in-category products, expectations
regarding the commercial launch of XACIATO in the U.S.,
expectations regarding commercial collaborations and potential
payments under commercial collaboration agreements, expectations
regarding market potential for women’s health products outside of
oncology, expectations regarding potential for investment in
women’s health product candidates to be efficient and
disproportionately impactful in terms of translating dollars
invested in research and development to sales revenue, and
expectations regarding Daré’s business model. 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: Daré’s ability to develop, obtain
FDA or foreign regulatory approval for, and commercialize its
product candidates and to do so on communicated timelines; failure
or delay in starting, conducting and completing clinical trials of
a product candidate; 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; Daré’s dependence on third parties to conduct clinical
trials and manufacture and supply clinical trial material and
commercial product; Daré’s ability to raise additional capital when
and as needed to advance its product candidates, execute its
business strategy and continue as a going concern; the loss of, or
inability to attract, key personnel; the effects of the COVID-19
pandemic, macroeconomic conditions and geopolitical events 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 to fulfill their contractual obligations to Daré; 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 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 Roth Burns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonEvoke
Canale jake.robison@evokegroup.com 619.849.5383
Source: Daré Bioscience, Inc.
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