Daré Bioscience, Inc. (NASDAQ:
DARE), a leader in
women’s health innovation, today announced the publication of a
literature review article by Biology of Reproduction that
identifies and reviews 10 postcoital test (PCT) studies of vaginal
contraceptives involving 9 test products, including Daré’s
investigational hormone-free, monthly contraceptive Ovaprene,
currently under a license agreement with Bayer for
commercialization in the U.S.
The literature review was conducted with the
support and participation of the Department of Obstetrics and
Gynecology, University of Texas Medical Branch, Galveston, Texas,
and Daré Bioscience. Based on the literature review, the article
concludes that, for evaluating vaginal contraceptives, the PCT is
the closest analogue available as a predictor of contraceptive
effectiveness and is the best indicator of whether a test product
works before it is evaluated in a contraceptive effectiveness
study.
“The findings from our review clearly
demonstrate that the PCT is predictive of contraceptive
effectiveness, and that a test product that performs well in a PCT
study carried out in the same manner as recent PCT clinical studies
can be expected to demonstrate contraceptive effectiveness in a
pivotal study at a level predictive of a highly effective
contraceptive product,” said Christine Mauck, MD, MPH, Medical
Director for Daré Bioscience and co-author of the article. “We
believe the Ovaprene PCT study completed by Daré last year is the
most robust PCT clinical study ever conducted in the field of
contraception, and the findings are encouraging in the context of
other PCT studies with regard to Ovaprene’s potential as an
alternative to traditional hormone-based contraceptive
options. As summarized in the article, other contraceptives
that demonstrated PCT study results comparable to results seen with
Ovaprene in last year’s PCT study, went on to demonstrate six-month
typical-use contraceptive effectiveness of 86-91% in their
respective pivotal studies, which is similar in range to
typical-use effectiveness rates of hormonal methods like pills,
patches, and vaginal rings such as the NuvaRing® vaginal ring.”
The accepted manuscript for the article entitled
“The Postcoital Test in the Development of New Vaginal
Contraceptives” is currently available in the Advance Articles
section on the journal’s website, or at
https://doi.org/10.1093/biolre/ioaa099
Bayer and Daré Bioscience Exclusive Licensing
Agreement for U.S. Commercial Rights to Ovaprene:
In January 2020, Daré announced that it entered
into an exclusive licensing agreement with Bayer for U.S.
commercial rights to Ovaprene. Under the agreement, Daré
received an upfront payment and access to Bayer’s extensive
clinical and market capabilities 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.
The PCT Study Background:
The PCT study was initially developed to assess
whether cervical factors played a role in infertility and became
standard practice in the evaluation of infertile couples for many
decades until it was replaced in the 1990s by more predictive
testing methodologies and the wider use of in vitro fertilization,
which bypasses the cervical mucus-sperm interaction. The World
Health Organization describes key aspects of the PCT procedure,
including the timing for collection of cervical mucus after
intercourse and the method of counting and characterizing sperm
found in the mucus. [1] The PCT has been used to evaluate both
chemical and mechanical barrier vaginal contraceptive products,
including spermicides and diaphragms. [2, 3]
- WHO laboratory manual for the Examination and processing of
human semen, 5th ed., World Health Organization, 2010, available at
https://www.who.int/reproductivehealth/publications/infertility/9789241547789/en/
- A phase I randomized postcoital testing and safety study of the
Caya diaphragm used with 3% Nonoxynol-9 gel, ContraGel or no gel.
Mauck CK, Brache V, Kimble T, Thurman A, Cochon L, Littlefield S,
Linton K, Doncel GF, Schwartz JL. Contraception. 2017
Aug;96(2):124-130.
- The Postcoital Test in the Development of New Vaginal
Contraceptives. Mauck CK, Vincent KL. Biology of Reproduction, 2020
June 16; accepted manuscript available at
https://doi.org/10.1093/biolre/ioaa099
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
hormone-free, monthly contraceptive intravaginal ring 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®; 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 replacement 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 its investor relations 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 on its investor relations website
(https://darebioscience.gcs-web.com/) 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. Such statements include, but are not limited
to, Ovaprene’s potential as an alternative to traditional
hormone-based contraceptive options, the potential of Ovaprene to
demonstrate typical-use contraceptive effectiveness in a pivotal
contraceptive safety and efficacy study comparable to current
FDA-approved, highly effective contraceptive products, and
potential payments and non-monetary benefits to Daré under its
licensing agreement with Bayer. 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: 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 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 risks that the license
under the agreement with Bayer may not become effective and, if it
becomes effective, that future payments to Daré under the agreement
may be significantly less than the anticipated or potential
amounts; the failure or delay in starting, conducting and
completing clinical trials or obtaining U.S. Food and Drug
Administration (FDA) or foreign regulatory approval for Daré’s
product candidates in a timely manner; Daré’s ability to conduct
and design 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; 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; developments by Daré’s competitors that
make its product candidates less competitive or obsolete; 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; the risk of failure associated with product
candidates in preclinical stages of development that may lead
investors to assign them little to no value and make these assets
difficult to fund; 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.
Daré Bioscience, Inc.
Investors on behalf of Daré Bioscience, Inc.:Lee
RothBurns McClellanEmail: lroth@burnsmc.com +1
212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonCanale CommunicationsEmail: jake@canalecomm.com +1
619-849-5383
Source: Daré Bioscience, Inc.
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Apr 2024 to May 2024
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From May 2023 to May 2024