Full Press Release Details
Bioscience Announces IDE Approval for a Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene ,
an Investigational Hormone-Free Monthly Intravaginal Contraceptive
has the Potential to be the First FDA-Approved Monthly, Self-Administered, Hormone-Free Contraceptive Product
DIEGO, October 10, 2022 (GLOBE NEWSWIRE) -- Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,
today announced that the U.S. Food & Drug Administration (FDA) approved an Investigational Device Exemption (IDE) application allowing
Dar to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene , an investigational
hormone-free monthly intravaginal contraceptive. The IDE approval reflects that the FDA determined the Company provided sufficient data
to support the initiation and conduct of the study. The IDE submission included the results of the postcoital test (PCT) clinical study
of Ovaprene, in which Ovaprene prevented essentially all sperm from entering the cervical canal across all women and all cycles evaluated.
PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness.
are driven to bring forward innovative options that support women's health and wellness, and we are motivated to accelerate the
development and introduction of differentiated product candidates, like Ovaprene, which is both hormone-free and designed to be conveniently
kept in place vaginally continuously over the weeks between menstruation," said Sabrina Martucci Johnson, President & CEO of
Dar Bioscience. "When it comes to contraception, many of the top-selling brands in the category are delivering both convenience
and efficacy, suggesting that women and healthcare providers have a preference for contraceptive methods that are effective, that don't
need to be administered every day, and that don't require action at the time of intercourse."
order for the planned study to serve as the primary clinical support for a future marketing approval or clearance, the FDA provided additional
study design considerations with the IDE approval letter.
FDA communication," Ms. Johnson continued, "confirms our alignment on a number of key aspects of the clinical study, including
the adequacy of a 12-month (13 menstrual cycles) duration. The additional study design considerations provided by the FDA are considered
by the FDA to be recommendations that do not need to be addressed in order for us to initiate and conduct this study. However, implementing
the guidance that we received from the FDA will further position this pivotal study to collect safety and effectiveness data that will
support the submission of a Premarket Approval (PMA) application. Therefore, we look forward to working with our collaborators at the
NIH and at Bayer to review and implement the recommendations and we are targeting mid-year 2023 study recruitment initiation."
multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive
device along with its safety and usability. If successful, Dar expects the pivotal study to support marketing approvals of Ovaprene
in the U.S. and other countries.
July 2021, Dar entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human
Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the
National Institutes of Health (NIH), to collaborate on the pivotal Phase 3 study of Ovaprene. The agreement gives Dar access
to the full contraceptive clinical trial expertise of the NICHD clinical trial network while also sharing the costs of the Phase 3 pivotal
study with the NICHD. The NICHD will hold an Ovaprene clinical trial investigator meeting in December of this year.
January 2020, Dar and Bayer announced an exclusive licensing agreement for U.S. commercial rights to Ovaprene. Under the agreement,
Dar 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 Dar . If Bayer, in its sole discretion,
makes payment to Dar of $20 million, which Dar intends to apply to reimbursement of clinical study costs, then the
exclusive license to commercialize Ovaprene in the U.S. will become effective. Dar will also be entitled to receive commercial
milestone payments potentially totaling $310 million, in addition to double digit tiered royalties on net sales.
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.
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
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. Dar '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 , Dar 's
full portfolio of women's health product candidates, and Dar 's mission to deliver differentiated therapies for women,
please visit www.darebioscience.com.
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. Dar
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 Dar
posts on its investor relations website or through social media channels may be deemed to be material information. Dar encourages
investors, the media, and others interested in the company to review the information Dar 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 Dar 's website.
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 Ovaprene's potential to be the first FDA-approved monthly, self-administered, hormone-free contraceptive product, Dare's
expectation that the planned pivotal clinical study of Ovaprene, if successful, would serve as the primary clinical support for future
marketing approvals, the anticipated study design and timing of initiation of subject recruitment into the study, and the ability to
successfully implement the additional study design considerations recommended by the FDA to further support a potential PMA application.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dar '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 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; Dar '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;
Dar 's dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial
product; Dar '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; 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; Dar 's
ability to accurately predict its future financial condition, operating results and performance; Dar '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 Dar and other protections for innovative products; and the exposure of Dar ,
its commercial counterparties and other third parties on which it relies to litigation, including patent litigation, and/or regulatory
actions. Dar '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 Dar 's risks and uncertainties, you are encouraged to review its documents filed
with the SEC including Dar '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. Dar 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
on behalf of Dar Bioscience, Inc.:
on behalf of Dar Bioscience, Inc.:
Dar Bioscience, Inc.