Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the article entitled “Pharmacokinetics
and tolerability of a novel progesterone intravaginal ring in
sheep” was published online in the journal Drug Delivery and
Translational Research. The goal of the research was to
characterize the in vitro release, pharmacokinetics and local
tolerability of DARE-FRT1, a novel ethylene-vinyl acetate
intravaginal ring (IVR) drug delivery technology delivering
progesterone, in drug-naïve ovariectomized female Dorset crossbred
sheep.
DARE-FRT1 is being developed as an optimized IVR technology
capable of delivering bio-identical progesterone hormone for the
prevention of preterm birth (PTB), and for pregnancy maintenance
and support as part of an assistive reproductive technology (ART)
procedure. DARE-FRT1 is designed to allow for convenient
non-invasive, non-oral administration of bio-identical progesterone
over a 14-day period.
“We believe the results of this study are highly encouraging as
they further validate the viability of the IVR technology platform
for drug delivery,” said David Friend, PhD, co-author of the
article and Chief Scientific Officer of Daré Bioscience. “As with
our previously reported study of DARE-HRT1, DARE-FRT1 was well
tolerated and we look forward to continuing its development into
the clinic as a potential first-in-category therapy for preterm
birth and fertility.”
The March of Dimes, an organization dedicated to the health and
wellbeing of mothers and infants, supports the use of progesterone
to reduce the risk of PTB, defined as birth before 37 weeks of
completed gestation1, and the Society for Assisted Reproductive
Technology supports the use of progesterone after egg retrieval to
support the lining of the uterus.2 According to the Centers
for Disease Control and Prevention (CDC), about 10% of women in the
U.S. between the ages of 15-44, or 6.1 million women, face
difficulty in getting or staying pregnant.3 AMAG
Pharmaceuticals, the maker of Makena®, the first and, until 2018,
only product approved by the U.S. Food and Drug Administration
(FDA) to reduce the risk of PTB, reported 2018 annual revenue in
excess of $320 million for Makena and its authorized generic4 and,
according to the research firm Global Market Insights, the global
ART market will surpass $32.5 billion by 2024.5
“With approximately 10% of all pregnancies in the United States
resulting in preterm births,6 and the increasing demand for
pregnancy support as part of ART procedures, DARE-FRT1 could
address significant unmet needs in women’s health. DARE-FRT1
has the potential to be the first and only FDA-approved product
capable of delivering bio-identical progesterone in a convenient,
non-systemic and non-invasive way over a period of several days,”
said Sabrina Martucci Johnson, President and CEO of Daré
Bioscience.
For more information, access to the scientific paper entitled
“Pharmacokinetics and tolerability of a novel progesterone
intravaginal ring in sheep” is available at
https://link.springer.com/article/10.1007/s13346-019-00646-x
1 – March of Dimes website,
https://www.marchofdimes.org/complications/progesterone-treatment-to-help-prevent-premature-birth.aspx
2 – Society for Assisted Reproductive Technology website,
https://www.sart.org/patients/a-patients-guide-to-assisted-reproductive-technology/stimulation/progesterone/
3 – U.S. Department of Health and Human Services Office on
Women’s Health website,
https://www.womenshealth.gov/a-z-topics/infertility
4 - AMAG Pharmaceuticals, Inc. press release dated February 7,
2019,
https://www.globenewswire.com/news-release/2019/02/07/1712029/0/en/AMAG-Reports-Fourth-Quarter-and-Full-Year-2018-Financial-Results-and-Provides-Company-Update.html
5 - Global Market Insights, Inc. press release dated January 23,
2019,
https://www.prnewswire.com/news-releases/assisted-reproductive-technology-market-to-hit-32-5-billion-by-2024-global-market-insights-inc--843521697.html
6 - Martin J, et al., Births: final data for 2017, National
Vital Statistics Reports, Vol. 67, No. 8, Nov 7, 2018,
https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_08-508.pdf1
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-class
candidates in clinical development: Ovaprene®, a non-hormonal,
monthly contraceptive intravaginal ring; 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 the company's website mentioned above.
This press release includes information obtained from, and makes
reference to, trade and statistical services and other third-party
publications and sources. Daré has not independently verified
such information and, although the company is not aware of
inaccuracies in such third-party information, there can be no
assurance as to its accuracy.
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, statements relating to plans to
advance DARE-FRT1 into a human clinical study and DARE-FRT1’s
potential to obtain FDA approval for the prevention of preterm
birth and/or pregnancy maintenance and support as part of an ART
procedure and to be a first-in-category product. 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; Daré’s ability to develop, obtain
regulatory approval for, and commercialize its product candidates;
the failure or delay in starting, conducting and completing
clinical trials or obtaining 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; 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.
Contacts:
Investors on behalf of Daré Bioscience, Inc.: Alex Gray
Burns McClellan agray@burnsmc.com 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.: Jordann Phillips
Canale Communications jordann@canalecomm.com 619-849-6009
Source: Daré Bioscience
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