Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced that it will be presenting two posters
at the 2019 Controlled Release Society Annual Meeting &
Exposition taking place in Valencia Spain, July 21st-24th.
The presentations will focus on recently completed studies
designed to determine drug concentration and release
characteristics for DARE-HRT1 and DARE-FRT1, novel intravaginal
ring (IVR) drug delivery product candidates containing
bio-identical hormones being developed for the treatment of
menopause-related vasomotor symptoms (VMS) and luteal phase
pregnancy maintenance, respectively.
“The findings from these studies demonstrate that FT-Raman
spectroscopy and hot-melt extrusion are useful analytical tools to
assess the physical state of active drug products as part of
quality control and long-term stability assessments, to evaluate
and demonstrate stability of the active drug in the IVR over time,”
said Dr. David Friend, Chief Scientific Officer of Daré
Bioscience.
DARE-HRT1 is a novel, segmented ethylene-vinyl acetate (EVA) IVR
delivering bioidentical 17β-estradiol and bioidentical
progesterone, and DARE-FRT1 is a novel, segmented IVR delivering
progesterone. These two product candidates are the most advanced
products from Daré’s IVR technology platform that was initially
developed by Dr. Robert Langer from
the Massachusetts Institute of Technology and
Dr. William Crowley from Massachusetts General
Hospital and Harvard Medical School. Unlike other IVR
product designs, Daré’s IVR technology is designed to allow for
active drug to be homogenized in a solid EVA polymer matrix that
eliminates the need for a membrane or reservoir to contain the
active drug or control its release. Individual drug segments
provide the opportunity for multiple drug and dosage level options.
Compared to other drug delivery vehicles, these features provide
flexibility to incorporate a wide molecular weight range, including
poorly bioavailable drugs.
The poster presentations will be led by Dr. Friend. on Monday,
July 22, 2019, and Tuesday, July 23, 2019, 5:30 PM – 7:30 PM (CET).
The posters are titled:
- Determination of Drug Crystallinity in Hot Melt Extruded
Ethylene Vinyl Acetate Copolymer
- Use of FT‐Raman Spectroscopy to Assess
17β‐Estradiol/Progesterone Ethylene Vinyl Acetate Based
Intravaginal Rings
The posters will also be made available on the Events and
Presentations page of Daré’s investor relations website
(http://ir.darebioscience.com).
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 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 uses these
channels to communicate with its investors and the public about the
company and other company-related matters. The information Daré
posts on its investor relations website 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: www.darebioscience.com.
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 the
potential of DARE-HRT1 to treat menopause-related vasomotor
symptoms and of DARE-FRT1 to provide effective pregnancy
maintenance therapy. 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.: Lee Roth
Burns McClellan lroth@burnsmc.com 212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.: Jake Robison
Canale Communications jake@canalecomm.com 619.849.5383
Source: Daré Bioscience
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