Daré Bioscience, Inc. (NASDAQ: DARE), a leader in clinical-stage
women’s health innovation, today announced that it has entered into
definitive agreements with Hammock Pharmaceuticals, Inc., TriLogic
Pharma LLC and MilanaPharm LLC under which Daré acquired the global
rights to MP-101 for the treatment of bacterial vaginosis (BV), as
well as the rights to utilize the underlying proprietary hydrogel
drug delivery technology for any vaginal or urological application
in humans.
Bacterial vaginosis is a type of vaginal
inflammation caused by the overgrowth of bacteria naturally found
in the vagina, which upsets the natural balance and is
characterized by vaginal discharge, vaginal odor, vaginal itching,
and burning during urination.
The proprietary in-situ gel system, which
consists of a combination of a tri block copolymer and a natural
polysaccharide, is designed to take advantage of body temperature
to undergo solution-to-gel transition, enabling transformation into
a bioadhesive gel formulation featuring extended release of the
incorporated drug following application at the site of action. In
MP-101 this proprietary technology is formulated with clindamycin,
an antibiotic used to treat certain bacterial infections including
BV, and has been engineered to produce a dual release pattern after
vaginal application, providing maximum duration of exposure to
clindamycin at the site of infection. Daré expects to commence a
Phase III clinical study of MP-101 in approximately 250 women in
the second half of 2019, and if the study is successful, to be in a
position to file a new drug application with the U. S. Food and
Drug Administration (FDA) in 2020. Based on MilanaPharm’s
discussions with the FDA, Daré believes that one Phase III study
with sufficient power and size may be sufficient for marketing
approval in the U.S.
Current BV therapies typically have a success
rate of less than 70%. In an investigator initiated pilot
study treating 30 women, MP-101 demonstrated an 88% cure rate with
just one administration.
“We believe this Phase III program will allow us
to move into a leadership position in an area of great concern for
both women and healthcare providers,” said Sabrina Martucci
Johnson, President and CEO of Daré. “Studies suggest that nearly 20
million women in the U.S. experience BV and many suffer from
episodes of recurrence. Current standard of care is oral
antibiotics taken either once or over the course of several days,
which can have systemic side effects, or antibiotics delivered
vaginally in creams or gels, typically over the course of several
days . If a cure rate consistent with the pilot study is
demonstrated in the Phase III program, MP-101 has the potential to
provide a significant improvement in efficacy over currently
marketed BV therapies and enhanced convenience for
women.”
“Hammock is excited to announce our partnership
with Daré Bioscience. The transaction allows Hammock to focus
on our OTC products and to potentially recognize value from MP-101
and the novel hydrogel technology. We look forward to working
with the Daré and MilanaPharm teams on the transition and the lead
product candidate and possibly other product candidates
incorporating the hydrogel technology,” said William R. Maichle,
CEO of Hammock Pharmaceuticals.
Under the agreements with Hammock and
TriLogic/MilanaPharm, Daré received an exclusive, worldwide,
royalty-bearing license to research, develop and commercialize the
technology, paid one-time upfront fees of $275,000 and will pay
one-time deferred fees of $450,000 within one year. In addition,
Daré agreed to make potential future milestone payments through the
term of the license based on clinical, regulatory, commercial
launch and sales events, and to pay royalties based on commercial
sales. Patents covering the licensed technology have been granted
with terms through 2028 and additional patents pending would have
terms through 2035.
Destum Partners advised Hammock Pharmaceuticals on the
transaction.
About Hammock Pharmaceuticals
Hammock Pharmaceuticals is an international
branded, specialty pharmaceutical and consumer health company
focused on the commercialization of differentiated brands and high
value generic products.
About MilanaPharm
MilanaPharm is a specialty pharmaceutical
company built upon a proprietary drug delivery platform for
numerous active compounds. MP-101 is part of the company’s
hydrogel platform which is designed to deliver drugs that remain in
place over periods ranging from several hours to several days,
depending on the desired delivery profile, in order to achieve an
effective treatment outcome.
About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s reproductive and sexual health. The
company’s mission is to identify, develop and bring to market a
portfolio of novel, differentiated therapies that expand treatment
options, improve outcomes and facilitate convenience for women in
the areas of contraception, vaginal health, sexual health, and
fertility.
Daré’s product portfolio includes two potential
first-in-class candidates in clinical development: Ovaprene®, a
non-hormonal, monthly contraceptive vaginal ring, and Sildenafil
Cream, 3.6%, a potential treatment for female sexual arousal
disorder utilizing the same active ingredient as Viagra®. To learn
more about Daré’s full portfolio of women’s health products, and
mission to deliver novel 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.
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 MP-101 to significantly
improve treatment outcomes in BV compared to currently marketed
products, the potential for MP-101 to receive marketing approval
for the treatment of BV following a single Phase III clinical study
in approximately 250 subjects, the potential application of the
licensed drug delivery platform for indications other than BV,
Daré’s ability to advance MP-101 into Phase III development, to
successfully conduct the planned Phase III clinical study, and to
achieve FDA acceptance of a new drug application for MP-101 in BV
on its anticipated timelines or at all, and the potential for
marketing exclusivity in BV and other indications based on issued
patents and pending patent applications. 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 and commercialize product candidates,
including MP-101; 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 efficacy of its product
candidates; Daré’s ability to retain our 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; 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.: Ami Bavishi
Burns McClellan abavishi@burnsmc.com 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.: Amanda Guisbond
Canale Communications amanda@canalecomm.com 781-405-8775
Source: Daré Bioscience, Inc.
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