- Daré may be entitled to up to $310 million in commercial
milestone payments plus tiered royalties on net sales in the
double-digits
- Daré is a clinical-stage biopharmaceutical company committed to
the advancement of innovative products for women’s health
Bayer, a leader in women’s health, and Daré Bioscience, Inc.
(NASDAQ:DARE), a clinical-stage biopharmaceutical company committed
to the advancement of innovative products for women’s health,
announced today that the companies have signed a license agreement
under which Bayer may commercialize Daré’s investigational
contraceptive product, Ovaprene® in the United States once approved
by the FDA.
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the full release here:
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Ovaprene is an investigational hormone-free monthly vaginal
contraceptive currently in clinical development for the prevention
of pregnancy. If approved, it could be the first monthly
non-hormonal contraceptive product.
"We believe Bayer is best positioned to maximize the market
opportunity for Ovaprene, which has the potential to be a
first-in-category product for women, as Bayer has with other
first-in-category products,” said Sabrina Martucci Johnson,
President and CEO of Daré Bioscience. “This agreement provides Daré
the opportunity to immediately benefit from Bayer’s expertise in
development, regulatory, and commercialization, to unlock the
program’s full value similar to other innovative contraceptive
brands.”
Under the agreement, Daré will receive 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 receives 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.
“Both Daré and Bayer share an intense passion of developing
products and medicines that enhance the lives of women,” said Dr.
Sebastian Guth, Bayer’s President of Pharmaceuticals, Americas
Region. “Low or no hormones in contraceptives is something many
women prefer, and we are proud to collaborate with a partner who
shares a similar commitment to bringing products to market that can
make a meaningful impact for women, their families and
communities.”
Daré plans to file an Investigational Device Exemption (IDE) for
Ovaprene in the first half of 2020 and, pending the U.S. Food and
Drug Administration’s review and clearance of the IDE, to initiate
a pivotal contraceptive effectiveness and safety clinical study of
Ovaprene in the second half of 2020. If successful, Daré expects
that study to support marketing approvals of Ovaprene in the U.S.,
Europe and other countries worldwide.
The Pharmaceuticals Business Development & Licensing team of
Bayer facilitated this collaboration.
About Ovaprene®
Ovaprene is an investigational hormone-free, intravaginal ring
currently in clinical development for pregnancy prevention.
Ovaprene releases a locally acting, non-hormonal agent which
impedes sperm motility and features a proprietary knitted polymer
barrier to physically block sperm from entering the cervical
canal.
Ovaprene recently completed a successful postcoital test (PCT)
clinical study where, in all women and across all cycles evaluated,
it prevented virtually all sperm from entering the cervical canal,
a surrogate marker for contraceptive effectiveness.1 The topline
results from the PCT clinical study support continued clinical
development of Ovaprene and its potential to be the first
hormone-free, monthly contraceptive option for women.
1
https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-positive-findings-postcoital-test
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 vaginal contraceptive; 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.
About Bayer
Bayer is a global enterprise with core competencies in the life
science fields of health care and nutrition. Its products and
services are designed to benefit people by supporting efforts to
overcome the major challenges presented by a growing and aging
global population. At the same time, the Group aims to increase its
earning power and create value through innovation and growth. Bayer
is committed to the principles of sustainable development, and the
Bayer brand stands for trust, reliability and quality throughout
the world. In fiscal 2018, the Group employed around 117,000 people
and had sales of 39.6 billion euros. Capital expenditures amounted
to 2.6 billion euros, R&D expenses to 5.2 billion euros. For
more information, go to www.bayer.us or follow us on social media
at Facebook, Twitter, Instagram and YouTube.
About Gynecology at Bayer
Bayer is committed to delivering Science For A Better Life by
advancing a portfolio of innovative treatments. Women’s health,
including family planning and menopause management, has been at the
center of Bayer’s gynecology franchise for many years. Today,
Bayer’s research efforts focus on finding new treatment options for
gynecological diseases with a high medical need, and includes
several investigational compounds in various stages of pre-clinical
and clinical development. Together, these projects reflect the
company’s approach to research, which prioritizes targets and
pathways with the potential to alter the way that gynecological
diseases are treated.
Daré 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 potential
payments and non-monetary benefits to Daré under its agreement with
Bayer, the potential for Ovaprene to become the first FDA-approved
hormone-free, monthly contraceptive option, the success and timing
of a contraceptive effectiveness and safety clinical study of
Ovaprene, and the potential for regulatory approval to market
Ovaprene in the U.S., Europe and other countries based on a single
successful contraceptive effectiveness and safety clinical study.
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;
Daré’s ability to develop, obtain regulatory approval for, and
commercialize its product candidates; the risks that 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 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 pre-pivotal clinical
studies of a product candidate may not be predictive of success in
pivotal clinical studies of that candidate; the risk that a product
candidate may fail to demonstrate equivalent or superior efficacy
and/or safety in a pivotal clinical study compared to results from
a pre-pivotal study or studies; 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.
Bayer Forward-Looking Statements
This release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer Group or subgroup
management. Various known and unknown risks, uncertainties and
other factors could lead to material differences between the actual
future results, financial situation, development or performance of
the company and the estimates given here. These factors include
those discussed in Bayer's public reports which are available on
the Bayer website at www.bayer.com. The company assumes no
liability whatsoever to update these forward-looking statements or
to conform them to future events or developments.
© 2019 Bayer
BAYER and the Bayer Cross are registered trademarks of
Bayer.
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version on businesswire.com: https://www.businesswire.com/news/home/20200113005274/en/
Bayer Media: Sasha Damouni
Ellis +1 646-842-2299 Email: sasha.damouni@bayer.com
Daré Bioscience, Inc. Investors: Lee
Roth +1 212-213-0006 Burns McClellan Email: lroth@burnsmc.com
OR
Media Jake Robison +1 619-849-5383
Canale Communications Email: jake@canalecomm.com
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