{"id":511551,"date":"2021-07-12T05:48:08","date_gmt":"2021-07-12T09:48:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\/"},"modified":"2021-07-12T05:48:08","modified_gmt":"2021-07-12T09:48:08","slug":"dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\/","title":{"rendered":"Dar\u00e9 Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene\u00ae, an Investigational Hormone-Free Monthly Contraceptive"},"content":{"rendered":"
\n

\n Funding and Clinical Operations Support will be Provided by the National Institutes of Health\u2019s Eunice Kennedy Shriver<\/em> National Institute of Child Health and Human Development (NICHD) Under the CRADA<\/strong>\n <\/p>\n

\n Dar\u00e9 Plans to Submit an Investigational Device Exemption (IDE) to the FDA in the Fourth Quarter of 2021 and Commence the Ovaprene Pivotal Study in 2022<\/strong>\n <\/p>\n

SAN DIEGO, July 12, 2021 (GLOBE NEWSWIRE) — Dar\u00e9\u00a0Bioscience, Inc.\u00a0(NASDAQ:DARE<\/u><\/a>), a leader in women\u2019s health innovation, today announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver<\/em> National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene\u00ae<\/sup>, an investigational hormone-free monthly intravaginal contraceptive currently in clinical development for the prevention of pregnancy. The agreement will allow Dar\u00e9 to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD. If Ovaprene\u00ae<\/sup> is approved by the U.S. Food and Drug Administration (FDA), it could be the first monthly non-hormonal contraceptive option for women.<\/p>\n

The pivotal Phase 3 study will be supported by the NICHD\u2019s Contraceptive Development Program (CDP). The CDP oversees the Contraceptive Clinical Trial Network (CCTN), which was established in 1996 to conduct studies of investigational contraceptives, and the Phase 3 study will be conducted within the CCTN with the NICHD contractor Health Decisions Inc. Dar\u00e9 will be responsible for providing clinical supplies of Ovaprene\u00ae<\/sup> and coordinating interactions with and preparing and submitting supportive regulatory documentation to the FDA. Dar\u00e9 and NICHD will each provide medical oversight for the trial and final data review and analysis, and will work together to prepare the final report of the trial results.<\/p>\n

Under the CRADA, Dar\u00e9 has also agreed to contribute $5.5 million toward the total estimated cost to conduct the pivotal Phase 3 study, which will be payable in four payments. The first payment is due within 30 days of the effective date of the CRADA and the final payment is due by April 1, 2023. NICHD will be responsible for the other costs related to the conduct of the pivotal study and will manage the payment of expenses to Health Decisions, the clinical sites, and other parties involved with the study.<\/p>\n

\u201cWe are thrilled to continue our work with NICHD to advance Ovaprene\u00ae<\/sup> through this pivotal study,\u201d said Sabrina Martucci Johnson, President and CEO of Dar\u00e9 Bioscience, Inc. \u201cGrant funding previously provided by NICHD supported the conduct of our pre-pivotal clinical study of Ovaprene. With this CRADA, we have the opportunity to leverage NICHD\u2019s experience in the design and execution of contraceptive studies, as well as continued funding to support the development of Ovaprene. We look forward to collaborating with NICHD, along with our partner Bayer\u00ae<\/sup>, to advance the development of additional non-hormonal contraceptive options for women.\u201d<\/p>\n

Bayer and Dar\u00e9 entered into an exclusive licensing agreement for U.S. commercial rights to Ovaprene\u00ae<\/sup> in January 2020. Under the agreement, Dar\u00e9 receives access to Bayer\u2019s extensive clinical and market capabilities while retaining control over Ovaprene\u2019s development and regulatory approval process. Bayer has 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\u00e9 and the NICHD. If Bayer, in its sole discretion, makes payment to Dar\u00e9 of $20 million, which Dar\u00e9 intends to apply to reimbursement of its portion of the clinical study and manufacturing costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective. Dar\u00e9 will also be entitled to receive commercial milestone payments potentially totaling\u00a0$310 million, in addition to double digit tiered royalties on net sales.<\/p>\n

\u201cThis collaboration between Dar\u00e9 and NICHD marks an important milestone in Women\u2019s Healthcare Innovation.\u00a0Women are at the center of everything we do and we are so pleased to continue to partner with Dar\u00e9 in support of our mission We\u2019re For Her <\/em>to provide women with education and access to contraceptive options,\u201d said John Berrios, Bayer\u2019s Head of Women\u2019s Healthcare.<\/em><\/p>\n

The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene\u00ae<\/sup> will evaluate its effectiveness as a contraceptive device along with its safety and usability. Dar\u00e9 plans to file an IDE for Ovaprene in the forth quarter of 2021 and, pending the FDA\u2019s review and clearance of the IDE, to initiate the pivotal study of Ovaprene in 2022. If successful, Dar\u00e9 expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.<\/p>\n

\n About Dar\u00e9 Bioscience<\/strong>\n <\/p>\n

Dar\u00e9 Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women\u2019s health. The company\u2019s 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.<\/p>\n

Dar\u00e9\u2019s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene\u00ae<\/sup>, a novel, investigational hormone-free monthly intravaginal contraceptive whose\u00a0U.S.\u00a0commercial 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\u00ae<\/sup>; 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 therapy following menopause. To learn more about Dar\u00e9\u2019s full portfolio of women\u2019s health product candidates, and mission to deliver differentiated therapies for women, please visit\u00a0www.darebioscience.com<\/a>.\u00a0<\/p>\n

Dar\u00e9 may announce material information about its finances, product candidates, clinical trials and other matters using the Investors section of its website (http:\/\/ir.darebioscience.com<\/a>),\u00a0SEC\u00a0filings, press releases, public conference calls and webcasts. Dar\u00e9 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 Dar\u00e9 posts on its investor relations website or through social media channels may be deemed to be material information. Dar\u00e9 encourages investors, the media, and others interested in the company to review the information Dar\u00e9 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 on the investor relations page of Dar\u00e9\u2019s website mentioned above.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

Dar\u00e9 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 \u201cbelieve,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cestimate,\u201d \u201ccontinue,\u201d \u201canticipate,\u201d \u201cdesign,\u201d \u201cintend,\u201d \u201cexpect,\u201d \u201ccould,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201ccontemplate,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201ctend to,\u201d 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 the conduct and funding of a Phase 3 pivotal clinical study of Ovaprene by the NICHD, anticipated timing of submission of the IDE and commencement of the Phase 3 study, Ovaprene\u2019s potential to become the first first monthly non-hormonal contraceptive approved by the FDA, the potential for regulatory approval to market Ovaprene in the U.S. and other countries based on a single pivotal study, and potential payments to Dar\u00e9 under its agreement with Bayer. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dar\u00e9\u2019s 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: the NICHD\u2019s ability to timely enroll, conduct and report results of the Phase 3 study of Ovaprene; the NICHD\u2019s ability to terminate the CRADA for any reason upon 30-days\u2019 notice; Dar\u00e9\u2019s ability to raise additional capital when and as needed to advance its product candidates and continue as a going concern; the effects of the COVID-19 pandemic on Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Dar\u00e9\u2019s ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Dar\u00e9 relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Dar\u00e9, including the NICHD under the CRADA; Dar\u00e9\u2019s 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 Dar\u00e9\u2019s product candidates in a timely manner; Dar\u00e9\u2019s 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; 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; the risk that developments by competitors make Dar\u00e9\u2019s product candidates less competitive or obsolete; failure of Dar\u00e9\u2019s product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; Dar\u00e9\u2019s ability to retain its licensed rights to develop and commercialize a product candidate; Dar\u00e9\u2019s 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; the risks that the license agreement with Bayer may not become effective and, if it becomes effective, that future payments to Dar\u00e9 under the agreement may be significantly less than the anticipated or potential amounts; Dar\u00e9\u2019s failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; Dar\u00e9\u2019s dependence on third parties to conduct clinical trials and manufacture clinical trial material; Dar\u00e9\u2019s ability to adequately protect or enforce its, or its licensor\u2019s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Dar\u00e9\u2019s product candidates which could expose its products to competition from other formulations using the same active ingredients; cyber attacks, security breaches or similar events that compromise Dar\u00e9\u2019s technology systems or those of third parties on which it relies and\/or significantly disrupt Dar\u00e9\u2019s business; and disputes or other developments concerning Dar\u00e9\u2019s intellectual property rights. Dar\u00e9\u2019s 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\u00e9\u2019s risks and uncertainties, you are encouraged to review its documents filed with the\u00a0SEC\u00a0including Dar\u00e9\u2019s 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\u00e9 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.<\/p>\n

\n Contact<\/strong>\n <\/p>\n

Lisa Walters-Hoffert, Chief Financial Officer
Dar\u00e9 Bioscience, Inc.
lwalters@darebioscience.com<\/a>
858.926.7655<\/p>\n

Source: Dar\u00e9 Bioscience, Inc.\u00a0<\/p>\n


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Funding and Clinical Operations Support will be Provided by the National Institutes of Health\u2019s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Under the CRADA Dar\u00e9 Plans to Submit an Investigational Device Exemption (IDE) to the FDA in the Fourth Quarter of 2021 and Commence the Ovaprene Pivotal Study in 2022 SAN DIEGO, July 12, 2021 (GLOBE NEWSWIRE) — Dar\u00e9\u00a0Bioscience, Inc.\u00a0(NASDAQ:DARE), a leader in women\u2019s health innovation, today announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene\u00ae, an investigational hormone-free monthly intravaginal contraceptive … <\/p>\n

Continue reading “Dar\u00e9 Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene\u00ae, an Investigational Hormone-Free Monthly Contraceptive”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-511551","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDar\u00e9 Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene\u00ae, an Investigational Hormone-Free Monthly Contraceptive - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dar\u00e9 Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene\u00ae, an Investigational Hormone-Free Monthly Contraceptive - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Funding and Clinical Operations Support will be Provided by the National Institutes of Health\u2019s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Under the CRADA Dar\u00e9 Plans to Submit an Investigational Device Exemption (IDE) to the FDA in the Fourth Quarter of 2021 and Commence the Ovaprene Pivotal Study in 2022 SAN DIEGO, July 12, 2021 (GLOBE NEWSWIRE) — Dar\u00e9\u00a0Bioscience, Inc.\u00a0(NASDAQ:DARE), a leader in women\u2019s health innovation, today announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene\u00ae, an investigational hormone-free monthly intravaginal contraceptive … Continue reading "Dar\u00e9 Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene\u00ae, an Investigational Hormone-Free Monthly Contraceptive"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-07-12T09:48:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI3ODE0OSM0MjkwNTgwIzIwMDgzNjQ=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Dar\u00e9 Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene\u00ae, an Investigational Hormone-Free Monthly Contraceptive\",\"datePublished\":\"2021-07-12T09:48:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\\\/\"},\"wordCount\":1916,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODI3ODE0OSM0MjkwNTgwIzIwMDgzNjQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-announces-collaborative-research-agreement-crada-for-the-pivotal-phase-3-study-of-ovaprene-an-investigational-hormone-free-monthly-contraceptive\\\/\",\"name\":\"Dar\u00e9 Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene\u00ae, an Investigational Hormone-Free Monthly Contraceptive - 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