{"id":767701,"date":"2023-07-05T08:31:06","date_gmt":"2023-07-05T12:31:06","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/"},"modified":"2023-07-05T08:31:06","modified_gmt":"2023-07-05T12:31:06","slug":"dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/","title":{"rendered":"Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis"},"content":{"rendered":"

\nDar\u00e9 to receive $1 million in July 2023 and $181.8 million in potential milestone payments from Organon\u00a0under XACIATO global license agreement\u00a0
\n<\/h2>\n
\n

SAN DIEGO, July 05, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, today reaffirmed its commitment to the commercial launch of XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% with collaborator Organon (NYSE: OGN), and announced that Organon will pay Dar\u00e9 $1.0 million in July 2023.<\/p>\n

\u201cWe believe Organon\u2019s commercial capabilities and track record of success in the branded women\u2019s health category will help ensure a successful introduction of XACIATO in the United States and, ultimately, that XACIATO reaches the global population of women suffering from bacterial vaginosis, which is estimated to impact between 23% to 29% of all women worldwide,\u201d said Sabrina Martucci Johnson, President and CEO of Dar\u00e9. \u201cDar\u00e9 has completed manufacturing validation activities required to support commercial launch. To provide for continuity of supply to support a robust commercial launch, additional manufacturing related activities are being performed and Organon and Dar\u00e9 are working towards a 2023 U.S. launch as soon as feasible. We are confident that XACIATO will be well positioned for commercial success given the knowledge and experience of Organon\u2019s sales team, which is the same sales team that helped drive the market acceptance and record sales of NEXPLANON\u00ae, coupled with Organon\u2019s payer outreach and provider and patient-centered initiatives, and we look forward to the launch later this year.\u201d<\/p>\n

Under the amended license agreement between Dar\u00e9 and Organon for XACIATO, Organon will pay Dar\u00e9 $1.0 million in July 2023 and will pay Dar\u00e9 $1.8 million upon the first commercial sale of XACIATO. In 2022, Dar\u00e9 received a $10.0 million upfront payment from Organon when the license agreement became effective. In addition to the upfront payment and the $2.8 million described above, Dar\u00e9 is also eligible to receive additional potential future milestone payments of up to $180.0 million and tiered double-digit royalties based on net sales.<\/p>\n

As Dar\u00e9 previously shared<\/a>, the New Drug Application (NDA) for XACIATO was supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating XACIATO (formerly known as DARE-BV1) for the treatment of bacterial vaginosis (NCT04370548).<\/p>\n

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

Dar\u00e9 Bioscience is a biopharmaceutical company committed to advancing 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 prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.<\/p>\n

Dar\u00e9\u2019s first FDA-approved product, XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Dar\u00e9\u2019s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene\u00ae, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial 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; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Dar\u00e9\u2019s full portfolio of women\u2019s health product candidates, and Dar\u00e9\u2019s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.<\/p>\n

Dar\u00e9 may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http:\/\/ir.darebioscience.com), SEC filings, 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 and 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 in the Investors section of Dar\u00e9\u2019s website.<\/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 \u201cobjective,\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 Dar\u00e9\u2019s expectations about commercial distribution and sale of XACIATO, receipt of payments from Organon, and expected timing of commercial availability of XACIATO in the United States. 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 those expressed or implied by the forward-looking statements in this press release, including, without limitation: the risks that none of the milestones under the agreement with Organon may be achieved and none of potential milestone payments become payable; the potential for royalty payments to be subject to reductions and offsets; dependence on Organon to commercialize licensed products and on other third parties for commercial supplies of licensed products and components and Dar\u00e9\u2019s lack of control over the efforts and resources expended by those third parties; Dar\u00e9\u2019s ability to raise additional capital when and as needed to support its operations, execute its business strategy and continue as a going concern; general industry conditions and competition; the effects of macroeconomic conditions such as inflation, rising interest rates and geopolitical events on Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; the risk that developments by competitors make Dar\u00e9\u2019s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and\/or commercial collaborators; failure of Dar\u00e9\u2019s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Dar\u00e9\u2019s ability to retain its licensed rights to develop and commercialize a product or 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 and product candidates; 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; product liability claims; governmental investigations or actions relating to Dar\u00e9\u2019s product or product candidates or the business activities of Dar\u00e9, its commercial collaborators or other third parties on which Dar\u00e9 relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; 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 SEC including 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 Contacts:<\/strong>\n <\/p>\n

\n Investors on behalf of Dar\u00e9 Bioscience, Inc.:<\/strong>
\n
Lee Roth
Burns McClellan
lroth@burnsmc.com
646.930.4406\u00a0<\/p>\n

OR<\/p>\n

\n Media on behalf of Dar\u00e9 Bioscience, Inc.:<\/strong>
\n
Jake Robison
Evoke Canale
jake.robison@evokegroup.com
619.849.5383<\/p>\n

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


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Dar\u00e9 to receive $1 million in July 2023 and $181.8 million in potential milestone payments from Organon\u00a0under XACIATO global license agreement\u00a0 SAN DIEGO, July 05, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, today reaffirmed its commitment to the commercial launch of XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% with collaborator Organon (NYSE: OGN), and announced that Organon will pay Dar\u00e9 $1.0 million in July 2023. \u201cWe believe Organon\u2019s commercial capabilities and track record of success in the branded women\u2019s health category will help ensure a successful introduction of XACIATO in the United States and, ultimately, that XACIATO reaches the global population of women suffering from bacterial vaginosis, which is estimated to impact … <\/p>\n

Continue reading “Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis”<\/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-767701","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis - 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-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Dar\u00e9 to receive $1 million in July 2023 and $181.8 million in potential milestone payments from Organon\u00a0under XACIATO global license agreement\u00a0 SAN DIEGO, July 05, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, today reaffirmed its commitment to the commercial launch of XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% with collaborator Organon (NYSE: OGN), and announced that Organon will pay Dar\u00e9 $1.0 million in July 2023. \u201cWe believe Organon\u2019s commercial capabilities and track record of success in the branded women\u2019s health category will help ensure a successful introduction of XACIATO in the United States and, ultimately, that XACIATO reaches the global population of women suffering from bacterial vaginosis, which is estimated to impact … Continue reading "Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-07-05T12:31:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2OTE3NyM1Njc3MTgxIzIwMDgzNjQ=\" \/>\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=\"7 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-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis\",\"datePublished\":\"2023-07-05T12:31:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\\\/\"},\"wordCount\":1434,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODg2OTE3NyM1Njc3MTgxIzIwMDgzNjQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\\\/\",\"name\":\"Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis - 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(NASDAQ: DARE), a leader in women\u2019s health innovation, today reaffirmed its commitment to the commercial launch of XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% with collaborator Organon (NYSE: OGN), and announced that Organon will pay Dar\u00e9 $1.0 million in July 2023. \u201cWe believe Organon\u2019s commercial capabilities and track record of success in the branded women\u2019s health category will help ensure a successful introduction of XACIATO in the United States and, ultimately, that XACIATO reaches the global population of women suffering from bacterial vaginosis, which is estimated to impact … Continue reading \"Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/","og_site_name":"Market Newsdesk","article_published_time":"2023-07-05T12:31:06+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2OTE3NyM1Njc3MTgxIzIwMDgzNjQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis","datePublished":"2023-07-05T12:31:06+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/"},"wordCount":1434,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2OTE3NyM1Njc3MTgxIzIwMDgzNjQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-provides-update-on-activities-to-support-commercial-launch-of-xaciato-clindamycin-phosphate-vaginal-gel-2-fda-approved-treatment-for-females-12-and-older-with-bacterial-va\/","name":"Dar\u00e9 Bioscience Provides Update on Activities to Support Commercial Launch of XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2%, FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis - 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