Daré Bioscience Provides Update On Activities To Support Commercial Launch Of XACIATO Vaginal Gel, 2%, FDA-Approved Treatment For Females 12 And Older With Bacterial Vaginosis, And Announced That Organon Will Pay Daré $1M In July 2023
Daré Bioscience Provides Update On Activities To Support Commercial Launch Of XACIATO Vaginal Gel, 2%, FDA-Approved Treatment For Females 12 And Older With Bacterial Vaginosis, And Announced That Organon Will Pay Daré $1M In July 2023
Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's 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 Daré $1.0 million in July 2023.
女性健康創新的領導者Daré Bioscience, Inc.（納斯達克股票代碼：DARE）今天重申了其對與合作者Organon（紐約證券交易所代碼：OGN）商業推出XACIATO [zah-she-ah-toe]（磷酸克林黴素）****凝膠的承諾，並宣佈Organon將在2023年7月向Dare支付100萬美元。
"We believe Organon's commercial capabilities and track record of success in the branded women's 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," said Sabrina Martucci Johnson, President and CEO of Daré. "Daré 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 Daré 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's sales team, which is the same sales team that helped drive the market acceptance and record sales of NEXPLANON, coupled with Organon's payer outreach and provider and patient-centered initiatives, and we look forward to the launch later this year."
達瑞總裁兼首席執行官薩布麗娜·馬圖奇·約翰遜說：“我們相信，Organon的商業能力和在品牌女性健康領域的成功記錄將有助於確保XACIATO在美國成功推出，並最終使XACIATO覆蓋全球細菌性****病的女性人羣，據估計，細菌性****病將影響全球23％至29％的女性。”“Dare 已經完成了支持商業發佈所需的製造驗證活動。爲了提供持續的供應以支持強勁的商業發射，正在開展更多與製造相關的活動，Organon和Dare正在努力盡快在2023年在美國發射。我們相信，鑑於Organon銷售團隊的知識和經驗，XACIATO將完全有能力取得商業成功，該團隊幫助推動了NEXPLANON的市場接受度和創紀錄的銷售額，再加上Organon的付款人拓展以及以患者爲中心的計劃，我們期待在今年晚些時候推出。”
Under the amended license agreement between Daré and Organon for XACIATO, Organon will pay Daré $1.0 million in July 2023 and will pay Daré $1.8 million upon the first commercial sale of XACIATO. In 2022, Daré 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, Daré 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.
根據Dare和Organon之間修訂的XACIATO許可協議，Organon將在2023年7月向Dare支付100萬美元，並將在首次商業出售XACIATO時向Dare支付180萬美元。2022年，許可協議生效後，Dare收到了Organon的1000萬美元預付款。除了預付款和上述280萬美元外，Dare還有資格獲得高達1.8億美元的額外潛在未來里程碑付款，以及基於淨銷售額的兩位數分級特許權使用費。
As Daré previously shared, 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).
正如Dare之前分享的那樣，XACIATO的新藥申請（NDA）得到了評估XACIATO（前身爲 DARE-BV1）治療細菌性****炎（NCT04370548）的DARE-BVFREE3期隨機、多中心、雙盲、安慰劑對照臨床試驗的積極結果的支持。
譯文內容由第三人軟體翻譯。