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Daré Bioscience Announces Achievement of First Commercial Milestone Under License Agreement for XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2%, FDA-Approved Treatment for Bacterial Vaginosis in Females 12 Years or Older
Daré to receive $1.8 million payment; eligible for additional potential milestone payments of up to $180 million and tiered double-digit royalties based on
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Daré to receive $1.8 million payment; eligible for additional potential milestone payments of up to $180 million and tiered double-digit royalties based on net sales\nSAN DIEGO, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the first shipment of XACIATOTM [pronounced zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% in connection with the first commercial sale of the product in the United States, triggering a $1.8 million milestone payment to Daré under its global license agreement with Organon. “This is a major achievement for Daré Bioscience, proving our ability to accelerate the development of much-needed, innovative medicines for women,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “In less than five years since licensing the technology, we advanced a pivotal clinical trial, gained U.S. Food and Drug Administration approval, and ensured supply to support the launch of XACIATO. We look forward to our continued collaboration with Organon and its established sales force to offer this important treatment for bacterial vaginosis in females 12 years or older.” The New Drug Application 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). Daré and Organon entered into a global exclusive license agreement for XACIATO in March 2022. Daré received a $10.0 million upfront payment after the license agreement became effective and a $1.0 million payment in July 2023. In addition to the $1.8 million milestone payment, Daré is eligible to receive potential future milestone payments of up to $180 million and tiered double-digit royalties based on net sales. About Bacterial Vaginosis Bacterial vaginosis is the most common vaginal condition in women of reproductive age in the United States. The condition results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor or discharge. Bacterial vaginosis may self-resolve in up to 30% of women, but most symptomatic women require treatment. If left untreated, bacterial vaginosis may lead to serious complications. Bacte...