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.
"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."
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.
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).