Organon and Daré Bioscience announced they have entered into an agreement whereby Organon will license global rights to Xaciato (clindamycin phosphate vaginal gel, 2%). Xaciato is an FDA-approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older. It received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis.

“Our agreement with Daré aligns well with our long-term growth strategy focused on delivering new options for women where therapeutic gaps exist,” said Kevin Ali, Organon’s Chief Executive Officer. “Organon will bring its commercial expertise to this collaboration so that we can deliver this option to women, specifically in a condition like bacterial vaginosis where more treatment choices are needed.”

BV is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S. The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge.

Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer, commented, “Organon shares our commitment to advance critically needed innovations in women’s health. We are excited to be collaborating with one of the premier companies in women’s health as we believe that Organon’s commercial capabilities will ensure that Xaciato reaches the women most impacted by this condition.”

Daré will receive a US $10 million upfront payment from Organon. Daré is eligible to receive potential milestone payments of up to US $ 182.5 million and tiered double-digit royalties based on net sales. Xacatio is expected to be available commercially in the U.S. in Q4 2022. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in Q2 2022.