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Daré Bioscience Announces Closing of Global License Agreement with Organon to Commercialize XACIATO™ (clindamycin phosphate vaginal gel, 2%), FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis
Daré will receive a $10 million upfront payment from Organon An estimated 21 million American women experience bacterial vaginosis SAN DIEGO, June 30, 2022
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Daré will receive a $10 million upfront payment from Organon An estimated 21 million American women experience bacterial vaginosis SAN DIEGO, June 30, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the exclusive license agreement entered into on March 31, 2022 with Organon (NYSE: OGN), a global women’s healthcare company, has become fully effective. Under the agreement, Organon licensed global rights to XACIATO (clindamycin phosphate vaginal gel, 2%), an FDA-approved medication for the treatment of bacterial vaginosis in females 12 years of age and older. XACIATO received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis. In connection with the closing, Daré will receive a $10 million upfront payment from Organon. Daré is eligible to receive potential milestone payments of up to $182.5 million and tiered double-digit royalties based on net sales. XACIATO is expected to be available commercially in the U.S. in Q4 2022. “Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S.,” said Sabrina Martucci Johnson, President and CEO of Daré. “The Daré team identified bacterial vaginosis as an area in need of new treatment options. We are thrilled to be collaborating with Organon, one of the premier companies in women’s health, as we believe Organon’s commercial capabilities will ensure that XACIATO reaches the women most impacted by this condition.” About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s 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, fertility, and vaginal and sexual health. Daré’s first FDA-approved product, XACIATO™ (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 intrava...