Daré Bioscience Announces Achievement of First Commercial Milestone Under License Agreement for XACIATO

Daré Bioscience, Inc. recently announced the first shipment of XACIATO [pronounced zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% in connection with the first commercial sale of the product in the US, 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 5 years since licensing the technology, we advanced a pivotal clinical trial, gained US FDA 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-million upfront payment after the license agreement became effective and a $1-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.

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. Bacterial vaginosis has also been shown to disproportionately affect non-Hispanic Black and Mexican American women.

XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose user-filled disposable applicator delivers 5 g of vaginal gel containing 100 mg of clindamycin.

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, vaginal health, reproductive health, menopause, sexual health and fertility.

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. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose US commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder (FSAD) and/or female sexual interest/arousal disorder (FSIAD) utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. For more information, visit www.darebioscience.com.