Daré Bioscience Announces Global Licensing Rights to Novel Antimicrobial Glycerol Monolaurate for Vaginal Health

Daré Bioscience, Inc. recently announced it has entered into a license agreement with Hennepin Life Sciences LLC under which Daré acquired the exclusive global rights to develop and commercialize treatments delivering the novel antimicrobial glycerol monolaurate (GML) intravaginally for a variety of vaginal health conditions, including bacterial, fungal, and viral infections.

GML is a naturally occurring fatty acid monoester that has shown broad antimicrobial activity, killing bacteria, fungi and viruses and importantly, represents a new class of antimicrobial agents. Additionally, due to its mechanism of action, GML has shown low potential for the development of antibiotic resistance. In vitro testing has shown GML to be effective at inhibiting growth of the major strains of Candida causing vulvovaginal candidiasis (VVC), as well as Gardnerella vaginalis, the primary bacteria associated with bacterial vaginosis. Furthermore, a randomized, double-blind pilot study investigating the effects of GML on vaginal microflora in colonized or infected women showed reductions in Candida and Gardnerella vaginalis while not altering the healthy Lactoacillus bacterium or vaginal pH.

“Vaginal health conditions, particularly infections such as bacterial vaginosis and VVC, which is second only to bacterial vaginosis as the reason women seek gynecological care, remain prevalent and serious problems that can negatively impact a woman’s quality of life and create economic burden for women, employers, and the broader healthcare system. Women impacted by these conditions may have multiple episodes in a year, and treatments for one condition may increase the likelihood of developing another condition. We believe that an antimicrobial providing a broad spectrum of activity against bacteria and fungi, but with a low potential for developing resistance, represents a unique multi-target development candidate for our portfolio. GML could both delay recurrence following an effective primary treatment of an episode, as well as mitigate common side effects of the primary treatment,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “As a company, we are committed to addressing unmet needs in women’s health, including enhancing treatment options for vaginal health conditions. Earlier this year, Organon, a global women’s healthcare company, and Daré entered into a global license agreement to commercialize Daré’s XACIATO (clindamycin phosphate) vaginal gel, 2% for the treatment of bacterial vaginosis in female patients 12 years of age and older.”

Under the agreement with Hennepin, Daré received an exclusive, worldwide, royalty-bearing license to research, develop and commercialize the licensed technology. Daré agreed to make potential future milestone payments through the term of the license based on clinical, regulatory, and commercial events, and to pay royalties based on commercial sales. Patents covering the licensed technology have been granted with terms through 2034 and additional patents pending would have terms through 2040.

Founded in 2009 from a technology transfer out of the University of Minnesota, Hennepin Life Sciences LLC is a private, development stage human health company that is uniquely focused on the development of patent-protected, novel, naturally derived anti-infective compounds for the prevention and treatment of a wide array of infections. Hennepin Life Sciences has created innovative nature-based therapies by applying molecular concepts of infection to clinical applications.

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 intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly 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 utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. For more information, visit www.darebioscience.com.