San Diego’s Daré Bioscience (NASDAQ: DARE) announced it achieved milestone positive results from a study evaluating the effects of a targeted female sexual arousal cream made with sildenafil, the generic form of erectile dysfunction (ED) medication Viagra. Details were shared in the company’s second quarter 2023 financial results which went public this month.
“Sildenafil Cream, 3.6% is an investigational proprietary topical formulation of sildenafil being developed as a potential first-in-category treatment for sexual arousal disorder in women. There are no FDA-approved treatments for any form of arousal disorder in women,” President & CEO Sabrina Martucci Johnson said. “The group receiving Sildenafil Cream in the [study] demonstrated improvements in arousal lubrication, orgasm and sexual desire, which persisted through the end of study assessment.”
The biopharma company name comes from the Italian word “dare” which means “to give.” In English, it means “to be bold.” Its researchers have been working steadily on accelerating innovations to address a myriad of women’s health concerns, including arousal disorder.
“It’s a condition in women that is as prevalent as ED is in men. Specifically, market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing no or low sexual arousal, and are actively seeking solutions to improve their condition. In comparison, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70,” she added.
Daré plans to change that.
“For context, Pfizer secured an FDA approval for Viagra in 1998 and March 2023 marked the 25th year since Viagra was first approved” Martucci Johnson said.” In the intervening years, there have been no FDA approvals for the treatment of [female sexual arousal and interest disorders]. Viagra sales peaked at $2 billion in 2012.”
Pre-Term Birth Prevention
In another move to empower women’s healthcare needs, the company announced in July that it was awarded a federal grant to support the development of potential new therapeutics to prevent pre-term births. The $385,000 award comes from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH). Daré plans to collaborate with the nonprofit University of South Florida Research Foundation to find novel solutions to prevent and treat pre-term births.
It’s widely known that premature babies often suffer from serious health issues.
“These problems can vary in severity and the earlier a baby is born, the higher the risk of health-related complications, including difficulty maintaining normal body temperature, difficulty breathing or feeding, and susceptibility to severe infections and brain disorders,” Martucci Johnson said.
For more than a decade, Makena was the only drug available that was aimed at preventing preterm birth, but it was voluntarily pulled off the market this year after the FDA expressed reservations about whether it was effective.
“Since the removal of the only FDA-approved product indicated to reduce the risk of preterm birth in women with a history of history of spontaneous preterm birth, this area has re-emerged as an area of great unmet need,” she explained. “We view this grant as an acknowledgment that more innovation is required, and we are honored that the NICHD is funding this important collaboration.”
More Product Developments
Aside from its efforts to prevent premature birth, Daré is actively working with commercial collaborator Organon to achieve a 2023 launch of its FDA-approved XACIATOTM, a gel to treat bacterial vaginosis.
In Daré’s second quarterly earnings report, Martucci Johnson stated that the company is anticipating its first commercial sale of XACIATO, triggering a $1.8 million milestone payment from Organon. Daré received a $10 million upfront payment from Organon when the two companies entered into the commercial license agreement in March 2022. Daré is eligible to receive potential milestone payments of up to $182.5 million and tiered double-digit royalties based on net sales.
Daré is also expecting to soon enroll subjects in the third phase of its study on Ovaprene®, an investigational hormone-free monthly intravaginal contraceptive. U.S. commercial rights are under a license agreement with Bayer. In that agreement, which the two companies entered into in 2020, Daré may be entitled to up to $310 million in commercial milestone payments plus tiered royalties on net sales in the double-digits.
Also later this year, Daré expects to announce the topline findings from its Phase 1 trial of DARE-PDM1 – a new development program targeted at treating primary dysmenorrhea (better known as menstrual cramps and pain) by delivering the nonsteroidal anti-inflammatory drug diclofenac in a novel way. Prevalence rates of dysmenorrhea vary but range from 50% to 90%. Recent market research suggests that the global market for dysmenorrhea treatment was valued at $13 billion in 2022 and is expected to increase to $28.5 billion by 2029, Martucci Johnson said.
“We are working to identify and advance new therapies that provide additional choices and improve outcomes so that we can make a difference in the lives of women everywhere,” she added.
FOUNDED: 2015 as Daré Bioscience Operations
PRESIDENT & CEO: Sabrina Martucci Johnson
HEADQUARTERS: La Jolla
STOCK: DARE (NASDAQ)
REVENUE: $10 million (FY 2022)
NOTABLE: President & CEO Sabrina Martucci Johnson was named one of FiercePharma’s Most Influential People in Biopharma in 2023.