The company prioritizes unmet needs for women in contraception, fertility, and vaginal and sexual health.
Sabrina Martucci Johnson never planned on being a founder and CEO of a women’s healthcare company, but after identifying gaps in women's healthcare, she asked herself, “If not me, then who?"
"I'm not one of those people who always wanted to be a CEO," she says. "But I had a light bulb moment: if I don't do this, it's not going to happen."
Over the years, Johnson had always championed for women in her volunteer and charity work, supporting philanthropic activities surrounding STEM education for women, domestic violence awareness, and women's healthcare issues.
On the professional side, Johnson spent her entire career in the drug development industry, in a variety of roles. She began as a research scientist with Baxter Healthcare and went on to hold marketing and sales positions there.
Later, she held C-suite positions, including CEO, CFO and COO at WomanCare Global Trading, a specialty pharmaceutical company in female reproductive healthcare, and before that she served as CFO of Cypress Bioscience, a publicly traded pharmaceutical company.
"I felt there should be a way to match my extracurricular passion with what I do professionally," Johnson says. "There are all these needs of women that are not being met. So, I put my money where my mouth is, and started Daré Bioscience in 2015.
"In addition to aligning her life goals and working toward filling unmet needs for women, Johnson saw the business sense of investing in women's health. Market research shows that only approximately 1% of healthcare research is invested in female-specific conditions beyond oncology, and women’s health conditions outside of oncology comprise less than 2% of the current healthcare pipeline.
Yet, women’s health products outside of oncology make up 27% of the total number of blockbuster products (products that each have over $500 million in annual sales) and contribute 35% of the total sales dollars generated by blockbuster products. "This is why investment in women’s health is efficient and impactful in terms of translating dollars invested in R&D to ultimate revenue generated, and therefore, not only good for 50% of the population, but it is also a good business model," she says.
The company prioritizes unmet needs for women in contraception, fertility, and vaginal and sexual health. Daré’s first FDA-approved product, Xaciato, is a vaginal gel for the treatment of bacterial vaginosis in female patients 12 years 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 U.S. commercial rights are under a license agreement with Bayer; Sildenafil cream, 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. There are currently no FDA-approved products that continuously deliver this type of hormone therapy with both estradiol and progesterone together.
"It was a little bit shocking that there was no FDA approved product that met the guidelines that the medical experts in the space recommend for hormone therapy, which is the need that the two hormones be administered together," Johnson says. "When we started the company, this is why hormone therapy for menopause was high on our list."
DARE-HRT1 could become the first FDA-approved monthly intravaginal ring delivering such therapy. Due to its positive early phase results, the company has been cleared by the FDA to advance directly to Phase 3.
Johnson said that even though it was out of the ordinary, the company decided to ask the FDA if it would consider allowing them to go straight to Phase 3 trials.
"After the trial results we started discussions with the FDA to propose that we just go right to a single Phase 3 so that we can get this product moving forward and into the market to women," she says.
The trail blazer didn't think it was much of risk to take the request to the FDA, as long as they could pass the 'red face' test, meaning they had justification for asking and the ability to prove it. This was a case of 'you never know until you ask', she says.
"We made an ask that wasn't the normal path, but we scientifically could justify it," she says.
"If you can scientifically make a case for something, there is room to color outside the lines, and DARE-HRT1 is a great example of that."
If the FDA denied the request, Johnson reasoned, Daré would be in the same place as if it didn't ask. But surprisingly, the FDA said yes.
"We were really pleasantly surprised that the FDA came back and said yeah, that's reasonable," Johnson says. "Now we have a lot of work to do to get ready, beginning with formally filing the IND."
Currently, Daré's portfolio only contains products that aim to deliver drugs in a way that's never been delivered before and pushing the envelope on indications that haven't been studied before. Thinking outside the box this way is the company's credo and striving to be first in these areas is not without challenges.
"We are all about the firsts, and firsts are hard," she says, "It's challenging but it's such an incredible opportunity. And I would also say, in the same breath, it's the most fun program to work on in our portfolio because while it's hard to be first, it is also fun to be first and to get to set the stage and blaze the trail."
For example, the company is developing a cream formulation of sildenafil --the same active ingredient in Viagra--for women with female sexual arousal disorder. There's nothing approved for this indication. "We are really blazing a trail getting all the work that goes into a brand-new indication: getting the alignment on what to study, what are the endpoints. Like how to design a clinical trial for this, for starters."
Johnson keeps the company focusing on firsts by creating opportunities for employees to be free and open with brainstorming new ideas and solutions. It is cliché, Johnson says, but to her, there really is no bad idea or dumb question that employees can pose.
"I try really hard to be a very authentic leader," Johnson says. "I have a very authentic style and create very much a culture of dare to be different and be bold. Let's push the envelope. It's okay to suggest something that hasn't been done before. It's okay to put those ideas out there. I very much try to create a culture of 'let's think outside the box and be aggressive.'"
“I had an opportunity to make a difference and I did it. ”
Sabrina Martucci Johnson, CEO / founder, Daré Bioscience
Robin Robinson is a contributing writer for HealthLeaders.
In January, Daré Bioscience announced topline PK results from its Phase 1 / 2 clinical trial of DARE-HRT1, an estradiol and progesterone intravaginal ring for hormone therapy.
Also in January, Daré requested the FDA to allow DARE-HRT1 to advance into single Phase 3 efficacy trial .
Johnson founded Daré based on business sense and a passion for women's health needs.