Daré Bioscience launched in 2015 with the aim of assembling a portfolio of novel women’s health products intended to pique interest from major pharmaceutical companies.
Now the San Diego-based company has inked its first deal with Big Pharma, signing an agreement with German biopharma Bayer for its lead asset, a monthly non-hormonal form of birth control. Under terms announced Monday, Bayer will pay Daré an undisclosed upfront sum to secure the right to license its experimental contraceptive, Ovaprene, for US commercialization.
Daré (NASDAQ: DARE) this year plans to conduct a pivotal trial of Ovaprene, an insertable ring that uses a compound called ferrous gluconate and a physical barrier to prevent pregnancy. If Ovaprene does receive FDA approval, Bayer will have the right to pay Daré $20 million more to obtain an exclusive license to commercialize the prescription product in the US. (Daré plans to use the money to cover the costs of the clinical study.)
In November Daré reported data from a study of the contraceptive that it said it would use to support an FDA filing. It plans to ask the agency for its OK to test the product this year. If approved, Ovaprene could become the first monthly non-hormonal contraceptive product.
For Daré CEO Sabrina Martucci Johnson, the deal is validation of the thesis around which she started the company—that there was innovation happening in women’s health, but that potential new products were stalling out along the traditional route from research and development to commercialization.
“It really is proof of the model, that there is a commercial party interested, that they are looking for someone like us to do development, and they are looking for true innovation,” she said in an interview. “As long as we deliver it up, they’re ready to take it.”
Martucci Johnson said she considered Bayer a potential partner for Ovaprene since the start of Daré given the German company’s history in investing in women’s health products.
“We really felt it had to have a commercial partner who has shown they can build a novel brand from scratch,” she said. “Frankly, in the contraceptive category, Bayer is the only company that has built a [more than] $1 billion brand, which they did with the Mirena [the first hormonal interuterine device] family.”
If all goes according to plan, Ovaprene will launch in 2023.
The deal could garner Daré up to $310 million in payments tied to commercial milestones, plus royalties on net sales. The news boosted the company’s shares out of penny stock territory, from 84 cents per share as of market close Friday to $1.65 apiece Monday.
Daré is also advancing a cream to treat female sexual arousal disorder; a single-application treatment for bacterial vaginosis; and an intravaginal ring for hormone replacement therapy following menopause.
Oral contraceptives (or “the pill”), one of the common methods of contraception used today, use hormones to block pregnancy. Marianne De Backer, who joined Bayer in September to head business development and licensing for its pharmaceutical division, said there is demand among a subset of women for a non-hormonal birth control option.
“Younger women tend to prefer these kinds of contraceptives, so we have been scanning the market for an opportunity in this space,” she said in an interview.
Its the third deal Bayer has made recently that relates to women’s health.
Last week the pharma firm announced it had expanded its collaboration with another German company, Evotec, with a new five-year, multi-target collaboration focused on treating polycystic ovary syndrome, one of the most common causes of infertility. In November, Bayer announced it was teaming up with Dewpoint Therapeutics on a research agreement to find out if Dewpoint’s work on biomolecular condensates and Bayer’s library of small molecules could yield new drugs for cardiovascular and gynecological diseases.