Christine Mauck, Daré Bio’s medical director, said other products that had similar results in such studies went on to show effectiveness rates of 86 percent to 91 percent over six months when used “typically”—the same range as currently available hormonal methods.
The company plans to use the data to support an FDA filing. If OK’d, it plans to conduct a pivotal trial testing Ovaprene in the second half of 2020.
Other biopharmas are also busy advancing new contraceptive options, including Evofem (NASDAQ: [[ticker:EVFM]]), which has said it will submit its nonhormonal birth control gel, Amphora, to the FDA for review this quarter. In anticipation of approval, the company has been building out a commercial infrastructure.
Daré Bio, in contrast, intends to acquire and advance the development of innovative women’s healthcare products far enough to interest a partner in carrying it through to commercialization. Johnson has positioned the company to take advantage of a disconnect she identified between innovation in the field and potential strategic acquirers of novel therapies for women.
The landscape for women’s health has shifted in recent years as some pharma companies have unloaded their units focused on the sector. Teva Pharmaceutical (NYSE: [[ticker:TEVA]]) last year sold its remaining women’s health assets, including Paragard, a nonhormonal IUD. Botox maker Allergan (NYSE: [[ticker:AGN]]) also announced plans in 2018 to sell its women’s health unit, but reversed the decision earlier this year.
Like Merck, Bayer also has a presence in women’s health: Its Mirena family of IUD products contributed $1.1 billion in revenue in 2018.
Other products Daré Bio is advancing, and aiming to find a partner for down the line, include a one-time gel treatment for bacterial vaginosis, the most common vaginal infection among women of reproductive age, which is typically addressed with oral antibiotics; and a cream formulation of sildenafil—the active ingredient in Pfizer (NYSE: [[ticker:PFE]]) erectile dysfunction pill Viagra—to treat female sexual arousal disorder.
Cheryl Blanchard, Microchips’ CEO and president, will join the Daré Bio board of directors as part of the deal. The San Diego company will also add some big names in healthcare and VC to its list of shareholders: Under the agreement, in exchange for the cash balance of about $6.9 million Microchips has on its books, Daré Bio will issue 3 million shares of stock to Microchips investors, including Polaris, Metronic, Intersouth Partners, Flybridge Capital Partners, InterWest Partners, and Teva.
