Daré to Add Microchip-Based Birth Control to Women’s Health Portfolio

Xconomy San Diego — 

The list of activities our smartphones can control grows daily. Transfer money? It’s simple. Order groceries? That, too. Turn off the bedroom lights? Check.

How about contraception?

Advancing new forms of birth control is a central focus at Daré Bioscience (NASDAQ: DARE), a San Diego-based biopharma company that’s built a pipeline of experimental devices and treatments tailored for women’s health.

This week it announced plans to add another contraceptive contender to its lineup with an agreement to acquire Microchips Biotech, an MIT spinout that—with the backing of the Bill & Melinda Gates Foundation and others—has been working to design an implant for drug delivery that could be controlled wirelessly.

Co-founded by researchers Bob Langer and Michael Cima, the company has received nearly $18 million from the Gates Foundation to design a microchip-based implant for the purposes of birth control. (It’s eligible for up to $2.5 million more next year from the organization to further the program, according to Daré Bio.)

Backed by venture investors, too, including Polaris Partners and Medtronic, Microchips also worked on applications for other conditions for which care involves regular injections or frequent dosing; it has vetted the tech in patients with osteoporosis.

In recent years Daré Bio CEO Sabrina Martucci Johnson (pictured above) and her team have been watching the work being done at Microchips as it relates to women’s contraception, she told Xconomy in a phone interview.

As envisioned by Microchips, the contraceptive implant would be gridded with tiny compartments, each containing a small dose of medication—in this case, the hormone levonorgestrel—to be released on a predetermined schedule.

Patients would be able to halt and resume the dosing regimen as needed. That would give the product an advantage over existing methods of contraception because of the increased control it would give for family planning purposes, Johnson says.

“It gives the woman the opportunity to have an effective, long-acting, reversible contraceptive for a meaningful period of time that she chooses, but also gives her a very straight-forward ability to reverse it on demand,” she says. “All you’re basically doing is controlling whether those reservoirs open and release product, or whether they stay closed and don’t release anything, and that’s not something you’re able to do right now with any of the current implant technologies.”

The only way to reverse the contraceptive protection provided by implants and intrauterine devices (IUDs) today is to have them removed in a physician’s office. Often, however, families are interested in a temporary break in birth control, rather than a permanent one. That means some patients end up having to return to their doctor to get a new implant or IUD.

Long-acting reversible contraceptives, a category that includes hormonal implants that go under the skin and IUDs, have been around for decades. But their use increased nearly five-fold among women ages 15 to 44 in the decade that started in 2002, from 1.5 percent that year to 7.2 percent in 2011-2013, according to a Centers for Disease Control and Prevention survey.

Nearly all women use some form of contraception in their lifetime, and 65 percent in the US were doing so from 2015 to 2017, according to the CDC. But the most popular hormonal method in many countries, daily oral contraceptives, is easy to forget, and can cause unpleasant side effects.

Daré Bio is also advancing a nonhormonal contraceptive called Ovaprene, a monthly contraceptive device. The product, a flexible piece of plastic inserted into the vagina by its user, is the same size and shape as NuvaRing, a monthly hormonal contraceptive device from Merck (NYSE: MRK) that pulled in $902 million in revenue last year. (The pharma company’s other contraceptive product, an implant that releases hormones, brought in $703 million that year.)

Instead of using hormones, the Ovaprene ring was designed to prevent pregnancy with a knitted mesh-like barrier and a compound called ferrous gluconate, both of which interfere with the forward motion of sperm cells.

Daré Bio recently tested the device with about 25 women in what’s called a post-coital study, and reported that it met its goal of blocking almost all sperm from entering the cervical canal—a surrogate marker for contraceptive effectiveness. (The women who participated in the study had previously undergone tubal ligations, so they weren’t at risk of pregnancy.)

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: 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: TEVA) last year sold its remaining women’s health assets, including Paragard, a nonhormonal IUD. Botox maker Allergan (NYSE: 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: 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.