Vaginas are complex, self-regulating organs that use acidity levels to keep out infection—at least for most women. Those who frequently suffer sexually transmitted infections like gonorrhea, chlamydia, or bacterial vaginosis, however, have to rely on antibiotics to stay healthy. However, antibiotics tend to strip out both the good and bad bacteria, making one’s vagina more vulnerable to future infection. Bacteria has also gotten more resistant to antibiotics, leaving women with even fewer treatment options when they get sick.
None of this is good news. But a recently released study offers a bright spot. It indicates that when vaginal ecology is in harmony, it naturally protects against chlamydia.
A new bioscience company called LUCA Biologics wants to harness that strength. It’s currently developing a series of therapeutics that creates a healthy vaginal microbiome as a way of preventing disease. The first product the company is working on is a treatment for urinary tract infections [UTI] that increases a certain type of bacteria in the vagina in order to create an environment that’s more resistant to infection. The approach is similar in concept to eating yogurt to create a healthy gut.
This is not a solution to a rare problem. Half of all women in the U.S. will get a UTI at some point in their lives, according to the Department of Health and Human Services. UTIs account for roughly six million annual visits to the doctor. While there are treatments available for UTIs, there’s no prevention.
“It’s really a testament to how underserved the community feels and how far behind the science is when the best recommendation that doctors and the medical community have is to remind women to wipe from front to back,” says Raja Dhir, cofounder and chairman of LUCA. “Honestly, that’s a little—it’s appalling, right?”
Women first, finally
LUCA is one of several companies developing new therapies for women that deal with some of their most persistent issues through medicines with fewer side effects. In the #MeToo era, women have put on their power suits and taken center stage to talk about the most pervasive social structures that have been holding them back. Now the spotlight is turning to those in the medical and bioscience community who are making women’s health a priority.
This year a public company called Evofem Biosciences, which is developing a nonhormonal birth control gel, signed a securities deal with PDL BioPharma for up to $80 million in financing. PDL BioPharma was once a high-flying drug company until several of its key patents for cancer drugs expired. Evofem has sold PDL 6.6 million per shares of stock at $4.50 per share—well above its current share price. The company’s drug, Amphora, is set to launch in 2020. It’s a gel that women apply up to an hour before they have sex. It’s supposedly leak-resistant and has the added bonus of providing lubrication.
“Women are more empowered than they’ve ever been,” says Saundra Pelletier, CEO of Evofem. “We think it’s about time that a company truly stepped into clinical innovation just focused on women because we know that women are the healthcare decision makers.” Pelletier is referring to a 2015 industry research survey that found that 94% of working moms make healthcare decisions for themselves and others.
Despite women being major consumers of health products, there has been little innovation into prescribed women’s health products over the past 20 years. For TherapeuticsMD, which was cofounded in 2008 by gynecologist Brian Bernick and former medical device sales executive Rob Finizio, the dearth of investment in women’s health looked like an opportunity. “What I saw was massive growing markets with an aging demographic with almost no investment in products since— God—the early 2000s?” says Finizio, the company’s CEO. He notes that the majority of investment and innovation in this space happened in the three decades preceding the new millennium. TherapeuticsMD makes three products, all of which were approved by the Food and Drug Administration last year, including birth control, a lubricant for menopausal women who experience pain during sex, and a treatment for hot flashes.
Women’s health is expected to be a $50 billion market by 2025 worldwide, according to CBInsights. As of the second quarter of 2019, venture-backed companies in this arena had raised $500 million. Much of the early investment in the field has gone into so-called fem tech: apps and direct-to-consumer services that deliver better care for women. Fertility technology and marketplaces that deliver everything from birth control to retinol have gotten the lion’s share of the attention.
In this year alone, Pill Club, a platform that both prescribes and fills birth control orders, raised $51 million; Modern Fertility, an at-home fertility test, raised $15 million; Ro, parent company to women’s menopause relief brand Rory, raised $90 million; and Tia, a women’s health-focused app, launched its first clinic to address women’s health in a more holistic way.
Less talked about are the new drug therapies for women’s health issues. In 2017, GlaxoSmithKline released a U.K. based spinoff of a spinoff called KaNDy Therapeutics to research the use of a potential new drug on the effects of menopause symptoms. That same year, ObsEva, a Merck Ventures-backed company that makes therapeutics for complications that arise prior to giving birth, went public, raising $97 million in the process. Last year, AbbVie garnered approval for its endometriosis related pain reliever.
Part of the reason for the interest in women’s health is a new focus on value-based care, says LUCA Biologics CEO Luba Greenwood. “The health insurers are saying to pharma and biotech companies that we’re not going to reimburse these medications that are actually causing adverse events and not improving outcomes for women,” she says.
In the past decade, insurers have been moving away from fee-for-service and investing in value-based care models. Under that structure, health insurers pay health providers a monthly fee per patient to treat illness and keep patients healthy. Doctors are pressed to make cost-effective choices for their patients and reconsider prescribing medications that have more side effects and worse health outcomes than a competing treatment.
These dynamics are creating a competitive landscape for bioscience companies that are putting women’s health and comfort first. “The number one reason that women stop hormonal contraception is because of side effects, whether it’s weight gain or bleeding, or headaches, or they just don’t feel like themselves,” says Evofem’s Pelletier. She says, that gives her company a potential advantage in the market as a nonhormonal option.
Part of what has made way for newcomers like Pelletier is that larger drug development companies have found that it’s more profitable to generate drugs that sell for big money, even if in small quantities. “The market has shifted to high-cost, low-volume products on Wall Street that are getting funded,” says Finizio, adding that big companies are not going to make some of these more cost-effective therapeutics, because it doesn’t pay for them to do so. But for the entrepreneurial set, developing new low-cost therapies has become ripe territory to refresh outdated products that have not served women well.