The CEOs of women's health companies have adopted innovative strategies to bring the male-dominated investor community to the table, including bringing male executives with them to meetings, finding parallels with conditions or situations that impact men, and, when the condition is too intimate, avoiding the details and skipping "right to the dollars and cents."
And once the products are ready for market, an uphill battle still awaits from a pool of doctors who are unused to innovation, and patients who are, for the most part, healthy.
On every step of the drug development journey, companies such as Daré Bioscience Inc. and Myovant Sciences Ltd. have to adjust their pitch for the next person who needs to get on board for the product to be successful.
"I anticipated the education, why women's health is important, and the complexities, frankly, of doing clinical study in women who are otherwise healthy," Daré CEO Sabrina Johnson said in an interview on the sidelines of the J.P. Morgan Healthcare Conference in San Francisco in early January. "But the piece I underestimated was just the awkwardness."
Bringing men to the table
Johnson and her industry peer Lynn Seely, Myovant President and CEO, see the multibillion-dollar potential of women's health products, from contraceptives to endometriosis treatments. Seely sees 2019 as a "historic year" to come for the Brisbane, Calif.-based company, with a Japanese drug approval pending and phase 3 data in several major programs expected.
But for women-led healthcare companies seeking therapies for conditions that affect women, the path to market is indicative of the gender diversity challenge in the industry as a whole. Getting investor dollars has sometimes meant some awkward conversations for Seely and Johnson, as Daré and Myovant have had to broach traditionally hush-hush subjects, often with male investors.
San Diego, Calif.-based Daré is focused on four therapeutic pillars: contraception, sexual health, fertility and pregnancy, and vaginal health. Johnson said Daré has sought to fill gaps in these areas and provide more choices for women — especially in contraception.
"It's a category where women have very specific needs, and their own personal lifestyle choices are a big driver," Johnson said.
Other therapy gaps Daré is looking to fill are in bacterial vaginosis, female sexual arousal disorder, and vulvar and vaginal atrophy in certain breast cancer patients.
Myovant is developing its GnRH antagonist, relugolix, to treat endometriosis and uterine fibroids. These conditions can cause serious, life-altering symptoms, with some cases resulting in surgical removal of the uterus. The company's partner Takeda Pharmaceutical Co. Ltd. has filed for Japanese approval for the product in uterine fibroids following two positive phase 3 trials. Relugolix, if approved, would be taken once daily in oral form, similar to the regimen of oral contraceptives.
Lynn Seely, president and CEO
Sabrina Johnson, president and
In order to keep conversations with investors moving on these therapeutic areas, Daré has in some instances reconsidered which team members to bring to investor meetings. Johnson said the company has found that having men on Daré's side of the table has helped investors see that "men can understand the opportunity … and see the potential."
Another strategy Johnson uses is finding parallels between women's conditions and men's conditions, such as female sexual arousal disorder and erectile dysfunction, and then, perhaps less obvious, condoms and Daré's non-hormonal contraceptive vaginal ring Ovaprene.
"Most of the guys on the other side of the table will have had some experience with a condom, can understand the inconvenience, and appreciate an option that [is] nonhormonal, not in the moment," Johnson said.
For conditions that may not have a clear parallel, such as bacterial vaginosis — "a really uncomfortable conversation" according to Johnson — she takes investors "right to the dollars and cents."
Investors also understand what Viagra is, which makes the conversation about Daré's female sexual arousal disorder treatment easier. The treatment adapts sildenafil, more commonly known as Viagra, in the form of an on-demand topical cream. Viagra was originally developed by Pfizer Inc. to alleviate erectile dysfunction in men.
The sildenafil product is part of the company's unusual approach of bucking the pharmaceutical industry trend towards new chemical entities for drug development, which Johnson says has contributed to the dearth of innovation in women's health. The company instead has turned to "enhancing" more familiar products.
Data gaps hamper research
A critical lack of data on women's health, which has hampered innovation, can also be traced to communication issues. National epidemiological and government surveys often do not include uterine fibroids, according to Seely. And the obstetrician-gynecologists who serve the women with these conditions "are not equipped to ask questions," she added.
Most of the data on these conditions is currently accrued from surgical specimens, meaning uteruses that have been removed through hysterectomies.
To gather that crucial data and avoid the awkwardness introduced by humans, Myovant is working with Flo Period Tracker, an app powered by artificial intelligence, to help educate women by allowing them to report how much bleeding and pain they experience during their periods. Myovant head of corporate strategy and advocacy Jarred Aguirre said the data has been a missing component in diagnosing conditions such as uterine fibroids and would play an integral role in educating women in what might be "normal" pain versus pain associated with uterine fibroids or endometriosis.
Data on heavy bleeding and pain will also help doctors determine what questions to ask their patients. According to Aguirre, physicians historically have not asked, for example, how many pads women use during their periods.
Another complication to developing therapies for women's health issues is the fact that the patients who have these conditions are otherwise healthy, Johnson said, and the first objective among doctors is to do no harm.
"It's really do no harm — solve their problem, but do no harm," Johnson said.
Once a therapy is approved, companies also face hurdles in trying to get their medicines adopted by doctors who are partial to older therapies with proven track records. Seely said that gynecologists are primarily surgeons who are not used to innovation in their field, so even getting them used to offering a new product can be challenging.
"They're still using drugs from 10, 20 years ago," Seely said. She added that Myovant aims to show physicians the durability of its treatments, as they tend to be unwilling to adopt something that is not a long-term solution.
But a new drug can often spark conversations between doctors and patients about an intimate condition that may have previously gone unaddressed.
"Often what creates the dynamic where a medical condition is discussed, particularly one that's considered embarrassing or private, is a drug," Johnson said. "So if you're a physician and you don't have anything to offer for a condition, you're unlikely to want to talk about it, and you're unlikely to want to engage in that education conversation — and then as a society, we don't talk about it."