After several years marked by lackluster debuts and a relatively low amount of innovation, the women’s health sector is heating up again. But it’s not just about new products hitting the market or old ones being repurposed. Rather, drug companies have adopted new strategies around mainstay therapeutics, broadening the definition of what should be considered a “women’s health product” and marketing to women as the main medical decision-makers for their families.
About a decade ago, women’s health was a “booming market,” recalls Leslie Sandberg Orne, senior partner at Trinity Partners. However, “a large majority of those products have gone off patent. The market has become kind of sleepy. It’s well served in generics, and there’s not a lot of funding.”
Christina McHugh Mullen, senior director of strategy at DiD, agrees, adding, “The sentiment is that there is still a lag, from a pure Rx viewpoint.”
With the sector still reeling from the dampening effect of Addyi, a female libido drug that failed to deliver on its promise to revolutionize the market, very few bold or game-changing drugs have been approved in the past several years. Instead, the traditional women’s health market has seen its share of approvals in breast cancer, ovarian cancer, and osteoporosis — drugs that bring important but incremental improvements to the standard of care.
Addyi wasn’t the only flop. This year, the FDA rejected Amgen’s eagerly awaited osteoporosis drug romosozumab, owing to safety concerns that emerged in Phase III data.
So while there remains a significant need for novel therapies, that may soon be met by a robust product pipeline. Mullen says the most promise exists in categories with unmet need, including infertility, endometriosis, and polycystic ovarian syndrome. In addition, pharma is working to improve access to contraception by petitioning for over-the-counter models.
Much of the innovation and development in women’s health is being driven by deal-making among small- to mid-cap pharma companies, Orne notes. Meanwhile, the industry is broadening the scope of drugs that are advertised to women, recognizing a missed opportunity to target disorders such as constipation, depression, migraines, and IBS. All are highly stigmatized ailments that often disproportionately affect women.
Beyond broadening the notion of what constitutes a women’s health drug, marketers have increasingly reoriented their efforts around the growing recognition that women are the primary healthcare decision-makers in most households. What that potentially means: Even products geared toward men and children should be marketed in a way that reaches female decision-makers of all ages and backgrounds. As a result, medical marketing to women has shifted away from TV and toward online ads that aim to raise awareness of a particular condition, rather than tout a specific product.
Baby steps, not bold leaps
So far, 2017 has seen three major drug approvals in women’s health: Novartis’ Kisqali (ribociclib) for metastatic breast cancer, Radius Health’s TYMLOS (abaloparatide) for osteoporosis in postmenopausal women with a high risk of fracture, and Tesaro’s Zejula (niraparib) for recurrent ovarian cancer. However, most experts characterize those drugs as modest improvements rather than groundbreaking advances in medicine.
“The big new tactic in products launched in the past 12 months is aggressive contracting,” says Jay Carter, AbelsonTaylor SVP, director of business development. By way of example, he notes Express Scripts added TYMLOS to its formulary in August and excluded established osteoporosis agent Forteo. “The remaining new products approved [over the past 12 months] were new formulations of already approved generic agents,” he says.
In terms of new product launches, Orne notes the big pharma behemoths that have traditionally dominated women’s health are backing away. “There has been a vacuum of innovation, and that’s where these [smaller] companies are popping up, such as Sprout and TherapeuticsMD,” she explains.
AMAG Pharmaceuticals recently bought two women’s health drugs, one for vulvovaginal atrophy and another for female sexual dysfunction. Considering the general sleepiness of the sector, “it was surprising to see a company put money into women’s health,” Orne says. “What’s been nice about these incremental improvements is that a lot of them are based on established technology and established molecules.”
Indeed, companies are re-engineering drugs, dusting off old molecules, and reformulating standbys to make them longer-acting or administer them differently. “They’re sort of the low-risk, low-return types of opportunities,” Orne adds.
However, Carter says several soon-to-arrive drugs represent more dramatic advancements. “As we look at women’s health products in Phase III of development, we will see an onslaught in two key disease states. Five different companies are about to go to war in improving the treatment of uterine fibroids and six different agents are being developed in migraine, a disease that is disproportionately female in its incidence,” he explains.
Many small- to mid-cap companies working in and around the sector have been absorbed by or partnered with big pharma. For example, Myovant Sciences’ 2016 IPO was bolstered by a $30 million investment from Pfizer. Now, the company’s Phase III drug, Relugolix, is poised for FDA approval for uterine fibroids.
Meanwhile, Allergan has partnered with Hungarian biotech Gedeon Richter on Esmya, another uterine fibroid drug that has been submitted to the FDA for approval. Texas-based Repros Therapeutics, a development-stage company, has its own candidate in Phase III development. And TherapeuticsMD, has three products in later-stage development, including candidates for dyspareunia in postmenopausal women, vasomotor symptoms related to menopause, and secondary amenorrhea.
On another front, generic contraceptives are being looked at as a potential new over-the-counter medication, says Mullen. She points to HRA Pharma and Ibis Reproductive Health, which are engineering OTC versions of their Rx contraception drugs. In addition, Merck is said to be developing an on-demand birth control delivery system that the company is calling “Uber for birth control.”
“The entire landscape of how you interact with your healthcare professional is completely changing with retail clinics and telemedicine,” Mullen adds.
Beyond the pelvis
Although in decades past pharma’s view of women’s health rarely veered too far beyond the pelvic region, companies have finally come around to a more expansive view of the sector. With conditions ranging from lupus, multiple sclerosis, and depression to fibromyalgia, celiac disease, and constipation affecting women disproportionately, marketers and commercial teams have taken note.
“It will be interesting to see how those novel therapies are approved and developed, as they are redefined and marketed to women specifically,” says Mullen. “Pharma is starting to get a little smarter about targeting and retargeting advertising. You’re going to see more pharma women’s health brands living in social media.”
Surveys show women are active consumers of information on healthcare and active in researching insights into their own treatment. Women also rely on peer feedback and consumer reviews. Given that much of their information consumption takes place in active online forums — rather than via passive TV ads — pharma marketers are adjusting their channel mix to a combination of online appeals and work around disease-specific online communities.
“There has been a backlash against the traditional ads on TV,” says Orne.
A prime example of the newer thinking infiltrating the sector is Sage Therapeutics’ Silence Sucks campaign for postpartum depression. Though it generated some controversy — the campaign depicted adult women with pacifiers — it more than achieved its goal of starting a conversation and empowering women to talk about a heavily stigmatized topic.
“There’s been a real consumer mentality taking over the women’s health markets,” Orne continues. “I think pharma has been waking up to the digital world in general. I think women are central to that.”
Mullen notes the intensity of the movement toward self-care and patient empowerment. “The idea is that women are the number one consumers of healthcare,” she says.
Research backs that up. A 2015 study by The Center for Talent Innovation found that 94% of women make medical decisions for themselves and 59% make medical decisions for others. In addition, 94% of working mothers make healthcare decisions on behalf of others. The study also revealed 58% of women lack confidence in their healthcare-related decision-making, and 83% do not fully trust pharma companies.
It’s possible, then, that marketers might benefit from turning their attention to women first and foremost, even if a drug targets a condition affecting both men and women. “I don’t believe it would be a missed opportunity to actively target women, because women are by and large the healthcare decision-makers anyway,” says Mullen.