Women's health

When the COVID-19 pandemic hit the U.S. in early 2020 it briefly shut down clinical trials worldwide. Astellas Pharma was in the midst of phase 3 testing for Veozah, its now-approved nonhormonal drug to treat vasomotor symptoms — hot flashes and night sweats in menopausal women — which it assumed would become low priority amidst the crisis.

“We thought, this is a vasomotor symptom trial. I’m sure we’re going to put this on the back burner,” Marci English, vice president and head of biopharma development at Astellas, said. “We were so wrong. We had (employees at) sites saying ‘You don’t understand. I have patients calling me saying, You’re not closed, right? You’re going to stay open for this trial?’ That really just speaks to the demand for products like this.”

The FDA’s May approval of Veozah was a boon to those looking for a new way to treat hot flashes, which affect up to 80% of menopausal people. By blocking neurokinin 3 (NK3), a brain receptor that helps regulate body temperature, the drug is particularly in-demand option for those who can’t or don’t want to use hormone replacement therapy.

In a series of phase 3 trials, nearly 60% of women saw the frequency of their hot flashes cut in half after 12 weeks, English said. Some 30% saw them cut by 75%, and just over 10% of patients saw their hot flashes eliminated. The effect was maintained at the one-year mark. While traditional hormone therapy can reduce hot flash frequency and intensity by 90%, Veozah has the advantage of working quickly — usually within a week. Hormone therapies, on the other hand, can take up to a month to kick in.

Another NK3 receptor antagonist, elinzanetant from Bayer, is also making its way through the pipeline using a similar nonhormonal approach, while also targeting the NK1 receptor to steady the body’s internal thermostat. In a phase 2b study, elinzanetant showed a statistically significant reduction in the frequency and severity of hot flashes, and produced mild to moderate side effects, said Dr. Yesmean Wahdan, vice president of medical affairs and women’s health at Bayer. More details about how well it works will come with top-line results from its ongoing phase 3 study, which will likely be released in early 2024.

Other menopause-focused drugs are also in the works including Dare Bio’s two early-stage candidates— a hormone-based therapy for hot flashes and a nonhormonal, tamoxifen-based treatment for vulvar and vaginal atrophy. Mitsubishi Tanabe Pharma, meanwhile, also has a phase 2 drug, Elismetrep, for hot flashes.

Even so, the menopause drug pipeline seems meager in the face of demand. Some six thousand people enter menopause every day in the U.S. experiencing a range of well-known symptoms that last, on average, for seven years. And although its effects can vary from bothersome to debilitating, menopause is left untreated in six in every 10 women, English said.

In general, the femtech sector — including telehealth and device companies — is in the midst of a boom. According to FemHealth Insight Data, over 60% of femtech startups were launched in the last five years. But the general momentum in women’s health has yet to translate into a strong pipeline of new drugs.

Last year, PhRMA released a list of drugs in development for women’s health, which only included six drugs for menopause symptoms. By comparison, PhRMA listed 200 in the works for women’s cancers and 34 for dry eye disease.

Now the pressure is on to get more menopause treatments going.

“Socially, you see that there is this intense wave around supporting menopause,” said Wahdan.

Women with large social media platforms, government officials and celebrities have been talking publicly about their menopause symptoms, struggles, and how they’re no longer willing to just grin and bear it.

“By 2030, the world population of menopausal and postmenopausal women is projected to be around 1.2 billion, with 47 million new entrants each year,” Wahdan said. “It's been long enough that women have suffered in silence.”

The question is: Will more drug companies step up to fill the menopause pipeline?

A stagnant pipeline

Hormone replacement therapy has long been a mainstay in menopause treatment, but isn’t recommended for patients with certain health conditions, including a history of breast cancer, endometrial cancer or cardiovascular disease. And some might be hesitant to take hormones due to potential — or perceived — health risks such as the slight increase in the risk of certain cancers. They’ve also been linked to a higher risk of dementia and gallbladder disease.

Still, the hormone space is vast with more than 30 approved treatments on the market that come in many forms including estrogen-only, or estrogen and progestin combination pills, patches, sprays and more. Patients can also choose from systemic hormones that enter the bloodstream and travel throughout the body or local hormone treatments, such as creams.

Despite the general safety of hormone treatments, the FDA cautions that patients should take the lowest dose for the shortest amount of time due to their various health risks.

Meanwhile, non-hormonal options have trickled onto the market over the years. In 2013, the FDA approved Osphena, a non-hormonal, oral selective estrogen receptor modulator that works like estrogen to treat vaginal dryness and painful intercourse caused by menopause. But it carries some of the same risks as hormone therapy.

Doctors have also reached for serotonin and norepinephrine reuptake inhibitors (SNRIs) and serotonin reuptake inhibitors (SSRIs) to treat hot flashes. By targeting the brain’s epinephrine and serotonin, which are involved in temperature signaling, the medications have shown to be effective in reducing hot flashes by up to 60%. But Brisdelle, the only SSRI the FDA approved for hot flashes, can’t be taken by some patients with breast cancer.

And ultimately, the door is still wide open for new approaches.

Opportunities for more

Earlier this year, Bayer announced it is no longer prioritizing research and development in the women’s health market. But in a recent interview, Wahdan insisted the company remains committed to women’s health throughout the life stages.

“Bayer has been a leader in women's healthcare for quite some time, including introducing the first oral birth control over 60 years ago,” she said.

While neither Bayer nor Astellas is developing any additional menopause drugs, both companies indicated they’re open to the possibility — and agreed that in general, potential in the space remains large.

“Women's health is ripe for this type of energy, this excitement around bringing innovative treatments to the table that will impact the quality of life for women, impact the journeys that they are on, to help improve the experience that they have throughout those journeys,” Wahdan said.

When the FDA approved the first-ever over-the-counter daily birth control pill this year, Frederique Welgryn breathed a giant sigh of relief for all the reasons you might expect.

As a leader at the Paris-based HRA Pharma and now global vice president of women’s health at its parent company Perrigo, Welgryn has worked with U.S. regulators for close to a decade to move the progestin-only Opill onto drugstore shelves.

The victory, she said, was well worth the wait.

“When we saw that we had a unanimous, positive vote from the 17 members of the (FDA) advisory committee panel, (it) was probably one of the greatest moments of my professional career,” Welgryn said. “It's been difficult. It's been long. But it's so rewarding to see all the reactions.”

Perrigo’s application landed on the FDA’s desk just weeks after the U.S. Supreme Court ruled 6-3 to eliminate federal abortion protections last year, sparking fears that the court could also soon attempt to restrict contraceptive access. And while the drugmaker’s application was unrelated, the weight of the moment led to increased scrutiny of the FDA’s review.

Now, the drug’s approval has been heralded as a major milestone toward expanding access to contraception and reducing the risk of unintended pregnancies in the U.S. Still, advocates remain concerned that pricing and coverage constraints could continue to limit access. And some are pushing the federal government to mandate that health plans cover OTC contraception.

Here, Welgryn discusses how Perrigo is approaching conversations about access and affordability, the target audience for Opill and what the approval means for women across the U.S.

This interview has been edited for brevity and style.

PHARMAVOICE: Perrigo’s application for OTC birth control came just weeks after the Supreme Court overturned Roe v. Wade. Walk me through the decision to apply for OTC status at that moment.

FREDERIQUE WELGRYN: It’s completely coincidental to be honest. Opill was first approved by the FDA in 1973. And HRA acquired the drug in 2014 with the intent from the very beginning to conduct an Rx to OTC switch, because at the time, we knew that there was a massive need for more access to effective contraception in the United States. The whole point of the process was to prove that women can select birth control pills themselves and can use them without the supervision of a health care professional.

For more than nine years, we've been working to conduct the research, actual use trials and other clinical research, which are necessary to apply to get the FDA to bring Opill OTC. It’s been a long journey and when we came to the end, yes Roe was overturned. We had all the research completed and we thought ‘So many freedoms are being taken away from women in this country, it’s a necessary step forward for women.’ It’s not that contraception is ever going to replace abortion, but it’s probably the first good news for women's reproductive rights in this country for at least a couple of years. We didn't hesitate for one second because it was just something that was even more important at the time.

What was it like to be a scientist suddenly at the center of a major political debate?

When you start to touch anything that relates to women's reproductive rights in the United States, you know that it is always going to be under the spotlight. Fortunately, this is another win — not only the approval but the fact that the processes has been based on science. It's been based on a thorough research program. It's been supported by independent experts from the advisory committee panel. In addition, we've had support from all major medical organizations, including the American College of OBGYNs, the Society for Adolescent Health and Medicines, etc. So, fortunately this process has never been political.

Who do you anticipate the target patient for this OTC birth control will be, as opposed to prescription formulations?

Today, 40 million women of reproductive age are sexually active and don't want to get pregnant. 15.3 million women in the U.S. are using a less effective method of contraception or no method at all — so they're using condoms, spermicide or no method. And 10 million are using the pill, yes. But 30% that use it sometimes don't have time to get an appointment; they don't have time to miss work to go see a doctor; they don't see the necessity of doing these things. So those women are really the ones that will benefit from having Opill available OTC because they can just walk to their store and get the product and that's what they want. Some women will continue to take the pill exactly as before; they will continue to see a doctor; they will continue to get their prescription and that's perfectly fine. Others who are suffering from the barrier of getting a prescription will be happy to find Opill OTC. And this is for those women that Opill is here.

What pricing and access conversations you are having at this moment?

Since the very beginning, we’ve been saying that Opill would be accessible in all stores nationwide and online. We also said that we would work on pricing so that Opill is affordable for most women. There's still going to be an out-of-pocket cost, of course, but we're looking at something that is affordable. We will probably talk about the manufacturer's suggested retail price in a couple of months. We're in discussion to get Opill listed at launch with insurers. We're also working on a consumer assistance program as well to make sure that people who struggle to make ends meet can access Opill. And we are also on a journey to understand what we can do to take insurance coverage. In the United States, OTCs are not covered by insurance. So that's going to need more work to get that done. But because Opill was approved, there are voices saying, ‘We need to get that covered. We need to get birth control covered.’ So I feel there is momentum and we want to be here to support that momentum.

Are you working with insurance companies to facilitate that?

We have already started having conversations and we're trying to see what can possibly be done. Again, this would need a change of regulation. But there are many people in the country who are keen on making this happen sooner rather than later and we want to support those efforts.

You said you are expecting to go to market by the beginning of 2024. What informed that timeline?

Essentially, we need to manufacture the product. We were granted approval only on the 14th of July There are a couple of tweaks to the back (of the packaging) because we needed to get FDA’s comments on all those elements of the brand. Now the process is starting, and I believe that it's reasonable that we'll have Opill in stores and online in 2024.

Are you worried about how the future political environment in the U.S. could impact access to this medication?

One can’t predict the future, but so far, what we've seen is that there has been bipartisan support for OTC birth control. Seventy-seven percent of women support birth control OTC. I believe this is a fundamental right and contraception should not be at the center of any political debate. This has been the case until now, and I hope that will continue to be the case.

More women with breast cancer are surviving the disease than ever before. Five years after diagnosis, on average some 90% of women with breast cancer are still alive thanks to earlier detection and treatment advances.

However, within those statistics are the numbers behind subtypes of the disease, such as triple negative breast cancer, that are harder to treat and often more aggressive.

Triple negative breast cancer comprises 10% to 15% of breast cancers. It's estrogen receptor-negative, progesterone receptor-negative and HER2-negative — making it more complicated and less responsive to treatments used in other types of cancer.

But the clinical picture for these patients is finally starting to change thanks to a spate of newly approved drugs and a number more that are moving through the pipeline, said Millie Gray, a healthcare analyst on the oncology team at Citeline, which provides R&D intelligence to the pharma industry.

Efficacy boosts from ADCs

One of the biggest advances has come in the form of antibody-drug conjugates (ADCs), a potent combination of synthetic immune-system proteins and chemotherapy drugs designed to target cancer cells while sparing healthy ones.

The current star in this category is AstraZeneca and Daiichi Sankyo’s Enhertu. The clinical results of the drug’s phase 3 Destiny-Breast04 trial, announced in June, vastly exceeded expectations and earned the drug FDA approval to treat metastatic human epidermal growth factor receptor 2 (HER2) low breast cancer, a newly defined cancer subtype.

“The phase 3 Destiny-Breast04 trial was huge news in the breast cancer community,” Gray said. “The reason these results were so important is because they were essentially in a new segment of breast cancer. HER2-low patients did exist, but there weren’t any targeted agents specifically approved (for) HER2-low breast cancer before. It also is now the first HER2-targeted agent to be approved for HER2-low breast cancers, and it's the first targeted therapy to be approved across all three subtypes of breast cancer. So, it’s a lot of firsts and that is why it was just such big groundbreaking news.”

Of the nearly 300,000 new breast cancer cases each year, “approximately 80% to 85% of new cases were defined as HER2-negative subtype, including hormone receptor positive and triple negative breast cancer,” according to the FDA. Now, some 60% of these HER2 negative breast cancers are considered HER2-low. Enhertu provides a promising new option for these patients.

“It didn’t just show moderate efficacy. The efficacy data was really, really positive,” Gray said. Results were called “practice changing,” by the ASCO Post.

But the good news on Enhertu wasn’t necessarily welcome for its competitor, Gilead’s Trodelvy, which was itself initially greeted with excitement as the first ADC approved for triple negative breast cancer patients whose only option at the time was aggressive chemotherapy.

“It provided an option for heavily pretreated metastatic patients — people who don't really have very many other options,” Gray said. It also extended overall survival by just over three months. But with the advent of the more-effective Enhertu, it’s likely to lose a lot of its luster.

Enhertu does have its drawbacks, however, including the potential for serious adverse side events. In the phase 2 trial, patients developed unusually high rates of a toxic lung condition called interstitial lung disease, Gray said. But an increased awareness among physicians and prescribers about interstitial lung disease helped to catch and treat the condition early in the drug’s phase 3 trial, which saw fewer of the adverse events, Gray said.

An emerging alternative to Keytruda

Another game-changing advance came with the approval of two immunotherapies, Tecentriq and Keytruda for the treatment of triple negative breast cancer.

Tecentriq was the first to receive accelerated FDA approval for this condition, but Roche made the decision to discontinue the drug after disappointing follow up studies failed to confirm the benefits seen in earlier trials.

Keytruda, which saw better clinical results, of course, remains on the market and has become one of the bestselling drugs of all time. However, Keytruda is not effective in patients with low levels of PD-L1, a protein found on cancer cells. For these patients another option may be on the horizon, according to Gray.

G1 Therapeutics recently completed enrolling triple negative breast cancer patients in a phase 3 trials for a Cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, Cocella (Trilaciclib), which interrupts the growth of cancer cells. While a number of CDK 4/6 inhibitors, such as Verzenio, Ibrance and Kisqali are used to treat some types of breast cancer, they haven’t been used in triple negative breast cancer, Gray said. Depending on trial results, it may one day offer an alternative for people who can’t take Keytruda.

“Obviously, there isn't any late-phase data, and it is hard to say without that, but it's been granted fast track status by the FDA, which is promising, and it has pretty positive early phase data,” Gray said.

New formulations with ‘huge’ potential

Another group of drugs working their way through the pipeline for difficult to treat breast cancers are the selective estrogen receptor degraders (SERDs) for hormone receptor positive and HER2-negative breast cancer.

“They have the potential to be huge,” Gray said.

These new oral drugs may provide an alternative to fulvestrant, which is given by injection, Gray said. This category includes Elacestrant, which Radius Health out licensed to the Menarini Group, Genetech’s Giredestrant, AstraZeneca’s Camizestrant, and Eli Lilly’s imlunestrant, among others, Gray said.

Because frequent injections can be painful, oral formulation of these drugs provide a major advantage.

“This is why as the reason they could be so big. It's likely the patients will hugely prefer the oral drugs if they are approved and if they can show a similar efficacy,” Gray said. “Once these (drugs) start to gain approval, competition will be really stiff. (But) the numerical data is really going to be key in differentiating them.”

Gaps still exist

While progress is being made there is still a lot more ground to cover.

“Especially in triple negative breast cancer a lot more needs to be done,” Gray said.

Over the next few years, it’s likely that there will be a push among drug companies to get some of these potent drugs, which are often used only in metastatic patients, to people with earlier-stage disease in hopes of improving outcomes, Gray said.

“One really big trend that we're going to expect to see is a lot of therapies moving into earlier stages of therapy, like the adjuvant and neoadjuvant setting,” she said. This is already starting to happen. For example, Keytruda is now approved for use before cancer treatment begins for triple negative breast cancer.

“Companies want to get drugs into earlier settings because there is a much larger population there for them to treat and potentially sell that drug to,” Gray said. But this will require companies to curb some of the more serious side effects.

“The big question is going to be how a company is going to be able to manage the side effects often seen in the metastatic setting,” Gray said.

Among so many questions Merck & Co.’s Mary-Ann Etiebet has about the U.S. healthcare system, one in particular rises to the top: “Why are we failing our mothers?”

Despite the country’s wealth relative to the rest of the world, the U.S. ranks 20th in maternal mortality, and we’re headed in the wrong direction, said Etiebet, who is the executive director of the Merck for Mothers program at the pharma giant. More than 80% of maternal deaths were preventable from 2017 to 2019, according to CDC data — and then during the pandemic, pregnancy-related mortality spiked further, especially among Black women, according to research released this year.

“We’re one of the only high-income countries that is getting worse, not better,” Etiebet said. “The disparity gap is increasing, and when you pull all of these things together, the question we have to ask ourselves is, why is this the case?”

When the Merck for Mothers program began in 2011, the company made a $500 million commitment to “create a world where no woman has to die while giving life,” not just in the U.S. but around the world. That lofty goal required a better understanding of the problem and its causes, and so Merck set out to invest in evidence generation, said Etiebet, who is also the assistant vice president of health equity at the company.

“We have come to a place where it is now the norm and an expectation that every maternal death is counted, every maternal death is investigated, and the insights and findings and recommendations are actually put into action,” Etiebet said. “That was not the case in 2011, and so we’re proud that in 10 years we’ve made those gains.”

The company committed $150 million more into the program in 2021 for focused efforts in countries like India, Nigeria and Kenya, as well as the U.S. in direct response to Vice President Kamala Harris’s call to action.

But race and ethnicity are still leading determinants of maternal mortality, and the gap is growing.

“In New York City, where I’m from, between 2005 and 2008, the maternal death disparity gap was five to six times more likely if you’re Black — most recently, that’s risen to eight to 12 times more likely,” Etiebet said. “The first step is to understand the problem and acknowledge the problem, and we’re doing that as a society, but we need to come together for action.”

‘Systemic racism’

Social determinants drive health outcomes more so than what is happening in the health sector, Etiebet said.

“Where we live, where we work, where we play, get educated, pray — unless we address those social determinants of health and how systemic racism is reflected in the structures and processes and practices of our health system, we are not going to make a dent in reducing health inequities,” Etiebet said.

Seeing how strongly the societal current flowed against health equity was a humbling realization for Etiebet and the Merck for Mothers team. Early investments went to improving hospital systems and “safety bundles” to deal with obstetric emergencies with the hope that the benefits would lift everyone’s standards.

“But we didn’t see that,” Etiebet said. “Even when you take into account differences in education, in age, in pre-existing conditions, if a white woman and a Black woman walked into the same hospital that’s ostensibly giving the same care, the Black woman would still have worse outcomes.”

To combat these social inequities, Etiebet and Merck for Mothers needed to understand where these differences were manifesting.

“What we are learning is that more of the deaths are happening after women are being discharged from the hospital and are back in their homes and communities,” Etiebet said. “Previously a lot of the efforts were happening within the four walls of the hospital, and so realizing that dichotomy, we purposely thought through how best to partner with communities.”

The program launched the Safer Childbirth Cities Initiative in 2018 “to surface and support community-based solutions that were created and led by people with lived experiences in those communities.” They provide mental health services for pregnant women; identify, recruit, train and support doulas and other health workers; create daycare centers and other facilities in the community; and engage in other activities across 20 cities in the U.S.

And from the investments Merck made toward community growth, Etiebet said other grassroots efforts have arisen.

“We have emphasized that we want to support collaboration on the ground, and we’ve seen that it has catalyzed even more collaboration between folks we may not be directly funding, and these groups are working locally to advocate for policies and relationships with the healthcare system to sustain the initial investments Merck and others have made,” Etiebet said.

Why Merck?

Merck for Mothers began the year Kenneth Frazier became CEO of the pharma company, and Merck has said in a statement that the effort is tied to the leader’s “legacy and commitment” to the issue, naming an equity award after him. Though Frazier stepped down in 2021, Etiebet said the company remains aligned with those goals.

“One thing you hear from Merck leaders is that this is a very concrete example of how we are working toward the end goal of improving health outcomes,” Etiebet said. “I talk about maternal mortality not just being a vital sign of the health system but of society, and so it’s going to take many of our contributions to get there faster.”

Although maternal mortality is outside of Merck’s innovation portfolio, the company’s efforts “offer something from the private sector that wasn’t previously there,” Etiebet said.

“It manifests in the legacy of programs that we’ve had over the past decades to run toward the really difficult global health challenges, whether it be cervical cancer, HIV, river blindness, and committed to making treatment available in ways that it’s needed,” Etiebet said.

‘Slivers and inklings’

Improving maternal health outcomes in the U.S. and around the world requires incremental success, Etiebet said.

“The question you ask yourself every day through the difficulties is, are we seeing the population-level impacts?” Etiebet said.

Merck for Mothers takes several measures into account, and Etiebet said the program has reached more than 20 million around the globe. Implementing hospital safety bundles, providing information about danger signs and symptoms, and making sure women have access to community services and support are also tangible effects.

But, future maternal mortality data is where the impact will be most evident.

“These are all processes and output metrics, but the Holy Grail is moving the needle on the maternal mortality rate, as well as closing the gap on disparity,” Etiebet said. “And we’re seeing slivers and inklings of that happening.”

Within the span of a few years, the menopause space has been transformed from a quiet sector of healthcare into a loud and bustling target of research and investment dollars. From flashy startups to emerging treatments, it’s suddenly become hot to talk about hot flashes.

“Nobody wanted to talk about menopause three years ago and now you’re hearing a lot more about it,” said Alicia Jackson, founder and CEO of Evernow, a telehealth company that offers support to women in menopause.

The attention is long overdue.

In the U.S., more than 1 million women experience menopause each year, according to the National Institute on Aging. And 84% of women surveyed by AARP said that menopause symptoms interfere with their lives.

Yet, a woeful 20% of OB-GYN residency programs offer menopause training, AARP found, which has created a treatment and services gap so vast that the market to fill it could reach $600 billion, a venture capital firm called Female Founders Fund estimated in 2020.

Among the companies that have blossomed in the menopause space, Evernow has grabbed headlines thanks to its star-studded cast of financial backers. Earlier this year, the actresses Gwyneth Paltrow, Drew Barrymore and Cameron Diaz all signed on as investors in Evernow, which garnered $28.5 million in series A fundraising.

And although Evernow is among several startups — including Alloy Women’s Health and Elektra Health — that provide telehealth and hormonal support to menopausal women, its mission runs deeper.

In fact, Jackson wasn’t drawn to the menopause space only because women were lacking adequate education and treatments for the array of symptoms it brings. And she wasn’t just interested in smashing the stigma around menopause. Instead, what caught Jackson’s attention was research she stumbled upon one evening showing that women who went through early menopause were potentially doomed to an earlier death.

“It’s a train wreck for women’s bodies,” she said. “It can bring cardio issues, osteoporosis, metabolic problems, cognitive issues … and we think it’s a trigger for Alzheimer’s disease.”

“My head was exploding,” Jackson continued. “I’m living in Silicon Valley where people are obsessed with longevity and here is this really clear factor for that — but nobody was talking about it.”

At that point, it was “game over” — Jackson had found a calling to treat menopause to help women live “longer, healthier lives.”

From senators to startups

For Jackson, finding the right career path meant first realizing that she was on the wrong one. While pursuing a Ph.D. in nanotechnology at MIT, she noticed the long hours her adviser was clocking in the lab.

“I started thinking that I didn’t feel the same way he felt about being here all the time and maybe this path was not for me,” she recalled. “But I thought: ‘Oh my god, I’m four years into my Ph.D. What am I going to do?’”

After a dinner conversation with the president of MIT, Jackson was steered in the direction of public policy. An introduction to then-Senator Joe Leiberman’s legislative director led to a fellowship on Capitol Hill and work geared toward clean energy policy. Importantly, Jackson said her time working on public initiatives taught her to think about issues on a national level and how to ignite change on a major scale.

Years later, Jackson’s government connections also helped her land a role inside the Defense Advanced Research Projects Agency (DARPA). With its focus on investing in emerging tech for the military, the position gave Jackson a “front row seat” to a range of up-and-coming biotech innovations — such as CRISPR and mRNA — long before they were commonplace in the industry.

Eventually, her position also triggered a desire to be on the other side of the table, alongside bold entrepreneurs blazing new trails in healthcare.

“I wanted to be with a team with vision and people making something that has never existed in the world become real … but there was no startup culture in D.C.,” Jackson said.

Jackson officially leapt into the excitement of Silicon Valley as a co-founder of a diagnostics firm called Drawbridge Health. Then, through another venture aimed at fertility, she wound her way toward women’s health. Although Jackson originally intended to target the “huge opportunity” for innovation in the fertility space, her eye-opening realizations about menopause — one study associated early menopause with not just a likelihood of an earlier death, but also a twofold risk of developing Type 2 diabetes — flipped on the lightbulb to launch Evernow.

More than menopause

At first, Jackson envisioned that she’d help pioneer a “cool science” solution for menopause, which is defined by a precipitous drop in estrogen. Then a doctor set her straight, explaining that the problem isn’t a lack of treatments — many hormone therapies on the market are often effective — but rather that doctors and patients don’t know enough about these options.

In 2019, Evernow was born as a way to link women with menopause-certified specialists who assess their health and guide them toward therapies. For $49 a month, patients can now connect regularly with these experts and get prescriptions for care and educational materials.

Evernow is not currently interconnected with a larger healthcare system, but Jackson said she could see that type of partnership developing.

“It could be like how you get a referral to see a specialist, you get a referral to come to us and then we can share medical records with your regular doctor back and forth,” Jackson said. 

Evernow is growing all the same. So far, Jackson said about 150,000 women have gone through an initial health assessment, and the company exceeded its 2022 goal of $6 million in annual recurring revenue. It’s also looking to potentially expand prescription offerings to include medications for various menopause symptoms.

With a solidifying foothold in the market, Jackson said the company is now reaching the point where it could consider partnering with pharma to develop new treatments. In particular, Jackson believes selective estrogen modulator receptors — that would bind with a type of estrogen to improve menopause symptoms without increasing the risk of cancer — could be a new frontier for menopause care.

“In our bodies, there are two types of estrogen receptors: alpha and beta. It’s believed that alpha leads to self-proliferation of cancer cells and if unchecked, can lead to an increase in certain types of cancer,” Jackson explained. “So if you can create a type of estrogen that only binds with beta, you can get a lot of the positive effects with few of the negative ones.”

Or, to make an even more dramatic impact, Jackson said she’d love to look at how to slow the aging of ovaries to delay menopause all together.

“Just because it’s natural doesn’t mean that it’s a biological imperative,” she said.

While the industry wises up to the fact that menopause could be “big business” for healthcare companies, Jackson said that Evernow is evolving as a “telehealth 2.0” company that goes beyond just dispensing prescriptions to collecting longitudinal data on patients, partnering with others in the industry, and leveraging its entire platform to “improve overall care” or women.

“I would like to be a best-in-class healthcare company for women over 40,” she said. “That‘s the big opportunity from my perspective.”

Forget Blanche, Dorothy and Rose. The new “Golden Girls” are the more than 41 million American women over the age of 50 who have $15 trillion in spending power at their disposal. Labeled by Forbes as the “super consumer,” this new generation of women is more active, healthier, wiser and wealthier than any previous generation of their peers. Yet, they are often vastly overlooked by the business world — from marketers to pharma.

Despite an upsurge in interest in FemTech by venture capital firms and the emergence of female-disease focused startups like Daré Biosciences, Evofem Biosciences and the spinout of Organon in 2021 from Merck, there is still a huge gap in the drug development pipeline for the most common conditions associated with menopause and post-menopause like heart and blood disease, osteoporosis, urinary incontinence, sexual function, weight gain and hot flashes.

According to PhRMA, in 2022 there were more than 600 drugs in development for conditions that impact women — predominantly cancer, infertility or contraception. But fewer than a dozen products are being explored specifically for menopausal or post-menopausal issues.

One of the biggest untapped markets is that of overactive bladder (OAB) or incontinence, which is estimated to be valued at more than $5 billion by 2027. Of the 33 million adult Americans suffering from some form of urinary incontinence, 75% to 80% of those are women. And about 23% of these women are over 60.

Ready to tap into this lucrative field is Urovant Sciences, a relative newcomer to the urology market. The company gained commercial status during the pandemic with the launch of its first product Gemtesa after receiving FDA approval in December 2020 — the first nod in the U.S. for an oral OAB medication since 2012.

While approved for both men and women, Urovant is looking to make inroads with the millions of women who are affected by overactive bladder and at the same time change the face of what post-menopause looks like. And because Bayer pulled its OAB candidate eliapixant from trials in 2021, Urovant is well positioned to become a market leader.

Not bad for a company that less than three years ago had fewer than 50 employees, no commercial team and was managing through a CEO turnover.

“These were the moments where you pause for a minute and you think what does the future look like, how are we going to move forward, how are we going to prepare this product for launch?” said Alana Darden Powell, who joined the company as executive director of marketing, near its inception almost four years ago. “(Gemtesa) had already been submitted to the FDA for review in March 2020. So, all of a sudden the year ahead changed for everybody.”

Powell credits Jim Robinson, an industry veteran who stepped off Urovant’s board to assume the CEO role in March 2020, for his steady leadership in prepping the company to launch Gemtesa. Robinson, a PharmaVoice 100 honoree who helped oversee multiple blockbusters during his long career at Astellas, crafted a deal with Sunovion to co-promote the product to primary care physicians upon its approval. Urovant is a wholly owned subsidiary of Sumitovant Biopharma Ltd. and Sunovion, which are owned by the same parent organization Sumitomo Pharma.

A blockbuster in the making?

As Urovant looked to launch Gemtesa in the specialty and long-term markets, Powell was named vice president of marketing — a position that allowed her to lean into her decade-plus of experience working at Allergan, where she led the consumer marketing efforts for its urology products, including the blockbuster Botox. Instinctively, Powell knew Gemtesa could be a game-changer for women over 50.

“I worked on Botox and brought it to market for overactive and neurogenic bladder conditions, and I remember thinking even then that research showed women were still getting their advice from what their mom or their grandmother did,” she said. “Women were still sitting around book clubs and laughing about having to go to the bathroom all the time or having some leakage. I had to stop and ask: Why are we laughing about that and why are we just accepting this? It’s not funny. It’s not something we should just laugh away because I plan on traveling, and being active and spontaneous, and enjoying my life for a long time to come.”

Powell’s goal is to “wake up” the market — encompassing more than 33 million Americans who experience bothersome bladder symptoms, which increase with age — and help change how women approach OAB.

“The average woman waits about three and a half years before they say anything about their overactive bladder symptoms to a doctor,” she noted. “And what they do is go to the drugstore and pick up what they are familiar with, usually what they used when they were menstruating, but OAB is nothing like menstruation.”

She also hopes to refresh the images associated with aging women. In other words, she said it’s time to ditch the old “Golden Girls” personas to reflect the new reality of what 50-plus looks like.

“It’s shocking that this is the mental picture that comes to mind, and not Cindy Crawford,” Powell said. “This generation of women has entered this stage of life with more energy, more capability, and more ability to take on the second half of life in a really different way. Today, women are really empowered and that excites me. We need to catch up with the way we portray (post-menopausal) women in the media and to our doctors.”

To that end, Urovant recently signed on the actress Holly Robinson Peete to help raise awareness for OAB treatment options as part of its “Time to Go” campaign.

When the announcement was made in January, Peete said in a statement: “I experienced OAB symptoms for years prior to talking to my doctor about potential treatment options, and I wish I had sooner.”

Powell is enthusiastic about the future and the reach Gemtesa could have. Last year, the company penned an agreement with France’s Pierre Fabre Medicament to commercialize the drug in the EU, U.K. and potentially other French-speaking countries around the world.

“I firmly believe this brand’s going to be a blockbuster, and that is not something we see in the small molecule world very often anymore,” she said. “We’re the fastest growing beta-3 in the category. We now have 75% coverage in Medicare and 72% lives covered in commercial. The cherry on top of this story is the number of people we are going to be able to help. That excites me.”