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Women's health 'wide open' for drugmakers as would-be blockbusters near launch

As experimental treatments for uterine pain edge closer to market, popular culture and drugmakers' interests are converging on what could be multibillion-dollar treatment areas.

Elagolix, developed by pharmaceutical giant AbbVie Inc. and its partner Neurocrine Biosciences Inc., is slated for a U.S. Food and Drug Administration decision in the third quarter of this year following a slight delay after the agency asked for more liver safety data.

Though the decision date is on the horizon and liver safety remains a question, analysts are already predicting elagolix will be a blockbuster: Barclays' Geoff Meacham forecast more than $2 billion in peak U.S. sales, even accounting for the regulatory delay.

Meanwhile, AbbVie launched an endometriosis awareness campaign, SpeakENDO, earlier this year with a television spot depicting a woman in a doctor's office, playing down her pelvic pain and menstrual cramps. A personified version of her thoughts moves around behind her, urging the woman to "speak up!" about pain that feels like "stabbing knives."

Last year, the drugmaker also enlisted dancer and actor Julianne Hough to talk about her endometriosis in a series of videos on their YouTube channel and sponsored site.

AbbVie's campaign came together after research showed that women with the disorder or symptoms "often hold back from speaking to their doctor about their symptoms for many different reasons, including being told that painful periods are 'normal' and 'just part of being a woman,'" the company said in a statement.

Yet not all the discussion around women's pain has been industry-driven. Actor and director Lena Dunham published a Vogue editorial earlier this year about her own endometriosis experience, which eventually led her to get a hysterectomy at the age of 31.

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Women's health is "wide open," said Lynn Seely, president and CEO of Myovant.

Source: Myovant Sciences

Uterine fibroids, benign yet painful tumors that grow inside uterus walls, may be lesser-known but have also had some recent pop culture visibility: the indie musician FKA Twigs discussed the "excruciating" experience of fibroid tumors in a May 2018 Instagram post, saying her six tumors' sizes added up to "a fruit bowl of pain every day."

There is a confluence of factors building women's health dialogue right now including new drugs, but also women feeling like they can discuss these issues, said Lynn Seely, president and CEO of the women's health-focused biotech Myovant Sciences Ltd., which has its own endometriosis and uterine fibroid therapy in the pipeline.

"I'm a woman and a physician, and I was surprised at how common these diseases are," she said in an interview. "We need women talking about them and the advent of new therapies helps that."

Myovant's relugolix is in phase 3 trials. It is likely to follow AbbVie's elagolix to market in women's health but may eventually make the jump into prostate cancer treatment as well. Myovant also has an early stage candidate for fertility treatment and expects to grow its pipeline from there, Seely said.

"The reason we're so focused on women's health is it's wide open," she said. "It's an area that pharmaceutical companies have largely ignored."

Lack of motivation

Interest in the women's health sector can be gauged numerous ways, but one is through the slew of recent IPOs, said Sabrina Johnson, president and CEO of Daré Bioscience Inc. — which itself went public in a 2017 merger with Cerulean Pharma.

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Five companies with a central focus on women's health have made initial public offerings over the past six years, including Myovant and the latest, Switzerland-based ObsEva SA. Before those listings, the landscape was quiet for roughly a decade; Vermillion Inc. listed in 2000, and a spate of others went public in the 1990s, including TherapeuticsMD Inc. and Repros Therapeutics, which Allergan PLC acquired in December 2017. Both Repros' pipeline uterine fibroid product and Allergan's Esmya have been followed by liver toxicity concerns, and Allergan expects an FDA decision on Esmya this August.

Daré's pipeline includes a nonhormonal, monthly birth control called Ovaprene and a female-focused, topical version of sildenafil, the same active ingredient used in Pfizer Inc.'s Viagra to treat erectile dysfunction. Daré also recently gained exclusive rights to Juniper Pharmaceuticals Inc.'s intravaginal ring, a device to deliver drugs more efficiently to female patients.

There was not a "motivated industry player" in women's health when Johnson formed her company, she said in an interview.

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There were no motivated industry players, said Sabrina Johnson, president and CEO of Daré Bioscience.

Source: Daré Bioscience

"There was clearly an interest in access to products once they had completed late-stage development, or even better were already ready for FDA approval, but there wasn't that same level of commitment in mid-stage development," she said.

"It wasn't even until the late '90s that we started mandating that women were included in clinical trials," Johnson added. "Women's health historically hasn't been the focus."

Out of investors' comfort zones

Even with rising market activity, women's health executives say investors still see their medicines, especially ones outside of family planning products' clearer pathway, as far from a sure bet.

Sprout Pharmaceuticals Inc.'s Addyi, the first drug on the market for low sex drive in women, cleared a pathway for the FDA to recognize women's sexual dysfunction needs, said Johnson. Yet that drug was plagued by questions about its effectiveness, and after the larger Valeant Pharmaceuticals International Inc. bought Sprout in a $1 billion deal, Addyi stalled.

Sprout's founder, Cindy Eckert, sued Valeant and settled out of court to get Addyi's license back. The pill was relaunched this month at a slashed price, which Eckert said in a recent Forbes interview is designed to give the pill parity pricing, and hopefully parity coverage, with male sexual disorder drugs.

Female sexual dysfunction can be a difficult area for investors to understand, but even family planning is not necessarily easier, said Johnson.

"Working in women's health, I think the biggest challenge we face is that the people on the other side of the table are male, and they don't necessarily intuitively get what we are talking about," she said.

Still, it's not being a woman that makes Johnson or other female executives more equipped to deal with these questions and drug developments, she said.

"I've worked in a lot of different therapeutic areas where, fortunately, I didn't have those disorders. Every CEO that's running an oncology company doesn't have cancer," she said.

"The investment community hasn't had the time to understand the space the way they do other areas, where they might be more comfortable making an investment," Johnson said. "This is true for any healthcare sector where you are the first working there."