Better Birth Control Could Exist, But It Wouldn’t Pay for Big Pharma

(Bloomberg Businessweek) -- Since the contraceptive pill transformed women’s lives almost 60 years ago, there’s been precious little innovation in birth control for women. Now a company in San Diego claims to be on the verge of something that could advance the field: a gel women can apply an hour before sex, without having to mess with their hormones. “There hasn’t been innovation in this category in decades,” Evofem Biosciences Inc. Chief Executive Officer Saundra Pelletier says. “It’s time that women have the opportunity to have sex on demand, like men have had with condoms for years.”.That’s a powerful message. But look more closely and Evofem’s product, Amphora, is also a case study in why real advances in birth control are so rare. With plenty of consumer interest in an easier-to-manage female contraceptive, you’d think there’d be many more choices. Yet Amphora is a little-changed version of an over-the-counter lubricant cleared for sale more than a decade ago..The reason there aren’t more and better options for women is simple: money. In the era of $20 billion blockbusters such as the arthritis drug Humira and $2 million-a-patient gene therapies to treat rare diseases, the pharmaceutical industry doesn’t see a big payoff in rolling out products that don’t have record-breaking potential. Bayer AG’s Yaz family of medicines, one of the best-selling lines of birth control pills, generated about $1.4 billion in revenue at its sales peak. Evofem estimates its birth control gel could top out at just under $1 billion in annual U.S. sales. “Pharmaceutical companies don’t really see the benefit,” says Emma Gargus, who leads contraceptive projects at Northwestern University’s Woodruff research lab..That argument means little to the many women who are ready for improved contraceptive choices. Those on the market today may be complicated to use, and they can hijack hormones, leaving some users with headaches, bloating, or depression. Although the pill is tried and true, it comes with its own baggage, including an increased risk of high blood pressure and blood clots. Long-term options such as intrauterine devices can have side effects—not the least of which is heavy bleeding every month. “Women today are basically using the same birth control methods for the most part that our grandmothers did,” says Nomi Fuchs-Montgomery, deputy director of the family planning program at the Bill & Melinda Gates Foundation. “If we don’t galvanize the field and nothing changes, this will be true for our daughters and sons as well.”.The industry funnels only 2% of annual revenue from contraceptives back into research and development, according to the Gates Foundation. That works out to about $100 million, less than a sixth of what a company might spend to bring a single cancer drug to market. Even though the government often backs patient trials—the most expensive and riskiest part of bringing a treatment to patients—for birth control medicines, the progress is still slow..Diana Blithe, who heads the National Institutes of Health’s contraceptive development program, contrasts the plodding advance of an innovative contraceptive with the pace of testing a tumor drug. A cancer trial can enlist a very small number of people and usually needs to show a single key result: that patients don’t die as quickly. Side effects are less of a concern. A contraceptive, on the other hand, must be safe for vast numbers of healthy individuals, a far higher hurdle. Women seeking a birth control method “have other options,” Blithe says. “Their lives are not generally at risk.”.That safety hurdle has made the contraceptives industry a target for waves of lawsuits starting back in the 1970s, when drugmaker A.H. Robins pulled its Dalkon Shield intrauterine device from the market after 2.5 million women had used it. Robins eventually filed for bankruptcy. Bayer faced more than 11,000 Yaz-related lawsuits over risks including blood clots, heart attacks, and strokes. Over the past three years, the courts dismissed two multidistrict litigation cases involving an IUD known as Mirena for lack of evidence. Bayer says it remains committed to the IUD market and is investigating nonhormonal approaches and smaller devices..Still, the litigious landscape has resulted in few companies being willing to push forward with a new product, says Régine Sitruk-Ware, a scientist at the Population Council’s Center for Biomedical Research. That leaves the job mostly to academics and nonprofits..The Population Council, which conducts medical research, developed Annovera, a vaginal ring that lasts longer than others and won U.S. Food and Drug Administration approval last summer. A year later, the device still hasn’t reached potential clients. TherapeuticsMD Inc., which licensed the ring, expects a full introduction next year, when it’s had time to build its manufacturing processes..The Gates Foundation plans to boost its contraceptives spending to as much as $56 million a year by 2021—more than double its investment of $26.4 million in 2015. Spurred in part by that funding, some academic labs are looking to make more than incremental improvements. Researchers at Northwestern, for example, are exploring gene networks to find ways to control ovulation and perhaps also maintain fertility, Gargus says. But such measures are at best years off..The road to market for Amphora, the Evofem gel, shows how long and winding it can be for contraceptives. About 20 years ago, Rush University’s labs in Chicago developed a version of the gel at a time of surging interest in products that could tackle both birth control and sexually transmitted diseases such as HIV. Amphora works by keeping vaginal pH, which usually spikes in the presence of semen, artificially low to create an inhospitable environment for sperm. The approach dates back to ancient Egypt, where a sticky paste made with acacia and honey may have acted as a crude contraceptive..Spermicide gels failed to halt the spread of HIV, though, and most drug developers gave up, recalls NIH’s Blithe, who was involved in early studies of some of the products. That left Amphora as “the last gel standing,” Evofem’s Pelletier says. Evofem—then called Instead Inc.—got FDA clearance in 2004 to market the gel as a vaginal lubricant, arguing that it was basically the same as two products already on the market. But the lubricant was never sold..Now, Evofem is basing its business model on getting the gel—with the same recipe as the 2004 version, but what it says are better versions of some of the ingredients—approved as a prescription medicine. The company says it’s aiming for a list price similar to that of branded contraceptive pills, about $140 to $170 a month..Still, U.S. regulators already rejected the prescription version once. Evofem is planning to resubmit its application by the end of this year. Pelletier says that should be quick enough to bring Amphora, after all its twists and turns, to the market by mid-2020. “It isn’t just a kitschy lifestyle category,” she says. “It’s something that’s really serious and meaningful.”.This sentiment can’t override that pharmaceuticals companies will never be able to sell birth control drugs at anything like the prices they get on new treatments for cancer, rheumatoid arthritis, obesity, or heart disease, lowering interest in reproductive health medicine..“The pill is as cheap as chips,” says Anna Glasier, honorary professor at the University of Edinburgh. “So everything has to be not much more expensive than that.”.To contact the editor responsible for this story: Marthe Fourcade at mfourcade@bloomberg.net, Rick SchineJames Ellis.©2019 Bloomberg L.P.

Better Birth Control Could Exist, But It Wouldn’t Pay for Big Pharma

Evofem’s contraceptive gel is a big advance, but also a case study in why such innovation is so rare.

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