◼ BUSINESS Bloomberg Businessweek August 12, 201914
of medicines, one of the best-selling lines of birth
control pills, generated about $1.4 billion in reve-
nue 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 devel-
opment, 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 can-
cer 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 indi-
viduals, 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 dismissedtwo 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 med-
ical 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 cli-
ents. 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 con-
traceptives spending to as much as $56million a
year by 2021—more than double its investment of
$26.4 million in 2015. Spurred in part by that fund-
ing, some academic labs are looking to make more
than incremental improvements. Researchers at
Northwestern, for example, are exploring gene net-
works to find ways to control ovulation and perhaps
also maintain fertility, Gargus says. But such mea-
sures are at best years off.
The road to market for Amphora, the Evofem
gel, shows how long and winding it can be for con-
traceptives. 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, artifi-
cially 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 get-
ting the gel—with the same recipe as the 2004 ver-
sion, but what it says are better versions of some of
the ingredients—approved as a prescription medi-
cine. The company says it’s aiming for a list priceCancer$58.4bAutoimmune diseases$54.1bCardiovascular disease$10.5bVaccines$11.4bAntibiotics$5.7bHormonal contraception$5.4b● U.S. drug sales
for selected
categories, 2018