Can She Make It Gel?

Saundra Pelletier’s com­pany, Evofem, is de­vel­op­ing a con­tra­cep­tive gel that could be the big­gest break­through in birth con­trol since the pill. All she has to do is sur­vive its get­ting ap­proved by the FDA

Inc. (USA) - - FEATURES - By Kim­berly Weisul

Saundra Pelletier’s com­pany, Evofem, has de­vel­oped a con­tra­cep­tive gel that could be the big­gest break­through in birth con­trol since the pill. But first she has to con­vince the FDA, which has turned her com­pany down once al­ready.

WHEN YOUR JOB in­volves try­ing to bring to mar­ket what could be the big­gest break­through in birth con­trol since the pill, you keep your morn­ings pre­dictable. Ev­ery week­day, Saundra Pelletier gets up at 4:30 a.m., try­ing not to wake her 10-yearold son while she slips into her work­out gear, which in­cludes a sweat­shirt with the word bull­shit printed on the left shoul­der. By 5, the 48-year-old sin­gle mom—who lives about a half hour from the San Diego of­fices of her com­pany, Evofem Bio­sciences—is on the phone, of­ten with her in­vestors in Lon­don. At 5:30, still on the phone, Pelletier ex­its her garage with a quick nod to the nanny, who is on her way in. Half an hour later, she’s at ei­ther CrossFit or Fit­wall, where she can work all the ma­jor mus­cle groups in 40 min­utes. As the cool- down ses­sion be­gins, Pelletier bolts, al­ready en route to her next stop and a triple soy latte from Star­bucks. Since there are no locker rooms at ei­ther gym, she swings back home—the phone au­to­mat­i­cally click­ing over to a wa­ter­proof speaker in her bath­room—to clean up. Back in her car, she dic­tates emails to her as­sis­tant, un­til ar­riv­ing at the of­fice by 8:30. “We get quite a lot done, ac­tu­ally,” she says.

But there’s al­ways room for im­prove­ment. When Thomas Lynch, the chair­man of Evofem’s board and the head of Ire­land’s largest hospi­tal group, asked what he could do to thank Pelletier for her work as CEO—aside from stock—she re­sponded by ask­ing that a shower be in­stalled at the of­fice. “So what you’re telling me,” he said, “is you want some­thing that lets you work more?” She did. (Lynch obliged.)

In Pelletier’s list of pri­or­i­ties, her morn­ing rou­tine comes third, af­ter only her son and her com­pa­nies. That leaves her mom and her fi­ancé (the founder of ap­parel com­pany Ath­leta) duk­ing it out for fourth place.

Per­haps the rea­son Pelletier is so wed­ded to early-morn­ing cer­tainty is not be­cause of any de­fi­cien­cies in her re­la­tion­ships with her loved ones, but be­cause her com­pany is deal­ing with a level of un­cer­tainty that most star­tups, and their founders, will never con­tend with. “We’ve had a sig­nif­i­cant amount of fail­ure,” Pelletier con­cedes. That un­cer­tainty may ex­plain why, when ev­ery­one in her son’s class at school had to say what their par­ents would like as a hol­i­day gift, her son replied: “My momma would like a dirty mar­tini.”

For Pelletier to achieve Evofem’s goal of be­com­ing a global leader in women’s health, for its in­vestors to see a re­turn, and to po­ten­tially af­fect women from San Diego to Malawi, she needs to suc­cess­fully com­mer­cial­ize what is now the com­pany’s only prod­uct: Am­phora, a new form of con­tra­cep­tive gel that has yet to be ap­proved by the U.S. Food and Drug Ad­min­is­tra­tion.

In­no­va­tions in con­tra­cep­tion, at least in the U.S., have in re­cent years been few and far be­tween. Yet, ac­cord­ing to the Guttmacher In­sti­tute, 45 per­cent of all U.S. preg­nan­cies are un­planned. Since the in­tro­duc­tion of the pill, many birth con­trol ad­vances have been new de­liv­ery meth­ods for the same hor­mones that have been used for decades. But about 5.3 mil­lion women can’t safely take those hor­mones, of­ten be­cause of pre­vi­ous sick­nesses. Mil­lions more sim­ply don’t want to be on hor­mones if they’re only oc­ca­sion­ally hav­ing sex. When a pa­tient asks her doc­tor for a hor­mone hol­i­day, says Kelly Cul­well, a prac­tic­ing gy­ne­col­o­gist and Evofem’s chief med­i­cal of­fi­cer, “we just hand them a bunch of con­doms and cross our fin­gers.”

A new form of birth con­trol that doesn’t re­quire a doc­tor to ad­min­is­ter, is used only when a woman needs it, and is hor­mone-free would be a break­through. In a clin­i­cal trial, Am­phora worked about as well as other con­tra­cep­tive gels. It may also pro­vide pro­tec­tion against syphilis and gon­or­rhea. Un­like other gels, Am­phora doesn’t con­tain sur­fac­tants, which can cause ir­ri­ta­tion and make it more likely that a woman will be­come in­fected with HIV. And with­out hor­mones, Am­phora doesn’t pro­duce side ef­fects such as weight gain, de­pres­sion, or nau­sea. “This could be one of the big­gest in­no­va­tions since the first birth con­trol pill in 1960,” says Pelletier.

That would be enough to put Evofem on the path to be­com­ing a billion- dol­lar com­pany. The cur­rent U.S. mar­ket for con­tra­cep­tives is es­ti­mated to be about $6.6 billion. About 4.5 mil­lion women who are sex­u­ally ac­tive don’t use a con­tra­cep­tive. Then there’s the mar­ket for pre­vent­ing sex­u­ally trans­mit­ted dis­eases. “When I was do­ing my train­ing, we wouldn’t put IUDs in any­body,” says An­drea Thur­man, the di­rec­tor of Con­rad Clin­i­cal Re­search Cen­ter at East­ern Vir­ginia Med­i­cal School. “Now we put them in ev­ery­body. It’s very pos­si­ble that 20 years from now,

In the world of new drugs, startup mantras like “Move fast and break things” sound silly.

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