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'For a woman to have gotten this in the last two years was like winning the Powerball:' How Sprout is trying to re-launch its 'female Viagra' drug

Business Insider | Jun 13, 2018, 04.30PM IST

Cindy Whitehead

Brad Barket / Getty Images

Sprout CEO Cindy Eckert

  • The first - and only - drug to treat women with a chronically low desire to have sex was approved in 2015.
  • But over the last three years, the drug Addyi hasn't been a big success, in part because it was never fully launched by Valeant, the company that acquired the drug a day after its approval.
  • Now, Valeant has sold back Addyi to Sprout, the drug's creator. Sprout CEO Cindy Eckert has a new plan to relaunch the drug with a different strategy. "I'm throwing out the pharma rulebook. It is broken in so many ways," Eckert said.

Almost three years after it was initially approved, the first treatment for women with a chronically low desire to have sex is ready to re-launch with some new strategies for getting to patients.

It hasn't exactly been smooth sailing for Addyi, the first FDA-approved treatment for women with hypoactive sexual desire disorder, or HSDD. Marketed as a drug that could increase the libidos of women who struggle with chronically low sex drives, it quickly earned a predictable nickname: the "female Viagra."

The drug faced two rejections by the FDA before it was approved in August 2015. Valeant then acquired Sprout Pharmaceuticals, the small company shepherding the drug through the approval process for $1 billion.

But shortly after the deal, Valeant went through a rough patch filled with controversies over drug pricing and its business practices. Addyi was officially available at the pharmacy as of October 2015, but after scientists questioned its efficacy and without an official launch campaign, prescriptions for the drug fell flat.

Ultimately, Sprout CEO Cindy Eckert left Valeant, and Sprout's investors sued Valeant claiming that failed to commercialize the drug, pushed Sprout into a deal with Valeant's secret pharmacy just days before it faced accusations of fraud, and hiked the drug's price to a point that made it too costly. A former Valeant employee and the head of that pharmacy in May were found guilty of a multi-million kickback scheme.

Now, Addyi is back in Eckert's hands after a settlement with Valeant in which Sprout acquired the drug for $0 and $25 million in loans, Eckert said.

Among its first steps: cutting the list price in half to $400 and a full-out launch of Addyi more than two years after the drug officially hit the shelves.

Sprout's new launch playbook

Addyi's first launch technically happened in October 2015, but getting it in the hands of patients hasn't been easy. Eckert is plotting some new strategies that include virtual visits with doctors and delivering the drug directly to women, which allows them to avoid a potentially uncomfortable conversation at the doctors' office and the pressure of picking up the prescription at the pharmacy.

"For a woman to have gotten this in the last two years was like winning the Powerball," Eckert told Business Insider. To start, she'd have to get prescribed Addyi from one of the researchers who had worked on the drug trial. Then, she'd have to go to a pharmacy where the chances of the drug sitting on the shelf were "slim to none," Eckert said.

Even then, a month's supply would likely cost $800 out-of-pocket based on the original price Valeant set and the fact that the drug wasn't covered by insurance plans apart from a co-pay assistance program.

To change that, the plan isn't to run a big ad campaign like you might see for Viagra. Instead, because doctors who prescribe Addyi need to have gone through a special certification program mandated by the FDA, Sprout has created an alternative route to get a prescription.

"I'm throwing out the pharma rulebook. It is broken in so many ways," Eckert said.

Here's how it works. While women can still go to their doctors' offices if they choose, they also have the option to speak with a physician virtually to get the drug prescribed.

The prescription is then processed by Pillpack, a pharmacy startup that mails prescriptions.

If insurers covers Addyi, the prescription will cost $25 a month. If patients pay in cash or insurance doesn't cover Addyi, the most they are expected to pay is $99, Eckert said.

Eckert said she picked up the idea for the strategy looking at other startups that combine a pharmacy with telemedicine and are focused on one particular business, such as erectile dysfunction.

"I was a student of [erectile dysfunction drug company] Roman, [men's wellness firm] Hims, or 1-800 Contacts, of all of these different mechanism which were for sure what I would want to do as a consumer and have the availability of that path," Eckert said. "I think what they've done is fascinating, and I think that we'll see if it works as well in this category."

Another part of the plan is moving away from the "female Viagra" nickname, more importantly because Addyi doesn't work in the way Viagra does for men.

There are critical differences in how men and women get aroused. Men get aroused when blood flows into their genitals, making a drug like a Viagra work for them. Women don't respond that easily. To increase sexual desire in women, it involves making a change in the brain, closer to how an antidepressant works.

To be sure, Addyi is a controversial drug. A 2016 study in JAMA Internal Medicine found that women taking Addyi experienced one more sexually significant event than those on placebo. The drug also carries some rather serious warnings. It causes severe side effects like a drop in blood pressure and fainting when consumed with alcohol.

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