Sprout regains rights to Addyi from Valeant and relaunches

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Cindy Whitehead
Sprout CEO Cindy
Eckert


Brad Barket /
Getty Images



  • 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

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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.