Sprout Pharmaceuticals 'Viagra for Women' pill

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Update: An FDA panel has recommended approval of Sprout Pharmaceuticals' drug for boosting sexual desire in women. The only condition is that the Raleigh company must provide safety restrictions to manage the side effects. WRAL TechWire reported on elements of that safety plan earlier today. Below is the preview story we published Tuesday, June 2.

Raleigh's burgeoning startup community is making national headlines this week not for a large funding announcement or new app launch, but for housing the pharmaceutical company that could be the first to bring 'Viagra for Women' to market.

Thursday, power couple Bob and Cynthia Whitehead of the Raleigh startup Sprout Pharmaceuticals will appeal to the Food and Drug Administration to approve their little pink pill called Addyi and finally bring to market a solution for the (reported) 43 percent of women who struggle with a lack of sexual desire. The FDA has a lot on the line besides another drug on the market—it's facing accusations of gender bias for failing to approve the drug twice before. Men have 26 different drug options to treat sexual dysfunction—Viagra was approved in 1998.

Meanwhile, an FDA report out today shows that the drug's effectiveness has increased since its last go around before the FDA in 2013. Yet there's still concern over side effects like fainting, especially when combined with alcohol. And according to an NPR story in February, it's unclear of the impact when taken alongside Prozac, Zoloft or other antidepressants. There's no telling what might happen when the FDA weighs the issue again Thursday, but the debate will likely continue in national media if there's another defeat.

That's evidenced by stories this week by the New York Times and TIME laying out the activist argument for approval versus that of scientists trusting the FDA's process or questioning whether lack of libido is really treatable by drugs. Social media has played a big part in the campaign for approval, and according to the Council for Entrepreneurial Development's Director of Entrepreneurship (and former marketing consultant to the pharma industry) Jay Bigelow, it's an increasingly common way drug companies are rallying support for new drugs. 

"Patient advocacy, and social media in particular, is a new tool in the pharma playbook," he told me. "To raise awareness of a condition and activate a patient base is a whole strategy piece."

Here's a Viagra parody video created by a campaign for approval that's racked up 40,000 online signatures:


So who are the Whiteheads?  Both husband and wife have dedicated their careers to bringing new drugs to market, most recently running Slate, a specialty pharmaceutical company in Raleigh focused on men's sexual health and the first to get approval and bring to market a long-acting testosterone replacement drug (in the form of a pellet inserted under the skin) called Testopel. They sold the company in December 2011 and promptly bought a drug called flibanserin from its inventor, German pharmaceutical company Boehringer Ingelheim. Flibanserin promised to activate chemicals in the brain that control the libido of women, but was declined by the FDA in 2010. 

But the Whiteheads had confidence they could get the drug to market, and were attracted to the potentially large market size—more than $4 billion in erectile dysfunction drugs are sold each year around the globe. The couple raised more than $50 million in the last four years, most recently closing $15 million in funding mid-last year even after the second denial. They've not revealed the names of investors in SEC filings—all are private versus large venture funds (Capitol Broadcasting Co., ExitEvent's parent company, is an investor)—though several investors sit on the company's board.

Investors clearly remain bullish on the company despite its rocky road to approval, and despite the failure of any other company to get to market a drug to address this women's health issue.

Bigelow has no ties or intimate knowledge of the company or its founders, but acknowledges their persistence, grit and commitment as pharma entrepreneurs, along with their ability to sell investors on a big vision.

"If someone gets a product in this market, it's a blockbuster, multi-billion dollar opportunity," he says. "The rewards are incredibly high if you're the one to get the product approved."

Sprout has also tested the drug with more than 11,000 women, with new data that shows driving isn't impaired after taking the drug (despite what the FDA feared in its 2013 rejection). In the All Things Considered interview with NPR, Cynthia Whitehead said she believes side effects (like nausea, sleepiness and dizziness) that still exist are common to many drugs and not dangerous. The benefits—users report a 53 percent increase in sexual desire and double the number of successful sexual events—outweigh the potential effects.

If approved, the Whiteheads can take several paths to market. They can sell the drug to a major drug company like Pfizer, which owns Viagra. They can license the drug to a major pharma company. Or they can build a boutique firm around the product and commercialize it themselves. So far, they're not revealing the plans.

And that's customary, Bigelow says: "You always want to have multiple options for generating a return for investors. The strategy for how you do that is a closely-guarded secret."

Photo credit: http://pixel.nymag.com/imgs/fashion/daily/2013/12/12/12-flibanserin-sprout-pharmaceuticals.o.jpg/a_4x-horizontal.jpg