Drug Review Incentive Pivotal to New Neglected Tropical Disease Treatment

June 14, 2018

Duke faculty proposed the federal voucher review system

Fuqua professor David Ridley's priority review voucher system has yielded a treatment for river blindness

A new treatment to help eliminate a neglected tropical disease was developed thanks in part to an incentive program devised by researchers at Duke University.

The U.S. Food and Drug Administration has approved moxidectin, a drug developed by non-profit biopharmaceutical company Medicines Development for Global Health. Moxidectin treats river blindness, a parasitic infection that affects more than 15 million people worldwide. The firm will be awarded a voucher for priority review of another drug, under a system first proposed by David Ridley, a professor at Duke University’s Fuqua School of Business, Henry Grabowski of the Duke Department of Economics, and Jeffrey Moe, of the Duke Global Health Institute.

“This is exactly what we had in mind when we proposed the priority review voucher program,” Ridley said. “This is a new treatment that isn’t profitable, but can benefit millions of people.”

Ridley, Grabowski, and Moe proposed the voucher system in 2006 to encourage research into unprofitable treatments for tropical diseases. The program became law the following year. When a company develops a new treatment for a neglected disease, it wins a voucher for speedier FDA review of another drug.

"(W)e’re one step closer to eliminating river blindness"

Those vouchers can be sold, and are worth millions to firms looking to launch a new commercial drug. The shortened review timetable – six months rather than the usual 10 – can make a huge difference when bringing a new product to market. Eleven of the 19 vouchers issued by the FDA so far have been sold. Recent voucher sales have fetched from $110 to $150 million.

“With a new treatment, we’re one step closer to eliminating river blindness,” Ridley said. “And the developer is a non-profit company,” added Moe, “which plans to use the proceeds of the voucher sale to make the drug available at cost or less.”

River blindness, also known as onchocerciasis, is found mostly in economically-distressed communities in sub-Saharan Africa. The Phase III clinical trial, published in The Lancet medical journal, found moxidectin to be more effective in treating the disease than the lone existing treatment, which drug manufacturer Merck is already giving away.

Ridley said Merck’s donation is noble, but also has the unintended effect of stifling development of other treatments.

“Merck is rightly proud of donating billions of treatments of their own river blindness drug,” Ridley said. “The problem with ‘free’ is that it kills any potential for more innovation because there’s no financial incentive for a better drug to come along and compete. But through the voucher program, we created a market for a better product. And it’s always better to have two treatments because it helps address drug resistance.”

“It’s a virtuous cycle"

The Global Health Investment Fund invested $13 million in the development of moxidectin, and will use its share of the voucher prize to fund further innovation for global health.

“It’s a virtuous cycle,” Moe said. “The award of this voucher can lead to more treatments for other tropical diseases that aren’t otherwise being addressed.”

The eight-figure investment was an example of impact investing – companies making money while providing a social or environmental benefit.

“Like other impact investment funds, the Global Health Investment Fund is serving an important role, finding ways to use private investment structures to produce public good,” said Cathy Clark, director of the CASE Initiative on Impact Investing at Fuqua. Clark also co-leads the Social Entrepreneurship Accelerator at Duke, which speeds global health solutions in developing countries and is part of USAID’s Global Development Lab.

“It’s also a great example of the innovative ways the private, nonprofit and government sectors can collaborate for impact. It’s a win for all of them, as well as for people with river blindness who get expanded treatment options,” Clark said. “I hope we see more cross-sector impact partnerships like this.”

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