Gilead Makes Record-Setting Purchase of Special FDA Voucher

Posted 19 November 2014 By Alexander Gaffney, RAC

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The Canadian pharmaceutical company Knight Therapeutics has reportedly sold its Neglected Tropical Disease Priority Review Voucher to Gilead Sciences, making it the first time a tropical voucher has ever been sold.

Background

FDA maintains two types of priority review voucher programs, which allow companies to have their products reviewed by FDA in just six months instead of 10. The first and oldest of the voucher types is intended to facilitate development of products for neglected tropical diseases. Companies that successfully develop and obtain approval for a product that treats any of 16 recognized diseases are eligible to receive the voucher, which can be sold once and redeemed by giving FDA one year's notice and a large fee (in FY 2015, $2,562,000 per voucher) meant to offset the additional review costs.

FDA also maintains a second voucher system intended to facilitate development of treatments for rare pediatric diseases. While the program is mostly similar, there are two substantial differences: The voucher may be sold an unlimited number of times, and the voucher is redeemable in just 90 days compared to the 365 days needed for the tropical voucher.

At present, both the Senate and House are considering legislation that would create parity between the two voucher programs.

Voucher Pitfalls

To date, neither voucher program has been all that successful. Despite FDA awarding several tropical disease vouchers, none had been sold as of October 2014, and none had been used successfully by their recipient companies. Novartis, which obtained a voucher after one of its tropical disease products (Coartem) was approved, used the voucher (unsuccessfully) on Ilaris (canakinumab).

The pediatric voucher, however, has been seen as being somewhat more successful. In July 2014, the biopharmaceutical company BioMarin announced it had sold its rare pediatric disease voucher to Sanofi and Regeneron for $67.5 million.

The high sale price speaks to the potential value of the vouchers for major pharmaceutical companies. By obtaining a faster review time for a potential blockbuster drug, companies can shave months off the review time for a drug and add months of revenue to their bottom lines.

But a question remained: If the pediatric voucher was worth $67.5 million, how much would the tropical disease voucher—which has more limitations—be worth?

In August 2014, the Canadian pharmaceutical company Knight Therapeutics said it would be auctioning off its tropical disease voucher, which it obtained after the March 2014 approval of Impavido (miltefosine) for patients with visceral, mucosal and cutaneous leishmaniasis.

"A big pharma may want our voucher if they are behind in a race to market and want to catch up or if they are ahead in a race and don't want their competitor to hop on a faster bus," the company's CEO, Jonathan Ross Goodman, said in a statement. "We hope to be the next to sell a Priority Review Voucher and would like to set the bar high to encourage others to invest in R&D for neglected tropical diseases."

Record First Sale, Record High Price

Now the company has announced it has sold its voucher to Gilead, and at a record-setting price.

In a statement, Knight said its voucher would be sold to Gilead for $125 million—almost twice the price BioMarin's pediatric voucher was sold for.

"We are thrilled to successfully transfer our priority review voucher in expectation that this will encourage others to invest in R&D for neglected tropical diseases for the benefit of humanity" said Goodman in a new statement.

The higher price could simply be a matter of increased attention on the program, a bidding war between interested parties, the potential value of the voucher to Gilead or the prospect of the voucher being worth more if legislative changes are enacted within the next few months.

Now the biggest outstanding question is what product Gilead will use the voucher for. While the drugmaker has made big headlines and bigger profits on the approval and sale of its new hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir / sofosbuvir), the massive purchase price for the voucher indicates the drugmaker has at least one more big drug in its pipeline that it wants to get to market as soon as possible.

 

Knight Statement

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Categories: Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration, News, US, CDER

Tags: Tropical Disease Priority Review Voucher, Neglected Tropical Disease Priority Review Voucher, Gilead, Knight Therapeutics, Priority Review Voucher, Voucher Sold

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