The market price of a priority review voucher at the FDA just doubled. Canada's Knight Therapeutics has auctioned off its voucher--which can be turned in to the FDA in exchange for a regulatory shortcut on a drug decision--for $125 million to Gilead ($GILD), one of the most aggressive developers in the industry.
The FDA came up with the priority review voucher, which is used to qualify for a quick, 6-month review of a new drug application, to help encourage developers working on tropical and rare pediatric diseases. Sanofi ($SNY) and Regeneron ($REGN) paid a now bargain-basement rate of $67.5 million to get BioMarin's ($BMRN) voucher so they could get their PCSK9 cholesterol therapy--now in a foot race with Amgen ($AMGN)--to the market ASAP. And now Gilead, which has been making waves for aggressively pursuing pricey new hepatitis C drugs that are swiftly capturing the market, has some plans to do something similar.
Montreal-based Knight says it went after the highest price for altruistic reasons, claiming that its chief concern was showing others in the industry that there are some significant bonuses available for any other company that can win a voucher for tropical disease work.
"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 Jonathan Ross Goodman, director of Knight.
The cash will certainly come in handy as well. The PRV was granted to Knight in March with the approval of Impavido (miltefosine), a treatment of patients with visceral, mucosal and cutaneous leishmaniasis.
Gilead has a big pipeline and a rep for making fast progress in the clinic. But for now, if it has any specific plans in mind, they're being kept under wraps.
"There are a number of potential clinical candidates in our pipeline where this could be beneficial," a spokesperson tells FierceBiotech. "We will make the decision to apply the PRV in conjunction with ongoing internal pipeline reviews."
The voucher, though, can't be used for anything immediately near-term, like Regeneron and Sanofi have in mind. This particular tropical disease voucher comes with strings, including a requirement to notify the FDA a year in advance that it plans to use the voucher.
Then again, Gilead rarely goes out of its way to explain its actions or signal its development strategy.
- here's the release