Knight Sells Tropical Disease Priority Review Voucher To Gilead

Knight Therapeutics has sold its Neglected Tropical Disease Priority Review Voucher (PRV) to Gilead. Knight announced the sale in a press release, stating that it received the PRV in March 2014 with the approval of Impavido (miltefosine) for treatment of patients with visceral, mucosal, and cutaneous leishmaniasis. The voucher entitles Gilead faster review of a newly submitted drug. Jonathan Ross Goodman, Director of Knight, said, “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.”

Knight and Gilead Agreement

Gilead has agreed to pay Knight $125 million in cash for the PRV. Other terms of the transaction were not disclosed, except that global investment banking firm Jefferies LLC advised Knight on the deal. Gilead did not disclose how it would use the voucher, however it must notify the Food and Drug Administration (FDA) a year in advance before using it and meet other criteria to secure a fast-track review of a candidate.

The Neglected Tropical Disease Priority Review Voucher Program

The FDA established the Neglected Tropical Disease Priority Review Voucher Program in 2007 under the FDA Amendments Act (FDAAA). The FDA also has a PRV program for rare pediatric diseases, for which it just published guidelines. The program works in conjunction with other programs, such as Orphan Drug, Fast Track, and Breakthrough Therapy. VFRs are an incentive to industry to find new drugs and vaccines for neglected tropical diseases. Leishmaniasis is one disease on the list, which includes 15 other diseases, such as cholera and tuberculosis. Recently, lawmakers have proposed adding Ebola Virus Disease (EVD) to the tropical disease program.

PRV Sales

The PRV is considered a transferrable asset, and it allows the bearer to a priority review for a drug of its choice. Instead of the standard 10-month review, Gilead is now entitled to a review within six months from the date the FDA accepts the application. Knight said it held out for the highest price and made the deal with Gilead for $125 million. Other companies have sold their PRVs. Earlier in 2014, Sanofi and Regeneron paid $67.5 million for BioMarin's voucher. That voucher was earned for a rare pediatric disease, which has slightly different rules than the tropical disease program. Unlike the 365-day waiting period to use a tropical disease voucher, Sanofi and Regeneron can use the pediatric rare disease voucher 90 days after notifying the FDA of its intent to use it.