Knight Therapeutics today announced the sale of its Neglected Tropical Disease Priority Review Voucher (“PRV”). The PRV was granted to Knight in March of this year with the approval of Impavido® (miltefosine) for treatment of patients with visceral, mucosal and cutaneous leishmaniasis. Upon closing of the transaction, Knight will receive US$125 million in cash from Gilead Sciences, Inc. in exchange for the PRV. Knight was advised in the transaction by global investment banking firm, Jefferies LLC.
“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.
About the Neglected Tropical Disease Priority Review Voucher Program
Developed by the U.S. FDA in 2007 under the Food and Drug Administration Amendments Act (“FDAAA”), a PRV is an incentive for companies to invest in new drugs and vaccines for neglected tropical diseases. Leishmaniasis is considered a neglected tropical disease and is one of 16 tropical diseases that qualify for a PRV. A PRV is a transferrable asset that entitles the holder to a priority review for a drug of its choice. Under Prescription Drug User Fee Act (“PDUFA”), the FDA sets a target of 10 months from the date the FDA accepts the application for a standard review of a New Drug Application (“NDA”) or a Biologic License Application (“BLA”). A priority review means that the FDA reduces its target review time for an NDA or BLA to 6 months from the date the FDA accepts the application, speeding up the initial review of the drug.
