Gilead buys priority voucher for $125M
Gilead Sciences scooped up a priority review voucher for $125 million from Knight Therapeutics, which received the voucher when the FDA approved its neglected tropical disease drug, Impavido (miltefosine).
The FDA issues priority review vouchers to help stimulate drug development in areas such as neglected tropical diseases. Companies are allowed to sell these vouchers, which can be attached to any drug of its owner's choosing.
Gilead would not share its voucher plans, other than to tell MM&M in an email that, “there are a number of potential clinical candidates in our pipeline where this could be beneficial. We will make the decision to apply the PRV in conjunction with ongoing internal pipeline reviews.”
Sanofi and Regeneron purchased a priority review voucher from BioMarin for $67.5 million in July, and expect to use it for the experimental PCSK9 inhibitor, alirocumab. Such a move will shorten alirocumab's regulatory review window, as well as narrow the lead between its drug and the PCSK9 inhibitor, evolocumab, which Amgen put in the FDA's in-box this summer.