Rare Daily Staff
Swedish Orphan Biovitrum said it agreed to sell its U.S. Food and Drug Administration Priority Review Voucher to AstraZeneca for $95 million.
A priority review voucher entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target review time to six months from ten months and may potentially lead to an expedited approval.
Companies have sold priority review vouchers for as much as $350 million and as little as $80.6 million. Sobi’s sale represents a downtick from the $105 million GW Pharmaceuticals got for its voucher in March 2019.
SOBI obtained the voucher through its acquisition of the emapalumab-related business of Novimmune, which it completed in July 2019. Under that agreement, Sobi paid $523 million (CHF515 million), $406 million (CHF400 million) of which was previously committed through an exclusive license agreement.
Emapalumab is a monoclonal antibody approved to treat the rare immune condition hemophyagocytic lymphohistiocytosis, or HLH.