AstraZeneca Signs an Agreement with Sobi to Buy its Priority Review Voucher for $95M

Shots:

• Sobi to sell its US FDA’s Priority Review Voucher to AstraZeneca for $95M in cash. The PRV was acquired as part of the acquisition of the emapalumab from Novimmune in July’2019
• The PRV entitles the holder to FDA priority review of a single NDA or BLA which reduces the target review time leading to an expedited approval. The transaction is subject to clearance under HSR Antitrust Improvements Act
• Emapalumab (marketed as Gamifant) is an anti-interferon-gamma (IFN-ɣ) mAb used for the treatment of hemophagocytic lymphohistiocytosis and has received FDA’s ODD, BT, rare pediatric disease designation and EMA’s PRIME designation

Source 1, Source 2 to­ read full press release/ article | Ref: AstraZeneca, Sobi | Image: Tfod