Therapy Areas: Oncology
AstraZeneca to buy US FDA Priority Review Voucher from Sobi for USD95m
23 August 2019 -

Science-led biopharmaceutical company AstraZeneca Plc (LON:AZN) announced on Thursday that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of USD95m from a subsidiary of Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI).

A PRV entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and may potentially lead to an expedited approval.

This transaction is subject to clearance under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.

Reportedly, for the purposes of the UK Listing Authority's Listing Rule LR 10.4.1 R (Notification of class 2 transactions), the total book value of gross assets attributable to the PRV is equivalent to the full consideration of USD95m. No operating profit or loss was attributable to the PRV in prior accounting periods at Sobi.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, CVRM and Respiratory.

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