FORM 6-K
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Report of Foreign Issuer
 
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 
For the month of August 2019
 
Commission File Number: 001-11960
 
AstraZeneca PLC
 
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __ No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
AstraZeneca PLC
 
INDEX TO EXHIBITS
 
 
1.
AstraZeneca agrees to buy US FDA Priority Review 
 
22 August 2019 07:00 BST
 
AstraZeneca agrees to buy US FDA Priority Review Voucher from Sobi
 
AstraZeneca today announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsidiary of Swedish Orphan Biovitrum AB (publ) (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.
 
The transaction is subject to clearance under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
 
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 $95m. No operating profit or loss was attributable to the PRV in prior accounting periods at Sobi.
 
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.com and follow us on Twitter @AstraZeneca.
 
 
Media Relations
 
 
Gonzalo Viña
 
+44 203 749 5916
Rob Skelding
Oncology
+44 203 749 5821
Rebecca Einhorn
Oncology
+1 301 518 4122
Matt Kent
BioPharmaceuticals
+44 203 749 5906
Jennifer Hursit
Other
+44 203 749 5762
Christina Malmberg Hägerstrand
Sweden
+46 8 552 53 106
Michele Meixell
US
+1 302 885 2677
 
 
 
Investor Relations
 
 
Thomas Kudsk Larsen
 
+44 203 749 5712
Henry Wheeler
Oncology
+44 203 749 5797
Christer Gruvris
BioPharmaceuticals (CV, metabolism)
+44 203 749 5711
Nick Stone
BioPharmaceuticals (respiratory, renal)
+44 203 749 5716
Josie Afolabi
Other medicines
+44 203 749 5631
Craig Marks
Finance, fixed income
+44 7881 615 764
Jennifer Kretzmann
Corporate access, retail investors
+44 203 749 5824
US toll-free
 
+1 866 381 72 77
 
Adrian Kemp
Company Secretary
AstraZeneca PLC
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
AstraZeneca PLC
 
 
Date: 22 August 2019
 
 
By: /s/ Adrian Kemp
 
Name: Adrian Kemp
 
Title: Company Secretary