AstraZeneca PLC — Capital/Financing Update 2019

Aug 22, 2019

6-K 1 a8505j.htm ASTRAZENECA AGREES TO BUY US FDA PRIORITY REVIEW Document created using Blueprint(R) - powered by Issuer Direct - www.issuerdirect.com Copyright 2019 Issuer Direct Corporation Blueprint

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 |

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