AstraZeneca plc agrees to buy US FDA Priority Review Voucher from Sobi

Astrazeneca plc

AstraZeneca plc (LON:AZN) today announced that it has agreed to buy a US Food and Drug Administration Priority Review Voucher for a total cash consideration of $95m from a subsidiary of Swedish Orphan Biovitrum AB.

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.

AstraZeneca plc 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.

Share on:

Latest Company News

AstraZeneca wins US approval for Imfinzi in early gastric and GEJ cancers

AstraZeneca has received US approval for Imfinzi combined with FLOT chemotherapy for adults with resectable early-stage and locally advanced gastric and gastroesophageal junction cancers.

AstraZeneca Plc to invest $2 billion in major Maryland manufacturing expansion

AstraZeneca has confirmed a $2 billion investment to expand its manufacturing presence in Maryland, including a larger biologics facility in Frederick and a new clinical manufacturing site in Gaithersburg.

AstraZeneca Tezspire approved in the US for chronic rhinosinusitis with nasal polyps

The US FDA has approved AstraZeneca and Amgen’s Tezspire (tezepelumab) as an add-on maintenance treatment for patients aged 12 and over with inadequately controlled chronic rhinosinusitis with nasal polyps.

AstraZeneca Plc reaches agreement with Trump administration to cut US drug prices

AstraZeneca has signed a landmark agreement with President Donald J. Trump’s administration to reduce the cost of prescription medicines for American patients.

AstraZeneca’s Tezspire recommended for EU approval in chronic rhinosinusitis with nasal polyps

The European Medicines Agency’s CHMP has issued a positive opinion recommending approval of Tezspire (tezepelumab) for adult patients with chronic rhinosinusitis with nasal polyps.

AstraZeneca to invest $50bn in the US, new Virginia manufacturing site planned

AstraZeneca will invest $50bn in the United States by 2030, including a multi‑billion dollar drug substance facility in Virginia for its weight management and metabolic portfolio.

    Search

    Search