AstraZeneca announced that MedImmune, its biologics unit, has received
a second complete response letter (CRL) on motavizumab from the US Food
and Drug Administration (FDA).

Based on the preliminary
assessment of the CRL, it contains the following requirements that the
company should address to advance the motavizumab registration: The FDA
has requested evidence from an additional clinical trial that supports
a satisfactory risk/benefit profile in the population(s) for which the
prophylaxis indication is being requested.

The company
continues to believe in the clinical benefit of motavizumab, and it
will conduct a complete review of the CRL, continue ongoing
constructive dialogue with the FDA as well as make a decision regarding
next steps in due course.

Motavizumab is an investigational
monoclonal antibody (MAb) being considered to help prevent serious
respiratory syncytial virus (RSV) disease. MedImmune filed the original
Biologics License Application (BLA) on 30 January 2008, and received a
(CRL) in November 2008. It filed the response to the CRL in December
2009. Motavizumab was reviewed by the FDA's Antiviral Drugs Advisory
Committee on 2 June 2010.

As previously disclosed, the Group
holds intangible assets of $445 million relating specifically to
motavizumab, which may be subject to impairment following completion of
the Group's analysis of the CRL. Any impairment would be excluded from
Core earnings and, as such, the company's Core earnings per share
guidance for 2010 remains unchanged at $6.35-$6.65.

MedImmune,
the worldwide biologics unit for AstraZeneca PLC, has approximately
3,300 employees worldwide and is headquartered in Gaithersburg,
Maryland.

AstraZeneca is a global, innovation-driven
biopharmaceutical business with a primary focus on the discovery,
development and commercialisation of prescription medicines.