motavizumabTreatment for Respiratory Syncytial Virus
Medimmune Receives Complete Response Letter On Motavizumab
AstraZeneca today announced that MedImmune, its biologics unit, has received a second complete response letter (CRL) on motavizumab from the U.S. 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 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 January 30, 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. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com
Neil McCrae +44 20 7304 5045 (24 hours)
Chris Sampson +44 20 7304 5130 (24 hours)
Sarah Lindgreen +44 20 7304 5033 (24 hours)
Abigail Baron +44 20 7304 5034 (24 hours)
Investor Enquiries UK:
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032
Karl Hård +44 207 304 5322 mob: +44 7789 654364
Clive Morris +44 207 304 5084 mob: +44 7710 031012
Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043
# # #
Posted: September 2010
- FDA Advisory Committee Reviews MedImmune's Motavizumab - June 3, 2010
- MedImmune Receives FDA Complete Response Letter on Motavizumab - December 1, 2008
- MedImmune Submits Biologics License Application to FDA for Motavizumab - February 4, 2008