MedImmune abstracts to be presented at PAS regarding influenza include:

• Factors Associated with Increased Vaccination in 2009 H1N1 School-Located Influenza Vaccination Programs. Ambrose CS, et al. Poster Session: May 1, 2011 Time: 4:15 –  7:30 PM,  Exhibit Hall F, Board: 468

• The Impact of School-Located Influenza Vaccination Programs on Student Absenteeism: A Review of the US Literature. Hull, HF, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM,  Exhibit Hall F, Board: 473

• An Integrated, Multistudy Analysis of The Safety of Ann Arbor Strain Live Attenuated Influenza Vaccine in Children Aged 2–17 Years. Ambrose CS,  et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM,  Exhibit Hall F, Board: 465

• Evidence of Homosubtypic But Not Heterosubtypic Immunity in Children After Wild-Type Influenza Illness. Ambrose CS, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM,  Exhibit Hall F, Board: 469

• Factors Associated with Increased In-Office Influenza Vaccine Coverage and Two-Dose Compliance Among Practicing U.S. Pediatricians. Toback, SL, et al. Poster Session: May 1, 2011 Time: 4:15 –  7:30 PM,  Exhibit Hall F, Board: 467

• Maternal Outcomes in Pregnant Women Receiving Live Attenuated Influenza Vaccine. Toback, SL, et al. Poster Session: May 1, 2011 Time: 4:15 –  7:30 PM,  Exhibit Hall F, Board: 466

MedImmune abstracts to be presented at PAS regarding RSV include:

• RSV Prophylaxis: Chronologic Age, Number of Doses, and Timing of RSV Hospitalization. Griffin M., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 558

• Safety Profile, Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) Vaccine in RSV/PIV3 Seronegative Children. Bernstein D., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 458   

• Burden of RSV Disease Among Infants 32-35 wGA in Outpatient Clinic Settings: The REPORT Study – Season One. Elhefni H., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 556

• Hospitalizations Associated with Respiratory Syncytial Virus Among Infants 32-35 Weeks Gestational Age: Season One of the REPORT Study. Elhefni H., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 557

• Distribution of Respiratory Syncytial Virus (RSV) Subtypes A and B Among Infants Presenting to the Emergency Department (ED) with Lower Respiratory Tract Infection (LRI) or Apnea. Jafri H., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 559

Additional information about the 2011 PAS conference can be found at

http://www.pas-meeting.org/2011Denver/default.asp

About MedImmune

MedImmune, the global biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com. 

#    #    #

 As a result of this decision, AstraZeneca will incur a financial impairment charge of $445 million in the fourth quarter 2010 accounts. As previously disclosed, the Group holds intangible assets of $445 million relating specifically to motavizumab.  Consistent with previous disclosures, the impairment will be excluded from Core earnings, and thus has no impact on the Company’s guidance for Core earnings per share for 2010.

 Motavizumab is an investigational monoclonal antibody that was being considered to help prevent RSV disease.  MedImmune filed the original BLA on 30 January 2008, and received its first complete response letter (CRL) in November 2008. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory Committee on 2 June 2010, and the FDA issued a second CRL requesting additional clinical data in August 2010.  Subsequently MedImmune has decided to discontinue certain motavizumab development paths and withdraw the prophylaxis BLA from the FDA; however, motavizumab remains in development for other RSV treatment.

 NOTES TO EDITORS

 About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization 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

 About MedImmune

MedImmune, the worldwide biologics unit for AstraZeneca, has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com

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.

About MedImmune

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

About AstraZeneca

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

CONTACTS:

Media Enquiries:

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Investor Enquiries UK:

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Investor Enquiries US:

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# # #

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 Complete Response Letter (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.

- ENDS -

About Motavizumab

Motavizumab is an investigational humanized MAb being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease.

About MedImmune

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

About AstraZeneca
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.

]]> http://pressroom.medimmune.com/press-releases/2010/06/25/fda-resets-its-decision-date-for-motavizumab/feed/ 0 http://pressroom.medimmune.com/press-releases/2010/05/03/medimmune-to-present-five-abstracts-on-rsv-at-pediatric-academic-societies-annual-meeting/ http://pressroom.medimmune.com/press-releases/2010/05/03/medimmune-to-present-five-abstracts-on-rsv-at-pediatric-academic-societies-annual-meeting/#comments Mon, 03 May 2010 19:03:16 +0000 Tor Constantino http://pressroom.medimmune.com/?p=1283 GAITHERSBURG, MD, May 3, 2010 – MedImmune, the global biologics unit of AstraZeneca, announced today that researchers will present results from five studies in the areas of respiratory syncytial virus (RSV) at the 2010 Pediatric Academic Societies (PAS) annual meeting taking place May 1-4, 2010 in Vancouver, BC, Canada.

MedImmune abstracts to be presented at PAS regarding RSV include:

• Respiratory syncytial virus (RSV) Hospitalization in infants with Chronic Lung Disease (CLD): An eight- year retrospective national hospital survey Groothuis, J., et al; Poster Session:  May 3, 2010 Time: 4:00 – 7:30 PM; Exhibit Hall C (Vancouver Convention Centre) / Poster Presentation #353

• Recurrent wheezing in the third year of life among children born at 32-weeks gestation: relationship to laboratory-confirmed, medically attended infection with respiratory syncytial virus (RSV) during the first year of life, Escobar G., et al; Poster Session:  May 2, 2010 Time:  4:00 PM – 7:30 PM; Exhibit Hall C (Vancouver Convention Centre) / Poster Presentation # 562.

• A randomized controlled trial of RSV prophylaxis with motavizumab vs. palivizumab in young children with hemodynamically significant congenital heart disease (CHD).  Feltes, T., et al; Poster Session: May 3, 2010 Time:  4:00 PM – 7:30 PM; Exhibit Hall C (Vancouver Convention Centre) / Poster Presentation # 104.

• Characterization of Respiratory Syncytial Virus (RSV) from patients who failed immunoprophylaxis with motavizumab. Zhu, Q., et al; Poster Session: May 2, 2010 Time:  4:00 PM – 7:30 PM; Exhibit Hall C (Vancouver Convention Centre) / Poster Presentation # 563.

• Population pharmacokinetics analysis of Motavizumab in children at risk for RSV infection. Zhao, L., et al; Poster Session: May 2, 2010 Time:  4:00 PM – 7:30 PM, Exhibit Hall C (Vancouver Convention Centre) / Poster Presentation # 570

About RSV

RSV is the leading cause of lower respiratory tract infections in infants in the United States. It is the most common respiratory infection in infancy or childhood and is associated with both an inpatient and outpatient burden of disease.  Each year RSV hospitalizes up to 125,000 infants in the U.S. with severe RSV infections; it results in an estimated 236,000 hospital outpatient visits; 400,000 emergency room visits and 1.7 million visits to physicians’ offices. Approximately one half of all infants are infected with RSV during the first year of life, while nearly all children are infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV.

About Motavizumab

Motavizumab is an investigational humanized MAb being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease.  It is currently under review at the U.S. FDA.

About Palivizumab

Palivizumab is the only monoclonal antibody approved by the FDA to help prevent an infectious disease. Palivizumab was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002.  Palivizumab is currently available in 62 countries.

Palivizumab is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in infants and children at high risk. Palivizumab is given as a shot, usually in the thigh muscle, each month during the RSV season. Children who develop an RSV infection while receiving palivizumab should continue the monthly dosing schedule throughout the season.

Palivizumab should not be used in patients with a history of a severe allergic reaction to palivizumab or its ingredients. Cases of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with palivizumab. These reactions may occur when any dose of palivizumab is given, not just the first one. Very low platelet counts may occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Common side effects may include fever, cold-like symptoms (upper respiratory infection) including runny nose and ear infection, and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort). In children born with certain types of heart disease, other possible side effects include bluish color of the skin, lips or under fingernails and abnormal heart rhythms. These are not all the possible side effects of palivizumab.

Please see full prescribing information for palivizumab at the company’s website: http://www.medimmune.com/about_us_products.aspx. Additional information about the 2010 PAS annual meeting can be found at http://www.pas-meeting.org/2010Vancouver/default.asp

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.