ALLIANCE WITH SANOFI PASTEUR FOR MEDI8897

RNS Number : 4153Y
AstraZeneca PLC
03 March 2017
 

 

This announcement contains inside information

 

3 March 2017 07:00 GMT

 

MEDIMMUNE AND SANOFI PASTEUR FORM ALLIANCE TO DEVELOP AND COMMERCIALISE POTENTIAL NEXT-GENERATION RESPIRATORY SYNCYTIAL VIRUS ANTIBODY MEDI8897

 

MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, today announced an agreement to develop and commercialise MEDI8897 jointly. MEDI8897 is a monoclonal antibody (mAb) for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV), the most prevalent cause of LRTI among infants and young children. MEDI8897 is currently in a Phase IIb clinical trial in pre-term infants who are ineligible for Synagis, the current standard of care medicine, and the development plan includes a proposed Phase III trial in healthy full-term and late pre-term infants.

 

Under the terms of the global agreement, Sanofi Pasteur will make an upfront payment of €120 million and pay up to €495 million upon achievement of certain development and sales-related milestones. The two companies will share all costs and profits equally. MedImmune and AstraZeneca will continue to lead all development activity through initial approvals, and AstraZeneca will retain MEDI8897 manufacturing activities. Sanofi-Pasteur will lead commercialisation activities for MEDI8897.

 

Bahija Jallal, Executive Vice President, MedImmune, said: "By combining our development expertise and leadership in RSV with Sanofi Pasteur's significant global experience in commercialising paediatric vaccines we hope to provide an RSV disease prevention approach for all infants, both term and pre-term. This agreement supports  our focus on our three main therapy areas, while delivering value from the innovative science in our pipeline through partnerships."

 

AstraZeneca's commitment to the prevention of paediatric RSV disease will also continue through Synagis, the only medicine currently approved for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of severe RSV disease.

 

Financial considerations

AstraZeneca will maintain a direct ongoing interest in MEDI8897 through the alliance. Revenue from the agreement, including the upfront payment of €120 million and up to €495 million in milestone payments, will therefore be reported as Externalisation Revenue in the Company's financial statements. The agreement was completed at signing and does not impact AstraZeneca's financial guidance for 2017.

 

 

 

About Respiratory syncytial virus

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections among young children in the United States and worldwide. Most infants are infected before the age of one, and virtually everyone gets an RSV infection by the age of two.

 

Each year, on average, in the United States alone, RSV leads to:

 

·      57,527 hospitalisations among children younger than 5 years old

·      2.1 million outpatient visits among children younger than 5 years old

·      177,000 hospitalisations and 14,000 deaths among adults older than 65 years

 

Source: Centres for Disease Control and Prevention, US Department for Health and Human Services, https://www.cdc.gov/rsv/about/infection.html

 

About MEDI8897

MEDI8897 is a highly potent monoclonal antibody (mAb) that neutralises RSV by binding the RSV fusion (F) protein expressed on virions and infected cells and has been engineered to have a long half-life, so that only one dose will be needed for the entire RSV season. It is being developed for the passive immunisation of a broad infant population. MEDI8897 is currently being tested in a Phase IIb trial in preterm infants ineligible for Synagis. The current development plan includes a Phase III trial in healthy full-term and late preterm infants. MEDI8897 has received Fast Track designation from the FDA.

 

About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca's three global R&D centres, with additional sites in Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com.

 

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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

 

 

Media Enquiries

 

 

 

 

 

Esra Erkal-Paler

UK/Global

+44 203 749 5638

Vanessa Rhodes

 

UK/Global

 

+44 203 749 5736

 

Karen Birmingham

 

UK/Global

 

+44 203 749 5634

 

Rob Skelding

 

UK/Global

 

+44 203 749 5821

 

Jacob Lund

 

Sweden

 

+46 8 553 260 20

 

Michele Meixell

 

US

 

+1 302 885 2677

 

Investor Relations



Thomas Kudsk Larsen

 

 

 

+44 203 749 5712

 

Craig Marks

 

Finance, Fixed Income, M&A

 

+44 7881 615 764

 

Henry Wheeler

 

Oncology

 

+44 203 749 5797

 

Mitchell Chan

 

Oncology

 

+1 240 477 3771

 

Lindsey Trickett

 

Cardiovascular & Metabolic Diseases

 

+1 240 543 7970

 

Nick Stone

 

Respiratory

 

+44 203 749 5716

 

Christer Gruvris

Autoimmunity, Neuroscience & Infection

+44 203 749 5711

US toll free


+1 866 381 7277

 

Adrian Kemp

Company Secretary, AstraZeneca PLC


This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
AGRDXGDXUGGBGRD

Companies

AstraZeneca (AZN)
UK 100

Latest directors dealings