The US Food and Drug Administration (FDA) has granted fast track designation to the MEDI8897.
It is presently in a phase IIb clinical study in pre-term infants who are ineligible for Synagis.
Under the deal, the partnership is planning a phase III trial in healthy full-term and late pre-term infants.
As per terms of the deal, Sanofi Pasteur will pay an upfront payment of €120m to AstraZeneca, in addition to about €495m based on achievement of certain development and sales-related milestones.
The partnership will share all costs and profits equally. AstraZeneca will involve in development activity through initial approvals, as well as manufacturing activities of MEDI8897.
Sanofi-Pasteu will engage in the commercialization activities of MEDI8897.
MedImmune executive vice president Bahija Jallal 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.”
Image: MedImmune and Sanofi Pasteur to develop and commercialise MEDI8897 to prevent lower respiratory tract illness caused by RSV. Photo: courtesy of AstraZeneca.