PARIS (Agefi-Dow Jones)–The pharmaceutical company Sanofi announced on Tuesday that it has obtained full commercial control of nirsevimab in the United States, following an update of the contractual agreements relating to the development and commercialization of this experimental drug, designed to protect infants against infections caused by the respiratory syncytial virus (RSV) and developed jointly by Sanofi and the British laboratory AstraZeneca.
Under the new agreements, Swedish biopharmaceutical company Sobi, which held the right to all of AstraZeneca’s profit and loss in the United States for nirsevimab, “will terminate its participation agreement with AstraZeneca, and Sanofi and AstraZeneca will terminate update their collaboration agreement so that Sanofi has full commercial control of nirsevimab in the United States,” the French pharmaceutical company said in a statement.
“Sanofi has simultaneously entered into a direct royalty agreement with Sobi to share a portion of the net sales of nirsevimab in the United States,” added the group.
Sanofi also stressed that the updated agreements have “no impact on the registration and launch of nirsevimab in the United States, where all parties remain committed to making Beyfortus available to all infants. in time for the 2023/24 respiratory syncytial virus season”. Beyfortus is the brand name for nirsevimab.
The agreement remains unchanged outside the United States
With respect to territories outside the United States, the existing collaboration agreement between the British pharmaceutical company AstraZeneca and Sanofi continues to govern this relationship. In March 2017, the two companies entered into an agreement to develop and commercialize the Beyfortus. Under the agreement, AstraZeneca leads all development and manufacturing activities, while Sanofi is responsible for marketing activities and revenue recognition.
Under the terms of the global agreement, Sanofi made an upfront payment of €120 million, a milestone payment of €30 million and a regulatory payment of €25 million. Sanofi will pay up to 440 million euros to AstraZeneca, subject to the achievement of a number of regulatory and commercial objectives. Sanofi and AstraZeneca are sharing the costs and benefits of their agreement in certain territories.
Beyfortus has received marketing authorization in the European Union for the prevention of lower respiratory tract disease caused by RSV in neonates and infants from birth during their first RSV season.
-Dimitri Delmond, Agefi-Dow Jones; +33(0)141274731; [email protected]: VLV
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April 11, 2023 02:42 PM ET (06:42 GMT)
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