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AstraZeneca is set to divest United States rights to Synagis (palivizumab) to Swedish Orphan Biovitrum (Sobi), a biopharmaceutical company focused on rare diseases, for $1.5 billion.
On Nov. 13, 2018, AstraZeneca announced that it agreed to sell US rights to Synagis, (palivizumab) used for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV), to Swedish Orphan Biovitrum (Sobi), a biopharmaceutical company focused on rare diseases, for $1.5 billion.
Sobi will commercialize Synagis in the US and approximately 130 AstraZeneca employees will transfer to Sobi as part of the transaction. Sobi will also have the right to participate in AstraZeneca’s share of US profits and losses related to a potential new medicine MEDI8897. AstraZeneca will continue to develop MEDI8897 in collaboration with Sanofi Pasteur, the vaccines division of Sanofi.
Under the agreement, AstraZeneca will receive an upfront consideration of $1.5 billion, consisting of $1 billion in cash and $500 million in ordinary shares of Sobi upon completion. This would equate to an ownership interest of 8%, based on the current Sobi share price. AstraZeneca has undertaken not to sell the shares received as consideration for a period of 12 months following the closing date of the transaction.
AstraZeneca will also receive up to $470 million in sales-related payments for Synagis, a $175-million milestone following the submission of the biologics license application for MEDI8897; potential net payments of approximately $110 million on achievement of other MEDI8897 profit and development-related milestones; and a total of $60 million in non-contingent payments for MEDI8897 during 2019–2021. Under the agreement, Sobi will have the right to participate in payments that may be received by AstraZeneca from the US profits or losses for MEDI8897. The agreement is subject to customary closing conditions and is currently expected to complete very early 2019. AstraZeneca will provide additional information if closing conditions are achieved earlier and the agreement can complete late 2018.
Synagis is an RSV F protein inhibitor monoclonal antibody (mAb) that acts as a prophylaxis against serious RSV disease. AstraZeneca has an agreement with AbbVie for the distribution of Synagis outside the US, which will not be impacted by the proposed transaction with Sobi.
MEDI8897 is a single dose extended half-life anti-RSV F mAb being developed for the prevention of LRTI caused by RSV in all infants entering their first RSV season and children with chronic lung disease or congenital heart disease entering their first and second RSV season. It is being developed for the passive immunization of a broad infant population and has been engineered to have a long half-life so that only one dose will be needed for the entire RSV season, according to AstraZeneca. MEDI8897 received fast track designation from FDA in March 2015.
In March 2017, AstraZeneca and Sanofi Pasteur announced an agreement to develop and commercialize MEDI8897. Under the agreement, AstraZeneca is responsible for all development activity through initial approvals, as well as manufacturing of MEDI8897, while Sanofi Pasteur leads commercialization activities. The two companies share all costs and profits equally.
“We continue to streamline our portfolio, allowing AstraZeneca to allocate resources more effectively, while Sobi’s focus on Synagis will enable infants in the US to continue benefiting from this important treatment,” Pascal Soriot, CEO of AstraZeneca, in a company press release. “Meanwhile, the successful development and commercialization of MEDI8897 remains important for AstraZeneca.”