Sobi Enters Into New Royalty Agreement on RSV Antibody Drug Nirsevimab With Sanofi

Headquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB (Sobi) has announced the streamlining and simplification of contractual agreements for nirsevimab (Beyfortus), an antibody drug treating respiratory syncytial virus (RSV) in infants.

Sobi has entered into a new royalty agreement with Sanofi, in which the Swedish biopharma company will pay the French side $66 million as reimbursement for the expenses incurred in the research and development of nirsevimab in the United States.

Related article: AstraZeneca, Sanofi’s RSV Antibody Recommended For Approval In EU

Nirsevimab Protects Against RSV in Infants

Human RSV is one of the most common viruses to infect children worldwide and nearly all children will experience at least one RSV infection before the age of 2, causing symptoms that resemble a common cold. However, in some rare and severe cases, the virus may spread to the lower respiratory tract, causing life-threatening lower respiratory tract infection (LRTI) such as pneumonia or bronchiolitis.

With the aim of protecting infants, children other high-risk individuals from this highly contagious virus, several big pharmaceutical companies are in heated competition for the first FDA-approved RSV vaccine. Besides, the development of novel antiviral treatments for RSV is also underway. Examples include palivizumab (Synagis), a humanized monoclonal antibody (mAb) as an FDA-approved drug for RSV immunoprophylaxis for severe RSV-associated LRTI in high-risk pediatric populations. Another example is nirsevimab which appears in the latest agreement between Sobi and Sanofi. It is a single dose, long-acting mAb under development as a passive immunization for LRTI caused by RSV for children up to 24 months of age.

Nirsevimab was initially developed and commercialized in partnership by AstraZeneca and Sanofi. The drug won EU approval for the above-mentioned indication in November 2022. Also, the U.S. FDA accepted AstraZeneca’s Biologics License Application (BLA) for Nirsevimab for review in January, with the final decision to be announced in the third quarter. In January 2019, Sobi obtained the rights to participate in 50% of the U.S. profits of Nirsevimab together with the acquisition of Synagis by paying AstraZeneca $1.5 billion upfront.

Simplifying and Streamlining the Relationships With the Pharma Giants

According to the newly signed royalty agreement with Sanofi, Sobi will receive a quarterly royalty on net sales of nirsevimab in the US. Royalty rates will start at 25% at launch anticipated in 2023, continue in 2024 and increase each year from 2025 to 2028 in a tiered fashion to a range of 30 to 35% of net sales. Beyond 2028, royalty rates will remain at these levels.

Through a separate agreement with AstraZeneca, Sobi will pay AstraZeneca $15 million as an upfront final consideration, terminating the 2019 participation agreement related to nirsevimab. This termination removes Sobi’s right to AstraZeneca’s share of US profits and losses for nirsevimab, including US development and commercialization costs and the obligation to pay future milestones and royalties to AstraZeneca.

Author

Richard Chau