Bavarian Nordic is to receive up to US$225 and double-digit royalties for granting exclusive Chinese commercialisation rights for MVA-BN® RSV to Nuance Pharma.
Under the terms of the agreement, Bavarian Nordic A/S (Copenhagen) will receive an upfront payment of US$12.5m and potential milestone payments of up to US$212.5m from Chinese Nuance Pharma (Shanghai). In exchange, Nuance Pharma obtains the rights to commercialise the Danish company’s respiratory syncytial virus (RSV) vaccine MVA-BN® RSV in Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia and will be responsible for all costs, including development and regulatory authorisation. Subject to Chinese regulatory authority (National Medical Products Administration, NMPA) approval, Phase I and Phase III trials are planned for the vaccine approval in China. The parties have also entered into a supply agreement by which Bavarian Nordic will assume future commercial manufacturing and supply of the vaccine. The Phase III trial aimed to support regulatory approval of MVA-BN RSV in China, which will be conducted separately from Bavarian Nordic’s own Phase III trial planned for initiation later in the first half of 2022 to support a US Biologics License Application.
RSV usually causes mild, cold-like symptoms, but in serious cases can lead to severe lung infections, including bronchiolitis and pneumonia, which ultimately can lead to death. At-risk individuals typically include infants and older adults as well as immunocompromised individuals. The Phase III trials in China are designed to support market autorisation for adult patients. Currently there is no approved vaccine against RSV, which is predicted to open up a potential multi-billion-dollar vaccines market annually.
The Chinese target population for an RSV vaccine is estimated to be nearly 400 million people aged 60 years or older with an estimated annual growth rate of 3%.Bavarian Nordic’s vector vaccine incorporates five RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural response to an RSV infection.