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2022-03-24| Asia-PacificChina

Bavarian Nordic Establishes Asia Link for Its RSV Vaccines

by Joy Lin
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Copenhagen-based Bavarian Nordic has found a partner in Shanghai’s Nuance Pharma to commercialize its RSV vaccines in parts of Asia. Nuance obtains the rights to market MVA-BN RSV in Mainland China, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia. 

The Chinese company will cover the costs for vaccine development and regulatory submission in those regions. This includes a Phase 1 and Phase 3 trial to support MVA-BN RSV’s approval in China. Bavarian Nordic is also planning to initiate a separate Phase 3 this year to prepare the vaccine for a US approval. 

Under the deal, Bavarian Nordic will receive $12.5 million upfront and could receive up to $212.5 million in milestones, as well as double-digit royalties on product sales. The company will also manufacture and supply commercial doses post-launch. 

Paul Chaplin, CEO of Bavarian Nordic, believes the partnership will fulfill an unmet need for vaccines that combat RSV infections in the aging Chinese population. “With our plans to initiate a self-funded Phase 3 trial of MVA-BN RSV in the USA and Germany in the first half of 2022, we remain committed to the development and commercialization of the vaccine globally,” said Chaplin. 

 

No Approved Vaccine for RSV

 

RSV is a common virus that creates cold-like symptoms, but can cause severe lower respiratory tract infections in older adults and young children. To date, there are no approved vaccines for RSV, but several companies are edging closer to getting their shots approved. 

Last month, Moderna announced that the Data and Safety Monitoring Board has endorsed a Phase 3 trial for their mRNA-based RSV vaccine candidate. The support came after a positive independent review of a Phase 2 which demonstrated the safety of the shot. 

Bavarian Nordic has a proven track record for vaccines. The company had worked with the National Institutes of Allergies and Infectious Diseases (NIAID) and one of Janssen to develop a vaccine against Ebola to counter the outbreak in West Africa. Their Ebola vaccine went on to secure EU approval in 2020. 

Even earlier, Bavarian Nordic acquired two vaccines — Rabipur for rabies  and Encepur for tick-borne encephalitis — from GSK. The company also markets a smallpox vaccine which has bagged approvals from the EU, the US and Canada. 

MVA-BN RSV incorporates five RSV antigens to stimulate a broad immune response against subtypes of the virus. A previous Phase 2 trial indicated the vaccine has a 79% efficacy in preventing symptomatic RSV infection. 

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