Bavarian Nordic announced, that it has entered into an exclusive license and supply agreement with Nuance Pharma, a Shanghai-based specialty pharmaceutical company, on the development and commercialization of MVA-BN® RSV against respiratory syncytial virus (RSV) in adults in Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea, and certain Southeast Asian countries.
RSV is a common virus that 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 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%.
The agreement entails clinical development, including a Phase 3 trial to support regulatory approval of MVA-BN RSV in China, which will be conducted separately from the Company’s own Phase 3 trial planned for initiation later in the first half of 2022 to support a U.S. Biologics License Application.
Under the terms of the agreement, Bavarian Nordic will receive an upfront payment of USD 12.5 million and is eligible to receive future milestone payments of up to USD 212.5 million that are triggered upon achievement of certain clinical, regulatory, and commercial milestones, in addition to tiered, double-digit royalties on future net sales.
Nuance Pharma will assume all costs and responsibility for the clinical development, regulatory filings, and commercialization of the vaccine in territories covered by the agreement. Subject to Chinese regulatory authority (National Medical Products Administration, NMPA) approval, Phase 1 and Phase 3 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.
Paul Chaplin, President and CEO of Bavarian Nordic said:
We are pleased to partner with Nuance Pharma in our efforts to bring our late-stage RSV vaccine candidate to market. Their regional presence combined with a strong leadership and focus on respiratory diseases provides a unique first-to-market opportunity for MVA-BN RSV to fulfil the unmet need for a vaccine to prevent severe disease from 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 later in the first half of 2022, we remain committed to the development and commercialization of the vaccine globally.
Mark G. Lotter, CEO and Co-Founder of Nuance Pharma commented:
Nuance is thrilled to enter into this agreement with Bavarian Nordic on MVA-BN RSV, to set a new standard in the prevention of RSV, and to address the critical unmet medical needs of the highly vulnerable elderly patients. MVA-BN RSV represents an ideal fit for Nuance’s portfolio, given our focus in the respiratory space in China and the Asian markets. This is an opportune moment for us to be developing and commercializing MVA-BN RSV in the Territory, riding the wave of appreciably heightened awareness to the benefits of vaccination in the COVID-era.
While the upfront milestone payment was not included in the 2022 financial guidance it is still too early to change the guidance given the current market uncertainty.