Bavarian Nordic has entered into an exclusive license and supply agreement with Nuance Pharma, a Shanghai-based specialty pharmaceutical company.
The agreement concerns 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.
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, it states.
“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,” says Paul Chaplin, President and CEO of Bavarian Nordic.
An upfront payment of USD 12.5 million
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.
Photo: Bavarian Nordic manufacturing