Nuance Pharma Announces License and Supply Agreement with Bavarian Nordic on the Development and Commercialization of RSV Vaccine in Select Asian Markets

Nuance Pharma entered into an exclusive license and supply agreement with Bavarian Nordic A/S on the development and commercialization of MVA-BN RSV against respiratory syncytial virus (RSV) in adults in mainland China, Hong Kong, Macau, Taiwan, South Korea, Brunei, Myanmar, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand and Vietnam. The agreement entails clinical development, including a Phase III trial 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. Under the terms of the agreement, Bavarian Nordic will receive an upfront payment of $12.5M and is eligible to receive future milestone payments of up to $ 212.5M 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 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.