Core Viewpoint - Bavarian Nordic has entered into an exclusive agreement with Eurofarma to sell and distribute its chikungunya vaccine, CHIKV VLP, in Brazil, with potential expansion to the rest of Latin America [1][8] Group 1: Agreement Details - The agreement is based on transfer pricing and royalties, with no upfront or milestone payments involved [2] - Eurofarma will be responsible for seeking and maintaining regulatory approval for the vaccine in the exclusive territories, as well as covering sales and distribution costs [2] - Bavarian Nordic will continue to manufacture the vaccine, which will be provided to Eurofarma under a transfer pricing agreement [2] Group 2: Regulatory and Market Launch - The regulatory submission is expected to occur in the first half of 2026, depending on discussions with the Brazilian health authority, Anvisa, potentially supporting the vaccine's launch in Brazil in the second half of 2027 [3] - The partnership aims to improve access to chikungunya vaccines in Brazil, which accounts for half of all reported cases and related deaths globally [4][7] Group 3: Vaccine Information - CHIKV VLP is a single-dose, recombinant vaccine designed to provide active preventive immunization against chikungunya virus disease for individuals aged 12 and older [5] - The vaccine is non-infectious as it contains no viral genetic material, allowing a broad group of individuals to benefit from vaccination [6] - It was approved by the U.S. FDA and the European Commission in February 2025, and in the UK in May 2025 under the name VIMKUNYA [6] Group 4: Company Background - Bavarian Nordic is a global vaccine company focused on improving health and saving lives through innovative vaccines [8] - Eurofarma, founded in 1972, is a leading pharmaceutical company in Brazil, operating in 24 countries and producing 600 million units in 2024, with a net revenue of over USD 1.78 billion [10]

Core Insights - Bavarian Nordic A/S has entered into an agreement with Eurofarma for exclusive rights to sell and distribute its chikungunya vaccine, CHIKV VLP, in Brazil, with potential expansion to the rest of Latin America [1][8] - The agreement is based on transfer price and royalty, with Eurofarma responsible for regulatory approval and distribution costs, while Bavarian Nordic will manufacture the vaccine [2][5] - Regulatory submission to the Brazilian Health Regulatory Agency, Anvisa, is anticipated in the first half of 2026, aiming for a vaccine launch in Brazil by the second half of 2027 [3][4] Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines, including mpox and smallpox vaccines, and has a strong portfolio of travel vaccines [9] - Eurofarma, founded in 1972, is a leading Brazilian pharmaceutical company with operations in 24 countries and a significant presence in Latin America, having produced 600 million units in 2024 and achieving net revenue exceeding USD 1.78 billion [10] Vaccine Details - CHIKV VLP is a single-dose, prefilled, adjuvanted VLP recombinant protein vaccine designed for individuals aged 12 and older, with protective immunity developing as early as one week post-vaccination [5][6] - The vaccine is non-infectious, containing no viral genetic material, making it safe for a broad range of individuals [6] Disease Context - Chikungunya is a mosquito-borne disease that has emerged in over 110 countries, with Brazil accounting for more than half of the nearly 500,000 reported cases and over 200 deaths worldwide in 2025 [7] - The disease often presents with severe symptoms, and a significant percentage of patients may develop chronic symptoms lasting months or years [7]

Core Viewpoint - Bavarian Nordic A/S has received acceptance from Health Canada for the review of its chikungunya vaccine candidate, CHIKV VLP, which aims to prevent chikungunya virus infection in individuals aged 12 and older, with potential approval expected in the first half of 2026 [1][3]. Group 1: Vaccine Development and Approval - The New Drug Submission for CHIKV VLP is based on data supporting recent approvals in the US, EU, and UK, including results from two phase 3 clinical trials involving over 3,500 participants aged 12 and older [2][4]. - The vaccine demonstrated a neutralizing antibody response in up to 97.8% of vaccinated individuals 21 days post-vaccination, with a seroresponse rate of 96.8% at day 15 for the 12-64 age group and 82.3% for those over 65 [2]. - CHIKV VLP is designed to be non-infectious, containing no viral genetic material, making it suitable for a broad population [4]. Group 2: Market Context and Disease Impact - Chikungunya is a mosquito-borne disease that has emerged in over 110 countries, causing significant outbreaks, particularly in popular travel destinations [5]. - In 2024, there were 620,000 reported cases of chikungunya globally, with over 200 deaths, indicating a substantial public health concern [5]. - The disease often presents with severe symptoms, including incapacitating joint pain, and a significant percentage of patients may develop chronic arthritis [5]. Group 3: Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines, with a strong portfolio in travel vaccines and public health preparedness [6].