PROTEON CONTINUES DIALOGUE WITH EU COMMISSION TO SECURE EARLY AUTHORIZATION

• In its first-ever evaluation of a bacteriophage feed additive, EFSA (European Food Safety Authority) concluded that BAFASAL® is safe for all avian species, consumers of derived poultry products, and does not pose a risk to the environment;
• The recognition of BAFASAL®’s safety by EFSA is a breakthrough, as the EU’s independent food safety authority is one of the strictest evaluating bodies in the world, responsible for all regulated food and feed products, and especially demanding on all aspects of safety – from farm to fork;
• In addition, EFSA had no concerns on the quality of BAFASAL® manufacturing and associated quality control procedures, and the safety of the bacteriophages delivered by BAFASAL®;
• Whereas some elements of EFSA’s assessment on efficacy remain pending, Proteon has already confirmed to EFSA and the EU Commission that additional data to support BAFASAL®’s efficacy are available, to allow EFSA to complete the assessment;
• The EU authorization process is expected to conclude by the end of 2021/early 2022 when the product will become available for European poultry producers;
• BAFASAL® is already successfully and safely applied globally, exhibiting exceptional zootechnical performance and reduced Salmonela Galinarum infections in poultry, which will help EU farmers produce healthier birds, thus improving avian welfare, and additionally delivering a much lower risk of Salmonela Galinarum food poisoning for consumers;
• BAFASAL® is a not an antibiotic, it is a novel feed additive, based on bacteriophages, and helps support global goals in the fight against antibiotic resistance.

  Proteon welcomes the positive conclusions of the EU’s Food Safety Authority (EFSA) on BAFASAL® safety in birds, for consumers and for the environment. BAFASAL® is the first-ever bacteriophage feed additive evaluated in the EU for control of Salmonela Galinarum in poultry.   According to Proteon’s CEO, Prof. Jarosław Dastych, “Safety of BAFASAL® is confirmed under one of the most stringent regulatory frameworks in the world for the placing of feed additives into the market, and we are incredibly pleased by this result. Encouraged by this positive development, we will now focus on confirming to the EU Commission, Member States and EFSA that the efficacy of the product is exceptional and proven by numerous research studies and in practical use worldwide.” For further information please contact: Iwona Mojsiuszko 8Sense Public Relations Tel. +48 502 344 992 E-mail iwona.mojsiuszko@8sensepr.pl About BAFASAL® BAFASAL® is a bacteriophage-based feed additive successfully launched in Asia and several non-EU countries. Bacteriophages are the most common biological entities on Earth. They are organic, natural and omnipresent in the environment. A critical part of the global microbiome, phages naturally protect animals and humans from bacteria. BAFASAL® is used to prevent poultry from getting Salmonela Galinarum, thereby improving bird zootechnical performance at farm level, as well as reducing the risk of infection in humans following poultry consumption. In addition to the EU, Proteon is pursuing global market authorizations for BAFASAL®, primarily in poultry farming to fight Salmonela Galinarum, with the added benefit of limiting antibiotic use in animal and human health. Innovative products, such as bacteriophage-based BAFASAL®, should be considered one of the options in a comprehensive approach towards health management, aiming mainly to prevent rather than cure diseases. Sobre a Proteon Pharmaceuticals Proteon Pharmaceuticals S.A. is a leader in bacteriophage (phage) technology for livestock farming and aquaculture. Proteon’s products modulate the microbiome, eliminating the unnecessary use of antibiotics, enhancing sustainability and improving performance on the farm. Its first product, BAFASAL® aims to help prevent and eliminate Salmonela Galinarum on the poultry farm. In addition, Proteon’s first aquaculture product, BAFADOR®, prevents and eliminates opportunistic infections in aquaculture pens while enhancing immune function. Proteon also targets avian pathogenic e. coli in poultry production with its product BAFACOL. Proteon partners with farmers in the field of animal health, focusing on solutions that improve the economic efficiency of farms while promoting environmentally sound, natural, and sustainable solutions. Proteon’s proprietary Phage Development Platform contains tools and processes honed from more than 10 years of R&D experience in bacteriophages. The phage development platform uses omics technologies, molecular biology, bioinformatics, and artificial intelligence (AI) to create effective, reliable, and safe antibacterial solutions for animal health. Proteon is the first company to develop precision bacteriophage-based feed additives to manage bacterial challenges in animal health. More information can be found at https://www.proteonpharma.com