MONTREAL, QUEBEC--(Marketwired - Nov. 15, 2016) - Prevtec Microbia Inc. is pleased to announce that its German subsidiary, Prevtec Microbia GmbH, received a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA), recommending the granting of a marketing authorization for Coliprotec® F4/F18 in the European Union. Coliprotec® F4/F18 will be the first single dose oral vaccine intended for active immunization of pigs against enterotoxigenic F4- and F18-positive E. coli, a causative agent of post-weaning diarrhea (PWD), a major cause of economic loss for swine producers.
Through preventative immunization, Coliprotec® F4/F18 contributes to the health of piglets by reducing the incidence of moderate to severe post-weaning diarrhea (PWD) and the fecal shedding of enterotoxigenic F4- and F18-positive Escherichia coli from infected pigs.
"The adoption of the positive opinion by the CVMP represents an important milestone towards the registration of Coliprotec® F4/F18 in the European Union," says Michel Fortin, President and CEO of Prevtec Microbia Inc. "We believe our product will be very well received by veterinarians and swine producers in the European Union and will contribute to the responsible use of antibiotics for Escherichia coli control, enabling a shift towards more sustainable farming", added Dr. Éric Nadeau, Vice-President Scientific Affairs.
Following the adoption of the market authorization by the European Commission, Coliprotec® F4/F18 will be distributed in the European Union giving access for European Veterinarians and Swine Producers to an innovative product to better prevent both F4 and F18 E. coli causing post-weaning diarrhea.
A temporary use authorization for Coliprotec® F4/F18 was recently released by the French Agency for Veterinary Medicinal Products (ANMV).
Coliprotec® F4/F18 has been developed by Prevtec Microbia.
About Prevtec Microbia
Prevtec Microbia is a Canadian biotechnology company developing biological products for the prevention of diseases in food animals and as an alternative to antibiotics. The Company's mission is to find better ways to feed the planet by developing technologies that improve animal health and increase animal production performance.
Prevtec Microbia's first commercial product, Coliprotec®F4, a swine E. coli vaccine, has been sold across Canada since 2007. In March 2015, the European Commission granted a marketing authorization for for Coliprotec® F4 in the European Union. See more information at www.prevtecmicrobia.com.