The European Medicines Agency approves the world's first vaccine against swine dysentery.

The origin of the vaccine is the research of the Digesporc group, led by Professor Pedro Rubio, Professor of Infectious Diseases at the University of León

The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has positively evaluated the Biobhyo vaccine designed by the University of León spin-off Aquilón Cyl . It is the world's first vaccine against swine dysentery , a highly contagious gastrointestinal disease that causes significant economic losses in the livestock sector.

Swine dysentery affects more than four million animals in Spain each year, with an estimated economic impact of €15 million, considering the national pork industry alone. The disease, caused by the bacterium Brachyspira hyodysenteriae, causes mucohemorrhagic diarrhea in animals.   severe, weight loss and, in the most serious cases, death.

One of the factors motivating the development of this vaccine is the growing increase in resistance to existing antibiotics, as well as current animal management and welfare regulations, which make it difficult to control on farms. According to Marta García Díez, project director at Aquilón, the Biobhyo vaccine represents a health and production breakthrough for the European livestock sector.

In field trials conducted on various farms in Spain and Portugal, the vaccine has demonstrated an efficacy of nearly 90% and high safety, even in heavily pregnant sows.

The EMA's Scientific Committee's support for the vaccine developed in León represents not only a milestone for the biotechnology company Aquilón and the University of León, but also a clear example of the impact that collaboration between university research and the business sector can generate. This step marks the preliminary phase for final approval by the EMA, which would pave the way for its commercialization throughout Europe in the coming months.

ORIGIN OF THE VACCINE

The vaccine's origin lies in the research of the Digesporc group, led by Professor Pedro Rubio, Professor of Infectious Diseases at the University of León, which has focused on disease management since 2006.

Based on the knowledge acquired in this pioneering research, the vaccine project was developed. This was one of the three projects that formed the basis of the business plan that led to the creation of Aquilón in 2012, thanks to the entry of Janus Developments and the Seguranza fund into the company's management and capital, respectively.

The development of the vaccine, led by Aquilón with scientific support from the Digesporc group and industrial support from the Zendal group's CZV company, has resulted in two families of patents approved in more than 30 countries. The 12 years of work required to complete the project until its registration in the EU have involved an investment of approximately €4 million and the direct or indirect involvement of more than 50 people. Independent projections give the vaccine a sales potential of approximately €20 million annually in Europe alone.

It should be noted that the European Union's centralized veterinary product approval procedure is mandatory for highly innovative biotech products, and that over the last five years, fewer than 10 products from Spanish companies have been approved through this procedure.

For Aquilón, this registration marks the second veterinary product to be registered, following the approval of a diagnostic test for porcine brucellosis in February 2023, in collaboration with the University of Navarra. The fact that two of the veterinary biotechnology products approved in Europe through the centralized procedure in recent years come from Aquilón's research and development validates the company's highly innovative model, capable of acting as an agent of transformation of academic knowledge into useful services and products with a high impact on the veterinary sector.