Tuesday - March 26, 2019

Bayer receives positive opinion from European Medicines Agency for Baycox® Iron injection for piglets

Bayer’s novel, patented toltrazuril plus gleptoferron injectable combination is a step closer to European authorization
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Young piglets need to be protected from coccidiosis and iron deficiency anaemia

Monheim, March 26, 2019 – The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has, by consensus, adopted a positive opinion recommending marketing authorisation for the veterinary medicinal product Baycox® Iron (36 mg/ml toltrazuril plus 182 mg/ml gleptoferron) suspension for injection for piglets.

If granted marketing approval by the European Commission, Baycox® Iron suspension for injection will be an innovative combination for the concurrent prevention of clinical signs of coccidiosis (such as diarrhoea) in neonatal piglets on farms with a confirmed history of coccidiosis caused by Cystoisospora suis, and prevention of iron deficiency anaemia. Detailed conditions of the product will be described in the summary of product characteristics (SPC), which will be published together with the European public assessment report (EPAR) after approval.

About Coccidiosis
Coccidiosis is a major parasitic disease affecting a wide range of domestic and wild animals. In pigs, Cystoisospora suis is the most pathogenic species of swine coccidian, mainly affecting suckling piglets and causing sympotms such as pasty to watery diarrhea and weight loss. The disease will impact a piglet’s health and performance throughout its life. Long term consequences include lower growth rates, increasing the number of days to achieve market weight and related costs. Due to its worldwide presence, coccidiosis is considered to be one of major causes of economic loses for farmers. Bayer introduced the first toltrazuril based oral solution (Baycox® 5%) for swine more than 20 years ago helping farmers to prevent the clinical signs of coccidiosis in neonatal piglets with a single oral treatment.

About Iron Deficiency Anemia
Due to their rapid growth, the limited iron reserves at birth and the low levels of this element provided through the sow’s milk, piglets are at risk of developing iron deficiency anemia in the early stages of their life. Iron deficiency anemia will manifest in poor growth levels and ill thrift. To ensure proper health and development, supplementation of iron in the first week of the piglet’s life has been a standard practice in swine farms worldwide.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.com.

Find more information at www.animalhealth.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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