Veterinary Medicines Directorate Grants Provisional Marketing Authorisation to Merck Animal Health for First Vaccine Targeting Schmallenberg Virus

Bovilis® SBV to Ship in United Kingdom in Coming Weeks 

London, UK, 21 May 2013 – Merck Animal Health announced today that the Veterinary Medicines Directorate (VMD) of the United Kingdom has granted the company a provisional marketing authorisation for Bovilis® SBV, the first vaccine specifically targeting the Schmallenberg virus (SBV) in cattle and sheep.

SBV, which emerged in late 2011, is transmitted via insect vectors, mainly midges, and causes transient clinical symptoms in adult cattle and sheep, such as fever, diarrhea and reduced milk yield, as well as congenital malformation in newborn calves and lambs. As of March 31 2013, 1753 cases of SBV have been confirmed throughout the UK. SBV has now been detected in every county in England and Wales.

“On behalf of Merck Merck, we would like to thank the VMD for its partnership and support to fast track the availability of Bovilis® SBV to the market,” said Andras Bolcskei, Country Manager, Merck Animal Health UK. “There was a tremendous urgency for a SBV vaccine in the UK especially given the marked increase in confirmed cases over the past year and the increasing importance to help control this devastating disease.”

Studies conducted by Merck Animal Health in support of the provisional marketing authorisation reported that all animals responded with formation of virus neutralizing antibodies. During the studies, reduced viraemia against SBV was observed in sheep vaccinated once and prevention of viraemia was observed in cattle vaccinated twice, whereas all animals in the control groups developed infection and became viraemic. In studies to date, Bovilis® SBV has been shown to be efficacious in cattle and sheep.

The vaccine is based on wild-type SBV that has been inactivated and contains an adjuvant that stimulates the immune response. The vaccine will be available in 20ml and 100ml vials. Bovilis® SBV is indicated for the active immunization of cattle to prevent viraemia against SBV and for the active immunization of sheep to reduce viraemia against SBV.

Merck Animal Health will continue to provide resources and services for the latest disease research. According to KJ Varma, Senior Vice President, Research & Development, Merck Animal Health. “We are committed to working closely with the livestock community to ensure the well-being of their animals.”

Merck Animal Health is working diligently to expedite stocks to the UK. Farmers interested in more information about the vaccine should contact their veterinary surgeon or Merck Animal Health’s Veterinary Support Group on 01908 685685.

About Merck Animal Health
Today’s Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as Merck Animal Health in the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit .

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