Bovilis® SBV to Ship in United Kingdom in Coming Weeks
London, UK, 21 May 2013 – MSD 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 MSD, 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, MSD 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 MSD 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.
MSD Animal Health will continue to provide resources and services for the latest disease research. According to KJ Varma, Senior Vice President, Research & Development, MSD Animal Health. “We are committed to working closely with the livestock community to ensure the well-being of their animals.”
MSD 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 MSD Animal Health’s Veterinary Support Group on 01908 685685.
About MSD Animal Health
Today’s MSD is a global healthcare leader working to help the world be well. MSD Animal Health, known as Merck Animal Health in the United States and Canada, is the global animal health business unit of MSD. MSD Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. MSD 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. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com .
Merck forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).