Merck Animal Health Receives Approval for PORCILIS® PCV M Hyo Vaccine in Europe
Europe’s First Single-Shot Vaccine to Protect Piglets from Both Porcine Circovirus Type 2 and Mycoplasma hyopneumoniae Infections
SUMMIT, N.J., November 24, 2014 – Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced that, following a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission has approved PORCILIS® PCV M Hyo, the only, ready-to-use single-injection combination vaccine in Europe that protects piglets against Porcine Circovirus and Mycoplasma hyopneumoniae infections during the fattening period.
PCV2 is widely prevalent in swine herds around the world and can affect weight gain and overall performance, even if there are no outward signs of infection. Severe cases of the disease can result in rapid weight loss, diarrhea and even death. M. hyopneumoniae damages the airways of the lower respiratory tract and allows for secondary infections to occur, which can reduce productivity and lead to significant economic losses for producers.
“PCV2 and M. hyopneumoniae are two of the most important contributors to respiratory diseases in pigs and are a considerable burden to swine producers,” said Narciso Bento, Global Swine Business, Merck Animal Health. “PORCILIS PCV M Hyo is a convenient new option for producers and provides the immunity piglets need during a crucial time in their development.”
The PORCILIS PCV M Hyo vaccine reduces the number of vaccinations given to young piglets by providing protection against both diseases for at least 21 weeks after a single injection with no restrictions to maternally derived antibody levels. The vaccine comes ready-to-use and does not require mixing.
“Combining these two vaccines into a single injection is a technical breakthrough,” said Ruud Segers, Global R&D Swine Biologicals, Merck Animal Health. “It delivers a favorable safety profile while retaining strong efficacy against both pathogens providing protection for piglets and assurance for farmers.”
PORCILIS® PCV M Hyo is indicated for the active immunization of piglets to:
- Reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by Porcine Circovirus type 2 infection
- Reduce severity of lung lesions caused by Mycoplasma hyopneumoniae infection
- Reduce the loss of daily weight gain during the finishing period in face of infections with M. hyopneumoniae and/or PCV2 (as observed in field studies)
The product has expiry dating of 2 years. Detailed conditions of the product are described in the summary of product characteristics (SPC), published on the European Medicines Agency’s website.
About Merck Animal Health
Today’s Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck.Through its commitment to the Science of Healthier Animals™, 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 www.merck-animal-health.com or connect with us on LinkedIn.
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 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 2013 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).