Basel, Switzerland, 1 May, 2002 - Novartis Animal Health will relaunch its swine antibiotic Econor® (valnemulin) in the European Union following a decision by the European Commission (EC) to lift the 19-month marketing suspension on the unique new-generation pleuromutilin.
The EC ruling was based on a unanimous recommendation from the Committee of Veterinary Medicinal Products (CVMP) to reinstate Econor's Marketing Authorisation with an amended label, says Hans-Beat Gürtler, CEO of Novartis Animal Health.
Econor was introduced to Europe in 1999, but reports of adverse drug reactions (ADRs) emerged in four countries, principally Scandinavia, explains Dr. Ulrich Klein, professional services veterinarian for Novartis Animal Health. The antibiotic was withdrawn from the market in 2000. However, an exhaustive investigation demonstrated that ADRs occurred almost exclusively in Swedish and Danish pigs, which appear to have a liver enzyme deficiency that makes them sensitive to Econor.
Econor's label will now advise that the product be used with "extreme care" in pigs of Scandinavian origin, particularly the Danish and Swedish Landrace breeds and their crossbreeds, Klein says.
The veterinarian points out that Econor was developed specifically for use in food animals and that no pleuromutilin antibiotics are used in human medicine. "This is a tremendous benefit considering the growing concern for cross-resistance and transfer of resistance to humans," he says.
The foregoing information contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations regarding future research and development results could be affected by, among other things, unexpected regulatory delays or government regulation generally; uncertainties relating product development; the introduction of competitive products; changes in the company's ability to obtain or maintain patent and other proprietary intellectual property protection and competition in general. Some of these factors are discussed in the Form 20-F filed by Novartis with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
Novartis Animal Health researches, develops and commercialises leading animal treatments that meet the needs of pet owners, farmers and veterinarians. Headquartered in Basel, Switzerland and present in 40 countries, Novartis Animal Health employs approximately 2300 associates worldwide and achieved sales of CHF 962 million in 2001. For more information, please consult www.ah.novartis.com.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 71 000 people and operate in over 140 countries around the world. For further information please consult www.novartis.com
