Veterinary market

Veterinary medicines and inspections. This unit is responsible for veterinary marketing authorization procedures and inspections. 

Concurrent with the development of ivermectin for the veterinary market, Merck began to report field studies demonstrating the insecticidal potential of ivermectin s parent structure, avermectin B1 (abamectin) (6). Avermectin B1 is currently under development for control of phytophagous mites and certain insect species such as leaf miners in crops and omamentds (g). 

Ticks have been the predominant focus of anti-ectoparasite vaccine resejuch, since the report by Trager (/2(5). During the 64 years since that publication, many attempts have been made to induce anti-tick immunity with whole tick extracts, salivary gland extracts, and most recently with defined immunogens. Conunercial development of the anti-. microplus vaccines TickGARD Plus in Australia and GAVAC Plus in Latin America establish the feasibility and utility of anti-tick vaccines in the veterinary market 12, 22). 

The use of controlled delivery systems for veterinary applications hcis increcised in recent years. The veterinary market can be divided in two segments production animals... 

Furium. N[4-(5-Nitro-2-furanyl)-2-thia2olyl]acetamide, has demonstrated activity against baciUi and pathogenic enterobacteria (24). The product, prepared from thiourea and 2-bromo-l-(5-nitro-2-furanyl)ethanone followed by acetylation of the intermediate aminothia2ole with acetic anhydride in pyridine (25), is marketed in several countries for both human and veterinary use. 

Nitrovin. 2- 3-(5-Nitro-2-furanyl)-l-[2-(5-nitro-2-furanyl)ethenyl]-2-propenyhdene hydrazinecarboximidamide hydrochloride has been marketed for both human and veterinary use as an antibacterial agent. The product, which has also seen use as a veterinary food additive (32), is prepared from 5-nitro-2-furan-carboxaldehyde and acetone followed by treatment of the resulting dione with aininoguariidine (33). 

Commission Regulation (EC) No. 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State... 

The previous chapters examined the process for the development and authorisation of a drug product containing a ne v active ingredient for human use. This represents the most arduous path to market for any medicinal product. This chapter proceeds to examine the process of bringing a veterinary medicinal product to market. While the process shares most of the principles that apply to human drugs, there are some additional features that are unique to veterinary products. These include methods of use and the requirement to evaluate vithdra val periods and maximum residue limits in food-producing species. 

The process of developing and bringing to market veterinary medicines is fundamentally the same as that for human medicines. However, there are a number of features associated with veterinary medicines that can have either a positive or negative bearing on the overall process. 

The authorisation of veterinary medicines containing a new chemical entity for use in food-producing animals involves a two-stage application process (i) an application to establish MRLs and (ii) an application for a marketing authorisation. 

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

Figure 7.6 Outline of the dossier structure for a marketing application for a veterinary product.

In the EU, a basic requirement for marketing authorisation holders (MAHs) is that they must have permanently and continuously at their disposal a nominated qualified person, with responsibility for pharmacovigilance. This person should have experience in all aspects of pharmacovigilance and, if not the holder of a medical or veterinary qualification, they should have access to such a person. The duties of the qualified person include ... 

EMEA/CVMP/004/98 final Note for Guidance— Excipients in the dossier for application for marketing authorisation for veterinary medicinal products (February 1999)... 

Although, MediChem is a biosecurity products manufacturer, its biotechnology-based R D capabilities are worth mentioning here. The attended markets include Medical, Laboratory, Veterinary, and Environmental sectors. Medicinal chemistry services and drug discovery form the basis of the company, though their capabilities might be applied in a broader range of sectors. These capabilities comprise the areas of Proteomics, Combinatorial and Computational Chemistry, Medicinal Chemistry, Enzymes, Process Development, Analytical and Separations Chemistry, Chemical Synthesis and Scale Up. 

Enzymes involved in TG synthesis continue to represent challenging and intriguing targets for small-molecule intervention against the worldwide epidemic of obesity, metabolic syndrome, and type 2 diabetes, as well as smaller market indications from rare familial diseases to veterinary use. There is also intriguing evidence that inhibition of these enzymes may be beneficial for diseases unrelated to the area of metabolic disorders, such... 

Although most biopharmaceuticals approved to date are intended for human use, a number of products destined for veterinary application have also come on the market. One early such example is that of recombinant bovine GH (Somatotrophin), which was approved in the USA in the early 1990s and used to increase milk yields from dairy cattle. Additional examples of approved veterinary biopharmaceuticals include a range of recombinant vaccines and an interferon-based product (Table 1.7). 

The application of vaccine technology forms a core element of modern medicinal endeavour. It plays a central role in both human and veterinary medicine and represents the only commonly employed prophylactic (i.e. preventative) approach undertaken to control many infectious diseases. The current (annual) global vaccine market stands at in excess of US 3 billion. Immunization programmes, particularly those undertaken on a multinational scale, have served to reduce dramatically the incidence of many killer/disabling diseases, such as smallpox, polio and tuberculosis. 

---