Vetoquinol Universal Registration Document 2019

2 48   Vetoquinol  Universal Registration Document 2019  Financial report STATEMENT OF NON-FINANCIAL PERFORMANCE Our products 2.6 Our products 2.6.1 Overview of the R&D process The process of taking a molecule or compound through to its approval by the regulatory authorities can take as much as ten years, usually divided into four distinct phases: • Research – The primary purpose of this phase is to identify new biological targets involved in pathological processes. Once these targets are identified and finely characterized, a large number of potential candidate molecules are tested on them (screening) in order to measure their pharmacological activity. • At this stage, the Group incurs limited expenditure and develops a network of contacts with academic and industrial partners in order to evaluate promising candidate molecules and, where appropriate, sign licensing agreements. The Group has built up exten- sive expertise in developing appropriate screening programs and innovative dosage forms which make the drug more competitive (tolerance, means of adminis- tration, etc.). This initial phase culminates in a proof of concept designed to show that the candidate mole- cule(s) is/are suitable for treating the target disease. • Preclinical demonstration of efficacy and tolerance – The purpose of this phase is to assess the selected drug candidate molecule in a controlled environment in accordance with administered doses, and establish a preliminary pharmacokinetic (absorption, distribution, metabolism, elimination) and pharmacodynamic profile vis-à-vis the target animal species. These results allow us to verify the suitability of the candidate molecule for treating the target disease, as well as the future drug’s safety margin (product tolerance). Lastly, this phase enables us to determine and confirm the dosage schedule, i.e. the optimum treatment regime designed to maximize efficacy and minimize side effects. In the animal health industry, this type of preclinical trial corresponds to phases I and II of the human medicine development process. • In the case of drugs destined for food-producing animals (cattle, pigs and poultry) whose products (meat, milk and eggs) are destined for human consumption, residue studies need to be conducted in order to guarantee consumer safety. These studies aim to determine the time lag between the end of treatment and the time of slaughtering (meat industry) or sale of the animal’s products (eggs and milk). The animal or its products cannot enter the food industry chain after this time lag has expired. • Lastly, in the case of drugs destined for food-produ- cing animals, ecotoxicology studies are conducted to demonstrate the harmlessness of drug residues excreted by the animal (droppings, urine, etc.) for the environment: ground, flora and fauna (environmental health). • Development of the production process – This phase is aimed at developing a robust and repeatable pro- duction process resulting in a suitable formulation of the drug candidate and at developing all the processes required for industrial production of the future product. • This phase includes developing the analytical methods used to test product stability and the consistency of its subsequent quality throughout the product’s lifetime. • Clinical trials – These trials conducted on sick animals are the final phase of studies completed before the market authorization application is filed. They cor- respond to phase III of the human drug development process. These trials aim to test the efficacy and safety of the drug and are conducted on a larger sample of animals (200-300) than during the preclinical phase in order to confirm the data generated by the preclinical trials. Lastly, in order to sell a veterinary drug it is necessary to obtain marketing authorization (MA). The MA application contains all the information obtained during develop- ment. After filing, it is subjected to scientific review by the supervisory health and/or farming authorities, in order to verify the quality of the veterinary drug, its har- mlessness to the treated animal, user, consumer and environment, and its efficacy in the strict sense of the word.