Product Development
Dechra Veterinary Products focuses on the sales, marketing and development of specialist pharmaceuticals for companion animals. Key therapeutic areas of expertise include:
- Endocrinology
- Local anaesthesia
- Equine musculo-skeletal disorders
In developing its own range of branded pharmaceutical products, Dechra is ideally positioned thanks to the benefits it derives from being part of a wider group of companies operating in the animal health sector. As such it remains close to market developments, manufacturing techniques, distribution channels and regulatory issues.
Dechra’s technical expertise is far reaching:
- Development of different product presentations and formulations (tablets, liquids etc)
- Comprehensive understanding and experience of pharmaceutical manufacturing
- Clinical trials design and management
- Toxicology monitoring and reporting
- Thorough understanding of the veterinary regulatory environment
- Global licensing
There are a number of exciting initiatives currently underway as part of Dechra’s ongoing product development programme and some of the key milestones include:
Expanding Dechra’s endocrine therapies
Vetoryl Capsules, which are used for the treatment of Cushing’s disease in dogs, have received approval for marketing in all 19 European territories which were applied for. This is a major achievement for the Regulatory team and is now the second product that has been successfully licensed throughout the key territories of Europe.
Guidance has been received on Vetoryl Capsules from the US regulators , the FDA, providing clear requirements on the further clinical trial work necessary to satisfy US regulations. Protocols for these trials have been submitted and are awaiting approval. Trial sites have been identified on the East coast of America and implementation will commence shortly. These trials are expected to be completed by the end of 2007.
A 10 mg strength Vetoryl Capsule, which will improve maintenance dosage options, is also under development for introduction to all markets.
Felimazole coated tablets, Dechra’s own-developed tablet for feline hyperthyroidism, is also currently undergoing trials within the USA. The protocol for the efficacy study has been approved by the FDA and the trials have commenced.
Felimazole coated tablets and Vetoryl Capsules also represent a sizeable opportunity in other territories. Dossiers have already been submitted to the Australian and Canadian authorities and negotiations are underway to identify partners in other territories where there are significant companion animal markets.
A series of international agreements for Dechra’s own branded products
A development and marketing contract has been agreed with Vétoquinol, Canada.
Vétoquinol will lead the licence applications for Vetoryl and Felimazole coated tablets and will market the products following approval, initially for a period of five years, in the Canadian market.
Dechra has secured a distribution agreement with Orion Pharma in Finland to market Vetoryl and Felimazole coated tablets into the Nordic countries. An agreement with Veterinaria to market Equipalazone, Vetoryl and Felimazole coated tablets in Switzerland was also signed.
Introduction of new equine product
Dechra has been granted a UK marketing authorisation for Ovuplant implant, whose chemical entity is the intellectual property of the Australian biotechnology company, Peptech Animal Health. Ovuplant is a controlled-release, synthetic hormone that stimulates ovulation in brood mares and it is used widely by horse breeders in a number of worldwide markets. |