The product development pipeline continues to deliver:
- new products for global markets:
- Methoxasol, an antimicrobial for swine and poultry has been approved in the EU;
- Buprenodale, a multi-dose small animal analgesic, has received authorisation throughout the EU; and
- Anesketin, a generic companion animal sedative, has been approved in seven EU countries.
registrations in new territories:
- Soludox, our water soluble antibiotic for swine and poultry, has a new indication for turkeys in the EU;
- Felimazole 1.25mg, a new low dose strength to increase dosing options has been approved throughout the EU; and
- Comfortan, a companion animal analgesic has received an extension to its approval for use in cats.
- Libromide, used in the treatment of canine epilepsy, has had its EU registration extended into France, Austria, Portugal and Switzerland;
- Felimazole, for feline hyperthyroidism, has been approved in Australia; and
- Vetoryl, for the treatment of canine Cushing's syndrome, has been approved in South Korea, Brazil and New Zealand.
The Methoxasol and Soludox registrations extend our portfolio of food producing animal antimicrobial products which will provide new opportunities in this competitive market. The Comfortan, Buprenodale and Anesketin approvals give us the widest and most complete range of analgesics and sedatives of any animal health company within the EU. This further strengthens our position as a market leader in critical care. The Felimazole 1.25mg registration increases dosing options which allows veterinarians to better manage feline hyperthyroidism where each cat requires its own specific dosing regime. The introduction also further differentiates us from a generic version of the drug which has recently been launched in a number of EU territories.
There has been material progress on our novel product pipeline. We have previously reported that the first major product launch, an equine lameness product, to be branded Osphos®, had experienced delays due to an enforced change to a new third party manufacturer. We anticipate making a submission for registration of this product in the UK, Canada and Australia imminently. As the horse, in the majority of the EU, is classed as a food producing species we are currently conducting work to establish a maximum residue level prior to submission for approval throughout the rest of Europe. In the US the product already has complete safety and efficacy sections from the FDA. CMC section, the final requirement for the US submission, is dependent upon a successful FDA inspection of the third party manufacturing site.
A second major product, for a canine endocrine disorder, was originally intended to be manufactured by a third party. However, following ongoing external supply problems and the successful FDA approval of our own site in Skipton for solid oral dosage forms, a strategic decision was made to invest in manufacturing in-house wherever possible. The necessary equipment has been acquired and validated at our Skipton site and the pilot batch has been manufactured. The clinical trial is at an advanced stage with all the dogs now enrolled and initial results are very positive.
There are an additional six novel products in the development pipeline, three of which have long term patent protection: four novel products are for the global market and two are targeted specifically at the EU. There are also three major differentiated generic products for food producing animals under development. A potential twelfth product is at an advanced stage of assessment for inclusion in the programme.
We anticipate a further two clinical trials to commence within the new calendar year.
In addition to the novel products in development we have several generics, territory expansion and range extending products in development. Furthermore, we have a number of exploratory ideas to pursue.