Pharmaceutical Product Development

Vetoryl

• It is pleasing to report that we have received notification of compliance for all parts of the Vetoryl USA application from the FDA. An administration process has now commenced and the product will be launched at the North American Veterinary Conference in Florida in January 2009.
• We continue to make satisfactory progress in our Vetoryl applications for Japan, Canada and Australia.
• Vetoryl has been approved in Switzerland and is being marketed by our partner, Veterinaria.

• The completed dossier for Felimazole for the US market has been submitted and we have subsequently had notification of approval of the CMC and safety sections. We remain very confident as to the progress of the efficacy section and anticipate being in a position to receive approval for this product in the first half of the next calendar year.

• Trial work for Equidone® for the US market is almost completed and has provided excellent results.
• Research into other potentially lucrative applications for Equidone has continued at two US universities; initial trial results for one therapeutic indication are very positive.

• Ovuplant® has been approved and marketing commenced in Germany, Spain, France, Ireland, Italy and the Netherlands.

• Prednidale 25, a new dosage form of an existing product, has been approved and launched within the United Kingdom.

• Intraepicaine®, one of our specialist equine products, has been registered and marketed into Ireland.

• Vetivex No 1 has been approved in Ireland and will be marketed soon.

• Atipam®, a UK branded generic, has been approved in partnership with the marketing authorisation holders, Eurovet, and has been launched in the UK.

• Dossiers for two new significant generic products have been submitted for approval.