Osphos (clodronate injection), a novel equine product, has received approval from the US FDA and the UK Veterinary Medicines Directorate (VMD) and is expected to be launched at the beginning of our new financial year.
The product is an intramuscular injection used to control the clinical signs of navicular syndrome, estimated to cause a third of all forelimb lameness in horses. There are several benefits to the product relating to its efficacy, safety and relative ease of administration by the veterinarian.
The opportunity was first identified by our Business Development team who developed a relationship with a German veterinarian, the inventor. He had an excellent proof of concept study, enabling us to feel confident that the drug would be both safe and efficacious.
After evaluating the market potential, our Marketing teams decided that this product represented a strong addition to our equine portfolio. On this basis we reached a commercial agreement and designed the development project.
Following the dose characterisation study, we conducted a multi-site clinical field study to evaluate the effectiveness of Osphos. After completing all our development activities and preparing a registration dossier, we filed successfully in the UK and US.
However, in Europe, where horses are considered a food-producing animal, we required additional information about the product's maximum residue limit (MRL) to establish the safety of the product for a human consuming horse meat. The approval application for the EU has now been submitted.
Manufacturing presented the single greatest challenge for the approval of Osphos. As neither of our manufacturing sites has FDA approval for manufacturing aseptic fill products, manufacturing has been contracted to an outside firm.
Osphos is one of many projects that show our strategic focus on pipeline delivery, as well as demonstrating our ability to work effectively with the authorities to deliver products with clinical benefits that complement our existing portfolio.
Our launch plans in the US and UK are ready and Osphos will be available in the first half of our 2015 financial year. We are eagerly anticipating the launch of this new major product.