Dechra set for overseas sales boost after winning approval for new drugs
PHARMACEUTICALS group Dechra has received a boost to its international sales after receiving marketing approvals for new products within its equine and ophthalmic veterinary businesses.
It has received approvals from both the US Food and Drug Administration (FDA) and the UK Veterinary Medicines Directorate (VMD) for its specialist product Osphos®.
Osphos (clodronate injection) is used for the control of clinical signs associated with equine lameness or navicular syndrome in horses.
Winning approval was not without its problems as in the majority of Europe, the horse is classed as a food producing species therefore the group had to conduct additional studies relating to maximum residue limits for food safety. The studies are now complete and it said it would be filing the European dossier imminently.
Ian Page, CEO at Dechra, said: “Osphos represents a significant product opportunity to Dechra with estimates that navicular syndrome is responsible for one third of all chronic forelimb lameness in adult horses. The product will be manufactured from June 2014 and we anticipated launch in both the US and UK at the beginning of our new financial year.”
Dechra has also received marketing approval for two major sterile ophthalmic products, Vetropolycin® and Vetropolycin® HC. They have been cleared for re-launch in the US following their transfer into a new manufacturing site.
These ophthalmic products are unique in being the only veterinary approved products within their sector. Historically they were sold by the group up until January 2010 under an exclusive marketing agreement and at their peak sales were approximately $2.2m.
Dechra took ownership of the marketing authorisations in October 2012 and has spent the period since identifying a suitable manufacturer, transferring the technology and seeking FDA approval for the new site.
Page said that in anticipation of approval, the group had already manufactured first stocks and although the initial launch of these ranges would be sold to distributors immediately, it did not anticipate there would be a material effect on group sales and profitability in the current financial year.
In addition to these successful approvals, Dechra has also submitted the dossier for a canine endocrine product for approval through the Centralised Procedure in the EU, and will imminently be submitting the dossier for FDA review. The product, which strengthens the group’s business in the therapeutic area of endocrinology, is targeted for approval in the 2016 financial year. A progress update will be given in due course.
