FDA & VMD approvals for equine and US ophthalmics

RNS Number : 1329G

Dechra Pharmaceuticals PLC

02 May 2014

 

Friday, 2 May 2014

Immediate Release

Dechra Pharmaceuticals PLC (Dechra or the Group) MARKETING APPROVALS Successful FDA and VMD Approvals for Equine Lameness Product and US Ophthalmics Dechra is pleased to announce marketing approvals for products within its equine and ophthalmic veterinary product portfolio: ·      Equine Lameness Dechra 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 navicular syndrome in horses.  In the majority of Europe, the horse is classed as a food producing species therefore we have had to conduct additional studies relating to maximum residue limits for food safety.  The studies are now complete and the European dossier will be filed imminently. Commenting on these successful approvals 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." ·      US Ophthalmics Dechra is also pleased to announce that two major sterile ophthalmic products, Vetropolycin® and Vetropolycin® HC, have received marketing approval 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 US$2.2 million. Dechra took ownership of the marketing authorisations in October 2012 and has spent the subsequent period identifying a suitable manufacturer, transferring the technology and seeking FDA approval for the new site. Ian Page, CEO at Dechra added: "We are delighted to have also received approval for the re-launch of these major products.  In anticipation and ahead of approval, we have already manufactured first stocks and although the initial launch of these ranges will be sold to distributors immediately we do not anticipate there will be a material effect on Group sales and profitability in the current financial year." ·      Canine endocrine submission In addition to the successful approvals outlined above, Dechra has also recently 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 our key therapeutic area of endocrinology, is targeted for approval in the 2016 financial year.  A progress update will be given in due course.

About Osphos® Osphos (clodronate injection) is an injectable bisphosphonate that inhibits the bony resorption in the navicular bone that leads to pain and lameness in the forelimbs of horses affected by navicular syndrome.  Osphos has a direct effect on osteoclasts and also binds calcium phosphate crystals in the bone matrix.  Dechra's Osphos has the unique advantage of intramuscular injection versus other currently approved bisphosphonates which require a lengthy intravenous infusion protocol for administration.  Clinical improvement is most evident at 2 months post-treatment with 74.7% of the horses experiencing improvement in their lameness score. Of the horses that responded to treatment with Osphos in the field study, 65% maintained their level of improvement through the six month evaluation. For horses that initially respond to Osphos, it may be re-administered at three to six month intervals based on recurrence of clinical signs. Dechra has acquired rights to operate within a third party's patent which covers bisphosphonates for the treatment of navicular disease and we also have two patents granted in the EU and US and further international patents pending for our specific product and its application.  About Vetropolycin® and Vetropolycin® HC Vetropolycin (bacitracin-neomycin-polymyxin) Veterinary Ophthalmic Ointment is the only triple antibiotic ointment approved by the FDA for use in dogs and cats for the treatment of superficial bacterial infections of the eyelid and conjunctiva. Vetropolycin HC (bacitracin-neomycin-polymyxin-hydrocortisone acetate 1%) Veterinary Ophthalmic Ointment is the only triple antibiotic ointment with hydrocortisone approved by the FDA for use in dogs and cats with acute or chronic conjunctivitis.   About Dechra Dechra is an international specialist veterinary pharmaceuticals and related products business.  Its expertise is in the development, manufacturing and sales and marketing of high quality products exclusively for veterinarians worldwide.  Dechra's business is unique as the majority of its products are used to treat medical conditions for which there is no other effective solution or have a clinical or dosing advantage over competitor products.  For more information please visit: www.dechra.com Stock Code: Full Listing (Pharmaceuticals): DPH Trademarks Dechra and the Dechra "D" logo are registered trademarks of Dechra Pharmaceuticals PLC. Trademarks appear throughout this release in italics

Enquiries:
Dechra Pharmaceuticals PLC
Ian Page, Chief Executive Officer	Mobile: [phone]
Anne-Francoise Nesmes, Chief Financial Officer	Mobile: [phone] Office: [phone]
e-mail: [e-mail]
TooleyStreet Communications Ltd
Fiona Tooley, Director e-mail: [e-mail]	Office: [phone] Mobile: [phone]

 

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