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Pharmaceutical Product Update

9th Feb 2005 07:00

Dechra Pharmaceuticals PLC09 February 2005 Issued by Citigate Dewe Rogerson Limited, BirminghamDate: Wednesday, 9 February 2005 Embargoed: 7.00am Dechra Pharmaceuticals PLC Dechra adds new licensed veterinary products and marketing partnership to its portfolio In line with the Board's strategic focus of developing the Group's ownpharmaceutical portfolio both in the UK and internationally, the Directors ofDechra Pharmaceuticals ("Dechra" or "the Group") are pleased to announce thefollowing achievements in their veterinary product development programme: Group launches its first significant licensed branded generic product for dogsDechra has also secured marketing approval for its first licensed brandedgeneric veterinary product. This significant new product will be the firstgeneric entrant to be launched in a UK market worth approximately £1.9 million;it will be marketed for the Group by Arnolds from April when further detailswill be made available. Ovuplant(R)Dechra's regulatory team have been successfully granted a UK marketingauthorisation for Ovuplant(R) whose chemical entity is the intellectual propertyof the Australian bio-technology company, Peptech Animal Health. Arnolds Veterinary Products ("Arnolds"), the sales & marketing division ofDechra is expected to commence marketing the product in the last quarter of thecurrent financial year. Ovuplant(R), is a controlled-release, synthetic hormone that stimulatesovulation in brood mares within 48 hours of implantation. The seasonal productis used widely by horse breeders in a number of worldwide markets including NewZealand, Argentina, South Africa, Canada and Australia. It is estimated byPeptech that there are approximately 10,000 thoroughbred mares bred each year inthe United Kingdom, from a total population of 120,000 commercial horses. The Mutual Recognition process has commenced to licence Ovuplant(R) in Europe(EU), a primary market which accounts for approximately 45,000 thoroughbredmares, of which around 25,000 are in France, Italy and Germany. Canadian Marketing Partnership for Felimazole(R) and Vetoryl(R)The Group has signed a marketing agreement with Vetoquinol, Canada. Thepartnership, which will run for an initial period of 5 years, allows Vetoquinol,Canada the marketing and distribution rights to Dechra's own developed productsFelimazole(R) and Vetoryl(R). Dechra will retain all intellectual propertyrights to both products which will be manufactured for the Canadian market atDales Pharmaceuticals, Dechra's manufacturing division. This agreement follows on from similar successful partnerships established bythe Group. It clearly underpins the Group's strategy to develop and license theGroup's own branded veterinary pharmaceutical portfolio in key internationalterritories. continued... -2- Preliminary FDA Meeting for Felimazole(R)Dechra has been granted a meeting on the 2nd March with the United States Foodand Drug Administration ("FDA") to review the suitability of the Felimazole(R)dossier for the US Market. Range ExtensionsAs previously indicated, the Group has received authorisation in the UK from theVeterinary Medicines Directorate ("VMD") for its Felimazole(R) and Vetoryl(R)range extensions. A 30mg Vetoryl(R) capsule, targeted specifically at small dogsand a 2.5mg Felimazole(R) tablet for cats have been added to our successfulportfolio. These important extensions offer greater flexibility and dosingoptions to the veterinary practitioner. Vetoryl(R), currently supplied in bulk packs of 100, will also be re-launched inApril in blister packs of 30 capsules. Interim ResultsThe Group will announce Interim Results on Tuesday 1 March 2005. Enquiries:Ian Page, Chief Executive Fiona Tooley, DirectorSimon Evans, Group Finance Director Katie Dale, Account ManagerDechra Pharmaceuticals PLC Citigate Dewe RogersonToday: +44 (0) 1782 771100 Today: +44 (0)121 455 8370Mobile: 07775 642222 (IP) or 07775 642220 (SE) Mobile: 07785 703523 (FMT)www.dechra.com Editors Background Notes: Peptech Limitedwww.peptech.comPeptech focuses on the research and development of peptides and proteins in theareas of human pharmaceuticals and animal health. The company is positioned tobecome a globally recognised leader in bio-pharmaceutical development. PeptechAnimal Health is a wholly owned subsidiary of Peptech Limited. Vetoquinolwww.vetoquinol.comVetoquinol is a family-owned, independent company exclusively and passionatelydedicated to all aspects of animal health: research, development, manufacturing,marketing and sales. Since 1933, the Company has been providing its expertise toveterinary surgeons in the fields of anti-infectives, anti-inflammatories,anti-parasitics, vaccines and nutraceuticals. Vetoquinol supplies products in 5Continents through a network of subsidiaries in 15 countries and distributors inover 80. About Dechra Pharmaceuticals PLCwww.dechra.comDechra Pharmaceuticals are specialists in the UK and international veterinaryand animal healthcare markets. Key to the Group's strategy is the development ofits veterinary pharmaceuticals portfolio. Quoted on the London Stock Exchange(under pharmaceuticals and biotech: Reuters: DPH.L), the business is split intotwo divisions: the pharmaceutical division which includes Arnolds VeterinaryProducts ("Arnolds") and Dales Pharmaceuticals ("Dales") and the servicesdivision which includes National Veterinary Services ("NVS"), NationWideLaboratories ("NWL"), Cambridge Specialist Laboratory Services ("CSLS") andVetcom Practice Management Systems ("Vetcom"). Arnolds Veterinary ProductsArnolds is one of the most well respected and recognised brand names in theveterinary markets and holds a leading position in several specialist veterinarypharmaceutical sectors of the UK market such as endocrinology, local anaesthesiaand equine anti-inflammatory with strong positions in several other companionanimal sectors. Its pipeline in product development remains centred around:cardiology, endocrinology, respiratory and oncology. Ovuplant(R)Ovuplant(R), is a controlled-release, synthetic hormone that stimulatesovulation in brood mares within 48 hours of implantation. It is estimated byPeptech that there are approximately 10,000 thoroughbred mares bred each year inthe United Kingdom, from a total population of 120,000 commercial horses. Theability to pinpoint ovulation with a high degree of accuracy allows breeders toschedule natural or artificial insemination, and maximise the chance ofconception. This greatly reduces the potential need for repeats visits bystallions during one ovulation cycle. Stallion service fees, which are payableupon confirmation of pregnancy, can be as high as £50,000 in the United Kingdom. Vetoryl(R)Vetoryl(R) developed and launched to the UK market in 2001 by Arnolds ismanufactured at Dechra's facility, Dales Pharmaceuticals and marketed anddistributed under the Arnolds brand. The chemical entity Trilostane has beenhighly effective in the treatment of Cushing's syndrome, an endocrine disorderin dogs, where it selectively blocks glucocorticoid synthesis, reducing serumcortisol levels. Research has shown that, by controlling the clinical signs ofthe disease, symptoms in over 90% of dogs with the condition have been relieved. Felimazole(R)Felimazole(R) was launched into the UK market in April 2002, its license beingextended for lifelong treatment of Feline Hyperthyroidism in December 2002.Felimazole(R) is the only licensed product on the market and was developedin-house by Arnolds Veterinary Products. Feline Hyperthyroidism is the mostcommonly diagnosed endocrine disorder in cats, in over 70% of cases the thyroidgland is enlarged. Clinical signs are hyperactivity, weight loss, increasedheart rate and anxiety. The disease affects cats mainly over the age of 10years. Methimazole, the chemical active in Felimazole(R) is effective inreducing the high serum thyroid hormone concentrations, thus enabling the cat tostabilise its thyroid hormone production and alleviate the clinical symptoms ofthe disease. This information is provided by RNS The company news service from the London Stock Exchange

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