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Product Update

12th Jul 2005 07:00

Sinclair Pharma PLC12 July 2005 SINCLAIR PHARMA PLC OBTAINS EU REGISTRATION FOR TWO NEW ORAL HEALTH PRODUCTS: DECAPINOL(R) TOOTHPASTE AND DECAPINOL GEL(R) REGISTRATION SIGNIFICANTLY INCREASES ADDRESSABLE MARKETS IN EU Godalming UK, 12 July, 2005: Sinclair Pharma plc ("Sinclair" or the "Company")(SPH.L), the specialty pharmaceutical company, announces that it has obtained EUregistration for two new oral health products - Decapinol(R) Toothpaste (atoothpaste for treating gingivitis) and Decapinol(R) Gel (a product for theintensive professional treatment of gum infections). Both products are based onthe technology behind Decapinol(R), the company's EU and US approved oral rinsefor the treatment and prevention of gingivitis. These registrationssignificantly increase the addressable market for Decapinol(R) as the sale ofmedicated toothpastes is greater than that for oral rinses. Today's announcement represents a further step of the Company's stated objectiveto fully exploit the novel mechanism of action behind Decapinol(R). Decapinol(R) is a new type of oral rinse which has been clinically proven in tests withover 2,000 patients to treat and prevent gingivitis. Decapinol(R)'s novelmechanism of action includes the creation of a bioadhesive barrier on the teethand gums. This barrier selectively interferes with the attachment of harmfulbacteria to the teeth and gum surfaces thus preventing the colonisation ofbacteria at the interface of teeth and gum - the starting point for gingivitis.Decapinol(R)'s action is different from antiseptics and antibiotics which maykill all oral bacteria and can consequently affect the natural balance ofbeneficial bacteria in the mouth. Sinclair believes that Decapinol(R) is thefirst new chemical entity approved for gingivitis in the past 30 years and thatit has the potential to grow the existing market. The combined market for allmouthwashes and toothpastes is estimated to be worth $12.5 billion of which$10.5 billion is toothpastes. The market for specific gingivitis products iscurrently estimated to be worth £1.5 billion. Prof. Rolf Attstrom from the Department of Periodontology, at Lund University,Sweden, said: "It is very important for patients with gingivitis that 'ecological' balance inthe oral cavity is maintained and that not all bacteria are eradicated. Currentdata indicate that the biofilm composition formed under the influence ofDecapinol(R) is compatible with a healthy gum. Decapinol(R) achieves this andis as efficacious in treating gingivitis as the gold standard, chlorhexidine,but, significantly, without chlorhexidine's unpleasant side effects. Also,Decapinol(R) appears to influence the production of substances believed to be apart of the caries disease process." Dr Michael Flynn, Chief Executive of Sinclair, said: "Decapinol(R)'s unique method of tackling dental plaque make it highly suitableas a medicated toothpaste. With the medicated toothpaste market for gingivitisthought to be worth some 2.5 times that of the gingivitis mouthwash market,today's registration opens up an important new market. Our immediate priorityis discussing sales and marketing with potential partners." Enquiries: Sinclair Pharma plc Dr Michael Flynn, CEO Tel: 01483 426 6444 John Barrington-Carver (Corporate PR) Tel: 07831 655 630 Financial Dynamics Ben Atwell or Lucy Briggs Tel: 0207 831 3113 www.sinclairpharma.com Notes to Editors Gingivitis: Surveys show that more than 60% of the adult population suffers fromgingivitis. Apart from halitosis, gingivitis can lead to periodontitis, whichis caused by accumulation of bacteria within dental plaque. These bacteriacause local inflammation of the gum, causing it to bleed easily, and caneventually lead to tooth loss. Improved attention to oral hygiene routine canhelp to prevent and control the condition. Clinical trials have shown Decapinol(R) to have fewer side effects and to be better tolerated than chlorhexidinewhich is presently one of the best recognised mouthwash treatments forgingivitis. "Safe Harbor" Statement under the US Private Securities Litigation Reform Act of1995: Some or all of the statements in this document that relate to futureplans, expectations, events, performances and the like are forward-lookingstatements, as defined in the US Private Securities Litigation Reform Act of1995. Actual results of events could differ materially from those described inthe forward- looking statements due to a variety of factors. This information is provided by RNS The company news service from the London Stock Exchange

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