20th Mar 2007 07:04
Sinclair Pharma PLC20 March 2007 Sinclair Pharma plc announces further EU Decapinol(R) registrations, and publication of positive clinical data 20 March 2007, Godalming, UK. Sinclair Pharma plc (SPH.L), the internationalspecialty pharmaceutical company, today announced further EU approvals of itsDecapinol(R) range. The newly approved products are fluoride-containingDecapinol toothpastes, in a paste and a gel format. These registrations consolidate the registered range of Decapinol products inthe EU, which now includes Decapinol oral rinse, Decapinol toothpaste (withoutfluoride), Decapinol spray, and Decapinol gel (for site-specific gingivitis,this also contains ingredients designed to give pain relief after a dentalvisit). The approvals announced today are for Decapinol(R) Toothpaste fluorideand Decapinol Toothpaste Gel fluoride. The approvals come shortly after the publication of a meta-analysis of clinicaldata in the leading dental journal, J Clinical Periodontology (footnote 1).This paper analysed eight controlled clinical trials including more than 1,300patients and concluded that Decapinol is a "third-generation anti-plaque agent...effective as an adjunct measure for reducing plaque burden and indices ofgingivitis, whether or not it is used under supervision." These recent approvals and independent analysis further enhance the commercialpotential of Decapinol, Sinclair's flagship brand for gingivitis (gum disease)and dental plaque. The US launch of Decapinol Oral Rinse by Johnson & Johnson's dental division,OraPharma Inc., is expected in the next few months. It has already beenlaunched successfully in Italy and Sinclair is in negotiations for other keyEuropean territories. Decapinol brings an innovative new technology to the management of gingivitis;other gingivitis products launched in recent decades have been anti-infectiveagents that indiscriminately kill bacteria in the mouth. In contrast, Decapinolworks by interfering with the ability of plaque bacteria to adhere to the toothsurface, and to aggregate to each other. Decapinol is more selective forbacteria that are associated with gum disease, and so promotes a healthy balanceof bacteria in the mouth. " Sinclair is committed to creating innovative and useful products for improvingoral health. These two new EU approvals are part of the process of building acomprehensive portfolio of products to help reduce the burden of gum disease."said Dr Michael Flynn, CEO of Sinclair Pharma plc. " In another area of oralhealth, mouth ulcers, we have already built a worldwide brand with our Aloclairproduct range, which has been launched in 26 countries, and is now inregistration or preparing for launch in another 31. We have even more ambitiousplans for our gingivitis product Decapinol." - ends - For further information please contact: Sinclair Pharma plc Tel: +44 (0) 1483 410 600 Dr Michael Flynn, CEO Zoe McDougall, Director of Communications UK: Capital MS&L Mary Clark, Halina Kukula Tel +44 (0)20 7307 5340 Germany: MC Services Raimund Gabriel, Hilda Juhasz Tel +49 89 210 228 0 Notes to Editors Gingivitis Gingivitis is present in as much as 75% of the population (footnote 2). It iscaused by a build-up of bacteria on the tooth and gum surface. These bacteriaform a colony, held together by a matrix of substances called glucans. It is this matrix that makes dental plaque so difficult to remove with atoothbrush, once it has become established. Gingivitis often starts between theteeth, where toothbrushes do not reach. Some bacteria in the colony release toxins into the gum, damaging the gum tissueand in the long term detaching the gums from the surface of the tooth. In itsmild form, gingivitis results in red, inflamed and sensitive gums that bleedduring toothbrushing or eating. As the condition progresses, the pockets holdingthe teeth in place can deepen, leading to further problems. Although gingivitisis reversible, if left untreated it can progress to periodontitis, a much moresevere condition that can lead to tooth loss. Gingivitis is also associatedwith bad breath, as the plaque bacteria can release sulphur-containing compounds(footnote 3). Beyond gum disease There are significant problems associated with gum disease that reach beyond thehealth of the teeth and gums. For example, many studies have pointed to apotential link between periodontitis and cardiovascular disease (footnote4,5,6,7). The scientific community suggests that this may be due to bacterialmigration from the dental plaque across the damaged gum barrier and into thebloodstream. Once in circulation, these bacteria (or the toxins that theyrelease) could potentially damage the heart and blood vessels or induce bloodclotting (footnote 8). There is also a statistical link between mothers who have gum disease duringpregnancy and pre-term birth or low birth-weight infants (footnote 9, 10, 11,12) and suggestions that type 2 diabetes and periodontitis might be linked and/or exacerbate each other (footnote 13, 14). All of these factors emphasise the increasing importance of maintaining healthyteeth and gums. This has even been acknowledged by some leading US insurancefirms, that have started to provide routine periodontal treatment for patientswith may be at risk of cardiovascular disease (footnote 15). Treating gingivitis The standard treatment for mild to moderate gingivitis is 'scaling and rootplaning', where the dentist or dental hygienist mechanically cleans a patient'steeth and gums. Patients with moderate gum disease are usually also recommendeda mouthwash or additional treatment. For decades, dentists have been recommending chemical mouthwashes, manycontaining the agent chlorhexidine, that indiscriminately kill bacteria withinthe mouth and at the gums. As these mouthwashes kill the bacteria that make updental plaque, they have been accepted as the standard treatment of gum disease. However, the introduction of Decapinol will offer a new way to treat thisdisease that affects so many of the population. About Decapinol Decapinol works in a completely different way from standard antibacterialmouthwashes. Firstly, it is much more selective in targeting bacteria that are associatedwith gum disease. Rather than killing the bacteria, Decapinol interferes withtheir ability to adhere to each other and to the surfaces within the mouth,making it much easier to remove than during normal toothbrushing. At the same time, Decapinol interferes with the matrix of glucans, the "glue"that holds the plaque bacteria together. This makes the plaque bacteria lesscohesive, allowing a patient to remove plaque bacteria during their normaltoothbrushing, even when situated between the teeth. With this more selective and 'intelligent' mode of action, Decapinol promotes ahealthy balance of bacteria within the mouth, dominated by "good" bacteria thatis associated with healthy teeth and gums. The paper published this monthgathers clinical data from different studies in more than 3,000 patients, andconcludes Decapinol was "effective as an adjunct measure for reducing plaqueburden and indices of gingivitis, whether or not it is used under supervision." Therefore, the need to maintain a good standard of dental and gingival healthhas even greater importance today, given the recent, well documented andsupporting evidence of the link between periodontal disease and other medicalconditions. Decapinol will soon be available in the United States, where the healthcarecompany Johnson & Johnson's dental division, OraPharma, will launch Decapinol inthe next few months. It is already sold in Spain and Italy. 1 Addy M, Moran J, Newcombe RG. Meta-analyses of studies of 0.2% delmopinol mouth rinse as an adjunct to gingival health and plaque control measures. J Clin Periodontol. 2007 Jan;34(1):58-65. Epub 2006 Nov 20 2. Hugoson A, Laurell L, Lundgren D. Frequency distribution of individuals aged 20-70 years according to severity of periodontal disease experience in 1973 and 1983. J Clin Periodontol. 1992 April; 19 (4): 227-32 3. Association between oral malodor and adult periodontitis: a review. J Clin Periodontol. 2001 Sep;28(9):813-9 4. Severity of Periodontal Disease and Number of Remaining Teeth Are Related to the Prevalence of Myocardial Infarction and Hypertension in a Study Based on 4,254 Subjects. Holmlund A, Holm G, Lind L. J Periodontol. 2006 Jul;77(7): 1173-1178. 5. Bacterial Profile and Burden of Periodontal Infection in Subjects With a Diagnosis of Acute Coronary Syndrome. Renvert S, Pettersson T, Ohlsson O, Persson GR. J Periodontol. 2006 Jul;77(7):1110-1119. 6. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. D'Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Am Heart J. 2006 May;151(5):977-84. 7. Okoro CA, Balluz LS, Eke PI, Ajani UA, Strine TW, Town M, Mensah GA, Mokdad AH. Tooth loss and heart disease: finsings from the Behavioural Risk Factor Surveillance System. Am J Prev Med 2005 Dec; 29 (5 Suppl 1) 50-6 8. Genco R, Offenbacher R, Beck J. Periodontal disease and cardiovascular disease: Epidemiology and possible mechanisms. JADA 2002 June: 133 (Suppl) S14-22 9. Farrell S, Ide M, Wilson RF. The relationship between maternal periodontitis, adverse pregnancy outcome and miscarriage in never smokers. J Clin Periodontol 2006 Feb; 33 (2): 115-20 10.Lopez NJ, Da Silva I, Ipinza J, Gutierrez J. Periodontal therapy reduces the rate of preterm low birth weight in women with pregnancy-associated gingivitis. J Periodontol 2005 Nov; 76 (11 Suppl): 2144-53 11.Radnai M, Gorzo I, Urban E, Eller J, Novak T, Pal A. Possible Association between monther's periodontal status and preterm delivery. J Clin Periodontol 2006 Nov; 33 (11); 791-6 12.Marin C, Segura-Egea JJ, Martinez-Sahuquillo A, Bullon P. J Clin Periodontol. 2005 Mar; 32 (3): 299-304 13.Periodontal disease and diabetes: a two-way street. Mealey BL. J Am Dent Assoc. 2006 Oct; 137 Suppl 25S-31S 14.Diabetes Mellitus and periodontal disease. Mealey BL, Oates TW; American Academy of Periodontology. J Periodontol. 2006 Aug; 77 (8): 1289-303 15.Etna, Cigna, and Blue Cross & Blue Shield of Massachusetts. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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