29th Jun 2006 07:01
Sinclair Pharma PLC29 June 2006 Sinclair Pharma Plc licenses US rights for lead product Decapinol(R) Godalming UK, 29 June 2006: Sinclair Pharma plc ("Sinclair"), the specialtypharmaceutical company, announces that it has licensed the exclusive US rightsof one of its key products, Decapinol(R) Rinse, to OraPharma, Inc., a subsidiaryof Johnson & Johnson. Under the terms of the deal announced today, Sinclair will supply Decapinol(R)Rinse to OraPharma, who will be responsible for the marketing and distributionof the product in the United States market. OraPharma will have the exclusiverights to promote Decapinol to dentists' offices for Rx sales. Sinclair willreceive up-front and milestone payments, and a margin on product sales. Salesare expected to commence within the next 12 months. Decapinol(R) received marketing clearance from the US Food and DrugAdministration (FDA) in 2005 as a prescription product. It has also receivedapproval in the EU where the oral rinse presentation of Decapinol(R) wasrecently launched in Italy and Spain by Sinclair's distributors. Sinclair believes that Decapinol(R) is the first new product class to enter thegingivitis market for several decades. It is an award-winning, patented productwith a new mode of action for the treatment of gingivitis (gum inflammation) anddental plaque, and for the prevention of periodontitis (a severe form of gumdisease causing tooth loss). With approximately 80 per cent of the adult population in the US estimated tohave some degree of gum inflammation, Decapinol(R) oral rinse addresses a largeand growing market in the US currently exceeding $600 million (1). Sinclair isdeveloping a number of new products and line extensions incorporating Decapinol(R). Dr Michael Flynn, CEO of Sinclair Pharma, said: "We are very pleased that OraPharma will market our lead product. With arespected presence in oral health, we believe there is no better company totake Decapinol(R) to the US market. We are confident that OraPharma willestablish Decapinol(R) as a successful new brand in the US." Professor Rolf Attstrom, a leading independent expert on oral health andDirector of Educational Research and Technology, University of Malmo, Sweden,said of Decapinol(R): "Decapinol(R) is a huge leap forward for oral health and has the potential toradically change the gingivitis market. Whilst traditional mouthwashes aim tokill all oral bacteria, Decapinol(R) removes rather than kills bacteria. It isalso more selective and preserves 'good bacteria', leading to a healthierecology in the mouth. We now have a tool that will help to improve gum healthin a more intelligent way." 1 "Anti-gingivitis markets", a summary of the gingivitis market. Datamonitor, October 2004 A conference call for analysts will be held at 8.15am today, please call MoNoonan on +44 (0) 207 269 7116 for further details. For further information please contact: Sinclair Pharma plcDr Michael Flynn, CEO Tel: +44 (0) 148 342 6644John Barrington-Carver, Corp. PR Tel: +44 (0) 207 351 3409Mike Killeen, US Tel: +1 972 478 4380 UKFinancial DynamicsBen Atwell Tel +44 (0) 207 831 3113John Gilbert GermanyMC ServicesRaimund Gabriel Tel +49 89 210 228 0Hilda Juhasz Notes to Editors: About Decapinol(R) Gingivitis is an inflammation of the gum surrounding the teeth. Periodontitisis a more advanced and severe condition that may result in bone or tooth loss.Both conditions are associated with dental plaque bacteria. Current treatment of gingivitis may involve the use of an oral rinse, alongside'scaling and planing' (mechanical cleaning of the teeth by a dentalprofessional). Decapinol(R) has a new mechanism of action that offers an 'intelligent' way totreat gingivitis. It acts at the interface between dental plaque bacteria andthe surface of the tooth/gum - the starting point for all gingivitis. Decapinol(R) prevents the bacteria that cause gingivitis from adhering to these surfacesand to one another. This adhesion is essential for the bacteria to cause thedisease and if it is prevented it allows the desirable bacteria responsible formaintaining a healthy mouth to dominate again. This softens dental plaque,making it easier to remove, and prevents its re-formation. It thereforepromotes better gum health and clinical studies have shown that Decapinol(R)significantly reduces gingivitis. Decapinol(R) has advantages over existing products, which may causesemi-permanent tooth staining or have high alcohol content. While other leadingproducts work by killing oral bacteria indiscriminately, Decapinol(R)specifically targets the 'bad' bacteria associated with gum disease. Decapinol(R) therefore promotes a healthy balance of oral bacteria. Decapinol(R) is already cleared for sale in the USA by the FDA, as aprescription product. It is also approved in the EC and Decapinol(R) hasalready been launched in Italy and Spain. In March 2006, Decapinol(R) Oral Rinse was awarded the 2006 Oral and Dental CareProduct of the Year by Frost & Sullivan in the US. About Sinclair Pharma Plc www.sinclairpharma.com Sinclair Pharma Plc, based in Godalming in the UK, is an international specialtypharmaceutical company focused on the sourcing and development, registration andsubsequent commercialisation of those products. Sinclair currently focuses onoral health and dermatology and is expanding into eye care. Sinclair has a global distribution network in more than 60 countries and iscurrently developing its own sales and marketing network. Sinclair Pharma plc is quoted on the Alternative Investment Market (AIM) on theLondon Stock Exchange. The Sinclair Portfolio in the US Decapinol(R) will add to the portfolio of Sinclair oral health products that aresold in the USA. Rincinol Rinse & Gel (for mouth ulcers - sold as Aloclair(R)in non-US markets) is currently marketed by Sunstar Butler in the US and severalother countries worldwide. Align Pharmaceuticals recently launched Numoisynlozenges and liquid (sold as SST(TM) and Salinumin(TM) non-US markets) forxerostomia (dry mouth). Xclair(TM) Sinclair's product for radiation dermatitisis also licensed to Align Pharmaceuticals. Chester Valley Pharmaceuticals (CVP)is licensed to market Atopiclair(R) and Sebclair(TM) (for atopic and seborrheicdermatitis respectively). Lastly Gelclair(TM) (for oral mucositis) is licensedto Helsinn Healthcare. Other languages For versions of this press release in German, French, Spanish or Japanese,please see the Sinclair website at www.sinclairpharma.com or [email protected] "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 ExchangeRelated Shares:
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