12th Jul 2006 07:01
Sinclair Pharma PLC12 July 2006 Sinclair Pharma Plc Announces First Ophthalmology Product Approval and Two Further Product Approvals Godalming UK, 12 July 2006: Sinclair Pharma plc ("Sinclair" or the "Company")(SPH.L), the specialty pharmaceutical company focused on the acquisition anddevelopment of patented pharmaceutical products, today announces EU regulatoryapproval for a new ophthalmology product for dry eye syndrome and two new lineextension products in their key therapeutic areas of oral health anddermatology. The following products have been approved in the EU: SPHP700 will address the prescription market for dry eye. It has been approvedas a Medical Device Class I (sterile). SPHP700 will offer a new approach to relieving the symptoms of dry eye, that areexperienced by as many as 30% of the over 65s. It contains a specificpolysaccharide that is able to bind large quantities of water and designed todeliver moisture to the eye surface for fast and prolonged symptom relief. The current market leader in prescription dry eye products in the US achievessales of $100m. Sinclair's product will be commercialized through marketingpartners in key territories; licensing discussions will start in the second halfof the current financial year. Decapinol(R) Spray is a new presentation of Sinclair's gingivitis productDecapinol(R) Rinse, which is already approved in the EU and USA. Decapinol(R)Spray is now approved in the EU as a Medical Device Class IIa. This newpresentation offers a convenient alternative to the oral rinse. Two otherDecapinol(R)-containing products, Decapinol(R) Gel and Decapinol(R) Toothpastehave already been approved in the EU and have been filed for approval in theUSA. Further presentations of Decapinol(R) are in development. Decapinol(R) Rinse is on sale in Italy and Spain. In the USA, Johnson &Johnson's oral health subsidiary, OraPharma Inc., will be launching Decapinol(R)Rinse as a prescription product following their recent appointment as USlicensees. Launch is expected within the next twelve months. 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 estimated to have somedegree of gum inflammation, Decapinol(R) addresses a large and growing market,estimated at more than $1.5bn (1). AtopiclairTM Fluid is a new presentation of Sinclair's dermatitis productAtopiclairTM. It is designed for those with large areas of skin affected bydermatitis, with a lower viscosity for easier application. Atopiclair Fluidwill complement AtopiclairTM cream, an effective, steroid-free product that hasbeen shown to relieve the signs and symptoms of atopic dermatitis (eczema) andirritant contact dermatitis. Atopiclair fluid is now approved in the EU as aMedical Device Class IIa. AtopiclairTM cream is already on the market in the US (Chester ValleyPharmaceuticals Inc.), Spain and Portugal, and is also sold in Italy bySinclair's own sales force. Atopic dermatitis is one of the most common dermatological complaints; it isestimated to affect 1-3% of adults and up to 20% of school aged children. Thesector of the market in which AtopiclairTM competes is estimated at $1.9bn in2004, having grown at 11% since the year before. Dr Michael Flynn, Chief Executive of Sinclair Pharma Plc, said today "We arepleased to have achieved our first approval in the area of ophthalmology, atherapeutic area that is important to us in the future. We believe that SPHP700is well-differentiated from existing prescription dry eye products and areconfident that it will be an important product for the company. The EU approvalof Decapinol(R) spray and AtopiclairTM fluid will allow us to make furtherinroads into these two important markets." (1) Piper Jaffray Analyst Report 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 Financial DynamicsBen Atwell Tel +44 (0) 207 831 3113John Gilbert Notes to Editors About Dry Eye Syndrome. Tears are nature's lubricant and also provide protection against some forms ofinfection and inflammation in the eye Dry eye syndrome occurs when the qualityor quantity of tears is impaired. This commonly is seen in older ages. Dry eyesyndrome leading to a clinical diagnosis or severe symptoms is prevalent,affecting over 3.2 million American women middle-aged and older." (2) including5.7% of the over 50s and 9.8% of the over 75s (3) 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. In March 2006, Decapinol(R) Oral Rinse was awarded the 2006 Oral and Dental CareProduct of the Year by Frost & Sullivan in the US. (2) Schaumberg DA. Am J Ophthalmol 2003 Aug;136(2):318-26. Prevalence ofdry eye syndrome among US women (3) Schein OD Arch Intern Med 1999 June 28,159(12):1359-63. Dry eye and drymouth in the elderly: a population-based assessment. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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