19th Apr 2005 07:00
Sinclair Pharma PLC19 April 2005 SINCLAIR PHARMA PLC DECAPINOL(R) RECEIVES FDA APPROVAL Godalming UK, 19 April, 2005: Sinclair Pharma plc ("Sinclair" or the "Company")(SPH.L), the specialty pharmaceutical company focused on the acquisition anddevelopment of niche patented pharmaceutical products, announces today thatDecapinol(R), its oral rinse for the treatment of gingivitis (gum inflammation),has received registration approval from the FDA as a prescription medicaldevice. Records indicate that Decapinol(R) is the first new chemical entityapproved to help prevent and treat gingivitis in the past 30 years. Gingivitis is an inflammation of the gums caused by bacteria. This conditioncan lead to periodontitis, which is the main cause of loss of teeth. Currenttreatment of gingivitis includes attention to oral hygiene and antisepticmouthwashes. In the US approximately 80 per cent of the adult population areestimated to have some degree of gum inflammation, resulting in a USprescription market for mouthwashes that may exceed US$100 million("Anti-gingivitis markets", a summary of the gingivitis market. Datamonitor,October 2004). OTC mouthwash brands contribute to a several fold larger totalmarket. Decapinol(R) is a new type of oral rinse which does not function in ananti-microbial or an antiseptic manner and has been clinically proven in testswith over 2,000 patients. This novel mechanism of action includes the creationof a bioadhesive barrier on the teeth and gums, which prevents the aggregationand colonisation of bacteria at the tooth and gum interface - the starting pointfor gingivitis. This mechanism of action differs from the currently prescribedrinses which kill all or most of the oral bacteria and can destroy the naturalbalance of beneficial oral micro organisms. Clinical trials have provedDecapinol(R) has fewer side effects and is better tolerated than chlorhexidine,which is a leading prescribed treatment for gingivitis in the US. Decapinol(R)was determined by the FDA to be a medical device in April 2004. Following itsFDA 510(k) submission last year, the FDA requested re-processing as a 'de novo'513(f) in view of the fact there was no similar (predicate) device in the USwith which to compare it. Given its novel approach to gingivitis, Sinclairbelieves that Decapinol(R) has the potential to expand the current market. Michael Flynn, CEO of Sinclair, commented: "This Decapinol(R) approval is animportant milestone for Sinclair. It validates our business model - the searchand development of underexploited niche products, whether commercialised or not, which could significantly benefit from a vigorous regulatory and developmentre-appraisal. This strategy has so far enabled us to register 9 new products inthe US. We now have both US and EU approval for Decapinol(R), have alreadysigned European agreements for Decapinol(R) in Italy and Spain and will now beactively seeking a distribution partner in the important US market as well asthe remainder of Europe. The OTC market for Decapinol(R) is potentially muchlarger than the prescription market and we would expect to extend its use to theUS OTC market, subject to registration for OTC use, after further discussionswith dental health care professionals. In Europe, Decapinol(R) can already besold OTC. Decapinol(R) is a new type of technology which also lends itself toother presentations, methods of application and indications, both within andoutside the oral cavity, and we have an active ongoing development programme fornew products involving Decapinol(R)." Enquiries: Sinclair Pharma plcDr Michael Flynn, CEO Tel: 01483 426 644John Barrington-Carver (Media Enquiries) Tel: 07831 655 630US contactMichael Killeen, Vice President Tel: +1 972 478 4380 Financial DynamicsBen Atwell / Lucy Briggs Tel +44 (0) 207 831 3113 Notes to editors: Sinclair Pharma plc Sinclair Pharma plc based in Godalming in the UK, is quoted on the AlternativeInvestment Market (AIM) on the London Stock Exchange and has focused on theacquisition and development of niche patented pharmaceutical products in thefields of oral health, oncology support and dermatology, and bringing them tothe international market place via out-licensing partners. The Company combinesproduct evaluation, product development, regulatory and business developmentexpertise to add value to its acquired and in-house developed products. A keyelement of the Sinclair business model is to minimise risk and exposure byavoiding involvement in lengthy R&D programmes and rapidly achieving globaldistribution through a network of marketing partners. The Company has alreadylicensed its products for distribution in over 40 countries around the world. On 4th January 2005 Sinclair announced its first Decapinol(R) deal with Dompe SAfor the Italian market in an agreement involving almost 1.5 million Euros inupfront and milestone payments and a supply agreement with minimum purchaseobligations. In February the Company announced it had concluded its seconddistribution agreement for Decapinol(R) having licensed it to the Spanishcompany Inibsa. For more information: www.sinclairpharma.com "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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