4th Jan 2005 07:00
Sinclair Pharma PLC04 January 2005 SINCLAIR PHARMA PLC LICENSES DECAPINOL(R) TO DOMPE IN ITALY Godalming, 4 January 2005: Sinclair Pharma plc ("Sinclair") (SPH.L) announcestoday that it has signed an agreement to license the distribution rights toDecapinol(R) in Italy, its oral rinse for the treatment and prevention ofgingivitis and periodontitis, to the private Swiss based group DompeInternational S.A. ("Dompe"). Under the agreement Dompe will purchase Decapinol(R) mouthwash from Sinclair andbe responsible for sales, marketing and distribution in Italy. The agreementincludes up-front and sales performance related milestone payments, ofapproximately €1.5 million. Dompe is a leading European Pharmaceutical & Biotech Company with more than 800employees with consolidated sales of around 300 million Euros. Dompe is aleading manufacturing and patient care Group with close links to its local andInternational markets and with the research community. Dompe has a network ofAcademic collaborations as well as with leading Biotech Companies like Amgen,Biogen/Idec, Genzyme, Chiron and Cephalon. These strengths, combined with Dompe's research activities characterized by acompetitive edge in immunology and in inflammation, ensure that Dompe canconsistently improve its research approach. Sinclair received registration approval for Decapinol(R) as a Class IIA medicaldevice in the EU in June 2004. Decapinol(R) was also designated a medicaldevice in the US and was filed for 510(k) registration approval for gingivitisin June 2004. Gingivitis can lead to periodontitis, which is caused by accumulation ofbacteria within dental plaque. These bacteria cause local inflammation of thegum, causing it to bleed easily, and can eventually lead to tooth loss.Improved attention to oral hygiene routine can help to prevent and control thecondition. Decapinol(R) acts by selectively interfering with the attachment ofharmful bacteria to the teeth and gum surfaces, in contrast to antiseptics andantibiotics, which kill most oral bacteria and affect the natural balance ofbeneficial oral bacteria. Clinical trials have shown Decapinol(R) to have lessside effects and to be better tolerated than chlorhexidine which is presentlyone of the best recognised mouthwash treatments for gingivitis. Sinclairbelieves that Decapinol(R) is the first new chemical entity for gingivitis forthe past 30 years and that it has the potential to grow the existing markets. In the US Approximately 80 per cent of the adult population are estimated tohave some degree of gum inflammation. The combined OTC and prescription marketfor gingivitis for the main European countries, according to Datamonitor, isworth over €380 million. In Italy alone the annual prescription and OTC marketis approximately €50.6 million, not including unmedicated mouthwashes. Dr Michael Flynn, CEO of Sinclair commented: "Dompe is a long established andrespected company with an important presence in the Italian pharmaceuticalmarket and we are delighted that they have become our partner in Italy forDecapinol(R). We believe that by selecting strong partners in individual EUcountries we will be able to get products to market much more rapidly than byjust looking for one pan European company. Whilst a single distribution partnermight be attractive, the long time frames commonly required for such companiesto achieve "buy in" from their national sales operations and the consequent longdelays before launch provide a strong reason for us to look for strong nationaldistributors as better alternatives. The ability of companies like Dompe to makerapid decisions whilst offering strong sales and marketing capability has been adriver for this, our first deal, with Decapinol(R). There is a high level ofinterest in Decapinol(R) from other EU countries and we are hopeful that we willsoon receive a positive response from the US FDA which would also allow us toenter the large US market." "Decapinol(R) represents an interesting opportunity for us since the Company hassubstantial therapeutic and product development expertise in oral care. We werealso impressed by the progress Sinclair has made over the last few years and weare delighted to collaborate with Sinclair and to be able to contribute to thegrowth of the Company." said Dr. Sergio Dompe, President of Dompe Group. ENDS Contact details Sinclair Pharma plc Dr Michael Flynn, CEO Tel: +44 (0) 1483 426 644Jerry Randall ACA, CFOJohn Barrington-Carver, Corp. PR Tel: Mobile +44 (0) 7831 655 630 Financial Dynamics Ben Atwell / Lucy Briggs Tel +44 (0) 207 831 3113 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. 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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