24th Jan 2005 07:00
Sinclair Pharma PLC24 January 2005 SINCLAIR PHARMA PLC ALOCLAIR(R) SPRAY RECEIVES FDA 510(k) APPROVAL Godalming UK, 24th January, 2005: Sinclair Pharma plc ("Sinclair" or the "Company") (SPH.L), the specialty pharmaceutical company focused on theacquisition and development of patented pharmaceutical products, announces todaythat Aloclair(R) Spray, an OTC product for the treatment of mouth ulcers, hasreceived approval from the FDA as a medical device. Aloclair(R) now has three delivery systems - an oral rinse solution, an oral gelwhich is more suitable for children) and the oral spray. In the previousfinancial year the Aloclair(R) rinse and gel increased revenues by 150% to £1.8million. The Aloclair(R) oral rinse is already approved in the US and Europeand is currently being marketed OTC by - Sunstar Butler, in the US and somemajor EU countries. Aloclair(R) gel also has EU and US regulatory approval andis being marketed by Sunstar Butler in various countries and by Recordati (Srl)in Italy. Aloclair(R) spray was registered in 2004 in the EU and will be launched in thisfinancial year in the first markets. Aloclair(R) spray provides a controlledapplication of the soothing formulation in a mobile, easy to use packagedesigned for moments when rinsing with the Aloclair(R) solution is not anoption. The global mouth ulcers market is estimated to be worth more than $1 billion perannum. TNS market research conducted for Sinclair indicates that 16% of theadult population get an oral ulcer over a 12 month period and 64% of thatpopulation seek pain relief with a medication. That research translates to auser base of over 100 million adults in the EU and US. Dr Michael Flynn, CEO of Sinclair, commented: "Aloclair(R) is Sinclair's biggestproduct at present and the addition of the spray formulation provides a range ofdelivery mechanisms which cover most situations for treatment of mouth ulcers.We are expanding the range of countries where Aloclair(R) can be sold in itsvarious forms and are particularly pleased that this latest approval in the USwill assist our partners to capture further market share and help us toestablish a global brand for the treatment of this common condition." Enquiries: Sinclair Pharma plcDr Michael Flynn, CEO Tel: (0)1483 426 644John Barrington-Carver (Media Enquiries) Tel: (0) 7831 655 630US contactMichael Killeen, Vice President Tel: +1 972 478 4380 Financial DynamicsBen Atwell / Lucy Briggs Tel: (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. "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. www.sinclairpharma.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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