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Teething gel EU registration

6th Dec 2007 07:02

Sinclair Pharma PLC06 December 2007 Sinclair Pharma plc announces EU registration of new teething gel product, SPHO220 6 December 2007, Godalming, UK: Sinclair Pharma plc ("Sinclair": SPH:L), theinternational specialty pharmaceutical company, announces EU registration of itspipeline product for symptom relief for teething infants, SPHO220. Sinclair isnow free to sell the product in all EU territories. There are approximately 5 million live births in the EU annually. Infants startteething around six months, and parents might continue to use a topical painreliever for three months. The competitive advantages of SPHO220 are as follows: • Designed to meet a market need for symptom relief during teething,without the use of topical pharmacological agents in infants. • Builds on the proven, patented technology of Sinclair's existing mouthulcer product, Aloclair. • Presented in an applicator that can deliver the gel directly to theinfant's gum, facilitating easy and hygienic delivery. The current market is currently dominated by gels that contain the topicalanaesthetic lignocaine/lidocaine, or the analgesic choline salicylate. SPHO220is free from these pharmacological agents. The formulation includes hyaluronicacid, which has demonstrated efficacy in maintaining the integrity of the oralmucosa (mouth lining) and providing barrier-based pain relieving qualities. SPHO220 is registered as a Class 2a medical device and can therefore be soldwithout a prescription in the EU. Sinclair plans to commercialise the productthrough marketing partners. "Sinclair is already present in the oral care market with our mouth ulcerproduct Aloclair and our anti-gingivitis agent Decapinol," said Dr MichaelFlynn, CEO of Sinclair Pharma. "Using our expertise in topical formulations, wewill now be able to address the valuable teething gel market, offering parentsan alternative to applying anaesthetic or analgesic drugs to their childrens'mouths. Commercially we expect to leverage our existing marketing partnernetwork and also seek agreements with new partners for this new product." - ends - For further information please contact: Sinclair Pharma plc Tel: +44 (0) 1483 410 600Dr Michael Flynn, CEOJerry Randall, CFOZoe McDougall, Director of Communications Capital MS&LAnna Mitchell, Joanna Whineray Tel +44 (0)20 7307 5340 Notes to Editors: About Sinclair Pharma Plc www.sinclairpharma.com Sinclair Pharma plc is an international specialty pharmaceutical company. Ithas a growing sales and marketing operation that is already present in France,Italy, UK, Spain and Portugal, and a complementary marketing partner networkthat spans more than 80 countries. Sinclair has proven expertise in acquiring or developing commercially attractiveand undervalued products, registering these products and bringing them to marketwithin a short timeframe. The company focuses on niche therapeutic areas andits current portfolio includes products for dermatological conditions and oralhealth. "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 Exchange

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