28th Jan 2005 07:00
Sinclair Pharma PLC28 January 2005 SINCLAIR PHARMA PLC Pre-Close Statement and Five New Marketing Deals Godalming UK, 28 January, 2005: Sinclair Pharma plc ("Sinclair" or the "Company") (SPH.L), the specialty pharmaceutical company, today announces five newmarketing deals for its products and provides a pre-closed period trading updateahead of its results on 31 March 2005. In the six months to 31 December 2004, trading is expected to be in line withexpectations. Highlights of the period include the distribution agreement forAtopiclairTM in the USA with Chester Valley Pharmaceuticals, Inc. (announced on21 December 2004), and the acquisition of the Italian derma company Euroderm RDCSpA (announced on 22 December 2004). The Company has also made further progress in establishing a growing worldwidesales and distribution network for its products, with the following agreementsannounced today: • XclairTM marketing agreements in Germany and South Korea: Sinclair has signed agreements for the sale and distribution of XclairTM, for the treatment of radiation dermatitis, with Pharmbio Korea Co Ltd for South Korea and ORCA Pharm for Germany. • AloclairTM marketing agreements in Canada and Turkey: Sinclair has also signed agreements for the sale and distribution of AloclairTM Rinse, Gel and Spray, for the treatment of mouth ulcers, with John O Butler Ltd in Canada and for AloclairTM Rinse with SSM in Turkey. • SalinumTM marketing agreement in Germany: Sinclair has signed an agreement for the sale and distribution of SalinumTM, for severe xerostomia, in Germany with ORCA Pharm. In addition, the Company has continued to make good progress with its USregistration applications. Three products are currently under review with theFDA (Food and Drug Administration): • Decapinol(R): (for gingivitis) 510(k) filing was made in mid 2004 and the Company has responded to questions from the FDA. The FDA has recently advised the Company that Decapinol(R) would require a new device classification and accordingly Sinclair has requested that its filing be processed as a de novo device 513(f) application. The Company anticipates a positive response from the FDA and expects to generate first sales from this product in the US on schedule in the next financial year. • T-Go: (for sore throat) Sinclair's product for sore throat and SebclairTM (for sebborrhoeic dermatitis) have both been filed for 510(k) registration with the FDA and an outcome is anticipated before the end of the current financial year. Finally, the Company has been issued with the US patent for GelclairTM (itsproduct for mucositis or dry mouth). As a result, the Company anticipatesreceiving a milestone payment of $500,000 in this financial year from the USdistributor OSI. Dr Michael Flynn, CEO of Sinclair Pharma plc said, "This first half year hasgone according to plan and Sinclair has made good progress in expanding thecoverage of its products with the five marketing agreements announced today, inaddition to the recent deals on Decapinol(R) and AtopiclairTM, and the recentacquisition of Euroderm. "With a growing portfolio of approved products, an increasing number ofmarketing partners and a very healthy order book, Sinclair looks to the futurewith confidence." Contact details: Sinclair Pharma plcDr Michael Flynn, CEO Tel: +44 (0) 1483 426 644Jerry Randall ACA, CFO John Barrington-Carver, Corp. PR Tel: Mobile +44 (0) 7831 655 630 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 combines product evaluation, product development, regulatory andbusiness development expertise to add value to its acquired and in-housedeveloped products. A key element of the Sinclair business model is to minimiserisk and exposure by avoiding involvement in lengthy R&D programmes and rapidlyachieving global distribution through a network of marketing partners. TheCompany has already licensed its products for distribution in over 40 countriesaround the world. Sinclair Partners: Pharmbio Korea Co., Ltd is a rapidly growing specialty pharmaceutical company,currently marketing a range of licensed products in Korea from several overseaspharmaceutical companies in USA, France, Ireland, Italy and Japan. PharmbioKorea has 40 medical representatives covering hospitals, clinics and pharmaciesnationwide. O.R.C.A Pharm is a specialist oncology company with a scientifically trainedKey-Account Management sales force of 10 in Germany, actively promoting a rangeof products to hospital physicians. John O Butler is part of Sunstar Group, which is one of the worlds largest oralhealth companies and particularly strong in the North American market. Butleralready distributes AloclairTM in the USA and several EU countries. SSM was founded in 1987 and is a manufacturer and distributor of a range ofhospital and medical consumer products. SSM represents some of the leadingAmerican and European Medical Device Companies and has a strong image in Turkeyamong the medical community and a professional, well-educated sales team. Sinclar Product Information: Decapinol(R) is a new type of clinically proven oral rinse which is not anantiseptic. The novel mechanism of action includes the creation of an adherentbarrier on the teeth and gums, which interferes with the attachment of harmfulbacteria to the teeth and gum surfaces. This is in contrast to currently usedrinses which kill all or most of the oral bacteria and can affect the naturalbalance of beneficial oral micro organisms. Clinical trials have shown Decapinol(R) to have fewer side effects and to be 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. Gingivitis is an inflammation of the gums caused by bacteria. This conditioncan lead to periodontitis, which is the main cause of loss of teeth. Thesebacteria cause local inflammation of the gums, causing them to bleed easily.Current treatment of gingivitis includes attention to oral hygiene andantiseptic mouthwashes. In the US approximately 80 per cent of the adult population are estimated tohave some degree of gum inflammation, resulting in a US prescription market formouthwashes that according to research based on Datamonitor data may exceedUS$100 million (source: "Anti-gingivitis markets", a summary of the gingivitismarket. Datamonitor, October 2004). Several popular OTC mouthwash brandscontribute to a much larger total market. Sinclair believes that Decapinol(R)is the first new chemical entity to help patients with gingivitis in the past 30years and that it has the potential to grow the existing markets. AloclairTM is Sinclair's patented product range for the treatment of mouthulcers. It is presently marketed in the EU and the USA and is presented as arinse, a gel and a spray. The product claims rapid relief of pain and nostinging on application. T Go is Sinclair's patented product for the rapid relief of sore throat. It isregistered in the EU as a medical device and will be commercialised in the nextfinancial year. (T-Go is not a Sinclair trademark; it is an internal code name). SalinumTM is Sinclair's patented Saliva substitute for patients unable toproduce saliva. Sinclair acquired Salinum in 2002 through the acquisition of theSwedish company Biosurface AB. SebclairTM is Sinclair's patented product for the treatment of sebborrhoeicdermatitis - a common scaling dermatititis. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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