With this commercial progress and the 12 established products from CSD joining our portfolio, plus the benefit of our own sales forces in four European countries, we can expect that our dermatology brands will contribute increasingly to Sinclair revenues.
Sebclair(tm) Sebclair(tm) is a non-steroidal cream, indicated for phentermine paroxetine the management of seborrheic dermatitis, including relief and management of the most common phentermine paroxetine signs and symptoms such as scaling/flaking, reddening, burning and pain. Sebclair(tm) was licenced to CVP in the US this year and Sinclair anticipates US regulatory approval in H1 2007. Having already obtained EU regulatory approval, our dermatology sales team at Sinclair Srl launched the product in Italy in June this year.
At the Company's R&D day on 15th June Professor Ruggero Caputo, Professor & Chairman, Institute of Dermatological Sciences, University of Milan presented the full results of a multicentre, double-blind trial of Sebclair(tm) in the US and Italy. The study concludes that Sebclair(tm) is effective in the treatment of mild to moderate seborrheic dermatitis of the face and that its use in combination with topical or oral antimycotics might also be considered. Xclair(tm) Xclair(tm) is a hydrolipidic cream that has been formulated specifically for use in radiation dermatitis. Xclair(tm) was licenced to Align Pharmaceuticals for the US and Canadian markets in phentermine paroxetine late June at the end of the last financial year and they launched the product in the US this January. Crawfords launched Xclair(tm) in the UK in July 2005. During the year Xclair(tm) was licensed to Pharmis Group in Portugal, Brazil and Spain; Anabiosis in Greece and to Normeda in Estonia, Latvia and Lithuania. DermaChronic(tm) DermaChronic(tm) is an emollient moisturiser, developed specifically for long term use in remission by patients with chronic skin conditions, to moisturise, soothe and soften the skin where the skin is cracked and hardened due to a chronic skin condition. It is hypoallergenic, preservative and perfume free, and is therefore designed to avoid triggering recurrences of dermatitis. Tests in subjects showed no allergic or sensitivity responses. DermaChronic(tm) is now approved for sale in the EU and has been launched by Sinclair Srl. This new product has two presentations, a cream and a detergent. Products - Oral Care As at 30th June 2006, Sinclair had ten Oral Health products including line extensions registered in the EU and seven in the US. The combined presentations of Aloclair(r) Rinse, Spray and Gel have provided the bulk of revenues from hydrocodone pharmacies our oral health portfolio to date. Decapinol(tm) rinse, toothpaste, gel Decapinol(tm) is Sinclair's novel product for the treatment of gingivitis and dental plaque, and the prevention of periodontitis. This year, Sinclair reached an agreement with OraPharma Inc., part of Johnson & Johnson, to market Decapinol(tm) rinse on prescription in the US and a US launch into the prescription market is expected this financial year. Decapinol(phentermine paroxetine tm) Rinse was also launched in Spain by our marketing partner Inibsa and new marketing agreements were completed with Pharmbio Co Ltd in South Korea and Dompe in Greece & Cyprus.
Kivema in Israel will market Decapinol(tm) toothpaste.
Regulatory endorsement for Decapinol(tm) was received when the FDA extended the labelling to allow the inclusion of the important wording "for the prevention of plaque." Decapinol(tm) Toothpaste and Decapinol(tm) Gel both received EU regulatory approval this year and were also filed with the FDA for US approval. Further Decapinol(tm) product innovations are in development. Aloclair(r) Aloclair(r) has been launched in more than phentermine paroxetine 25 countries including the US. With regulatory approval in the US and the how long will hydrocodone show up in my urine EU for Decapinol(tm) Rinse and EU approval for Decapinol(tm) toothpaste and gel, we have seen the first launch of this innovative technology in Europe.
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