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  1. stolwyk

    22,691 posts.
    European production facility for CellSpray® Regulatory process initiated for Europe 10 September, 2003 - PERTH, AUSTRALIA and EAST RUTHERFORD, NJ, USA: Clinical Cell Culture Ltd (ASX: CCE), also known as C3 and Cambrex Bio Science Verviers Sprl, a subsidiary of Cambrex Corporation (NYSE: CBM) today announced that they have entered into a contract manufacturing agreement for the manufacture of CellSpray® and CellSpray® XP (CellSpray® products) for the European market.

    CellSpray® products are cultured autologous (patient’s own cells) skin suspension for the treatment of major burns. The parties have also jointly submitted the regulatory dossier to the Belgium Ministry of Health for the cGMP production of CellSpray® products in the Cambrex facility in Verviers, Belgium.

    These are the first two important steps towards the launch of CellSpray® products in the European market. Troels Jordansen, C3 Chief Executive Officer said; “After several months of searching for the most appropriate partner, we are pleased to have teamed up with Cambrex. Cambrex obtained cGMP approval from the Belgium authorities earlier this year for their newly constructed tissue-engineering laboratory in Verviers.

    This partnership will allow C3 to have cost and time effective contract manufacturing of CellSpray® products in Europe without having to invest in a European laboratory and wait for its construction and validation. Over the coming months both parties will focus their attention on the technology transfer, ensuring that patients will be treated with the same quality as Australian patients have been treated for several years.

    C3 has already placed one CellSpray® products trained cell biologist in Europe, close to the Cambrex laboratory to support the technology transfer process.” “In order to obtain marketing approval, the Belgian authorities will first have to approve the manufacturing process to cGMP standards. Country specific submissions will then take place. While the exact timing of the approval process is dependent on regulatory agencies, we expect to be treating European patients during the first quarter of 2004.

    By then we will have sales and customer service resources trained and ready to support hospitals in Germany, Austria and Switzerland, with a population of approx. 100 million and thirty burn centres,” Troels Jordansen said.

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    Information on CCE:

    http://www.hotcopper.com.au/post_thread.asp?fid=1&tid=47983#118095

    http://www.hotcopper.com.au/post_thread.asp?fid=1&tid=53550&sym=CCE#134261

    Gerry

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