2013-01-08 11:55:36 -
co.don AG /
co.don® AG - Application filed for EU-wide approval for the articular cartilage
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Teltow, 08. January 2013
co.don® AG has submitted its application for EU marketing authorisation for the
articular cartilage product chondrosphere® to the relevant committee of the
European Medicines Agency in London.
The official approval procedure began on 26.12.2012.
A European regulation stipulates that tissue products derived from biotechnology
processes, which include the tissue transplants from co.don AG, require central
marketing authorisation from the European Commission.
Now that co.don® AG has filed the extensive approval documentation by the end of
2012, in line with its own internal timetable,
the European Medicines Agency is
responsible for carrying out the scientific evaluation of the application and
making a recommendation on marketing authorisation to the European Commission.
The product can still be sold in Germany, the main sales market for co.don® AG,
as the company applied for the appropriate approval from the national German
federal authority before the deadline. At the same time co.don® AG is
intensifying its marketing and sales activities in non-EU member states both
inside and outside Europe.
About co.don® AG:
The company is based in Teltow, Brandenburg, and was founded in 1993. Since
2001 the biopharmaceutical specialist has been listed on the Frankfurt Stock
Exchange (ISIN: DE000A1K0227). co.don AG(®) uses tissue engineering - the
cultivation and growth of autologous tissue cells - to develop innovative
products and therapeutic concepts for the orthopaedic and neurosurgical markets.
The cell-based biological drugs (autologous cell transplants for articular
cartilage and intervertebral disks) are produced without the use of antibiotics,
growth factors and genetic engineering. The Executive Board of co.don(®) AG is
made up of Dr Andreas Baltrusch (CEO) and Vilma Methner (COO, CSO).
Further information is also available from: www.codon.de
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