co.don AG / co.don® AG passes next key milestone on its track to European approval. . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
Teltow, 10 December 2012
Another success for co.don AG: on 30 November 2012, the European Medicines Agency EMA announced its official decision to approve the paediatric investigation plan (PIP) for co.don chondrosphere®. This means that an important condition for applying for European approval has now been met.
co.don® AG has successfully obtained a positive opinion from the European Medicines Agency for co.don chondrosphere®. co.don chondrosphere® is used to treat cartilage defects. Its active ingredient consists of spheroids of human autologous matrix-associated chondrocytes.
The PIP (paediatric investigation plan) is a development plan showing what data about a medicine are available for children and how further data collection is to be ensured in order to give children and young people access to the medicine as well. Pharmaceutical companies must submit their PIP to the Paediatric Committee (PDCO) of the European Medicines Agency, which then publishes an opinion on it.
The company is now required to gather further data on young people who have already been treated with co.don chondrosphere®. Initial data shows good clinical results and documents the safety of using co.don chondrosphere® to treat patients below 18 years of age. co.don® AG is confident that it will meet the EMA specifications and receive EMA approval for using co.don chondrosphere® to treat patients below 18 years of age who already have stopped growing.
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 Siodla (COO, CSO).
Further information is also available from: www.codon.de (http://www.codon.de/)
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co.don AG
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