co.don® AG passes next key milestone on its track to European approval.
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co.don AG /
co.don® AG passes next key milestone on its track to European approval.
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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
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Press release (PDF):
http://hugin.info/132731/R/1663675/539577.pdf
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Source: co.don AG via Thomson Reuters ONE
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Unternehmensinformation / Kurzprofil:
Datum: 10.12.2012 - 14:05 Uhr
Sprache: Deutsch
News-ID 211151
Anzahl Zeichen: 3648
contact information:
Town:
Teltow
Kategorie:
Business News
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