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co.don Aktiengesellschaft: early submission of document packages for EU marketing authorisation

DGAP-News: co.don Aktiengesellschaft / Key word(s): Study
co.don Aktiengesellschaft: early submission of document packages for EU
marketing authorisation

01.12.2016 / 10:00
The issuer is solely responsible for the content of this announcement.

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co.don AG: early submission of document packages for EU marketing
authorisation

Berlin / Teltow, 01 December 2016 - co.don AG started the process of
submitting its application dossier to the European Medicines Agency (EMA)
today.

One element of the application dossier is the data gathered from the
clinical Phase III trial "cowisi". The aim of the clinical trial is to
compare the effectiveness and safety of the product offered by co.don for
matrix-associated autologous chondrocyte implantation with the
microfracture method of treating articular cartilage defects.

The trial is a pivotal, multi-centric, prospective and randomised open-
label study (ClinicalTrials.gov: NCT01222559) in accordance with the
acknowledged international standard Good Clinicial Practice (GCP).

Dirk Hessel, CEO of co.don AG: "Obtaining central EU marketing
authorisation is the company's foremost strategic objective. By focussing
all our efforts we have been able to start submitting our updated
application dossier to the EMA ahead of schedule. This marks the final and
decisive phase on our way to EU marketing authorisation, which we are
expecting in the fourth quarter of 2017."



About co.don AG: Berlin-based co.don AG develops, produces and markets in
Germany autologous cell therapies for the minimally invasive repair of
cartilage damage to joints following traumatic or degenerative defects.
co.don condrosphere(R) is a cell therapy product that uses only the
patient's own cartilage cells ("autologous chondrocytes"). co.don
condrosphere(R) has been approved by the German federal agency PEI in
accordance with Section 4b of the German Pharmaceuticals Act (AMG) and is
currently undergoing Phase II and III clinical trials to obtain European
marketing authorisation. co.don condrosphere(R) has been used for more than
10 years in over 120 clinics to treat more than 10,000 patients. In Germany
the statutory health insurance companies have paid for the treatment of
knee and hip joints since 2007 and for the treatment of vertebral joints
since 2008. The shares in co.don AG are listed on the Frankfurt Stock
Exchange (ISIN: DE000A1K0227). Executive Board: Dirk Hessel (CEO), Ralf M.
Jakobs (CFO).

Further information can be found at www.ihre-zellzuechter.de or
www.codon.de

Press contact
Matthias Meißner, M.A.
Corporate communications / IR / PR
Tel. [phone]
Fax [phone]
Email: [e-mail]



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01.12.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: co.don Aktiengesellschaft
Warthestraße 21
14513 Teltow
Germany
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Internet: www.codon.de
ISIN: DE000A1K0227
WKN: A1K022
Listed: Regulated Market in Frankfurt (General Standard);
Regulated Unofficial Market in Berlin, Dusseldorf,
Hamburg, Stuttgart, Tradegate Exchange


End of News DGAP News Service
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525801 01.12.2016