CO.DON AG
co.don Aktiengesellschaft: early submission of document packages for EU marketing authorisation
DGAP-News: co.don Aktiengesellschaft / Key word(s): Study 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
2016-12-01 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
Language: | English | |
Company: | co.don Aktiengesellschaft | |
Warthestraße 21 | ||
14513 Teltow | ||
Germany | ||
Phone: | 03328 43460 | |
Fax: | 03328 434643 | |
E-mail: | info@codon.de | |
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 |