Don : Key milestone reached – documents for EU marketing authorisation of cartilage product submitted on time

19.12.2016 | press release, Aktuell

Berlin / Teltow, 19 December 2016 - co.don AG has submitted the documents for EU marketing authorisation for its articular cartilage product to European Medicines Agency (EMA) in London.

The EMA will evaluate the dossier from a scientific perspective and make a recommendation on product approval to the European Commission. co.don AG has been marketing the product in Germany, its main sales market, since 1997 and with the appropriate indication the costs are reimbursed by health insurers.

Dirk Hessel, CEO of the company: 'What the company has been working hard for over so many years is now finally within reach. A decisive milestone has been attained on the way to our most important strategic goal - EU marketing authorisation for our main product. We are successful in Germany: our product represents the highest level of personalised medicine and we are positioning ourselves clearly for German market leadership in the field of regenerative arthrosis prophylaxis. EU approval will open up even greater potential for us. Because we firmly believe in the international expansion of our company from autumn 2017 onwards we have already started to adapt our internal structures and to build external management capacities. On behalf of the Executive Board and the Supervisory Board I would like to thank all the employees of co.don AG who every day with great dedication help to drive our common vision: joint preservation before joint replacement.'

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® is a cell therapy product that uses only the patient's own cartilage cells ('autologous chondrocytes'). co.don condrosphere® 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® 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. +49 (0)30-240352330
Fax +49 (0)30-240352309

Email: ir@codon.de