Positive opinion from relevant committee for EU approval of articular cartilage product
BERLIN, TELTOW / ACCESSWIRE / May 18, 2017 / In the course of the ongoing application for EU marketing authorisation, CO.DON AG received today the official positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its articular cartilage product. The recommended indication is the repair of symptomatic articular cartilage defects on the femoral condyle and the knee patella; defects of up to 10 cm² for adults. The CHMP assessment forms the basis for a decision by the European Commission on EU-wide marketing authorisation for the product. In the past the European Commission has followed the recommendations of CHMP for the great majority of applications.
Dr. Bernd Wegener, Chairman of the Supervisory Board of CO.DON AG. "Obtaining EU marketing authorisation for the articular cartilage product is CO.DON AG's most important strategic goal and it is now within reach. This great success is the result of the work carried out by all the employees of CO.DON AG and I would like to take this opportunity to thank them most sincerely."
Dirk Hessel, CEO of CO.DON AG: "This positive opinion represents another decisive step towards EU-wide approval. The CHMP recommendation covers all the indications in the application. Our preparations for market entry mean we can start with the practical implementation as soon as marketing authorisation is granted. If the European Commission follows the recommendation, we are ready to treat the first patients outside Germany. We soon hope to be able to meet the high demand for our advanced methods across the EU, especially since no comparable product is currently available in our target markets."
About CO.DON AG: CO.DON AG develops, produces and markets in Germany autologous cell therapies for the minimally invasive repair of cartilage damage in 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 150 clinics to treat more than 11,000 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).
More information can be found at www.ihre-zellzuechter.de and www.codon.de.
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