Teltow / Leipzig, 03 June 2021 - The MHRA (Medicines and Healthcare products Regulatory Agency) has granted marketing authorisation for the autologous medicinal product Spherox marketed by CO.DON AG, thus completing the BREXIT-related transition of the medicinal product, which has already been approved throughout the EU. The regulatory authority MHRA regulates the approval of medicines, medical devices and blood components for transfusions in the UK.
The re-approval process had become necessary due to the UK's withdrawal from the European Union, as the scope of the original approval only covered EU member states.
Achim Simons, board member of CO.DON AG: "We are particularly pleased with the speed of the regulatory decision, which ensures further personalised, regenerative and sustainable treatment of knee cartilage defects of patients in the UK and is also the basis for the acquisition of further clinics."
CO.DON AG develops, produces and distributes autologous cell therapies for the minimally invasive repair of cartilage defects. The product being marketed is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint that uses only the patient's own cartilage cells ("autologous chondrocytes"). CO.DON's method is currently used in over 200 clinics in Germany and more than 16,000 patients have already been treated. In July 2017 CO.DON AG received central EU marketing authorisation for this product, followed by the marketing authorization for Switzerland in March 2019. At the Leipzig site, CO.DON has built one of the largest facilities for the production of human cells on an industrial scale for in-house and contract manufacturing. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Tilmann Bur, Dr Achim Simons.
Further information is available from www.codon.de.
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