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CO.DON: Recommendation to make EU marketing authorisation for Spherox valid for an unlimited period

Teltow / Leipzig 1 March 2022 – CO.DON AG has received the final assessment from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its pharmaceutical product Spherox, which has central EU marketing authorisation. The Committee recommends renewing the marketing authorisation for the product for an unlimited period and without any additional conditions. It further recommends removing Spherox from the list of medicines under additional monitoring five years after its initial authorisation.

The Committee for Human Medicinal Products, officially abbreviated to CHMP, is a scientific committee of the European Medicines Agency (EMA), which assesses the quality, effectiveness and safety of medicinal products for which pharmaceutical companies have applied for marketing authorisation.

Dr Christian Kaps, Vice President Scientific Affairs at CO.DON AG: “My thanks go to the entire team for their outstanding work. We are proud that the quality of the data submitted has resulted in this assessment. After the expected confirmation by the European Commission, this means that our medicinal product for the regenerative treatment of cartilage damage in the knee joint can be used throughout the EU.”

Tilmann Bur, Executive Board of CO.DON AG, added: “This important decision will help CO.DON to continue addressing promising, commercially attractive markets in Europe and to develop or expand our business there.”

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 17,000 patients have already been treated. In July 2017 CO.DON received EU-wide marketing authorisation for its product, with approval for Switzerland following in March 2019. At its site in Leipzig CO.DON has built one of the largest plants for the industrial-scale production and contract manufacturing of human cells. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A3E5C08). Executive Board: Tilmann Bur.

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Matthias Meißner
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