co.don AG: Further Progress On CO.DON's Launch Of Spherox In The UK
Published: Oct 05, 2017
- Autologous chondrocyte implantation recommended as first choice for surgical treatment in the United Kingdom
- Wholesale licence obtained for the UK
BERLIN & TELTOW, Germany--(BUSINESS WIRE)--The British National Institute for Health and Care Excellence (NICE) recommends the method of autologous chondrocyte transplantation for persistent symptoms after conservative non-invasive treatment (e.g. physiotherapy and pain medicine) of cartilage defects from 2 cm². NICE has two roles that are separate in Germany: the appraisal of and final guidance on Health and Social Care, and the reimbursement of costs for treatments.
“In addition to marketing authorisation, the licence is an essential prerequisite for finalising and realising the market launch. It gives CO.DON the right to distribute Spherox in the UK. It will be the first European country outside Germany.”
Dirk Hessel, CEO of CO.DON AG: "This is very good news, particularly in the context of the ongoing single technology appraisal for our articular cartilage implantation product Spherox, which was granted marketing authorisation by EMA (the European Medicines Agency) in July. Spherox is currently the only authorised cell-based pharmaceutical for the treatment of cartilage defects in the knee." "We are on track with planning market entries."
This week the UK Medicines & Healthcare products Regulatory Agency (MHRA) granted us a wholesale licence and now we are expecting the first treatments in the coming weeks." In addition to marketing authorisation, the licence is an essential prerequisite for finalising and realising the market launch. It gives CO.DON the right to distribute Spherox in the UK. It will be the first European country outside Germany.
About CO.DON AG: CO.DON AG develops, produces and markets autologous cell therapies for the minimally invasive repair of cartilage damage in knee joints following traumatic or degenerative defects. The product being marketed is a cell therapy product that uses only the patient's own cartilage cells ("autologous chondrocytes"). CO.DON's method 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. In July 2017 the company received EU marketing authorisation for Spherox. 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.codon.de
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