ChrondroCelect Receives First-of-Its-Kind EU Market Clearance
BY LAUREN UZDIENSKI, OCTOBER 8, 2009
TiGenix announced that ChondroCelect, its ACI treatment for cartilage regeneration, has been cleared by the European Commission for sale on the EU market. This is the first product to be approved in the EU as an advanced therapy medicinal product, the EC's term for products derived from genes, cells or tissues.
The company has said that what differentiates ChondroCelect from other ACI treatments (e.g., Genzyme's Carticel, the only ACI product available in the U.S.) is that TiGenix tests the tissue sample taken from the patient for certain genetic markers that predict whether the cells are likely to regenerate. Thus the company can identify and implant a more potent cell sample to the patient. Throughout the clinical trial, the company released milestone data to the public demonstrating the ChondroCelect's superiority to microfracture for the treatment of cartilage lesions. Outcomes superior new tissue quality, greater improvements on the Knee Injury and Osteoarthritis Outcome Score scale and an overall lower failure rate compared to microfracture. Results showing superior tissue quality were published in the American Journal of Sports Medicine in February 2008.
TiGenix plans to initiate a gradual rollout of ChrondroCelect, beginning in Germany, the Netherlands, United Kingdom and Belgium. They are focusing on gaining insurance coverage and are working with local payors to set pricing and reimbursement rates. As for marketing outside the EU, the company says they plan to apply for FDA approval, though no timeline has been announced for the U.S. filing. TiGenix purchased a Tennessee cell expansion facility in 2007, demonstrating their commitment to bringing the product Stateside.
