The European Commission has adopted the decision to authorise TiGenix to commercialise ChondroCelect in the 27 countries of the European Union as well as in Iceland, Lichtenstein and Norway. The authorisation arrives about three months after the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion on the European Marketing Authorisation Application (MAA).
With the formal approval of ChondroCelect, TiGenix is well positioned for commercial success. The commercial launch of ChondroCelect will be gradual, defined by reimbursement timelines. The first phase of the launch of ChondroCelect will focus on Germany, the Netherlands, United Kingdom and Belgium. The commercial core team is in place to support the efficient rollout of ChondroCelect in these markets and most of the targeted orthopaedic reference centres have been trained.
Meanwhile, TiGenix started negotiations with local health insurance bodies related to product pricing and reimbursement. The health economic dossier has been developed based on the long-term patient data and an in-depth analysis of the health-economic benefit of ChondroCelect, to support these reimbursement discussions.