Genpharm to help commercialise ChondroCelect in the Middle East
TiGenix and Genpharm have entered into an exclusive distribution agreement for the commercialisation of TiGenix' ChondroCelect in Saudi Arabia, the United Arab Emirates, Kuwait, Bahrain, Qatar, Oman, Lebanon, Jordan, Syria, Iraq, Iran and Egypt. Under the terms of the agreement, Genpharm will facilitate patient access to ChondroCelect in these Middle East countries by obtaining the required regulatory approvals, and providing training and product support to surgeons and healthcare professionals in selected orthopaedic centres. TiGenix continues to be the marketing authorisation holder and will be responsible for logistics and the manufacturing of ChondroCelect.
ChondroCelect for cartilage regeneration in the knee is an implantation suspension of characterised viable autologous cartilage cells. The product is administered to patients in an autologous chondrocyte implantation procedure known as characterised chondrocyte implantation, a surgical procedure to treat cartilage defects, in conjunction with debridement, a physical seal of the lesion and rehabilitation. ChondroCelect is to be the first cell-based product to complete the entire development track from research to clinical development to approval by the EMA as an Advanced Medicinal Therapy Product. It is currently commercially available in Belgium, the Netherlands, Luxemburg, Germany, the UK, Finland and Spain.