Date: 2016-07-05
Type of information: Withdrawal of the product
Product name: Chondrocelect®
Compound: characterised cultured chondrocytes derived from the patient’s own cartilage and used for autologous chondrocyte implantation
Therapeutic area: Regenerative Medicine - Bone diseases
Action mechanism: cell therapy
Company: Tigenix (Belgium)
Disease: repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults
Latest news: * On July 5, 2016, TiGenix announced the initiation of the withdrawal of the Marketing Authorization for ChondroCelect® due to commercial reasons. This decision is in line with TiGenix's strategy to concentrate its resources and capabilities on its allogeneic stem cell platforms, its upcoming Cx601 Phase III US trial and its other clinical stage assets. Due to the regulatory environment around autologous chondrocyte-based cell therapy products in Europe leading to a difficult competitive landscape for ChondroCelect®, together with the lack of reimbursement in key European countries, TiGenix has been prompted to initiate the withdrawal process of the Marketing Authorization for ChondroCelect® for commercial reasons. Consequently, TiGenix has come to an agreement with Sobi for the early termination of their existing commercial relationship and will also terminate its manufacturing agreement with PharmaCell. TiGenix will be working with the regulatory agencies on this withdrawal, and is in the process of notifying healthcare professionals and remind them of the availability of therapeutic alternatives for patients with cartilage lesions of the knee. Consequently, TiGenix has come to an agreement with Sobi for the early termination of their existing commercial relationship and will also terminate its manufacturing agreement with PharmaCell. * On July 1, 2014, TiGenix, a European leader in cell therapy, announced that the Committee for Medicinal Products for Human Use (CHMP) has renewed for an additional five years its marketing authorisation for ChondroCelect® in all of the 31 countries of the European Union (EU) and European Economic Area (EEA). In parallel to its commercialisation efforts, TiGenix is conducting an open-label, multicentre, non-interventional study in patients treated with ChondroCelect® for single symptomatic cartilage lesions of the knee of at least 2cm2 and symptom onset of less than 3 years. The results from an interim analysis of 153 patients in this study indicate statistically and clinically significant improvement in all KOOS1 subscale scores versus baseline. These data from treatment in daily clinical practice confirm the positive results from previous randomised clinical trials. * On February 4, 2014, TiGenix has announced that it reached a major milestone with the performance of the 1000th ChondroCelect implantation for cartilage repair in the knee. ChondroCelect is the first cell therapy that was granted approval by the European Medicines Agency (EMA) as an Advanced Therapy Medicinal Product (ATMP). Today it is routinely used in orthopedic centers of excellence across several European countries. * On June 7, 2013, TiGenix has provided an update on the commercial prospects of ChondroCelect®, its characterized chondrocyte implantation for symptomatic cartilage lesions in the knee. The Company has received notice from the Haute Autorité de la Santé (HAS) in France that ChondroCelect® will not be reimbursed in France. ChondroCelect is reimbursed nationally in Belgium, the Netherlands, and Spain, and through private payers in the UK. * On March 12, 2013, TiGenix, the European leader in cell therapy, has announced that it was informed by the Spanish Health Authority that its innovative cartilage repair therapy ChondroCelect® will obtain national reimbursement in Spain. * On July 17, 2012, TiGenix has announced that it has contracted with four major hospitals in the Netherlands to make its innovative cartilage repair therapy available to their patients on a routine basis. Discussions with other Cartilage Expert Centers are ongoing. Reimbursement for ChondroCelect® in the Netherlands is retroactive per January 1, 2011. * On June 8, 2012, TiGenix has announced that ChondroCelect® has obtained national reimbursement in the Netherlands. The Dutch National Health Authority (NZa) has formally announced that ChondroCelect® is to receive national reimbursement retroactively per January 1, 2012. Previously ChondroCelect® was made available in the Netherlands under a risk-sharing scheme. *On February 24, 2011, TiGenixhas received the notification by the Belgian Minister of Social Affairs of the approval of a convention agreement (Art 81) between the RIZIV/INAMI and TiGenix for the reimbursement of ChondroCelect® for wellindicated patients in specialised treatment centers. This convention covers a period of three years, and defines the specific treatment criteria and follow-up measures the company has to conduct. With the signing of this reimbursement convention, ChondroCelect is not only the first cellbased product to have obtained centralised European marketing authorisation, it is also the first Advanced Therapy Medicinal Product (ATMP) to obtain a national reimbursement. Also in other countries, progress is being made towards making the ChondroCelect® product available to patients. In France, where the transparency commission of the “Haute Autorité de Santé” (HAS) had in October 2010 declared that they were not able to evaluate the therapeutic benefit of the product and had not recommended ChondroCelect® to be put on the list of reimbursable products, a positive advice has now been issued by the ‘Haut Collège’ of the HAS recommending the conditional reimbursement of the combination of cultured autologous chondrocytes, membrane and surgical procedure under a special reimbursement scheme (“Remboursement dérogatoire” Art. 165-1-1). Since ChondroCelect® is the only approved medicinal product for autologous chondrocyte transplantation in France, this decision opens the perspective to obtain controlled access to the French market. In the Netherlands, the procedure for reimbursement of ChondroCelect under a special reimbursement scheme for innovative new medicines (Beleidsregel DureGeneesmiddelen) is still ongoing. A decision is now expected in the second quarter of 2011. In the United Kingdom, two primary care trusts (PCT) of the National Health Care System (NHS) as well as five of the largest health insurance funds are reimbursing ChondroCelect®treatments for well-indicated patients. Reimbursement discussions with additional public and private health insurance funds are ongoingIn Germany, thirty-six German hospitals filed for NUB approval at the end of 2010. These hospitals were recently informed by InEK that the product obtained this year NUB Status 4(“Neue Untersuchungs und Behandlungsmethode”). Contrary to Status 2 and 3, products with a Status 4 are eligible for reimbursement (on a case by case basis). In Spain, the reimbursement application for this first ATMP has been submitted in November 2010. A decision on the national level is expected in the second quarter of 2011. ChondroCelect® is the first cell-based product to have obtained centralised European marketing autorisation. It is also the first Advanced Therapy Medicinal Product (ATMP) to obtain a national reimbursement.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2009-10-06
Favourable opinion UE: 2009-06-25
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
