Date: 2014-04-03
Type of information: Licensing agreement
Compound: ChondroCelect® (characterised cultured chondrocytes derived from the patient’s own cartilage and used for autologous chondrocyte implantation)
Company: Swedish Orphan Biovitrum-Sobi (Sweden) Tigenix (Belgium)
Therapeutic area: Regenerative medicine - Bone diseases
Type agreement: licensing
commercialisation
Action mechanism: cell therapy. ChondroCelect® is an autologous, individualized cell therapy. This product is used in autologous chondrocyte implantation in which cells are taken from the patient's own knee, multiplied to reach a large quantity, and then re-implanted at the site of the defect.
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
Details: * On April 3, 2014, Swedish Orphan Biovitrum (SOBI) and Tigenix have concluded an agreement for the commercialisation of ChondroCelect®. Swedish Orphan Biovitrum has acquired the licencing rights to market and distribute this cell-based medicinal product for the repair of cartilage defects of the knee, from TiGenix.ChondroCelect® was the first cell-based product to be approved in Europe. It is currently available for patients and reimbursed in Belgium, the Netherlands and Spain. Sales of ChondroCelect®in 2013 were€4.3 million, a growth of 25% on a like-for-like basis over 2012.
Sobi will continue to market and distribute the product where it is currently available and will work to expand the product's availability to patients in a much wider area, including the rest of the European Union, Norway, Russia, Switzerland, Turkey, and the countries in the Middle East and North Africa. The agreement will take effect on 1 June 2014, and has a duration of 10 years.
Financial terms: TiGenix will receive a royalty of 22% of the net sales of ChondroCelect® in the first year of the agreement, and 20% of the net sales of ChondroCelect thereafter. There will be no upfront or milestone payments. The agreement will take effect on 1 June 2014, and has a duration of 10 years. While TiGenix will initially maintain responsibility for manufacturing, logistics and regulatory affairs, the costs of these activities will be borne by Sobi. TiGenix employees currently engaged in the marketing and distribution of ChondroCelect are expected to transfer to Sobi, thereby ensuring continuity of know-how.
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. 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.
