Belgian-based TiGenix said it was closing its biomaterials unit TiGenix Ltd. so it could fully focus on the further commercial roll-out of ChondroCelect®, the company’s commercial cell therapy product for cartilage repair in the knee, and its cell therapy product pipeline, which includes clinical stage allogeneic adult stem cell programs for autoimmune and inflammatory diseases.
“The formal closing of TiGenix Ltd. reduces complexity and allows us to exclusively focus on our high-value assets in the short and long term: ChondroCelect and our proprietary adipose-derived stem cell products,” Eduardo Bravo, TiGenix’s CEO, said in a statement.
The move comes some six weeks after TiGenix won European Medicines Agency approval Oct. 9 for commercial production of ChondroCelect at its European manufacturing plant in Sittard-Geleen, the Netherlands. TiGenix says the plant is fully geared towards the production of cell therapy products.
Earlier this month, TiGenix recorded a near-tripling (up 152%) of third-quarter sales, to €1.1 million ($1.4 million) from €0.4 million ($0.5 million), which the company attributed to increased use of ChondroCelect in Belgium and the Netherlands. For the first nine months of 2012, ChondroCelect racked up €3.2 million (about $4.2 million) in sales—€2.5 million from sales this year, the rest deferred from last year.
TiGenix’ pipeline is led by its Cx601, an adipose-derived allogeneic stem cell suspension for complex perianal fistulas in Crohn’s disease patients. Since July, the company has been enrolling patients in a Phase III clinical trial (ADMIRE-CD) designed to demonstrate safety and superior efficacy over placebo in perianal fistulas in Crohn’s disease patients who failed to respond to previous treatment(s)—in most cases, biological—and to confirm safety and efficacy results from the Phase II trial completed last year and published last month in the International Journal of Colorectal Disease.
Since July, ADMIRE-CD has been enrolling toward the approximately 278 patients it wants to study at 46 centers across seven European countries and Israel.
The company is also carrying out a Phase IIa trial of Cx611 in rheumatoid arthritis, for which patient enrollment was completed Aug. 8. TiGenix said it expects to report preliminary results in Q4 and final results no later than April 2013.