25 September 2012
TiGenix’s new European production facility obtains EMA approval for commercial production of ChondroCelect
Leuven (BELGIUM) – September 25, 2012 – TiGenix (Euronext Brussels: TIG) announced today that after the successful cGMP inspection by the Dutch authorities earlier this year, it has now obtained the crucial approval from the European Medicines Agency (EMA) for the production of ChondroCelect, the company’s commercial cell therapy product for cartilage repair in the knee, in its new state-of-the-art manufacturing facility in Sittard Geleen (NL).
“The EMA approval of our facility in the Netherlands for the production of ChondroCelect is another amazing feat from our manufacturing and regulatory affairs teams,” said Eduardo Bravo, CEO of TiGenix. “The complexities of manufacturing an advanced therapy medicinal product (ATMP) like ChondroCelect are hard to overstate, and the seamless transfer of these capabilities to a new production facility, while keeping all facets of the process on a par with the original and meeting all requirements of the European regulator are immensely demanding. Our production site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products. It provides us with crucial manufacturing capabilities to support the anticipated growth in demand for ChondroCelect for cartilage repair, with sufficient capacity for the production of other advanced stem cell therapy products.”
The EMA’s approval concerns a so-called Type II variation, which is required when a pharmaceutical manufacturer expands its production capabilities to a new location. At the time of approval of a medicinal product, its manufacturing procedures are an essential part of the Marketing Authorisation Application submitted to the agency, and are meticulously reviewed. When manufacturing is moved to a new plant, the EMA needs to approve the comparability of the manufacturing procedures to ensure there are no discrepancies with the original process. This Type II variation is particularly challenging for ATMPs that are characterized by more complex variables than traditional pharmaceutical products. ChondroCelect is the first ATMP ever approved by the agency.
TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix’ control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix’ expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.