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
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.