ChondroCelect approved in Europe

Leuven (BELGIUM) – October 6, 2009 – TiGenix (NYSE EURONEXT BRUSSELS: TIG)
announced that it has received today the approval from the European Commission
for ChondroCelect as the first Advanced Therapy Medicinal Product.

The European Commission has adopted the decision to authorise TiGenix to commercialise
ChondroCelect in the 27 countries of the European Union as well as in Iceland, Lichtenstein
and Norway. The authorisation arrives about three months after the Committee for
Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMEA) issued a positive opinion on the
European Marketing Authorisation Application (MAA).

With the formal approval of ChondroCelect, TiGenix is well positioned for commercial
success. The commercial launch of ChondroCelect will be gradual, defined by
reimbursement timelines. The first phase of the launch of ChondroCelect will focus on
Germany, the Netherlands, United Kingdom and Belgium. The commercial core team is in
place to support the efficient rollout of ChondroCelect in these markets and most of the
targeted orthopaedic reference centres have been trained.

Meanwhile, TiGenix started negotiations with local health insurance bodies related to
product pricing and reimbursement. The health economic dossier has been developed
based on the long-term patient data and an in-depth analysis of the health-economic benefit
of ChondroCelect, to support these reimbursement discussions.
“This approval represents a major milestone for our company. Being the first centrally
approved cell-based product in Europe and the first Advanced Therapy Medicinal Product
(ATMP) marks the culmination of years of development efforts” comments Gil Beyen, CEO
of TiGenix. “We are now pleased to make this important new treatment available to
European orthopaedic surgeons and their patients.”

www.tigenix.com

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