TiGenix : ChondroCelect update

Fri Jun 7, 2013 12:30pm EDT

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Regulated information
june 7, 2013

TiGenix provides ChondroCelect update

Leuven (BELGIUM) - June 7, 2013 - TiGenix (NYSE Euronext: TIG), the European leader in cell therapy, today provided an update on the commercial prospects of ChondroCelect, its characterized chondrocyte implantation for symptomatic cartilage lesions in the knee. The Company has received notice from the Haute Autorité de la Santé (HAS) in France that ChondroCelect will not be reimbursed in France. ChondroCelect is reimbursed nationally in Belgium, the Netherlands, and Spain, and through private payers in the UK.

Growth of ChondroCelect sales keeps accelerating. For the first five months of 2013, ChondroCelect sales were €1.9 million, up 59% compared with the same period last year. And this does not yet include sales from the Spanish market.

"We are disappointed by the decision of the HAS, but not completely surprised as it is consistent with their position in 2010," said Eduardo Bravo, CEO of TiGenix. "Importantly, the decision does not impact our objective to turn ChondroCelect into a cash flow positive asset in 2014. We will continue to efficiently allocate our resources to those markets where we are selling such as Belgium and the Netherlands, and build up a commercial presence in Spain and the UK. We will also continue to work on expanding the territories where ChondroCelect is available through local or regional distributors."

For more information:
Eduardo Bravo                             Claudia D'Augusta
Chief Executive Officer                  Chief Financial Officer
eduardo.bravo@tigenix.com          claudia.daugusta@tigenix.com

Hans Herklots
hans.herklots@tigenix.com
+32 16 39 60 97

About ChondroCelect

ChondroCelect is the first and currently only cell therapy that has been granted market authorisation by the European Union. For more information, including the European Public Assessment Report (EPAR), prescribing information, and the Summary of Product Characteristics (SPC) please visit the European Medicines Agency (EMA) website at www.ema.europa.eu

 

About TiGenix

TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed 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.

Forward-looking information

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 recognised 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.

 




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