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.'
For more information, please contact
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
Investor@tigenix.com
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on 'Regenerating Motion'. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and osteoarthritic
joints.
TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The lead indication among these is cartilage damage, which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an
increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical need. Current therapies do not provide satisfying, longterm durable repair and TiGenix therefore believes there is a need for more effective treatments for
cartilage damage.
About ChondroCelect
ChondroCelect®, the company's lead product for cartilage regeneration in the knee, is the first cellbased
product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of
characterised cultured chondrocytes derived from the patient's own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. Cartilage defects of the knee are very common, and the spontaneous healing capacity of cartilage is limited.
The objective of the ChondroCelect technology is to facilitate the regeneration of hyaline-like cartilage that more closely approximates the structure of healthy normal cartilage. TiGenix has successfully completed a randomised Phase III clinical trial comparing ChondroCelect to the present standard-of-care surgical intervention called microfracture. The results of this study have formed the basis for the regulatory approval in the EU for the repair of single symptomatic cartilage defects of
the femoral condyle of the knee in adults. The results of this pivotal clinical trial have also been published in the February 2008 issue of the American Journal of Sports Medicine.
The company is now in the process of launching and marketing the product in selected European markets, and is preparing the filing for regulatory approval in the U.S.
Forward-looking information
This document contains 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, withoutlimitation, '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 the Company's 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 the Company's 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.
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.'
For more information, please contact
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
Investor@tigenix.com
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on 'Regenerating Motion'. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and osteoarthritic
joints.
TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The lead indication among these is cartilage damage, which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an
increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical need. Current therapies do not provide satisfying, longterm durable repair and TiGenix therefore believes there is a need for more effective treatments for
cartilage damage.
About ChondroCelect
ChondroCelect®, the company's lead product for cartilage regeneration in the knee, is the first cellbased
product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of
characterised cultured chondrocytes derived from the patient's own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. Cartilage defects of the knee are very common, and the spontaneous healing capacity of cartilage is limited.
The objective of the ChondroCelect technology is to facilitate the regeneration of hyaline-like cartilage that more closely approximates the structure of healthy normal cartilage. TiGenix has successfully completed a randomised Phase III clinical trial comparing ChondroCelect to the present standard-of-care surgical intervention called microfracture. The results of this study have formed the basis for the regulatory approval in the EU for the repair of single symptomatic cartilage defects of
the femoral condyle of the knee in adults. The results of this pivotal clinical trial have also been published in the February 2008 issue of the American Journal of Sports Medicine.
The company is now in the process of launching and marketing the product in selected European markets, and is preparing the filing for regulatory approval in the U.S.
Forward-looking information
This document contains 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, withoutlimitation, '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 the Company's 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 the Company's 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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