TiGenix receives positive CHMP opinion on European MAA for ChondroCelect
Leuven (BELGIUM), June 26, 2009 - TiGenix (NYSE EURONEXT: TIG) announces that the company has received a positive opinion from the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMEA) on the European Marketing Authorisation application (MAA) for its lead product ChondroCelect.
ChondroCelect is a regenerative autologous medicinal product indicated for the repair of full thickness cartilage lesions of the knee. Clinical results demonstrated that ChondroCelect
formed regenerated cartilage that was superior to the repair tissue obtained by microfracture, the current standard of care for cartilage defects in the knee. This was accompanied by a better clinical outcome and sustained clinical benefit to the patient.
The CHMP opinion for ChondroCelect will now be forwarded to the European Commission for adoption of the final community Marketing Authorisation, which is typically issued
between 60 and 90 days from adoption of the CHMP opinion. The European Commission generally follows the advice of the CHMP. Upon approval, ChondroCelect will be the first
cell based product to be centrally approved in the 27 member states of the European Union as well as in Iceland, Lichtenstein and Norway under the new Advanced-Therapy Medicinal
Products (ATMP) legislation.
As part of the application the CAT and the CHMP have required the company to submit a risk management plan with a series of measures, including further studies to ensure that the
efficacy and the safety are followed up in a robust manner once in the market.(www.emea.europa.eu).
We are very proud on this achievement', comments Wilfried Dalemans, Head of Regulatory Affairs of TiGenix. 'Obtaining regulatory approval of the first ATMP product in Europe shows
that advanced cell therapy products can be developed according to the medicinal product regulatory requirements, and thus be made available to the patients in need of new
therapies'. 'The positive CHMP opinion is outstanding news for our company and is a great recognition for our entire team, that has worked very hard to achieve this important milestone.'
comments Gil Beyen, CEO of TiGenix. 'We are ready and looking forward to launch ChondroCelect following the European Commission's marketing authorisation and to
develop other regenerative medicine products for the joint.'
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext: TIG) is a late-stage biomedical company that focuses on innovative local treatments for damaged and osteoarthritic joints. The Company is
exploiting the power of regenerative medicine to develop durable treatments, validated through controlled clinical trials, for these indications. 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, long-term durable repair and TiGenix therefore believes there is a need for more effective treatments for cartilage damage.
About ChondroCelect
ChondroCelect® is the lead product for TiGenix that is in late stage development for applications in cartilage repair. 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 of the submission in the EU for regulatory approval which will be followed by a submission in the U.S. The results of this pivotal clinical trial have also been published in the February 2008 issue of the American Journal of Sports Medicine.
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, 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 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.
Medicines Agency (EMEA) on the European Marketing Authorisation application (MAA) for its lead product ChondroCelect.
ChondroCelect is a regenerative autologous medicinal product indicated for the repair of full thickness cartilage lesions of the knee. Clinical results demonstrated that ChondroCelect
formed regenerated cartilage that was superior to the repair tissue obtained by microfracture, the current standard of care for cartilage defects in the knee. This was accompanied by a better clinical outcome and sustained clinical benefit to the patient.
The CHMP opinion for ChondroCelect will now be forwarded to the European Commission for adoption of the final community Marketing Authorisation, which is typically issued
between 60 and 90 days from adoption of the CHMP opinion. The European Commission generally follows the advice of the CHMP. Upon approval, ChondroCelect will be the first
cell based product to be centrally approved in the 27 member states of the European Union as well as in Iceland, Lichtenstein and Norway under the new Advanced-Therapy Medicinal
Products (ATMP) legislation.
As part of the application the CAT and the CHMP have required the company to submit a risk management plan with a series of measures, including further studies to ensure that the
efficacy and the safety are followed up in a robust manner once in the market.(www.emea.europa.eu).
We are very proud on this achievement', comments Wilfried Dalemans, Head of Regulatory Affairs of TiGenix. 'Obtaining regulatory approval of the first ATMP product in Europe shows
that advanced cell therapy products can be developed according to the medicinal product regulatory requirements, and thus be made available to the patients in need of new
therapies'. 'The positive CHMP opinion is outstanding news for our company and is a great recognition for our entire team, that has worked very hard to achieve this important milestone.'
comments Gil Beyen, CEO of TiGenix. 'We are ready and looking forward to launch ChondroCelect following the European Commission's marketing authorisation and to
develop other regenerative medicine products for the joint.'
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext: TIG) is a late-stage biomedical company that focuses on innovative local treatments for damaged and osteoarthritic joints. The Company is
exploiting the power of regenerative medicine to develop durable treatments, validated through controlled clinical trials, for these indications. 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, long-term durable repair and TiGenix therefore believes there is a need for more effective treatments for cartilage damage.
About ChondroCelect
ChondroCelect® is the lead product for TiGenix that is in late stage development for applications in cartilage repair. 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 of the submission in the EU for regulatory approval which will be followed by a submission in the U.S. The results of this pivotal clinical trial have also been published in the February 2008 issue of the American Journal of Sports Medicine.
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, 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 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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