TiGenix - Business and Financial Update for the Third Quarter of 2009
Leuven (BELGIUM) - November 3, 2009 - TiGenix (NYSE EURONEXT: TIG) gives a business update and reports cash position as of September 30, 2009.
Business Update
European approval of ChondroCelect®
On October 5, ChondroCelect received the awaited European marketing authorisation from the European Commission and became the first centrally approved Advanced Therapy Medicinal Product in Europe. The approval authorises TiGenix to commercialise the product in the 27 countries of the European Union as well as in Iceland, Lichtenstein and Norway.
The authorisation arrived after the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on the European Marketing Authorisation Application.
Commercial launch of ChondroCelect
The marketing authorisation marks the start of the commercial launch of ChondroCelect in a first set of target markets. In Germany, the Netherlands, the United Kingdom and Belgium, a
commercial core team is in place to support the roll-out of ChondroCelect and most of the targeted orthopaedic reference centres have been trained. TiGenix has now started negotiations on price setting and reimbursement with local health insurance authorities and payers in each country.
In Germany, ChondroCelect already received the status of an innovative new treatment method ('Neue Untersuchungs- und Behandlungsmethode' or 'NUB') by InEK Gmbh, the
German Institute for the Hospital Remuneration System, as a first step towards reimbursement. This NUB status allows individual hospitals to apply for reimbursement of the ChondroCelect product with the health insurance funds ('Krankenkassen'). Thirty-three hospitals have already submitted a NUB dossier for ChondroCelect.
Similar processes are ongoing in the Netherlands, Belgium, and the United Kingdom.
TiGenix' GMP cell expansion facility in Leuven is fully operational to support the commercial launch of ChondroCelect in Europe. The basic design of the additional production facility in
Sittard-Geleen is finalised and construction work is expected to start before year-end.
US registration process
TiGenix has compiled a data package for discussion with the US FDA. A pre-BLA meeting with the FDA is expected to take place before the end of the year.
Product improvements and development pipeline
A proprietary biopsy tool, the ChondroCelect HarvesterT, allowing the surgeon to harvest a cartilage biopsy in an easy and consistent manner was developed in close collaboration
with Dr. Yves Fortems and the medical device company MedInvents. The ChondroCelect HarvesterT recently received CE Mark approval. Standardization of the biopsy procedure is an important element for the quality assurance of ChondroCelect.
ChondroCelect has been approved for use with a biodegradable collagen membrane to seal the defect. The use of the collagen membrane significantly facilitates the implantation procedure and has an improved safety profile as compared to the use of a periostal flap. It also opens the perspective to a minimal invasive implantation, possibly even an arthroscopic procedure for a number of indications. In collaboration with its clinical advisors,TiGenix is assessing the use of different scaffolds and membranes.
The company is continuing the development work on a stem cells based product for meniscus repair, as part of an IWT grant. The development of a proprietary stem cell platform aims at broadening the product offering to other musculoskeletal tissues and to move to allogeneic approaches. The researchers are also investigating new targeted therapies that can be used to modulate certain biological pathways with the objective to
prevent or delay the progression of osteoarthritis.
The company also evaluates opportunities to acquire businesses and technologies that it believes may be complementary to its business activities.
Publication of ChondroCelect trial results
The publication of the 3-year data of the ChondroCelect trial, entitled 'Treatment of Symptomatic Cartilage Defects of the Knee: Characterized Chondrocyte Implantation Results in Better Clinical Outcome at 36 Months in a Randomized Trial Compared to
Microfracture' by D. Saris, J. Vanlauwe et al. has been made available as e-publication ahead of print in the American Journal of Sports Medicine, the official journal of the
American Orthopaedic Society for Sports Medicine (AOSSM), one of the highest ranked, peer-reviewed orthopaedic and sport sciences journals.
In July 2009, the earlier publication entitled 'Characterized Chondrocyte Implantation Results in Better Structural Repair When Treating Symptomatic Cartilage Defects of the Knee in a Randomized Controlled Trial Versus Microfracture' by D. Saris, J. Vanlauwe et al. that appeared in the February 2008 issue of the ASJM (Vol. 36, No.2, pp. 235-246), was awarded with the prestigious Hughston Award.
Financial Update
Cash position of EUR 21.9 million on September 30, 2009
Net cash used in the third quarter was EUR 3.3 million. On September 30 2009, TiGenix had cash and cash equivalents of EUR 21.9 million on the balance sheet.
Outlook
Launch of ChondroCelect in selected European markets
Pre-BLA meeting and filing of BLA for ChondroCelect in the US
Clinical validation of the ChondroCelect 3D product
Start clinical development of MeniscoCelect
Active partnering discussions
For more information, please contact:
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
Investor@tigenix.com
Business Update
European approval of ChondroCelect®
On October 5, ChondroCelect received the awaited European marketing authorisation from the European Commission and became the first centrally approved Advanced Therapy Medicinal Product in Europe. The approval authorises TiGenix to commercialise the product in the 27 countries of the European Union as well as in Iceland, Lichtenstein and Norway.
The authorisation arrived after the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on the European Marketing Authorisation Application.
Commercial launch of ChondroCelect
The marketing authorisation marks the start of the commercial launch of ChondroCelect in a first set of target markets. In Germany, the Netherlands, the United Kingdom and Belgium, a
commercial core team is in place to support the roll-out of ChondroCelect and most of the targeted orthopaedic reference centres have been trained. TiGenix has now started negotiations on price setting and reimbursement with local health insurance authorities and payers in each country.
In Germany, ChondroCelect already received the status of an innovative new treatment method ('Neue Untersuchungs- und Behandlungsmethode' or 'NUB') by InEK Gmbh, the
German Institute for the Hospital Remuneration System, as a first step towards reimbursement. This NUB status allows individual hospitals to apply for reimbursement of the ChondroCelect product with the health insurance funds ('Krankenkassen'). Thirty-three hospitals have already submitted a NUB dossier for ChondroCelect.
Similar processes are ongoing in the Netherlands, Belgium, and the United Kingdom.
TiGenix' GMP cell expansion facility in Leuven is fully operational to support the commercial launch of ChondroCelect in Europe. The basic design of the additional production facility in
Sittard-Geleen is finalised and construction work is expected to start before year-end.
US registration process
TiGenix has compiled a data package for discussion with the US FDA. A pre-BLA meeting with the FDA is expected to take place before the end of the year.
Product improvements and development pipeline
A proprietary biopsy tool, the ChondroCelect HarvesterT, allowing the surgeon to harvest a cartilage biopsy in an easy and consistent manner was developed in close collaboration
with Dr. Yves Fortems and the medical device company MedInvents. The ChondroCelect HarvesterT recently received CE Mark approval. Standardization of the biopsy procedure is an important element for the quality assurance of ChondroCelect.
ChondroCelect has been approved for use with a biodegradable collagen membrane to seal the defect. The use of the collagen membrane significantly facilitates the implantation procedure and has an improved safety profile as compared to the use of a periostal flap. It also opens the perspective to a minimal invasive implantation, possibly even an arthroscopic procedure for a number of indications. In collaboration with its clinical advisors,TiGenix is assessing the use of different scaffolds and membranes.
The company is continuing the development work on a stem cells based product for meniscus repair, as part of an IWT grant. The development of a proprietary stem cell platform aims at broadening the product offering to other musculoskeletal tissues and to move to allogeneic approaches. The researchers are also investigating new targeted therapies that can be used to modulate certain biological pathways with the objective to
prevent or delay the progression of osteoarthritis.
The company also evaluates opportunities to acquire businesses and technologies that it believes may be complementary to its business activities.
Publication of ChondroCelect trial results
The publication of the 3-year data of the ChondroCelect trial, entitled 'Treatment of Symptomatic Cartilage Defects of the Knee: Characterized Chondrocyte Implantation Results in Better Clinical Outcome at 36 Months in a Randomized Trial Compared to
Microfracture' by D. Saris, J. Vanlauwe et al. has been made available as e-publication ahead of print in the American Journal of Sports Medicine, the official journal of the
American Orthopaedic Society for Sports Medicine (AOSSM), one of the highest ranked, peer-reviewed orthopaedic and sport sciences journals.
In July 2009, the earlier publication entitled 'Characterized Chondrocyte Implantation Results in Better Structural Repair When Treating Symptomatic Cartilage Defects of the Knee in a Randomized Controlled Trial Versus Microfracture' by D. Saris, J. Vanlauwe et al. that appeared in the February 2008 issue of the ASJM (Vol. 36, No.2, pp. 235-246), was awarded with the prestigious Hughston Award.
Financial Update
Cash position of EUR 21.9 million on September 30, 2009
Net cash used in the third quarter was EUR 3.3 million. On September 30 2009, TiGenix had cash and cash equivalents of EUR 21.9 million on the balance sheet.
Outlook
Launch of ChondroCelect in selected European markets
Pre-BLA meeting and filing of BLA for ChondroCelect in the US
Clinical validation of the ChondroCelect 3D product
Start clinical development of MeniscoCelect
Active partnering discussions
For more information, please contact:
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
Investor@tigenix.com
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