ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

Granted patentsThe granted patents broadly cover the Company’s leadcartilage repair product ChondroCelect and its stemcell technology platform. The granted European patent(EP1 218 037 B1, which patent can remain in force for up to20 years from its filing date, i.e. until October 6, 2019) and thetwo granted US patents (US 7,482,114 B1 & US 7,479,367 B1),entitled “In vivo assay for testing the phenotypic stability”,protects the tools and methods used to determine novelfunctional and molecular parameters that define maturecartilage-forming chondrocytes, as well as the use of theseparameters as quality control markers in the preparation of cellsused for autologous chondrocyte transplantation. The claimedmethods and markers form the basis of the potency assay, theproduct optimisation and the quality control procedures usedin the production of ChondroCelect. The equivalent filing inCanada (CA 2,397,610) is pending.The granted European patent (EP1 282 690 B1, which patent canremain in force for up to 20 years from its priority date, i.e. untilOctober 6, 2019), entitled “Isolation of precursor cells and theiruse for tissue repair”, protects TiGenix’ stem cell technologyplatform. The patent broadly covers methods for the isolationof adult mesenchymal precursor cells that are able to formskeletal or connective tissue such as cartilage, bone, ligament,tendon, meniscus, joint capsule, intervertebral discs or teeth.Further claims relate to cultures of these isolated precursor cellsand the use thereof for pharmaceutical purposes or for theproduction of specific growth factors. The equivalent filings inCanada (CA 2,386,506) and the US (US 12/176,256) are pending.The granted US patents US 7,485,310 B1 andUS12/345369 (notice of allowance) entitled “Use ofCXCL6 chemokine in the prevention or repair of cartilagedefects” protects the use of CXCL6 for the promotion ofcartilage and bone formation in vitro and in vivo and especiallyfor the repair of cartilage or osteochondral defects or for theformation of bone or cartilage in cosmetic surgery. Equivalentpatents are granted in Singapore and Russia. The Europeanequivalent, as well as applications in Canada, Australia, Japan,Norway, Israel, New Zealand and Hong-Kong are still pending.The granted US patent (US 7,780,994) entitled “Compositebiomaterials comprising calcium phosphate materials, collagenand glycosaminoglycans” relates to a precursor and compositematerial comprising a triple co-precipitate of collagen, one ormore glycosaminoglycans (GAG) and calcium phosphate, anda process for co-precipitating the components that forms thecore protection of ChondroMimetic. Additional equivalentswere granted in the UK, China and Singapore. The applicationis still pending in Australia, Canada, Europe, India, Japan, SouthKorea and Norway.Pending patent applicationsThe pending application (US 12/323,185) entitled “In vivo assayand molecular markers for testing the phenotypic stability ofcell populations for autologous transplantation” represents anexpansion of the claims granted in EP1 218 037 B1, coveringa large number of additional genes associated with thephenotype of stable hyaline cartilage, their use as qualitycontrol markers and cell populations characterised by thesemarkers.The patent application (EP1,498,146) entitled “In vivo assayand molecular markers for testing the phenotypic stabilityof cell populations, and selected cell populations forautologous transplantation” is filed as a divisional Europeanpatent application and includes claims to cell populations ofchondrocytes with a defined marker profile, pharmaceuticalcompositions and implants comprising these cell populations.TiGenix in-house target discovery programme has resultedin the identification of a number of novel molecules thatinfluence the proper development of chondrocyte precursorsinto high quality cartilage. These novel molecules can havean application as marker but also have revealed a number ofpotential therapeutic targets related to improper developmentand repair of cartilage with potential applications in the field ofOA.In the international application entitled “Marker genes for usein the identification of chondrocyte phenotypic stability andin the screening of factors influencing cartilage production”(WO2008061804), the use of specific genetic marker sets fordetermining the phenotypic stability of cultured chondrocytepopulations and in screening systems for identifyingcompounds of use in the treatment of cartilage defects andcartilage related diseases are claimed.The international application entitled “Methods to maintain,improve and restore the cartilage phenotype of chondrocytes”(WO2007107330) claims a novel regulatory cell populationthat can be used to maintain, restore or improve the cartilagephenotype of chondrocytes and chondrocyte precursorcells. The invention also relates to methods for isolating theregulatory cell populations from cartilage.127 •