ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

administration of ASCs), which is scheduled to enter the clinicin 2011, Cx602 (endoscopic treatment of Inflammatory BowelDisease (IBD)) and Cx603 (intraarterial administration of eASCsfor the treatment of osteoarthritis).Through their combination, TiGenix and Cellerix have createda new European leader in cell therapy with a proven ability todevelop, register, manufacture and commercialize novel celltherapies and the potential to accelerate key value drivingprograms and:• ensure appropriate support for the commercial success ofChondroCelect and ChondroMimetic in Europe;• speed up the further development of the allogeneic stemcell platforms, eventually widening the indications beingpursued;• exploit synergies between TiGenix’ and Cellerix’ platformsfor treatment of damaged and arthritic joints, particularly inosteoarthritis and rheumatoid arthritis;• allow cross fertilization of the companies’ expertise inmanufacturing (including scaling up), CMC, regulatory,pricing and reimbursement;• exploit out-licensing & partnering opportunities in theareas of biomaterials, Cx501, Cx601 and co-development ofproducts targeting other autoimmune disorders.By exploiting its leading position in Regenerative Medicineand cell therapy, a privileged access to key opinion leaders,its manufacturing expertise and consolidated capacity and acommercial infrastructure, TiGenix aims to develop into a fullyintegrated Regenerative Medicine and cell therapy company.The Company’s short term focus is set on maximizing salesof ChondroCelect, which it plans to achieve through theCompany’s own sales force in Western Europe and partneringin other regions.In terms of indication, the short term focus remains ondamaged and arthritic joints while mid and long term growthwill be sought through the expansion into indications in theinflammatory and autoimmune disease areas, capitalizing onthe newly acquired stem cell platform.The Company believes its competitive strengths are:• Positive cash-flows from first two commercialproducts. With ChondroCelect and ChondroMimetic,TiGenix benefits from two commercial products approvedfor marketing in Europe. ChondroCelect was the firstcell-based product to receive a positive opinion from theEMA and has recently received reimbursement approvalin Belgium for a period of three years under a convention(Article 81) with the National Institute for Health and DiseaseInsurance (NIHDI). While preparing for reimbursementin its other key target markets, TiGenix gradually startedwith the “pre-reimbursement” commercial roll out ofChondroCelect through a number of key reference centres.For ChondroMimetic, first distribution agreements are inplace.• Commercial core team in place. Recognizing theimportance of direct contact with the first prescribers ofits innovative regulatory approved product, TiGenix hasset up a high-level commercial core team consisting ofexperienced people with medical, scientific and commercialbackgrounds, and with experience in pharmaceuticalproducts as well as medical devices.• Demonstrated regulatory expertise and developmentexperience in Regenerative Medicine and cellbasedproducts. Starting from a strong scientificbase, and building on state of the art clinical validationprocesses, TiGenix has demonstrated its ability to bringa novel cell-based product ‘from Bench to Bedside’.ChondroCelect, is the first cell-based product that appliedfor central regulatory approval in Europe as a medicinalproduct and the first approved ATMP in Europe. Thisexperience and expertise is enhanced by the acquisitionof Cellerix, whose industrial cell manufacturing facility wasthe first European GMP facility to gain authorization forcommercial manufacturing of stem cell-based therapeutics.Furthermore, Cellerix’ expanded adipose derived stem cell(“eASC”) platform has preclinical and CMC packages agreedwith the EMA, allowing an accelerated route to clinical trials.The regulatory and development expertise also includesdevice products, building upon the experience of TiGenixLimited (formerly named Orthomimetics Limited) and theirtrack record in obtaining CE-mark approval for their leadproduct ChondroMimetic.• Clinical stage pipeline. TiGenix’ lead clinicaldevelopment stage product, Cx601, successfully completedPhase II clinical trials in 2010 and received positive scientificadvice from EMA in March 2011. Cx611 has recentlycommenced Phase I/II clinical trials and is targetingRheumatoid Arthritis (RA), with the potential to become aproduct offering a substantial revenue stream to the Groupin the mid-term.5 •