ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

in Barcelona, Spain (September 2010). ChondroMimetic willbe commercialised through a combination of the Company’sdirect core sales team and local distribution partners.Building on its frontrunner position in Regenerative Medicine,its privileged access to key opinion leaders, and this combinedcommercial infrastructure, TiGenix aims to develop a specialistregenerative and sports medicine commercial franchise inEurope. Next to the commercial efforts in Europe, the companyis engaged in expanding the geographic scope for its leadproducts through partnering. The focus of the ongoingpartnering search is on Eastern Europe, North America and keymarkets in Asia.Further leveraging its experience in developing, manufacturingand registering cell-based and biomaterial products, theCompany is continuing to advance its product developmentpipeline in markets with high unmet needs. TiGenix is alsoprogressing the development of its proprietary adult stemcell platform. Previously identified adult stem cell populationshave shown promising results in preclinical models for treatingmeniscal tears and joint surface lesions. In view of anticipatedregulatory review, these cell populations have been furthercharacterized and TiGenix is on track preparing a clinical proofof concept study. The company has also started to explorethe potential of its stem cell platform in preclinical models ofosteoarthritis.Recently, on the Contribution Date, TiGenix acquired all sharesin Cellerix. Further details on the acquisition of Cellerix and itsactivities are provided in sections 3.1.1, 3.5 and 6.14.6.2 Competitive strengthsThe 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 prescribersof its innovative regulatory approved product, TiGenixhas set 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 cell-basedproducts. Starting from a strong scientific base, andbuilding on state of the art clinical validation processes,TiGenix has demonstrated its ability to bring a novel cellbasedproduct ‘from Bench to Bedside’. ChondroCelect,is the first cell-based product that applied for centralregulatory approval in Europe as a medicinal productand the first approved ATMP in Europe. This experienceand expertise is enhanced by the acquisition of Cellerix,whose industrial cell manufacturing facility was thefirst 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.105 •