ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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like ChondroCelect or the future cell-based products of theCompany, compulsory have to be submitted through thecentral procedure at the EMA.When TiGenix started its product development activitiesno uniform European regulatory framework or well-definedregulatory path existed for cell-based products. At that time,cell-based products were (wholly or partially) subject tovarious legislations. This has led to a situation where certaincell-based products could nationally be marketed underdifferent legal status. The EU ATMP Regulation of 2009 nowrequires that all new cell-based products first need to receivecentral EU approval before they can be put on the market.ATMPs require now a marketing authorisation granted by theEuropean Commission (the centralised procedure), with theEMA co-ordinating the marketing authorisation application, thescientific assessment and post-authorisation supervision.Companies that already have tissue-engineered products onthe market before December 30, 2008 will have until December30, 2012 to meet the standards of the regulation. Any productsnot meeting the standards after the deadline will be no longerlegally on the market. Meanwhile, these products can legallyremain on the market on the basis of their former regulatoryapproval status.Finally, it is worthwhile noting that cell-based products alsohave to comply with the Directive 2004/23/EC of the EuropeanParliament and of the Council of March 31, 2004 on settingstandards of quality and safety for the donation, procurement,testing, processing, preservation, storage and distribution ofhuman tissues and cells (SANCO Tissues and Cells Directive),describing the conditions and quality requirements whichhave to be applied when sourcing the cells intended formanufacturing of the cell-based medicinal product. TheSANCO Tissues and Cells Directive has been translated into therespective national laws of the different EU Member States.Locally different interpretations of the directive have occurredduring the national legal implementations, and this has nowlead to a complex situation with respect to the respectivenational legislations. Differences in these national SANCOrequirements do not preclude marketing of the products,but rather add-on complexity in complying with the all-overrequirements in this already difficult regulatory field.Biologics Evaluation and Research (CBER), requiring productcharacterisation and solid clinical validation in prospectiverandomised clinical trials.The FDA generally requires the following steps for licensure of anew biological product:• pre-clinical laboratory and animal testing, conducted toassess a product’s biological activity, to identify potentialsafety problems and to characterize and document theproduct’s manufacturing controls, formulation and stability;• submission to the FDA of an Investigational New Drug (IND)application, which must become effective before clinicaltesting in humans can begin in the US;• obtaining approval of Institutional Review Boards (IRB) ofresearch institutions or other clinical sites to introduce thebiological drug candidate into humans in clinical trials;• adequate and well-controlled human clinical trials toestablish safety and efficacy of the product for its intendedindications, conducted in compliance with the FDA’s GCPrequirements;• compliance with all GMP regulations and standards;• submission to the FDA of a biologics licence application(BLA) for marketing that includes adequate results ofproduct quality testing, pre-clinical testing and results ofclinical trials;• FDA review of the BLA in order to determine whether theproduct is safe, effective and potent for its intended uses;• FDA review and inspection of the product’s manufacturingfacility for being compliant with GMP requirements,• in case of a positive review, granting approval of the BLA forcommercial sale or shipment of the product. In case of nonapprovability,request for additional studies or data.US – FDA approval processThe FDA was the first to adopt a regulatory framework forcell therapy products. With the exception of cell-basedproducts for skin repair, most cell therapy products areregulated as biologics (medicinal products) by the Center for233 •
Appendix 3: Overview of Patentsand trademarksA. Patents of TiGenix and its subsidiaries (excluding Cellerix)The table below gives an overview of TiGenix’ and its subsidiaries’ (excluding Cellerix) granted patents and pending patentapplications.Country/regionPatent/application number(publication number)TitleGranted patentsIn vivo assay for testing the phenotypic stability of cell populations for autologous transplantation Europe EP1 218 037 B1Isolation of precursor cells and their use for tissue repair Europe EP1 282 690 B1In vivo assay and molecular markers for testing the phenotypic stability of cell populations for USUS 7,482,114 B1autologous transplantationIn vivo assay and molecular markers for testing the phenotypic stability of cell populations for USUS 7,479,367 B1autologous transplantationUse of CXCL6 chemokine in the prevention or repair of cartilage defects US US 7,485,310 B1Use of CXCL6 chemokine in the prevention or repair of cartilage defects US US12/345369(WO05/014026)Notice of allowanceUse of CXCL6 chemokine in the prevention or repair of cartilage defects Singapore PN°118893Use of CXCL6 chemokine in the prevention or repair of cartilage defects Russia RU2363491Use of CXCL6 chemokine in the prevention or repair of cartilage defects New Zealand NZ54702Composite biomaterials comprising calcium phosphate materials, collagen and glycosaminoglycans ChinaCN100427151(Exclusive license from Cambridge Enterprise Ltd)Composite biomaterials comprising calcium phosphate materials, collagen and glycosaminoglycans UKGB2407580(Exclusive license from Cambridge Enterprise Ltd)Composite biomaterials comprising calcium phosphate materials, collagen and glycosaminoglycans(Exclusive license from Cambridge Enterprise)SingaporePN°121617Composite biomaterials comprising calcium phosphate materials, collagen and glycosaminoglycans(Exclusive license from Cambridge Enterprise)US US 7,780,994TitlePending PatentsIn vivo assay and molecular markers for testing the phenotypic stability of cell populations forautologous transplantationIn vivo assay and molecular markers for testing the phenotypic stability of cell populations, andselecting cell populations for autologous transplantationCountry/regionPatent/application number(publication number)US US 12/323,185(2009/0162328)Europe EPA 04077642.9(EP-A-1,498,146)(WO01/24833)In vivo assay and molecular markers for testing the phenotypic stability of cell populations, and Hong Kong HK 05106052.7selecting cell populations for autologous transplantation(WO01/24833)In vivo assay and molecular markers for testing the phenotypic stability of cell populations, and Canada CA 2,397,610selecting cell populations for autologous transplantation(WO01/24833)Isolation of precursor cells and their use for tissue repair US US 12/176,256(2009/0123927)Isolation of precursor cells and their use for tissue repair Canada CA 2,386,506(WO01/25402)Use of CXCL6 chemokine in the prevention or repair of cartilage defects Europe EP 1,653,994Use of CXCL6 chemokine in the prevention or repair of cartilage defects Canada CA 2,533,124(WO05/014026)234 • TiGenix • Rights Offering
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TiGenix NV(Public limited liability
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Table of ContentsSummary ..........
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3.7.1 Categories of potential inves
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5.7.1 Shares and warrants held by i
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7.5.2 Taxation.....................
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SummaryThe words written in capital
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Activities and strategy of the Comp
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• Two allogeneic adult stem cell
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• TiGenix’ success depends on i
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Unaudited pro forma income statemen
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Recent developmentsAcquisition of C
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In this context, we would like to s
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Announcement of the results of theO
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After the Contribution andafter the
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ContributionContribution AgreementC
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Risk factorsAny investment in the P
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commercialisation of ChondroCelect,
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in delays in bringing products to t
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The Company cannot predict what eff
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y each of its patents and patent ap
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to exercise preferential subscripti
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this prospectus which is capable of
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• investment professionals fallin
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1. General information and informat
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1.4.2 Company documents and otherin
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• the granting of discharge of li
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• in case of registered Shares, t
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cast at the meeting. If the amount
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No one may cast a greater number of
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If a Belgian resident individual ne
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Belgium has concluded tax treaties
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3. Information on the Contributiona
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In this context, we would like to s
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TiGenix has a limited financial deb
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Thousands of Euro (€) TiGenix Cel
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3.5.2 Issuance Price and RatioThe i
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(c)Rules for subscriptionSubject to
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The Scrips Private Placement will o
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to comply with any of its obligatio
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3.11.2 Scenario 1: Existing Shareho
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• a pledge of Locked Shares to a
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4. General information about THECOM
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DateINCORPORATIONFebruary 21,2000Tr
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Upon completion of the IPO of TiGen
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Issue dateMay 14,2004April 20,2005T
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4.7.2 Voting rightsAs further descr
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can be obtained free of charge at t
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5.2.4 Composition of the Board of D
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Amonis. Mr. Duron has been CEO of K
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5.3.4 Nomination and remunerationco
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• investor relations: nurturing c
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The remuneration of the members of
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5.7.2 Shares and warrants held by e
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Cellerix EBIP 2010An EBIP for senio
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The minutes must also contain a jus
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6. Activities of Tigenix andits sub
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• Clinical stage pipeline. TiGeni
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6.3.3 Acquisition of CellerixAs a r
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Full thickness articular cartilage
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Fig. 6.2: Autologous Chondrocyte Im
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Preclinical work in a meniscus repa
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The Company is also ensuring high q
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Recognising the importance of pre-l
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In Spain, since the passage of Orde
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Fig. 6.6: ChondroMimetic procedure
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6.5.3 Commercial strategyBuilding o
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6.7 Manufacturing & logisticsEffici
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The international application WO06/
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ChondroMimetic competitionThe main
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in Cellerix’ GMP facility in Madr
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6.14.3 History and development of C
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The table below gives an overview o
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Prevalence No. of cases (2010) Esti
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Fig. 6.9: Platform development stra
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In developing Cx601, Cellerix has b
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6.14.6 Manufacturing & logisticsCel
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population, methods for the isolati
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• Cimzia (certolizumab) - UCB: Al
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Spanish Ministry of Education and S
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7.2 Consolidated income statementTw
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7.3.1.2 Research and development ex
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7.3.2.3 Selling, general and admini
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7.4.1 Cash flows from operating act
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Cash & cash equivalents and intangi
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As of December 31, 2010, the Group
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8. Consolidated Financial informati
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8.1.3 Consolidated cash flow statem
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8.1.5 Notes to consolidated financi
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operating results and operating pla
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The Group does not account for work
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8.1.5.4 Operating result (EBIT)Resu
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8.1.5.7 TaxesThere is no current ta
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8.1.5.10 Tangible assetsThousands o
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8.1.5.14 Deferred charges & accrued
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Page 198 and 199: Weighted averageexercise priceTOTAL
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Page 208 and 209: Additional statementsThe preparatio
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Page 218 and 219: future against which they may be ap
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Page 224 and 225: Thousands of Euro (€)Laboratoryeq
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Page 234 and 235: GrantsCellerix received several gra
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Page 242 and 243: Appendix 2: REGULATORY APPROVALPROC
Page 246 and 247: TitleCountry/regionPatent/applicati
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Page 250 and 251: Title“Cell populations having imu
Page 252 and 253: D. Trademarks of CellerixThe table
Page 254 and 255: Decision resources.Dell’Accio, F.
Page 256 and 257: Noyes, F. R., Barber-Westin, S. D.,
Page 258 and 259: Appendix 5: 2008, 2009 and2010 mana
Page 260 and 261: Contents1. The year in brief ......
Page 262 and 263: 2. Financial informationa. The Inco
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Page 266 and 267: • Exercise price changed to 5.291
Page 268 and 269: 10 • TiGenix • Rights Offering
Page 274 and 275: Exceptionally, for the following re
Page 276 and 277: (d)(e)Duration: The Options Plan wi
Page 282 and 283: eceipt sent to the number or addres
Page 284 and 285: THE COMPANYTiGenix NVRomeinse straa
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ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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