ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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application protecting a method for the preparation ofregulatory T-cells using ASC, the use thereof in the therapyof diseases and kits comprising said cells.• “Cells, nucleic acid constructs, cells comprising saidconstructs and methods utilizing said cells in the treatmentof diseases.“: As described above, this patent family protectsa method for the preparation of regulatory T-cells usinggenetically engineered ASC, the use thereof in the therapyof diseases and kits comprising said cells.An overview of Cellerix’ patent portfolio is included in Section Dof “Appendix 3: Overview of Patents and trademarks”.Trademark PortfolioCellerix currently has 13 registered trademarks in Europe. TheCellerix brand is protected by registered CTM trademarksCellerix (figurative), Cellerix (word), Living Medicines (word),Cellerix Living Medicines (word) and Cellerix (Spanish“commercial name”). Additionally prospective product nameshave been registered as CTM word trademarks to protectthe brands Retrofect, Efisel, Idryon, Ontaril, Miredal, Alocellix,Adicell-X and Alofisel.In addition to its EU trademark portfolio Cellerix currently has3 trademark registrations pending before the USPTO namelyCellerix (figurative), Ontaril (word) and Cellerix Living Medicines(word).An overview of Cellerix’ registered trademark portfolio isincluded in Section D of “Appendix 3: Overview of Patents andtrademarks”.Other Proprietary RightsCellerix believes that part of its intangible assets is representedby several elements of its cell therapy program involvingunpatented proprietary technology, processes, know-how, ordata, including cell isolation, production and release processes.With respect to proprietary technology, know-how and datawhich are not patentable or potentially patentable, or processesother than production processes for which patents aredifficult to enforce, Cellerix has chosen to protect its interestsby relying on trade secret protection and confidentialityagreements with its employees, consultants and certaincontractors and collaborators. All employees at Cellerix areparties to employment agreements that include confidentialityagreements.Freedom to OperateIn regard to the Cx601 and Cx611 products, freedom to operatestudies have been carried out by independent legal counsels inthe US and Europe of the cell therapy product, manufacturingprocess and therapeutic uses. Cellerix has not identified anyvalid third party rights either in the US or EU and is unaware ofany third party rights in further territories that would preventthe commercialization of the expanded ASC products. In regardto the Cx501 and Cx911 products Cellerix is unaware of anythird party rights that would impede the commercialization ofthese products.6.14.8 CompetitionBiologicalsThe standard treatment of complex perianal fistula in Crohndisease patients involves the prescription of anti TNFs.Remicade® (Infliximab) is currently the only biological approvedfor the treatment of fistulizing Crohn. Remicade® is a chimericmonoclonal antibody that targets tumor necrosis factor alpha(TNF-α) and has been approved by EMA and FDA for treatingand maintaining fistula closure in patients with Crohn’s disease.In the pivotal 54 week ACCENT II trial, 296 Crohn’s patientswith some sort of disease related fistulae were administeredInfliximab at induction at weeks 0, 2 and 6. Patients whohad ongoing fistula response to the drug at week 14 werere-randomized and placed on a maintenance regimenadministered every 8 weeks thereafter. By the end of the trial,36% of the patients that went on to receive a maintenancetherapy continued to be incomplete remission. If remission afterinitial induction is taken into account, efficacy of Infliximab at1 year is limited to 23% (only 48% of patients evaluated afterinduction therapy achieved a complete remission). Remission ishereby defined as complete healing.Other biologicals being used in the treatment of luminal Crohn(but not specifically approved for the treatment of fistulizingCrohn) are:• Humira (adalimumab) - Abbott: Second generation antiTNF, which has been approved for the treatment ofCrohn’s disease (but not fistulizing Crohn’s). Humira has theadvantages of requiring only subcutaneous dosing (insteadof intravenous infusion) and being a fully human antibody.Fistula healing was studied as a secondary endpoint in theHumira maintenance trial (“CHARM”). Efficacy results were33% rate of complete closure at 56 weeks.147 •
• Cimzia (certolizumab) - UCB: Although not developed forthe treatment of fistulizing Crohn directly, fistula healing wasa secondary endpoint in one of Cimzia’s maintenance trials(PRECISE 1) and a small number of patients in PRECISE 2 alsohad fistula as a baseline. In none of the two trials did Cimziaoutperform efficacy of placebo.• Tysabri (natalizumab) – Elan-Biogen: Approved by the FDAfor the treatment of moderate to severe Crohn’s disease.However, Tysabri is not effective in the treatment offistulizing Crohn’s disease and the ENACT-1, ENACT-2 andENCORE trials all specifically excluded patients with activefistulae.Biologicals are currently also the standard of care for thetreatment of a large number of autoimmune-mediatedinflammatory diseases, including Rheumatoid Arthritis.However, and although a number of products are availabletoday for the treatment of RA, the lack of efficacy of biologicaltreatments in some patients, the non-tolerability or recurrentsecondary infections and the adverse effects from currentantirheumatic medication are widely documented andcontribute to the need of developing new therapies.Stem cell companiesAs a result of the significant promise of cell therapy, there aremore than 100 companies currently developing stem cells asa therapeutic modality to treat diseases. They can be broadlycategorized according to the following diagram:Fig. 6.10: Categorization of companies developing stem cells as a therapeutic modality to treat diseasesCellerix uses allogeneic expanded adult stem cells astherapeutic agent and bases its developments on the immunemodulatorycapacity of the stem cells (vs. differentiation intoother tissue types).Other clinical stage stem cell companies currently pursuing asimilar approach in terms of tissue source and mechanism ofaction are:• Celgene Cellular Therapeutics (USA): Celgene’s stemcell therapy business, which begun in 2002 through theacquisition of Anthrogenesis; The company is developinga platform around PDA-001, a placenta-derived expandedstem cell population; Clinical development focus is onimmune-mediated inflammatory diseases and ischemicstroke; A positive safety profile of PDA001 has beendemonstrated in a Phase I trial in Crohn´s.148 • <strong>TiGenix</strong> • 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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Page 111 and 112: Cellerix EBIP 2010An EBIP for senio
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Page 115 and 116: 6. Activities of Tigenix andits sub
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Page 135 and 136: 6.5.3 Commercial strategyBuilding o
Page 137 and 138: 6.7 Manufacturing & logisticsEffici
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Page 141 and 142: ChondroMimetic competitionThe main
Page 143 and 144: in Cellerix’ GMP facility in Madr
Page 145 and 146: 6.14.3 History and development of C
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Page 149 and 150: Prevalence No. of cases (2010) Esti
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Page 155 and 156: 6.14.6 Manufacturing & logisticsCel
Page 157: population, methods for the isolati
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Additional statementsThe preparatio
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9.1.2 Stand-alone balance sheetYear
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9.1.4 Stand-alone statement of chan
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) Standards and interpretations iss
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The clinical development of new dru
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future against which they may be ap
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Cellerix’ research and developmen
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YearThousandsof Euro2010 2009 2008E
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Thousands of Euro (€)Laboratoryeq
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Current financial assetsShown below
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At December 31, Cellerix’ share c
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9.1.5.17 Deferred revenueThe balanc
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9.1.5.21 Share-based paymentsThe EB
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GrantsCellerix received several gra
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10. Report regarding unaudited prof
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EMAFDAFibrous tissueGCPGMPGrowth fa
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Appendix 1: Press releases 2006-201
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Appendix 2: REGULATORY APPROVALPROC
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like ChondroCelect or the future ce
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TitleCountry/regionPatent/applicati
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TitleCountry/regionPatent/applicati
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Title“Cell populations having imu
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D. Trademarks of CellerixThe table
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Decision resources.Dell’Accio, F.
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Noyes, F. R., Barber-Westin, S. D.,
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Appendix 5: 2008, 2009 and2010 mana
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Contents1. The year in brief ......
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2. Financial informationa. The Inco
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The Directors shall call a Sharehol
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• Exercise price changed to 5.291
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10 • TiGenix • Rights Offering
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Exceptionally, for the following re
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(d)(e)Duration: The Options Plan wi
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eceipt sent to the number or addres
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THE COMPANYTiGenix NVRomeinse straa
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ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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