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RECEPTA RECEPTA biopharmabiopharma

Networking for cancer drug Networking for cancer drug

development: Why in development: Why in

Brazil?Brazil?Jose Fernando PerezJose Fernando Perez

CEOCEO

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Brief HistoryBrief History

OdebrechtOdebrecht//

MineiroMineiro

Ludwig InstituteLudwig Institute

for Cancer Researchfor Cancer Research

RECEPTA RECEPTA biopharmabiopharma

FernandoFernando

PerezPerez

PR&D PR&D

BiotechBiotech

October 10, 2006October 10, 2006

AprilApril 26, 200526, 2005

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Why in Brazil?: Leveraging of local Why in Brazil?: Leveraging of local

advantagesadvantages

�� Highly qualified human resources: scientists and technicians: Highly qualified human resources: scientists and technicians: BrazilBrazil’’s scientific output represents 3% of total world s scientific output represents 3% of total world production production

�� Excellent hospital facilities and qualified physicians with Excellent hospital facilities and qualified physicians with documented experience in the conduction of clinical trialsdocumented experience in the conduction of clinical trials

�� Lower costs of operation in Brazil than in traditional research Lower costs of operation in Brazil than in traditional research regions for required personnel at all levels. regions for required personnel at all levels.

�� Excellent infrastructure of services: CROs & LogisticsExcellent infrastructure of services: CROs & Logistics

�� Easier access to a diverse selection of informed patients and Easier access to a diverse selection of informed patients and tumor samples for Phase I and II clinical trials as compared tumor samples for Phase I and II clinical trials as compared with the more traditional testing regions of the US, EU and with the more traditional testing regions of the US, EU and Japan.Japan.

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Why in Brazil?: Leveraging of local Why in Brazil?: Leveraging of local

advantagesadvantages

�� Engagement of required R&D talent through research Engagement of required R&D talent through research fellowships and scholarships in public educational institutions fellowships and scholarships in public educational institutions at low cost. at low cost.

�� The New Culture towards innovation: Priority in funding The New Culture towards innovation: Priority in funding opportunities from several governmental sources (such as opportunities from several governmental sources (such as FINEP, BNDES, FAPESP) through R&D grants or low interest FINEP, BNDES, FAPESP) through R&D grants or low interest loans. Drug development is one the four stated priorities of theloans. Drug development is one the four stated priorities of theBrazilian industrial policy (PITCE) and biotechnology is also a Brazilian industrial policy (PITCE) and biotechnology is also a priority as one the areas treated as carriers of the future. priority as one the areas treated as carriers of the future.

�� The Brazilian market needs new cancer drugs manufactured The Brazilian market needs new cancer drugs manufactured in the country to reduce importsin the country to reduce imports

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Partnership with the Ludwig InstitutePartnership with the Ludwig Institute

�� The Ludwig Institute for Cancer Research (LICR) has The Ludwig Institute for Cancer Research (LICR) has licensed four antibodies to licensed four antibodies to ReceptaRecepta..

�� The agreement with the LICR creates conditions for The agreement with the LICR creates conditions for an effective transfer of scientific and technological an effective transfer of scientific and technological knowledge from the global network of scientists knowledge from the global network of scientists associated with the LICR to Recepta. associated with the LICR to Recepta.

�� The close collaboration with LICRThe close collaboration with LICR’’s scientists s scientists provides an extra validation of scientific and provides an extra validation of scientific and technological procedures. technological procedures.

�� The presence of LICR as a shareholder offers The presence of LICR as a shareholder offers Recepta an immediate international insertion. Recepta an immediate international insertion.

SLW3

Slide 5

SLW3 For consistency, replaced "Ludwig" with "LICR"Sarah L. White; 17/7/2007

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What we do?What we do?

–– Identification of targetsIdentification of targets

–– Generation of new Generation of new mAbsmAbs

–– Development of Development of mAbmAb

–– Pilot scale production of Pilot scale production of mAbsmAbs

–– PrePre--clinical Trialsclinical Trials

–– Phase I and Phase II Cancer Clinical TrialsPhase I and Phase II Cancer Clinical Trials

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Portfolio of ProductsPortfolio of Products

– Antibody hu3S193 – Anti-Lewis YSuccessful IHC, Pre-Clinical and Phase I trials carried out by LICR as an Ovarian

Cancer, with potential for ALL epithelial tumors.

– Antibody MX-35Successful IHC trials carried out for early Ovarian cancer by LICR and potential for

other cancer remedies

– Antibody hu58-1066 – Anti-Lewis B (Leb)Successful IHC trials carried out for Breast and Colorectal cancers by LICR and

potential for other cancer remedies.

– Antibody A-34Successful IHC trials carried out for Gastric and Kidney cancers by LICR and

potential for other cancer remedies.

– Four new Antibodies in developmentDiscovery:Targets and mAbs resulting from Recepta’s own R&D projects

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LICRLICR´́ss research programs:research programs:

Antigen discovery &Antigen discovery &

characterizationcharacterization

Cell line production,

Immunohistochemical

assays, Clinical trials

Phase I

Phase II trials and

new high yield cell

line production

RECEPTARECEPTA’’ss OperationOperation

New mAbs generated by Recepta’s research

Programs: Antigen discovery and characterization

AntiAnti- Lewis YLewis Y

MXMX--3535

AntiAnti-- Lewis BLewis B

AAntinti-- AA--34 34 4 new mAbs 4 new mAbs

Lab assays, Pre-

clinicals and

humanization

SLW5

Slide 8

SLW5 Consistency: replaced "Ludwig's" with "LICR's"Sarah L. White; 17/7/2007

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RECEPTARECEPTA´́ss Operational StructureOperational Structure

MAb R&D divisionMAb R&D division

•• Identification of new targetsIdentification of new targets

•• Generation of new antibodiesGeneration of new antibodies

•• High yield cell line construction High yield cell line construction

•• Cell banks constructionCell banks construction

•• GMP clinical grade pilot scale GMP clinical grade pilot scale

Oncology divisionOncology division

•• Clinical Trials Management Clinical Trials Management

•• ImmunohistochemistryImmunohistochemistry

•• Preclinical TrialsPreclinical Trials

•• Clinical trials Phase I (CRO, Clinical trials Phase I (CRO,

patients, hospital)patients, hospital)

•• Clinical trials Phase II CRO, Clinical trials Phase II CRO,

patients, hospital)patients, hospital)

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Virtue out of Necessity: An Unique Approach Virtue out of Necessity: An Unique Approach

through Strategic Partnershipsthrough Strategic Partnerships

Recepta as a Recepta as a ““Managed VirtualManaged Virtual”” BiotechBiotech

Partnerships: ReceptaPartnerships: Recepta’’s novel model s novel model

The ingredients:The ingredients:

� Experienced leadership and management with the capacity to establish mutually beneficial partnerships with leading research institutions and hospitals

� Excellent team of scientists both:

a) Internal and,

b) External: working inside labs of partner institutions

� Strong group of scientists affiliated to the partner institutions as PI’s of the R&D projects working together with Recepta’s team

� Last but no least: strong management!

SLW4

Slide 10

SLW4 "In contrast to" is better English than "Differently from"Sarah L. White; 17/7/2007

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ReceptaRecepta’’s Teams Team

Recepta’s Scientists:

InternalInternal::Dr Luiz Travassos Dr Luiz Travassos –– ProgramsPrograms DirectorDirector

Dr. Oren Smaletz Dr. Oren Smaletz –– ClinicalClinical TrialsTrials DirectorDirector

Dr. Keith Okamoto Dr. Keith Okamoto –– ScientificScientific DirectorDirector

Vivian Madrigal Vivian Madrigal –– RegulatoryRegulatory AffairsAffairs & & PharmacistPharmacist

Dr. JuDr. Juççara Parra ara Parra -- Project ManagerProject Manager

Dr. Igor Dr. Igor ProscushimProscushim -- ClinicalClinical TrialsTrials

ExternalExternal ((insideinside partnerpartner institutionsinstitutions): 22 ): 22 researchersresearchers

Instituto Instituto ButantanButantan: 4 : 4 PhDsPhDs, 2 , 2 MScMSc, 1 G, 1 G

Medical Medical SchoolSchool USP: 3 USP: 3 PhDsPhDs, 2 , 2 MScMSc, 2 , 2 MDsMDs, 3 , 3 techtech

Ludwig Institute São Paulo: 4 Ludwig Institute São Paulo: 4 PhDsPhDs, 1 , 1 MScMSc

ReceptaRecepta’’ss Management:Management:Dr. Fernando Perez, CEODr. Fernando Perez, CEO

Jose Barbosa Mello, COO & CFOJose Barbosa Mello, COO & CFO

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PartnerPartner InstitutionsInstitutions & & PIPI’’ss

� Ludwig Institute for Cancer Research

– Global

– Local Branch – SP (new targets and mAbs) �� Dr. Anamaria Dr. Anamaria CamargoCamargo

�� Dr. Dr. SandroSandro de Souzade Souza

� Instituto Butantan (Cell Biology)

-- Dr. Ana Maria MoroDr. Ana Maria Moro

� Medical School of the University of São Paulo (Immunohistochemistry)

Dr. Venancio AvanciniDr. Venancio Avancini

� Hospitals (Clinical Trials): Sírio-Libanês, Alemão Oswaldo Cruz, Albert Einstein, National Institute of Cancer (INCA), Brazilian Institute for Cancer Control (IBCC), Baleia (BH)

� MIT’s G-lab – Sloan School of Administration (valuation model)

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Recepta’s 1st Clinical Trial

� Ovarian tumor Phase II Clinical Trial with hu3S193 anti-Lewis Y

mAb.

� Protocol prepared by Dr. Oren Smaletz in close collaboration with

Dr. Alberto Wainstein from Biocancer, Dr. Eric Hoffman from the

LICR New York Office and Dr. Andrew Scott from the LICR

Melbourne Center.

� Logistics: World Courier and Safe Lab

� CRO: EuroTrials Scientific Consultants

� Adverse Events Database: Medanta (UK)

� FDA agent: Mary Jane Walling (Don Hill & Ass.)

� Central Lab: Laboratórios Fleury

� mAb cGMP production: Gala/Catalent (USA)

� mAb vialing: University of Iowa

� mAb production auditing: Don Hill & Associates

SLW12

Slide 13

SLW12

Corrected affiliations for Eric and Andrew.Sarah L. White; 17/7/2007

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Clinical Trials Hospitals

Recepta has established partnerships with hospitals

known for their excellence in conducting clinical trials for

its first Phase II clinical trial with anti-Lewis Y mAb.

– Instituto de Ensino e Pesquisa do Hospital Sírio Libanês (SP)

– Instituto de Ciências do Hospital Osvaldo Cruz (SP)

– Instituto de Pesquisa Albert Einstein (SP)

– National Institute of Cancer (INCA-RJ)

– Hospital da Baleia (BH)

– Brazilian Institute for Control of Cancer (IBCC-SP)

– Instituto do Câncer – Hospital das Clínicas (SP)

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RECEPTARECEPTA´́S S FundingFunding

Recepta has been awarded several grants under

different programs funded by the federal and Sao

Paulo state government.

- Federal programs:

FINEP: Program to fund partnership of Companies &

Research Institutions

FINEP: Subvention program

- State Program:

FAPESP: Program to fund partnership of Companies &

Research Institutions

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www.receptabiopharma.comwww.receptabiopharma.com

ThankThank youyou!!