recepta biopharma - usp · recepta biopharma fernando perez pr&d biotech october 10, 2006 april...
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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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ThankThank youyou!!