Progenika Biopharma, S.A. - madrimasd.org · Progenika Biopharma … pioneering personalized...
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Progenika Biopharma, S.A. ... Pioneering personalized medicine
Transcript of Progenika Biopharma, S.A. - madrimasd.org · Progenika Biopharma … pioneering personalized...
Progenika Biopharma, S.A.
... Pioneering personalized medicine
Progenika Biopharma… pioneering personalized medicine
Activities
- Development of new products for diagnosis, prognosis and drug-response prediction of human diseases.
Platforms
- Genomics - Proteomics
- Established in April 2000
- “As a leading company in Personalized Medicine”
Progenika Biopharma
DNA chips Protein Chips
Resources
TechnologiesGenomics (Progenika biopharma, SA. Progenika Inc.)
Spotting DNAchipsAffymetrixLuminexIllumina
Proteomics (Proteomika, SL)
2D Gel ElectrophoresisMass spectrometryProtein Chips
Bioinformatics
Recombinant proteins and mAB production (Abyntek, SL)
Quality AssuranceISO900
GLP procedures (Genechip)
EU Regulatory Certification for in vitro diagnostic tests (CE mark)
FDA approval
Human resources75 scientists + 25 admarket
… pioneering personalized medicine
Progenika group… pioneering personalized medicine
Progenika BiopharmaProteomikaAbyntek
Progenika Inc
Need of a personalized medicineNeed of a personalized medicine
The precise drug at the accurate dose in the right patient
Bases of genetic variability
…G G T A A C T G…
…G G C A A C T G...
Human Genome has three Billions of base pairs
Some people have a different base in some positions (0,1 % of human genome):
This is a Single Nucleotide Polymorphism or SNP
Biochip
Working schemeWorking scheme
Muestra de sangre
Amplificación y marcaje. PCR
multiplex Hibridación y lavados
Extracción de DNA
Impresión de los portas
Escaneo y análisis de
datos
One gene,many mutations
Clinical Routine
Overall specificity and sensitivity coefficients obtained for all the mutations tested were 99.7% and 99.9%, respectively
In routine clinical use in Spanish hospitals since May 2004.
Reimbursed by the Public Health System
More than 5,000 patients have been analyzed
Mutations which are not presently identified by the microarray are continuously being introduced on the assay (Lipochip v4.0 = 204 rLDL and 4 apoB )
Partial view of Lipochip
… pioneering personalized medicine
The first CE marked array
Several genes,several mutations
Blood group(Symbol/Number)
Antigen involved
ABO (ABO/001) ABO
RhD (RH/004) RhD
RhCcEe(RH/004)
RhcRhCRHD promotorCW
CX
RhE/RheVSVS/V
Kell (KEL/006) K/kKpa/Kpb
Kpc
Jsa/Jsb
European Ko
Kidd (JK/009) Jka/Jkb
Jknull
Duffy (FY/008) Fya/Fyb
FY-GATAmutFyx
MNS (MNS/002) M/NS/s
Diego (DI/010) Dia/Dib
KNOWLEDGESEROLOGY
The kit and technical dataThe kit and technical data
KIT Contents
Each kit allows analysis of 24 samples. The kit includes:
Multiplex PCR- PCR master mixes I, II and III (700ul each)
- Control DNA (15ul)
Fragmentation and Labelling
- Biotin 11-ddUTP (15ul)
- Cy5-dCTP (15ul)
- Alkaline Phosphatase (1000U)
- Dnase (1000U)
- Labelling kit (1)
Hybridisation
- External controls (600ul)
- Cy3-Streptavidin (3ml)
- BLOODchip slides (25)
Analysis- CD with Analysis Software
Specifications
Number of Arrays 24
Array Size 25 x 40 mm
Oligo Length 19-27 mer
Number of SNPs 116
Oligo replicates per SNP 40 spots
External hybridization controls
Background controls
Coefficient of variation
The coefficient of variation for replicates of each oligonucleotide ranged from 15to 25% in any given array.
Lund Sweden
UlmGermany
Bristol, UK(UWE
and BITS)
Rotterdam,Netherlands
Amsterdam,Netherlands
Prague, Czech Republic
BarcelonaSpain
CLB (Sanquin)
Progenika Biopharma - Confidential - 17
COMMISSION DECISION of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices
DNAchips Pipeline… pioneering personalized medicine
Portfolio
IBDCHIP
2005 2006 2007 2008
ES
EU
US
ES EU
US
CE
PROSCAN
US
US
LIPOCHIP ES
IBDCHIP
2005 2006 2007 2008
Clinical validation ES / EUCECE mark
DevelopmentES
EU
US
ES EU
US
CE
PROSCAN
US
US
LIPOCHIP ES
FIBROCHIP
2009
US
EUEU
IBDCHIP
2005 2006 2007 2008
CE
Spain
USA
Europe
Clinical validation US
Market Launch
ES
EU
US
ES EU
US
CE
PROSCAN
US
US
LIPOCHIP
IBDCHIP
2005 2006 2007 2008
Clinical validation ES / EUCECE mark
DevelopmentES
EU
US
ES EU
US
CE
PROSCAN
US
US
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
IBDCHIP
2005 2006 2007 2008
CE
Spain
USA
Europe
ES
EU
US
ES EU
US
CE
PROSCAN
US
US
LIPOCHIP ES
IBDCHIP
2005 2006 2007 2008
Clinical validation ES / EUCECE mark
DevelopmentES
EU
US
ES EU
US
CE
PROSCAN
US
US
LIPOCHIP ES
MSCHIP
FIBROCHIP
2009
US
EUEU
IBDCHIP
2005 2006 2007 2008
ES EU
US
CE
PROSCAN
US
US
LIPOCHIP
IBDCHIP
2005 2006 2007 2008
ES EU
ARTCHIP
US
CE
PROSCAN
US
US
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
ESEU
ESEU
ESEUESEU
USUSUSUS
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
ESEU
ESEU
ESEUESEU
USUSUSUS
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
CECECECE ESEU
ESEU
ESEUESEU
ESEU
ESEU
ESEUESEU
ADCHIP
2009
BLOODCHIP
OSTEOCHIP
PHARMACHIP
Spain
USA
Europe
ES
EU
USCE
Clinical validation US
Market Launch
ES
EU
US
Spain
USA
EuropeDevelopment
Clinical validation ES / EUCECE mark CE
Proteomika, S.L. –Product Pipeline… pioneering personalized medicine
2005 2006 2007 2008 2009
BLADDERCHIP CE
PROSTATECHIP CE
LUNGRESCHIP CE
ES
EU
EU
PROTEIN -CHIP
OVARIX
ENDOMETRIX EU
2005 2006 2007 2008 2009
BLADDERCHIP CE
PROSTATECHIP CE
LUNGRESCHIP CE
ES
EU
EU
PROTEIN -CHIP
ENDOMETRIX EUCECE
CECE
CECE EUEUMAMACHIP
EUEU
ES
EU
España
EuropaMarket
ES
EU
España
Europa
España
EuropaClinical validaton
CECE mark CE
Development
Scientific results (2004-2006)
11 scientific publications: Clin Chem, Clin Cancer Res, FEBS Lett, J Bacteriol, etc.
22 International conferences (oral communications)
… pioneering personalized medicine
Patents… pioneering personalized medicine
Diagnostic
- PCT/ES2004/070001(Familial hypercholesterolemia)- PCT/ES2005/070161 (Familial hypercholesterolemia)- ES 200502618 (Leukaemia and Lymphoma)- ES 200402513 (Venous thrombosis)- PCT/IB2006/000796 (DNAchip genotyping).- GB 0608758.9 (Inflammatory bowel disease)- GB 0613840.8 (Rheumatoid arthritis)- GB 0613842.4 (Prostate cancer)- GB 0613843.2 (Osteoporosis)- GB 0613844.0 (Fibromyalgia)
Therapeutic targets
- PCT/EP2004/003219, (Bladder cancer)- EP 03380238.0, (Pancreas cancer)- US 10/563,025, (Renal cancer)- US 10/596,857, (Multiple sclerosis)
Starting-up in BiotechGuidelines
Milestones
Founding Apr 00
AffymetrixService Provider
May 01
Cancer Discovery Program
Jan 01
NeurosciencesDiscovery Program
Mar 01
Rat 5K Genome array
May 02
First PatentFeb 03
Jan 02
LIPOchipMay 04
IBDchipDRUGchip
Jan 06Jun 06
… pioneering personalized medicine
1M€FFFSC
1,5M€VC
2M€PE
0,5M€PGK
0,5M€VC
2,5M€PE
BLOODchipMar07
9M€PE
Progenika IncAbr 07 (US)
6,5M$PE
Results… pioneering personalized medicine
-5.000.000 -
5.000.000 10.000.000 15.000.000 20.000.000 25.000.000 30.000.000 35.000.000 40.000.000 45.000.000
2.000 2.001 2.002 2.003 2.004 2.005 2.006 2.007 2.008
Financial Performance (euros)
Ingresos
Gastos
Beneficios
Income
Expenses
Profit
Starting-up in BiotechGuidelines
• Formación RRHH
• Incubadoras
• Espacio• Asesoramiento• Acompañamiento
• Financiación
• Administración• Subvenciones directas: Preparación. Constitución. Desarrollo.• Ayudas indirectas: Capital semilla. Incentivos Capital Riesgo.
Ayudas fiscales – SS, desgravación -• Cajas: Préstamos blandos. Programas de contratación.
• Capital privado• FFF, FFCP• Business angels• Fondos capital semilla. Fondos capital riesgo• Fondos de pensiones
… pioneering personalized medicine
… pioneering personalized medicine
Starting-up in BiotechGuidelines II
• Innovación - Competitividad
• Nicho de mercado. Especialización. Focalización
• Regulación (coordinación, incentivo)
• Propiedad intelectual
• Internacionalización
• Trabajo
• ILUSIÓN
