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Transcript of Progenika Biopharma, S.A. - · PDF fileProgenika Biopharma pioneering personalized medicine...

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

Amplificacin y marcaje. PCR

multiplex Hibridacin y lavados

Extraccin de DNA

Impresin de los portas

Escaneo y anlisis 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 promotorCWCXRhE/RheVSVS/V

Kell (KEL/006) K/kKpa/KpbKpcJsa/JsbEuropean Ko

Kidd (JK/009) Jka/JkbJknull

Duffy (FY/008) Fya/FybFY-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

Espaa

EuropaMarket

ES

EU

Espaa

Europa

Espaa

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

1MFFFSC

1,5MVC

2MPE

0,5MPGK

0,5MVC

2,5MPE

BLOODchipMar07

9MPE

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