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BIOMEDICA BIOMEDICA LIFE SCIENCES SA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic group of Biotechnology companies

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Page 1: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

BIOMEDICA BIOMEDICA LIFE SCIENCES SALIFE SCIENCES SA

Expanding a commercial SME

specializing in radiopharmaceuticals and

high-tech medical imaging instrumentation

into a dynamic group of Biotechnology companies

Page 2: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

BIOMEDICA LIFE SCIENCES SABIOMEDICA LIFE SCIENCES SAEstablished in 1994Total number of employees: 29 2003 revenue from sales 4,016 mil € EBT 0,9 mil €

Coupling BIOMEDICA’s management and marketing resources and expertise

withexcellence in biotechnological research

of Greek Research Institutes and University Laboratories

Main concept for the expansion:

Page 3: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

Strategy Main Points and ObjectivesStrategy Main Points and Objectives

1. Establishing the company’s R&D base through the collaboration with research groups in National Research Centres and Universities

2. Organizing and managing a state-of-the-art Radiopharmaceuticals Production Unit (GMP) based on the infrastructure and know-how of NCSR “Demokritos”

3. Designing, conducting and funding of multicenter clinical trials in Greece and abroad

4. Expanding into Molecular Diagnostics & Genetic Testing

Page 4: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

1.1. Establishing the R&D BaseEstablishing the R&D BaseCollaborating with the Greek Research Community I. Direct funding of novel research ideas in Radiopharmacy and Radiodiagnostics

1. Radiolabeled Biomolecules in Diagnosis and TherapyTc99m labelled bombesin, minigastrin and neurotensin analogues Principal Investigators: A. Varvarigou, NCSR “Demokritos”

T. Maina, B. Nock, NCSR “Demokritos” Greek patents granted – European patents pending

Tc99m labelled YIGSR for radiodiagnosis & immunotherapy Principal Investigator:G. Koliakos, University of Thessalonica

Greek patent granted – European patent granted

2. Peptide Design and Synthesis Principal Investigator: P. Cordopatis, University of Patras

Greek patents granted – European patents pending

Page 5: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

II. Participating as co-sponsor and/or end-user in II. Participating as co-sponsor and/or end-user in selected research programs funded by GSRT andselected research programs funded by GSRT and EUEU

EKBAN 2003-2006 «Τεχνητά Χρωμοσώματα Εντομοιών (ΤΕΧΠΕΝ) και Τεχνολογίες για Γονιδιακή Θεραπεία και Συνεχή Υψηλού Επιπέδου Έκφραση Θεραπευτικών Πρωτεϊνών σε εντομικά Συστήματα Παραγωγής», ΕΚΕΦΕ «Δημόκριτος», Ινστιτούτο Pasteur, Biomedica, 582.000 € (budget of project, Biomedica participation 245.000 €)

ΗΡΩΝ 2003-2006 «Ανάπτυξη και αξιολόγηση ραδιοεπισημασμένων βιομορίων για διάγνωση ή/και θεραπεία νεοπλασιών διαφόρων μορφών» Biomedica, 264.000 € (granted by 50%)

ΠΕΝΕΔ – ΔΙΑΚΡΑΤΙΚΕΣ ΣΥΝΕΡΓΑΣΙΕΣ

Page 6: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

Biomedica Biomedica Research PersonnelResearch Personnel

May 2004

BIOMEDICA Funded Research Programs:

7 full time positions – 4 PhDs

Co-Sponsored Research Programs:

5 full time positions – 4 PhDs

Page 7: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

2. Organizing and Managing 2. Organizing and Managing a a Radiopharmaceutical Production UnitRadiopharmaceutical Production Unit

A strategic alliance between BIOMEDICA and the Institute of Radioisotopes &

Radiodiagnostic Products has been approved by the Board of Directors of NCSR

“Demokritos” in May 2004

Page 8: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

Joint Venture

Organization and Management of the Institute’s unique Infrastructure

Implementation of Good Manufacturing Practice (GMP) Protocols

Page 9: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

Production of selected highly demanded radiopharmaceuticals in Greece and abroad

Pilot production of novel products for clinical trials Providing specialized GMP lyophilization services to

third parties Providing education and training

Page 10: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

NCSR “Demokritos” InfrastNCSR “Demokritos” Infrastrructureucture

Class 100 lyophilization clean room Class 100 lyophilization clean room Radiochemical – Radiobiological Quality Control Labs Radiochemical – Radiobiological Quality Control Labs Hot-CellsHot-Cells

A joint A joint BIOMEDICABIOMEDICA & & NCSR “Demokritos”NCSR “Demokritos” team will team will carry out development, carry out development, production and QC of production and QC of

radiopharmaceuticalsradiopharmaceuticals

Page 11: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

4. Expanding into Molecular Diagnostics & 4. Expanding into Molecular Diagnostics & Genetic TestingGenetic Testing

BioGenomica S.ABioGenomica S.A. Centre for Genetic Testing and Analyses

A spin-off Company of NCSR “Demokritos”

established in February 2004

The company’s business plan has been successfully incorporated in the PRAXE Phase B Program of GSRT with a total budget of 2 mil €.

Page 12: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

BioGenomicaBioGenomica SA SACentre for Genetic Testing and Analysesa spin-off company of NCSR “Demokritos”

Genetic testing for predisposition to hereditary diseases

Cancer -Neurological and Psychiatric Disorders - Rare Diseases

DNA sequencing tailoring specific laboratory needs

Food industry – Public health

Page 13: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

Providing services to hospitals, clinics and diagnostic centres in Greece and abroad

Participation in international genetic testing networks

Providing services to the food and agricultural industry

Page 14: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

June 2004:

total number of employees: 6 (3 PhDs)

State-of-the-art instrumentation:

Automated DNA Sequencing, dHPLC, Real-time PCR and DNA microarray-based technologies

European Molecular Quality Network evaluation and accreditation

Page 15: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic

BioGenomica ResearchBioGenomica Research

Establishment of International Scientific Advisory Board

Design of clinical research protocols jointly with medical centers and collaborative groups and networks

Participation in large-scale genetic epidemiology studies

Incubation of basic science, biochemical and biophysical research projects jointly with Universities and Research Institutes

Page 16: BIOMEDICA LIFE SCIENCES SA Expanding a commercial SME specializing in radiopharmaceuticals and high-tech medical imaging instrumentation into a dynamic