european regenerative medicine firms & their strategic approaches michael morrison university of...
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European Regenerative Medicine Firms & Their Strategic Approaches
Michael Morrison
University of York
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OVERVIEW
Creating the European RM ‘Universe’ of firms
Characterizing the European RM Universe
Strategic Analysis
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CREATING THE EUROPEAN REGENERATIVE MEDICINE ‘UNIVERSE’
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DEFINING REGENERATIVE MEDICINE
Regenerative medicine is a heterogeneous domain, incorporating multiple technological avenues of investigation.
United by a shared goal of stimulating, directing or augmenting the body’s capacity for self-repair and regeneration.
Our approach concentrates on technologies using novel biomaterials – living cells, genes and bioscaffolds.
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DEFINING REGENERATIVE MEDICINE
Excludes small molecules and biologicals (e.g. antibodies) that aim to stimulate in vivo regenerative action.
Large pharmaceutical companies with an interest in aspects of regenerative medicine such as Pfizer, Sanofi-Aventis, Smith and Nephew etc not included on the list
Basic cell culture tools/media suppliers not included unless have specialist focus.
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DEFINING REGENERATIVE MEDICINE
‘European’ companies must be based entirely in a European state, or have their headquarters there.
Subsidiaries of non-European firms are not included.
Company must have some publicly available details (usually in the form of a website).
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CHARACTERIZING THE EUROPEAN REGENERATIVE MEDICINE FIRM UNIVERSE
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FIRM TYPE BY PRIMARY ORIENTATION
N = 59
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GEOGRAPHIC DISTRIBUTION OF FIRMS
N =59
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FIRMS BY SIZE (EMPLOYEE NOS)
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FIRMS BY AGE (YEAR FOUNDED)
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SUMMARY OF FIRM CHARACTERISTICS
Cell therapy is the largest single sector Significant no. of bioscaffold and service
firms Most firms are small (< 99 employees) Wide range of company ages – many
remaining from 1990s and pre 2002 ‘crash’ UK and Germany are the main geographic
hubs of commercial RM activity
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STRATEGIC ANALYSIS OF EUROPEAN REGENERATIVE MEDICINE FIRMS
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AUTOLOGOUS VS ALLOGENIC CELL THERAPY
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STEM CELL VS SOMATIC CELL THERAPY
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THERAPEUTIC FOCUS OF CELL THERAPY FIRMS
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SALEABLE THERAPEUTIC PRODUCTS
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RM PRODUCTS IN DEVELOPMENT
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GENE THERAPY COMPANIES
Name Location
Size Found’d Disease focus
Notes
Amsterdam Molecular Therapeutics (AMT)
NL Small 1998 Metabolic disorder
Lead product Glybera submitted for EMA MAA in 2009
Ark Therapeutics UK Medium 1997 Vascular occlusion. Cancer
Cerepro submitted to EMA for MAA in 2008, received rejection 2009. Trinam in phase III trials
Arthrogen BV NL Small 2005 Rheumatoid Arthritis
Lead product still at preclinical stage
Diamyd Medical AB
Sweden Small 1976 Chronic pain, cancer
Main therapeutic programme is therapeutic vaccines for diabetes.
Oxford BioMedica UK Small 1996 Neurodegenera-tive, Ocular
Lead product in phase I/II
Transgene France Small 1979 Cancer Several cancer vaccines in development
Mol Med Italy Small 1996 Graft vs. Host disease
Lead product in Phase III trials
Mologen Germany Small 1998 Cancer Developing non- RM anti-cancer therapeutics
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GENE THERAPY LANDSCAPE
Engagement with Advanced Therapy Medicinal Products regulation:
Ark’s Cerepro rejected in 2009 but has named-patient approval in France and Finland
Amsterdam Molecular Therapeutics’ Glybera submitted for MAA in 2010
MolMed (Italy) have cell-based ex-vivo gene therapy in phase III trials
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Service Total Stem cell?
Cell and tissue based drug discovery / screening services / toxicity testing
4 2
Cell and tissue supply including research and clinical grade material
4 2
Contract manufacture of cells / cell line expansion, cell culturing and scale up
1 -
Specialist tools and reagents 3 -Distribution of bioscaffolds for tissue repair, wound healing etc
1 -
TOTAL 13 4
FOCUS OF DEDICATED SERVICE PROVISION FIRMS
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CONCLUSIONS
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CONCLUSIONS
Companies pursuing newer regenerative medicine models appear to co-exist with older tissue engineering and gene therapy firms.
Strong industry preference for less risky technologies – autologous cell therapy with somatic cells or adult stem cells.
Little commercial investment in iPS and embryonic stem cell technologies.
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CONCLUSIONS
Commercial development concentrated in Western Europe, and concentrated in hubs.
Importance of biotechnology infrastructure and financial support.
Regulatory environment is also an important shaping factor – as with hESCs
Can be illustrated by Germany – UK RM firm breakdown
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CONCLUSIONS
RM Sub-sector Germany UK
Cell Therapy 9 6
Gene Therapy 1 2
Bioscaffolds 2 4
Service/ other 3 9
TOTAL 15 21
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http://www.york.ac.uk/res/remedie