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INVESTMENT OPPORTUNITIES IN FINNISH LIFE SCIENCES 2012 7148 HealthBio_Rahoittaja_esite_16s_A4_uusijarjestys.indd 1

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BIOFINLAND INVESTMENT OPPORTUNITIES Dear Reader, Find BioFinland publication introduces Finnish life science investment Opportunities and knowhow. Over the past twenty years Finland has invested heavily in research and development in the field of bio-technology. A worldrenowned education system and close interaction between companies, universities and research institutes have provided a solid development environment for the Finnish biotechnology industry.

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A strong foundation in science and technological expertise are the strengths of our Finnish bioinnovations. These qualities also contribute to the fact that Finland is one of the most competitive nations in the world. Moreover, we Finns have a reputation for being innovative and reliable partners – we are proud of these assets. The publication’s “At the Top” cases present novel compounds, mechanisms, functions or methods found and invented by top researchers and businesses

available for partnering. The publication is not a comprehensive on the top level Finnish knowhow; rather, it provides interesting highlights, concrete collaboration proposals and short profiles of companies operating in selected areas. We hope this publication helps you in finding the business and research contacts you need. For more information, please contact us: www.healthbio.fi

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CONTENTS 4

BONE AND CARTILAGE RESEARCH PRODUCES INNOVATIVE WAYS OF TREATMENT

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CANCER EXPERTISE

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BIOLOGICAL DRUG DISCOVERY & DEVELOPMENT

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VACCINE EXPERTISE – LONG TRADITION, TOP EXPERTISE AND THE POWER OF COOPERATION

• Custom-made bones from stem cells • New synthetic bone revolutionises bone deficiencies treatment

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NEUROSCIENCE KNOWHOW IS INTERNATIONALLY RECOGNISED

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DIAGNOSTICS TO MEET THE END-USER

• Diagnostic biomarkers for Alzheimer disease • New medical approaches in treating CNS diseases

• Reporters for sensitive, easy and affordable quantitation • Reagents for all types of analytes and test formats

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• Biobanks enable research collaboration • Prostate cancer biobank

• Focus on gene therapy • Customised production at the Cell Factory

• A large market for a hantavirus vaccine • Diabetes overcome with a vaccine

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BONE AND CARTILAGE RESEARCH

produces innovative ways of treatment In Finland, bone, cartilage and biomaterial experts are second or even third-generation pioneers. In addition to expertise, there is a tradition of cooperation between different branches of science and across national borders. In Finland, treatments for bone deficiencies include the revolutionary synthetic bone innovation from the Turku Clinical Biomaterials Centre (TCBC) and innovative stem cell treatments by the Regea Cell and Tissue Center.

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CUSTOM-MADE BONES FROM STEM CELLS The treatments for different bone deficiencies have taken major steps forward during the past ten years. The Finnish tissue bank Regea started stem cell-based bone deficiency treatments in 2006, and so far 23 patients with different bone deficiencies in the head and neck area have already been successfully treated with this method, according to Professor Riitta Suuronen, Head of the tissue bank. According to Suuronen, Regea’s success with stem cell-based bone deficiency treatments is based on vast experience, the innovations of enthusiastic and skilled researchers, and surgeons and patients courageous enough to try out new treatments. “So far the stem cell-based bone deficiency treatments have been carried out on the head and neck area, but the method could just as well be used with other parts of the body. The size of the replaceable bone area will be investigated with future studies,” outlines Suuronen. Suuronen believes that the number of stem cell-based bone deficiency treatments will 4

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The bone defect in the mandibule caused by the removal of a tumor has been replaced by a transplant combined of stem cells and biomaterials granules within a titanium mesh.

increase in the future. When they become more common, their price will decrease. Regea also aims to have stem cells readily available for bone deficiency treatments i.e. there would be a top adipose donor who would donate lots of good stem cells to be used in treatments. The Regea Cell and Tissue Center is a multitissue bank at the University of Tampere. It processes and supplies tissues for clinical

use and prepares stem cell-based products from adipose tissue for treating bone deficiencies. Regea is the first and only organisation in the world to have carried out extensive stem cell-based bone deficiency treatments. As part of BioMediTech, Regea has access to top research in biosciences and medical technology along with strong networks to Finnish health technology expertise. www.regea.fi

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Bone research and cartilage research are no longer strictly separated, for nowadays the study often focuses on the relationship of different tissues. A large number of Finnish and foreign specialists in various disciplines such as medicine, epidemiology, biochemistry, biotechnology, engineering and physics are involved in these success stories. The interfaces between universities and hospitals are easily crossed in clinical research and in the development of treatments. Comprehensive population registers and conscientious Finnish participants ensure that it is possible to carry out even larger studies. The ageing of the population makes different bone and cartilage diseases even more significant economically. This is why even the scientific approach will increasingly be linked with the effort to develop cost-efficient research and treatment methods.

The following are at the forefront of Finnish bone and cartilage expertise: • innovative bone deficiency treatments • imaging techniques (improvement of X-ray examinations, development of ultrasonic techniques, MRI examinations) • development of computational models to illustrate the biomechanical behaviour of cartilage • modern measuring methods to determine the quality characteristics of the bone Experts include Professor Jukka Jurvelin from the University of Eastern Finland and Professor Heikki Kröger from the Kuopio University Hospital

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NEW SYNTHETIC BONE REVOLUTIONISES BONE DEFICIENCIES TREATMENT The Turku Clinical Biomaterials Centre – (TCBC) has developed a new, unequalled product for bone deficiency treatments. So far, the synthetic bone has been clinically tested in the head area, and it has proven to be a quick, safe and cost-efficient solution in situations where a person is suffering from bone deficiency as a result of an accident or treatment for a disease. During the past four years, Professor Kalle Aitasalo has treated patients with the new method at the Turku University Hospital, and the exceptionally good results have exceeded all expectations. The TCBC’s synthetic bone implant mimics the bone structure and contains bioactive glass, fibreglass and biocompatible plastic, thus acting mechanically like bone. The bioactive glass guarantees that the

patient’s bone grows into the custommade implant without separate growth substances and the implant is resistant to infections. The fact that the implant is metal-free is a great benefit now that magnetic imaging technology is widespread.

Treatment of large bone defects with non-metallic composite implants is providing a clinically and economically effective end-result.

“This product is the first one where the structure of real bone has been reproduced. Using synthetic bone is a quick way to treat bone deficiencies; it works instantly like real bone. With an infinitesimal chance of infection, expensive revision surgeries can be avoided. These are often required when using a bone transplant from the patient,” summarises Professor Pekka Vallittu from the University of Turku. www.biomaterials.utu.fi

CONTACTS Research institutions

• BioMediTech www.biomeditech.fi Institute of Biosciences and Medical Technology • Regea Cell and Tissue Center in University of Tampere www.regea.fi • Turku Clinical Biomaterial Centre www.biomaterials.utu.fi/ • University of Eastern Finland www.uef.fi/sovfys/laakfys

Companies:

• BBS-Bioactive Bone Substitutes Ltd www.bbs-artebone.fi ARTEBONE® bone void filler and graft substitute • Bioretec Ltd www.bioretec.com Bioabsorbable implants and device solutions • BonAlive Biomaterials Ltd www.bonalive.com 100% synthetic silica-based bone graft substitute • Bone Index Finland Ltd www.boneindex.fi Solutions for osteoporosis diagnostics • Inion Ltd www.inion.com Biodegradable and bioactive implants

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• Ozics Ltd www.ozics.com Comp06™ injectable bone reinforcement composite • Scaffdex Ltd www.scaffdex.com RegJoint™ implant for small joints in hand and feet • Skulle Implants Corporation www.skulleimplants.com Bioactive and biomimetic non-metallic composite implants for head-and-neck and CMF surgery • StickTech Ltd www.sticktech.com Fibres for dental applications • Vivoxid Ltd www.vivoxid.com Reinforced bioresorbable material for orthopaedic implants (FiberLive) and a synthetic surface modification for implants (MetAlive)

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NEUROSCIENCE KNOWHOW Photo: The Brain Research Unit at the University of Eastern Finland

is internationally recognised According to Pharma Industry Finland, there were approximately 65 research studies on central nervous system (CNS) related drugs underway in 2010. Approximately 1,800 candidates were involved in these studies. There are excellent examples of Finnish commercial success in treating and diagnosing CNS diseases. One of the most famous Finnish drugs is the globally marketed Entacapone that is used to treat Parkinson's disease.

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DIAGNOSTIC BIOMARKERS FOR ALZHEIMER DISEASE Early diagnosis and progress monitoring of neurodegenerative diseases is a central part of treatment since no cure for these diseases is available. The Brain Research Unit at the University of Eastern Finland, headed by Professor Hilkka Soininen has 30 years of experience and extensive national and international networks. One of

their primary areas of expertise is biomarkers which have shown to provide a reliable and early indication of AD prior to its major clinical symptoms. In their clinicalpathological study they have shown that Cerebrospinal fluid (CSF) amyloid-β42, Tau and phospho-Tau are markers for AD type pathology that can be used for prediction

of AD in a prodromal stage. Based on these studies, they have standardised the measurements of those markers and established a service laboratory that makes these tests available for clinicians and other interested parties. hilkka.soininen@uef.fi

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NEW MEDICINAL APPROACHES IN TREATING CNS DISEASES Neuroscience Center at the University of Helsinki and its Director Professor Heikki Rauvala carry out excellent and multidisciplinary research on the development, normal functions and disorders of the nervous systems. The center provides new information to improve the health and wellbeing of patients with neurodegenerative diseases. The Director of the Centre of Excellence in 6

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Trophic Factors in Neuronal Development, Plasticity and Disease, Mart Saarma, and his research group has shown that Neurotrophic factors play a significant role in drug efficacy. They play a key role on all levels of cerebral activity from molecular to cognitive processes. Saarma’s research group has identified new trophic factors and their receptors. Researchers in the

Centre of Excellence have also described medicinal substances that enhance the functioning of trophic factors. Several patents, patent applications and cooperation agreements with the industry and hospitals have already been realised on the basis of the research. heikki.rauvala@helsinki.fi

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CONTACTS

Photo: The Brain Research Unit at the University of Eastern Finland

Research institutions and networks • A.I. Virtanen Institute for Molecular Sciences www.uef.fi/aivi/introduction The research profile on molecular medicine of major diseases • Biocenter Finland www.biocenter.fi An umbrella organization of nine national research infrastructures • CNS.fi www.cns.fi A collaborative network of the Finnish Neuroscience Initiative • Kuopio University Hospital www.psshp.fi Neuroimaging • National PET-center, University of Turku www.turkupetcentre.fi/ World-class expertise and knowhow in PET imaging • Turku Brain and Mind Centre www.tbmc.fi Gathers twenty research groups from the University of Turku and Åbo Akademi University in systemic neuroscience, molecular neuroscience and brain imaging • University of Eastern Finland, Clinical Research Centre, Brain Research Unit www.uef.fi/crc/bru Biomarker research and clinical drug research, diagnostics, prevention and treatment of neurodegenerative and cerebrovascular disorders • University of Helsinki www.helsinki.fi/neurosci/ Neuroscience Center • University of Tampere www.uta.fi/ibt The Regea neuro group focuses on the differentiation of neurons and glial cells from human embryonic stem cells

Medical diagnosis is currently undergoing a major revolution due to they rapid discovery of molecular biomarkers. As we are living in the dawn of new drugs and prevention strategies, combined with the prevalance of increasing neurogenerative diseases, now is the time to combine the best forces to solve challenges and commercial support is needed for this. Researchers on CNS diseases in Finland have assembled a preclinical and clinical expertise network, Finnish Neurodegenerative Initiative. The network provides up-to-date information about participating laboratories and serves as a platform for the scientists and international companies. Therapeutic areas include e.g.: • Alzheimer disease • Anxiety • Brain trauma • Depression • Epilepsy • Pain • Parkinson’s disease (PD) • Schizophrenia Basic and clinical research on CNS is performed in universities and research units in Helsinki, Turku, Kuopio and Tampere. The multidisciplinary research groups have highly specialised research topics. To study the biology of CNS diseases, the groups can work with internationally unique and well-documented: • Patient populations • Human brain bank • Animal models • Excellent infrastructure • Extensive national and international networks Several successful research groups are nominated for the Academy of Finland’s Finnish Center of Excellence and they are located in the Neuroscience Center, Helsinki.

Drug development companies • Ark Therapeutics Ltd www.arktherapeutics.com A gene-based medicine company • Biotie Therapies Corp www.biotie.com New treatments e.g. for alcohol dependency (nalmefene), Parkinson’s disease, Alzheimer disease and cognitive disorders • Hermo Pharma Ltd www.hermopharma.com A biopharmaceutical company focused on discovering and developing novel treatments for severe neurological diseases • Medeia Therapeutics Ltd www.medeiatherapeutics.com A drug discovery company • Orion Corporation www.orion.fi Pharmaceutical and diagnostic business, developed entacapone, a pharmaceutical to treat Parkinson’s disease

Service providers • Biovian Ltd www.biovian.com Contract manufacturing organization, aseptic filling of sterile products • Cerebricon Ltd / Charles River Laboratories www.cerebricon.com Preclinical in vivo neurological disease models and in vitro CNS disease models • CNServices Ltd www.cnservices.com Animal models and state-of-art techniques for the development of pharmacotherapies for epilepsy, stroke and neurodegenerative diseases • CRST – Clinical Research Services Turku www.crst.fi Basic and clinical pharmacology and analytical chemistry, especially in disorders of the central nervous system, metabolic diseases and cancer • Medfiles Ltd www.medfiles.fi Contract research organization including pharmaceutical development and analytical services, clinical trials and regulatory affairs • Neurotar Ltd www.neurotar.com Contract research organisation (CRO), which provides imaging services based on in vivo two-photon microscopy • SYRINX Bioanalytics Ltd www.syrinxbioanalytics.com Bioanalysis and immunogenicity testing in compliance with GLP

Diagnostic providers • HyTest Ltd www.hytest.fi An immunogen producer for neurological diseases • MAP Medical Technologies Ltd www.mapmedical.fi/cms/en Develops and manufactures radiopharmaceuticals • Mediracer Ltd www.mediracer.com A medical technology company in the development of Point of Care (POC) diagnostic testing equipment for diseases of the peripheral nervous system • Nexstim Ltd www.nexstim.com Develops, manufactures and markets Navigated Brain Stimulation devices

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DIAGNOSTICS to meet the end-user

Medical diagnostic technology has strong reputation in Finland. The DELFIA速 technology developed by the former Wallac Ltd has spread around the globe. Southwestern Finland is home to the timeresolved fluorescence method for detecting in-vitro diagnostic (IVD) analysis methods.

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REPORTERS FOR SENSITIVE, EASY AND AFFORDABLE QUANTITATION Light-emitting reporter molecules are essential components in diagnostic assays because they enable precise and sensitive quantitation beyond what is discernible with visible colors. The Department of Biotechnology at the University of Turku (DBUT) research is focused on two kinds of optically readable light-emitting (photoluminescent) reporters that utilize unique properties of strategic rare earth metals (lanthanides) as light-emitters to eliminate the background disturbance caused by traditional fluorescent reporters. Recent advances have resulted in the development of entirely new kinds of optical reporters based on photon upconversion, i.e. anti-Stokes photoluminescence. The technology renders a detection limit well beyond that of the other currently existing optical reporter technologies. Photon upconversion might prove to be an ideal reporter technology for modern in vitro diagnostic test platforms and

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handheld battery-operated diagnostic test devices. The research activities of the nucleic acid diagnostics group are focused on lanthanide chelate based assay concepts using a timeresolved mode of measurement in closed compartments, novel nucleic acid detection systems using dual-tag lanthanide chelate sensors, simple sample pre-treatment methods, and ready-to-use dry reagents that use inexpensive chip formats. The present targets of the assays are the microbes that cause infections. www.sci.utu.fi/biokemia/en/research/ biotechnology The Laboratory of Biophysics at the Turku University is developing new tools to monitor biomolecular interactions in the field of in-vitro diagnostics, drug discovery studies and research.

Drug and population screenings have become an essential part of diagnosis in terms of improved medical treatment and health care. The development of new technologies in functional genomics and proteomics has enabled the discovery of more drug targets than ever before and promising early-stage drug candidates have emerged. However, further efficiency and improvement are required in these discovery processes. The research target is to develop novel, simple, high-sensitivity and cost-effective technologies by improving homogeneous screening technologies, total concentration measurement technology and the nonspecific binding of nanoparticle labels in bioaffinity assay and bioimaging systems. www.med.utu.fi/anatomia/en/research/research_mpe

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Point-of-care (POC), near-patient or decentralised testing techniques have established themselves relatively successfully, e.g as consumer diagnostics and home testing. For the big diagnostic actors, POC testing still remains under the auspices of the centralized laboratory. However, the diagnostic results are needed for the patient to assist in rapid decision making to save time and costs in the form of the correct treatment and a shorter amount of time in health care facilities. The challenge for future generations of POC tests is to reach state-ofthe-art performance comparable to that of centralised testing. Traditional and advanced IVD technologies are increasingly being used in a number of non-human situations, such as the monitoring of food safety and quality, household

AT THE TOP

and pet animal testing, agriculture and environmental monitoring. Also, techniques and applications in these areas are currently being developed in Finland. The different steps in the diagnostic process require technological developments to meet the needs of POC testing. Central aspects in the research and development of diagnostic technologies include: • Tailor-making all aspects of the binder for the biomarker as such and in the respective test format • Providing reporter molecules with required signal amplification and for universal applicability • Integrating assay components into inexpensive, intervention-free test platforms • Providing low-cost and robust reader concepts

REAGENTS FOR ALL TYPES OF ANALYTES AND TEST FORMATS Protein engineered components and recombinant antibodies, although available for more than a couple of decades, have not to any substantial degree been used in present day diagnostics, despite numerous proof-of-principle demonstrations of their superior applicability. The Department of Biotechnology at the University of Turku (DBUT) has a long tradition in tailoring the specificity of mono-

clonal antibodies. Isolating them from high-quality synthetic antibody libraries has yielded several differently constructed libraries, each containing up to tens of billions of different antibodies and making it possible for traditionally difficult antigens to be developed (e.g. toxic molecules or highly conserved proteins). The genes encoding the antibodies are also isolated during the selection process, and they can readily be further modified by means of genetic engineering.

A particularly novel option is the potential they provide for identifying completely new biomarkers (cells, tissues, biological fluids), while at the same time providing the critical reagent / binder for its identification. Many of the common diseases that lack or have inadequate diagnostic markers are good candidates for this approach: early stages of cardiovascular diseases and common cancers, neurodegenerative and aging-related diseases. www.sci.utu.fi/biokemia/en/research/biotechnology

CONTACTS Diagnostic research

• University of Turku www.sci.utu.fi/biokemia/en/research/biotechnology • University of Turku, Laboratory of Biophysics www.med.utu.fi/anatomia/en/research/research_mpe • University of Tampere www.uta.fi/ibt/institute/research/kulomaa

Companies

• Abacus Diagnostica Ltd www.abacusdiagnostica.com Rapid DNA testing utilizing its proprietary GenomEra technology • Ani Biotech Ltd www.anibiotech.fi EIAs and FEIAs for infectious diseases, neonatal screening and other disorders • ArcDia Ltd www.arcdia.com Immunoassay products based on the proprietary ArcDia TPX detection technology • Biohit Ltd www.biohithealthcare.com Unique GastroPanel diagnose of diseases of the stomach • DHR Finland Ltd, Innotrac Diagnostics www.innotrac.fi Immunoassays based on proprietary all-in-one dry chemistry and time-resolved fluorescence technology for myocardial infarction in Point-Of-Care and markers for infection and pregnancy • Kaivogen Ltd www.kaivogen.com Producer of high quality laboratory reagents and plate coatings • Labmaster Ltd www.labmaster.fi Next generation proprietary ECL-detection technology platform, specifically for IVD Point-of-Care use and TR-FIA kits for research use

• • • • •

• • •

Labquality Ltd www.labquality.com Impartial organization providing External Quality Assessment (EQA) programmes for clinical laboratories and point-of-care test on their performance compared with other laboratories Mediracer Ltd www.mediracer.com Point of Care (POC) diagnostic testing equipment for diseases of the peripheral nervous system Medix Biochemica Ltd www.medixbiochemica.com Monoclonal antibodies for IVD industry and diagnostic rapid tests. Mobidiaq Ltd www.mobidiaq.com Rapid diagnostics of infectious diseases with Prove-it™ technology based on PCR amplification followed by identification on microarray Orion Diagnostica Ltd www.oriondiagnostica.com Diagnostic tests, test systems and hygiene monitoring tests; infectious diseases and disorders of bone and soft-tissue metabolism protein and hormone assays e.g. a point-of-care for C-reactive protein PerkinElmer Human Health/Wallac Ltd www.perkinelmer.com From multi-vendor l aboratory services, software and informatics, to clinical lab testing diagnostic methods e.g. DELFIA® technology in screening assays, endocrinology and tumor marker immunoassays, DNA probe assays Reagena Ltd www.reagena.fi The ReaScan assay with novel ReaMobile® diagnostic platform and serodiagnostic rapid tests TeleChemistry Ltd www.telechemistry.com Real-time routine clinical chemistry results without laboratory facilities with the AutoPocT server VTT Technical Research Centre of Finland www.vtt.fi/service/bio Novel antibodies and new generation process analytics methods. Expertise in new measurement methods and sensor technologies for small analytes, such as hormones, narcotics and toxins.

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CANCER EXPERTISE Within the area of cancer research and its applications, Finland has an especially strong expertise in the field of hormonal cancers, such as prostate and breast cancer. Finns are developing biomarker-based cancer diagnostics and setting up biobanks that store samples donated by cancer patients. The aim is to improve treatment results with better clinical tools and more personalised medication. Finns are pioneers in using biotechnology to develop tailored measuring methods for biomarkers in order to be able to diagnose an individual patient’s cancer type faster and select the most suitable therapy.

Storage of blood, urine, cell and tissue biobank samples at Institute for Molecular Medicine Finland FIMM

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BIOBANKS ENABLE RESEARCH COLLABORATION Finland has one of the world’s best cancer registries and a record number of highly motivated cancer patients willing to contribute to scientific progress by donating blood and tissue samples for cancer research. HELPING LEUKEMIA PATIENTS The Hematology Clinic at Helsinki University Central Hospital, in collaboration with Hospital District of Helsinki and Uusimaa, the Finnish Red Cross Blood Service and the Institute for Molecular Medicine Finland FIMM, has started collecting tissue samples of patients suffering from blood diseases for the Finnish Hematology Registry and Biobank (FHRB). The goal of the hema10

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tology biobank is to improve the treatment results of malignant blood diseases. ”Our goal is to double or triple the number of patients surviving recurrent acute leukemia in the near future. We have already found a promising drug combination for a distinct form of this disease,” says Kimmo Porkka, Professor of Clinical Hematology at Helsinki University Central Hospital. The tissue samples are frozen and stored at –180°C at FIMM, which has storage room for 400,000 samples. The facilities can be expanded to include 1.2 million samples. Within a couple of years, other Finnish cities will join the hematology biobank, and the aim is to have nationwide

biobanking for leukemia patient samples by 2014. “When linked to patients’ clinical data, these biobanks can in the future evolve into reference databases that utilise genetic data in predicting the prognosis for new cancer patients,” suggests Head of Development Kimmo Pitkänen of FIMM. He says FIMM is already using the hematology biobank samples also for molecular profiling to find out if the existing cancer drugs or their combinations would suit the donors. kimmo.porkka@hus.fi kimmo.pitkanen@fimm.fi

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CCC-FIN – PROMOTING EXCELLENCE IN CANCER RESEARCH The Ministry of Social Affairs and Health is preparing to establish Comprehensive Cancer Center Finland (CCC-Fin), a national organisation that will combine high-quality treatment and diagnostics with research, education and consultations for cancer patients. The center, which will join the European Comprehensive Cancer Center network, will combine the cancer expertise of five Finnish universities and university hospitals – Helsinki, Tampere, Turku, Oulu and Kuopio – and promote collaboration with foreign cancer experts and companies. PERSONALISED CANCER DIAGNOSTICS “Cancer is caused by a change in cancer cells produced by a genetic fault. Since each cancer differs from all others, diagnostics must also be personalised. Instead of shooting with a shotgun, we must be able to use a precision weapon,” says Olli Carpén, Professor of Pathology at University of Turku. Carpén and his team are developing ovarian cancer biomarkers in an EU-funded, three-year pilot project. They collect blood and tissue samples from ovarian cancer patients at different stages of their disease and study them to find biomarkers that would predict how the cancer evolves. Promising biomarkers will be commercialised into clinical diagnostic products and services for the healthcare sector in collaboration with VTT Technical Research Center of Finland and Finnish biotech companies. olli.carpen@utu.fi

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PROSTATE CANCER BIOBANK “Treatment of urological cancers has improved considerably over the last decades. Prostate cancer is the most common cancer in Finnish men, but it has an excellent prognosis and a far lower death rate than, say, pancreatic or lung cancer,” says Antti Rannikko, Senior Consultant of Urology at Hospital District of Helsinki and Uusimaa.

He has been actively involved in setting up the Tekes-funded Helsinki Urological Biobank (HUB), whose samples are taken at Peijas hospital in Vantaa and stored at FIMM. Small tissue samples are taken from the surgically removed prostate cancer tumour.

Together with blood and urine samples and clinical data, they are then offered to researchers without disclosing the donor’s identity. Access to samples and clinical data is open to all who submit a research plan and meet strict predefined criteria. antti.rannikko@hus.fi

CONTACTS Research institutions • • • • •

Biocenter Finland www.biocenter.fi FIMM – Instutute of Molecular Medicine www.fimm.fi TCDM – Turku Center for Disease Modeling www.tcdm.fi Turku PET Centre www.turkupetcentre.fi VTT – Technical Research Centre of Finland www.vtt.fi

Drug development companies • • • • • •

Ark Therapeutics Ltd www.arktherapeutics.com Viral vector platforms and gene therapy products for cancer. GMP manufacturing services. Aurealis Pharma Ltd www.aurealispharma.com Gene and cell based therapies for cancer. Boneca Corporation www.boneca.fi Boron Neutron Capture Therapy (BNCT) treatment services DelSiTech Ltd www.delsitech.com Drug delivery – controlled release Faron Pharmaceuticals Ltd www.faronpharmaceuticals.com A fully humanised antibody for preventing cancer spread Hormos Medical Ltd www.hormos-med.com Novel hormonal therapies for breast and prostate cancers

• Laurantis Pharma Ltd www.laurantis.com Cellular pH homeostasis modulating small molecule for bladder cancer treatment • Oncos Therapeutics Ltd www.oncos.com Novel oncolytic viruses for cancer treatment • Orion Corporation www.orion.fi/en Cancer research focusing mainly on receptors located in the cell nucleus, especially on drug candidates affecting male sex hormone receptors

Diagnostic companies

• Biohit Corp. www.biohithealthcare.com Tools for colorectal cancer screening • Elekta Ltd www.elekta.com Tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems • MAP Medical Technologies Corp. www.mapmedical.fi Diagnosis and therapy for cancers and brain receptor imaging radiopharmaceutical development • Medix Biochemica Ltd www.medicbiochemica.com MedixMAB monoclonal antibodies for cancer diagnosis and follow-up

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• Orion Diagnostica www.oriondiagnostica.com Cancer marker assays • PerkinElmer Finland www.perkinelmer.com IVD products for cancer testing

Service providers

• Crown CRO Ltd www.crowncro.com CRO partner in clinical trials in the Nordic countries and the Baltic states • CRST – Clinical Research Services Turku, www.crst.fi Services in early phases of drug development • Encorium Ltd www.encorium.fi Full service clinical CRO • EPID Research Ltd www.epidresearch.com CRO specialised in conducting register-based pharmacoepidemiologic studies • Medfiles Ltd www.medfiles.fi Full service clinical CRO • Pharmatest Services Ltd www.pharmatest.com Preclinical contract research • Turku PET Centre www.turkupetcentre.fi Research services

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BIOLOGICAL DRUG discovery & development

Biological products include a wide range of medicinal products, such as vaccines, blood and blood components, antibodies, interleukins, allergenics, gene therapy and recombinant therapeutic proteins created by biological processes. Products are used in the prevention, diagnosis or treatment of different diseases. Biological drugs account for approximately 18% (150 billion $) of the total global pharmaceutical sales. Therapeutic proteins and monoclonal antibodies comprise approximately 80% of the total market.

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A.I. Virtanen Institute for Molecular Sciences at the University of Eastern Finland develops new gene and protein-based approaches for the treatment of cardiovascular diseases and malignant glioma. Its major achievements include discovering of the vasculoprotective effect of VEGF gene therapy, characterising the vascular effects of the members of the VEGF including their effects on lymphatic vessels, and identifying several new candidate genes for the

treatment of vascular diseases. Professor Seppo Ylä-Herttuala’s research group has made several significant improvements to adenoviral, lentiviral and baculoviral gene transfer vectors, their expression casettes and targeting properties. Two of their discoveries in gene-based drugs have been brought to phase II/III human clinical trials in EU and USA by the company called Ark Therapeutics Ltd. www.uef.fi/aivi/btmm/research

Photo: TThe A.I. Virtanen Institute for Molecular Sciences at the University of Eastern Finland

FOCUS ON GENE THERAPY

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Photo: Ark Therapeutics Ltd

CUSTOMISED PRODUCTION AT THE CELL FACTORY

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The Cell Factory of Technical Research Centre of Finland, VTT, focuses on a fundamental understanding of the molecular biology and physiology of industrially important organisms. It develops improved strains and biotechnical processes for the production of bulk chemicals, such as pharmaceuticals. Key expertise includes metabolic pathway engineering and protein production technologies by applying genomics and systems biology techniques,

complemented with high-throughput screening strategies. The Cell Factory offers customised production from the laboratory to the pilot scale, expertise in the whole value chain from raw materials to products and a comprehensive understanding of molecular biology and the physiology of the cellular processes in production organisms. www.vtt.fi/research/technology/ cell_factory.jsp

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Photo: Ark Therapeutics Ltd

ACADEMIC RESEARCH The life science universities in Finland (Biocenter Finland / Helsinki, Turku, Kuopio, Tampere, Oulu) have a strong and internationally recognized expertise in molecular genetics and genomics. This expertise and deep collaboration with Finnish and international drug developers, together with a diversified and multidisciplinary research, e.g. on cancer, CNS, immunological, infectious and cardiovascular diseases has led to novel therapy innovations in the field of biological drugs. Biomedical research in Finland is translational and aggregates the knowhow of biomedicine, other natural sciences, different technologies and clinical research. Molecular biology-based diagnostic tests together with biological drugs have enabled doctors to customise treatment for a particular patient. This personalised medicine approach is one of the key research areas of many Finnish academic research institutions, such as the Institute for Molecular Medicine (FIMM). In Finland, novel animal diseases models, bioimaging systems and advanced molecular screening applications support the development of novel biological drugs and therapies for more personalised medicine.

DRUG DEVELOPMENT AND SERVICES Many biological drugs and therapies invented in Finland are currently in various phases ranging from discovery up to phase III. The key research areas of Finnish biological drug development companies are gene therapy, viral vectors, oncolytic viruses, growth factors, neurotrophic factors, antibodies and cellular therapies. Examples of target indications include different cancers, Parkinson’s disease, cardiovascular diseases, lymphedema, acute lung injury and inflammatory diseases. The most advanced projects are at clinical phase III. Some service providers are focused on serving biological drug development companies and other actors in particular. REGULATORY KNOWHOW Fimea (Finnish Medicines Agency) plays a strong role at the EU level on biological medicines. Fimea evaluates and examines about 14% of all the biological medicine products of the EU's centrally authorised products testing programme. Fimea’s experts have had several key roles in preparing EU guidelines for biotechnological products.

CONTACTS Research institutions and regulatory knowhow • A.I. Virtanen Institute www.uef.fi/aivi/btmm/research Gene therapy and gene transfer technology • Biocenter Finland www.biocenter.fi Infrastructure networks & technology platform services, An umbrella organisation of biocenters in six Finnish universities • Finnish Medicines Agency (Fimea) www.fimea.fi Strong role and expertise in biological medicines at EU level • Finnish Red Cross / Blood Service www.veripalvelu.fi Advanced cellular therapies and tissue engineering • Institute for Molecular Medicine Finland (FIMM) www.fimm.fi International research institute focusing on human genomics, medical systems biology, translational research and biobanking. FIMM is part of the Nordic EMBL Partnership for molecular medicine • Technical Research Centre of Finland (VTT) www.vtt.fi/research/technology/cell_factory.jsp Bioprocess engineering and protein production technologies

Drug development companies • Ark Therapeutics Ltd www.arktherapeutics.com Viral vector platforms and gene therapy products for cancer and vascular diseases. GMP manufacturing services • Aurealis Pharma Ltd www.aurealispharma.com Gene and cell based therapies for the treatment of chronic inflammatory diseases, cancer and chronic wounds • Biotie Therapies Corp. www.biotie.com VAP-1 antagonist for inflammatory diseases • Faron Pharmaceuticals Ltd www.faronpharmaceuticals.com Interferon-beta for preventing vascular leakage in acute lung injury and a fully humanised antibody for preventing inflammation and cancer spread • FKD Therapies Ltd Develop advanced gene based medicines • Hermo Pharma Ltd www.hermopharma.com CDNF-family neurotrophic factors for Parkinson’s disease

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• Laurantis Pharma Ltd www.laurantis.com Vascular endothelial growth factor C (VEGF-C) in an adenoviral vector for lymphedema • Oncos Therapeutics Ltd www.oncos.com Novel oncolytic viruses for cancer treatment

Service providers • Biovian Ltd www.biovian.com Process development, scale-up and cGMP contract manufacturing of biopharmaceuticals • Galilaeus Ltd www.galilaeus.fi GMP contract manufacturing of biopharmaceuticals • Glykos Finland Ltd Service on glycoscience and glycobiological products • Macrocrystal Ltd www.macrocrystal.com Protein crystallization processes. • Medipolis GMP Ltd www.medipolisgmp.com cGMP production of therapeutic recombinant proteins and other biologics • SYRINX Bioanalytics Ltd www.syrinxbioanalytics.com GLP services of bioanalysis and immunogenicity testing of biological drugs

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VACCINE EXPERTISE

– long tradition, top expertise and the power of cooperation Finnish vaccine expertise has become renowned especially through clinical vaccine studies that have traditionally been based on strong research expertise, a functioning health care infrastructure and a population keen to participate. Finland's special expertise in virology has been behind some development projects such as efforts to tackle Type 1 diabetes and the Puumala virus that causes epidemic nephropathy.

AT THE TOP

A LARGE MARKET FOR A HANTAVIRUS VACCINE There are many known hantaviruses in the world, some of which cause viral hemorrhagic fevers with renal symptoms while others cause bronchial infections. The Puumala virus is the only hantavirus found in Finland that causes disease. It causes epidemic nephropathy, which is more common in Finland than anywhere else. There were as many as 3,500 reported cases in 2008. “Epidemic nephropathy is usually not life-threatening, but over half of those infected require hospital treatment for seven days on average. One in 20 infected patients requires hemodialysis and many require intensive care. Furthermore, patient

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follow-ups have revealed that epidemic nephropathy has several repercussions including hormone deficiency, hypertension and tachycardia. Both epidemic nephropathy and the treatment of its after-effects are costly, and of course they cause human suffering,” summarises Antti Vaheri, Emeritus Professor of Virology from the University of Helsinki. According to Vaheri, the diseases caused by hantaviruses could be prevented with a vaccine. The possibilities for developing the vaccine are being studied, and partners are being sought in e.g. Germany and USA: “There is a large market for a hantavirus vaccine especially in Europe and Asia, for

there are similar hantavirus types in these areas that cause feverish haemophilia. Every year these diseases require expensive hospital treatment for tens of thousands of people as well as the treatment of their after-effects.” Vaheri is hoping to establish a cooperation network where Finnish experts could take the lead the development of a hantavirus vaccine. “We have the expertise to study these viruses as well as to develop vaccines. Epidemic nephropathy is not as insignificant a disease as many think. Its prevention with a vaccine would be sensible, not to mention economical.” antti.vaheri@helsinki.fi

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However, the dynamic cooperation between several organisations operating in the field is considered the most important success factor in Finland. Vaccine expertise in Finland has centred around the administrative and research operations of the National Institute for Health and Welfare and the vaccine-related research and development work done in Tampere. Some 300 researchers are involved in Vactia, a Tampere-based research and product development centre for vaccines and infectious and immunological diseases. Vactia’s new operations model brings academic research, clinical research and companies closer together and lowers the boundaries between the organisations in the sector. New vaccines against HIV, Type 1 diabetes and tuberculosis are being developed based on Finnish innovations. The vaccine sector is growing rapidly. There are great commercial opportunities for new vaccines that improve immunological balance. These are being developed for the treatment and prevention of ailments such as allergies and autoimmune diseases along with vaccines for treating cancer. The use of biobanks is also a growing trend in the development of new vaccines. In this respect Finland’s expertise and field of operations also has much to offer internationally.

AT THE TOP

DIABETES OVERCOME WITH A VACCINE The treatment costs of Type 1 diabetes can be as high as hundreds of thousands of euros per patient. In Finland, 600 patients under 15 years old are diagnosed with Type 1 diabetes annually, and the number of cases increases every year. Studies show that Type 1 diabetes is triggered by genetic susceptibility along with environmental factors, the most significant of which are infections caused by certain enteroviruses according to the research team at the University of Tampere, headed

by Professor Heikki Hyöty. “Several studies indicate that enteroviruses increase the risk of diabetes. They can cause damage in the pancreas, which results in disruption in the production of insulin. The vaccine that is currently being developed aims to prevent these viruses from operating in the pancreas.” A product development project launched by Tampere-based Vactech Ltd aims to bring a diabetes vaccine onto the market within the next ten years. The vaccine is being developed by a large international consortium,

which includes pharmaceutical company Sanofi-Pasteur, the Karolinska Institutet from Sweden, the Universities of Tampere and Helsinki and Tekes (The Finnish Funding Agency for Technology and Innovation). The network operations and commercial progress are being coordinated by Vactech Ltd, which is a part of Vactia, a research and product development centre for vaccines and infectious and immunological diseases based in Tampere. www.vactech.fi

CONTACTS Research institutions

• BioProCenter in University of Oulu www.oulu.fi/bioprocess Bioprocess development • National Institute for Health and Welfare www.thl.fi • University of Helsinki www.helsinki.fi/university • Vactia www.vactia.fi Centre for Vaccine Research and Immunology

Companies

• FIT Biotech Ltd www.fitbiotech.com Vaccine development against HIV • Locusia Ltd kkoivu@elisanet.fi R&D and production of proteins in plant expression systems • Medipolis GMP Ltd www.medipolisgmp.com Process development, optimization and production of biopharmaceuticals • Vactech Ltd www.vactech.fi Developing vaccines against diabetes type 1, asthma and allergy

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