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Biotechnology Opportunities in New ZealandFebruary 2005

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Quick Facts - New Zealand AREA (~ UK or Japan) 271,000 sq km POPULATION 4 million (60,000 Indian) Auckland 1.3 million (40,000 Indian) Wellington (Capital) 0.5 million Christchurch (South Island) 0.5 million Unemployment 3.8% Real GDP US$ 86 million GDP / capita US$21,500 CORPORATE TAX RATE 33.0% University Enrolments 450,000 Graduates 85,000

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Investment NZ NZ Government investment attraction agency Specialist unit within NZ Trade and Enterprise Team of 40 professionals at 9 locations Auckland & Wellington, New Zealand Sydney & Melbourne, Australia Singapore Hong Kong London, UK Los Angeles & New York, USA Otherwise working through (48) NZTE offices

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What we do Promote NZ value proposition in global markets Support business strategies - increase the quality and quantity of investments - add value to the economy Match international opportunities with NZ economic development needs Coordinate investment attraction/promotion activities acting as single point of government contact for foreign investors Add value to NZ business through providing assistance and research advice, international alignment and focus, consistency and build networks and partnerships to facilitate foreign investment

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How we assist companies Facilitation Cut through government red tape Introductions - Economic Development Agencies, Service providers, Companies, Regulatory authorities Strategic Investment Fund (SIF) Projects over $50million 3 years or 200 new jobs Disbursed at INZ discretion Feasibility studies up to $100,000 for ½ costs Visiting Investor Programme (VIP)

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Biotech successes Pharmacia (Pfizer) – Endocrinz (Neuren) PPL Therapeutics – farm GSK – Medical Research Institute NZ Birnie capital – Protemix Iglobe - Treasury VIF Roche and Genentech - Proacta Inventages – Life Sciences Ventures VIF Nupharm

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New Zealand Biotechnology Sector Overview Government - key economic sector 50+ companies, 8 Universities, 11 research institutes Biomedical excellence in cancer, diabetes, immunology, neurological, metabolic disorders, nutrition, biomodels Leading technology underpinning agriculture and food production, health related foods and natural products World’s best animal health rating for animal sourced bioproducts R&D history- animal/plant breeding, environmentally sustainable production. Glaxo of GSK founded in NZ; Wilkins - Nobel laureate DNA structure; Liggins – steroids for premature infants; Murdock - inventor disposable syringe

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Supportive Environment Government is a strategic supporter of R&D - facilitation public/private partnerships Innovative, highest research standards =US, UK and Europe @50% cost Simple tax environment No payroll, social security, capital gains or regional taxes R&D 100% tax deductible; depreciation on IP costs High Standard Corporate Governance Audits, high economic freedom, low corruption Neutral foreign policy - seeking free trade agreements, IP protection – WIPO and Trips compliant

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Opportunity Areas Healthcare – drug discovery, manufacture, clinical studies, biomedical research, bioprospecting, medical devices, health IT Animal products (serum, proteins, enzymes & antibodies) disease-free, high security and traceability Agbiotech – sheep, dairy, deer, pasture, fruit, crop and forestry – environmentally sustainable production of food & biomaterials, bioprocessing Natural products, nutraceuticals & functional foods Bioinformatics, structural biology, forensic services, waste treatment

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Biopharmaceuticals - cardiovascular, type 2 diabetes and metabolic disorders. Laszarin™, orally active small molecule, developed for diabetes related heart disease in Phase IIb trials. Preclinical peptide hormones for diabetes CEO - Larry Ellingson (Eli Lilly / US Diabetes Assn) Founder, President, CTO - Prof Garth Cooper – University of Auckland, (Amylin) Chairman - Keith Mansford (GSK) Birnie Capital – series A $20m in 2003. USA - series B / licensing, partners other markets

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Cancer therapy – physiologically targeted drugs Low oxygen - hypoxic regions in solid tumors Broad portfolio of IP - 9 chemical families. Profs Bill Wilson & Bill Denny – University of Auckland, 15years experience - 6 drugs developed Collaboration with Professors Martin Brown & Amato Giacca - Stanford University CEO - Paul Cossum (NewBiotics, San Diego) Series A in 2004 $8million (Roche, Genentech, GBS Ventures, No8, Endeavour) for phase1 clinical trials

Neuren pharmaceutical : 

Neuren pharmaceutical Biopharmaceuticals - neuroprotection and repair, growth & metabolism regulation 5 patented families compounds - key indications for stroke, head injury, Parkinson’s, cognitive impairment, multiple sclerosis, and growth and metabolism disorders Lead Glypromate – phase 1 Professor Peter Gluckman (FRS) Liggins Institute, Auckland Partners Pfizer, Duke University (NC) Walter Reed Army (MD), University Texas and Metabolic Pharmaceuticals (Australia) CEO David Clarke Listed ASX, - licensing, investment partners

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Biologics for inflammatory or atopic disorders - skin (psoriasis, dermatitis), lung (asthma), autoimmune (lupus), tuberculosis and cancer. Genomics based discovery and immunology - dendritic, T and B cells. Products: Zyrogen – lupus, YB1 – cancer, RNAi - autoimmune Listed NZX and ASX CEO Stephen Hall Founder Dr Jim Watson (ex University of Auckland) Product development partnerships

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Wound healing – connexin protein targets - prevent lesion spread, inflammation and scarring to improve recovery. Patented antisense technology demonstrated in preclinical models - skin lesions, burns, cornea damage and spinal repair. Incorporate into wound dressings. Seeking strategic alliances, funding, licensing (specific indications or markets) Professor Colin Green - University of Auckland and Dr David Becker University College London. CEO - Aki von Roy (former President BMS, Europe) CoDaTherapeutics

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Cancer diagnosis and management - develop genetic based markers for rapid, accurate and non-invasive tests (serum, tumour, urine) Focus - Gastric, Bladder, Endrometrial, Colorectal cancers Established - NZ Seed Fund (VC), listed NZX. Pharmaceutical and other partnerships Professor Tony Reeve – University of Otago CEO David Darling

Slide 17: Living Cell Technology (LCT, Listed on ASX, research facilities in New Zealand, Australia, Italy and office US Encapsulated living cell products, treatment of Huntington's disease, haemophilia and insulin-dependent diabetes. New Zealand: hosts worlds most advanced porcine herd therapeutic transplantation. Focused primarily early stage research & manufacture product pre-clinical and clinical studies, virology department set world standard for porcine cell characterization Products Portfolio include: NeurotrophinCell a choroid plexus cell product, Fac8Cell a liver cell product aimed at treating haemophilia, DiabeCell a porcine pancreatic cell product treatment insulin-dependent diabetes

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NZ manufacturer pharmaceuticals – skincare, arthritus, diabetes, cardiovacular, digestive, pain, sports, cosmetics, nasel, dietary. Solid oral and liquid dose forms TGA (Australia), Ministry Health (NZ) MAF - licensed Marketing alliances and distribution – Pfizer, MSD, Ego, IBI, Nutricia, Serono, Eli Lilly, Solvay Duphar, Mundipharma Privately owned, 2 manufacturing sites, CEO - Graeme Douglas. Inquiries for manufacture, development and testing

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HMG is part of the Australian based API group 2000 product lines: pharmaceuticals, natural products, beauty/toiletry products Develops, manufacture/ markets own products + contract manufacturing Markets including, Australia, North America, the UAE, Europe, Malaysia, Hong Kong, China, Taiwan, Korea and the Pacific Islands Australian Pharmaceuticals Industries recently announced shift manufacturing base from Sydney to Auckland Kim Campbell - CEO

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NuPharm Laboratories – pharmaceutical development with contract services (formulation, clinical and stability batch manufacturing).Operating from Deeside, North Wales and Hamilton, New Zealand. Provide flexible services full turnkey projects to individual projects. Steve Tickle and Will Gould

Slide 21: Biomedical and Clinical Research Pregnancy and Labour Fetus and Newborn Brain and Behaviour Growth Development and Aging Established after Prof Mont Liggins – steroid use lung development in premature infants Profs Peter Gluckman and Jane Harding Spin offs Neuren (Neuronz and Endocrinz) and Brainz

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Auckland Cancer Society Research Centre New drugs for cancer treatment Six compounds licensed / clinical trials Targets: Immature vasculature solid tumors Protein products of genes Improved cytotoxic drugs - more targeted / less toxic Profs Bill Denny, Bill Wilson, Bruce Baguley Spin off – Proacta Therapeutics

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Anatomical and biophysical - mathematical models for human physiology (genes – organs) Computer models for drug development - CellMLTM Computational bioengineering tools, platform development Collaboration – Physiome Project Founder Prof Peter Hunter

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Gene therapy (decoy and antisense DNA, peptide nucleic acids) neurotrophins for prevention neuronal death Stem cells brain and spinal cord – repair in response to injury NZ neurological human brain bank – extensive collection Molecular biology and anatomy of Huntington’s, Alzheimers, schizophrenia, Parkinson’s and epilepsy Profs Richard Faull and Michael Dragunow Neurodegenerative diseases

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Associate Professor Rod Dunbar Human immune system - particular emphasis on T cells Developing new forms of therapeutic vaccines for cancer, particularly melanoma Leading synthetic chemists to design and produce novel formulations of vaccines capable of stimulating antigen-specific T cells, for pre-clinical testing in our lab using human tissue and cells.

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Dissection - genetic events that lead to cancer Wilms tumour - errors in genomic imprinting involved in tumourigenesis Mutations in the E-Cadherin gene define a cancer syndrome known as hereditary diffuse gastric cancer, involved in early onset of gastric cancer in New Zealand families Professor Anthony Reeve Spin Off: Pacific Edge Biotechnology Ltd Cancer Genetics

Slide 27: Biomedical research – Wellington Immunological Mechanisms of Asthma, Multiple Sclerosis, Cancer, Infectious Diseases (TB, RSV) Biodiscoveries group Mouse and rat colonies for cancer, asthma and neurological Collaboration Malaghan Institute and AgResearch

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MOLECULAR MEDICINE AND PATHOLOGY Focus - ways molecules regulate the human immune response in both normal and disease states Bacterial and super-antigens Crystallizing superantigens with soluable MHC class II and T cell receptors, producing a transgenic mouse to study the superantigens function further and searching for novel superantigens Prof. John Fraser, Head of Medical Sciences

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Parkinsons Disease - development of novel genetic models of disease and investigation of the mechanisms underlying Parkinson’s neuropathology FDA approval - world’s first human phase 1 clinical trial using a gene therapy approach for Parkinson’s disease. Prof. Matt During and Dr Deborah Young NEUROLOGICAL DISORDERS

Slide 30: Protein Structure and Function Part of international initiative – Mycobacterium, as cause of TB Bioinformatics, gene cloning and expression, protein purification and crystallization, 3D structural analysis by X-ray crystallography, and functional assay techniques to characterise potential new drug targets gaining a better understanding of the biology of this devastating human pathogen Prof. Ted Baker STRUCTURAL BIOLOGY

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Phase I & II Clinical Trial Centres Dr Richard Robson Phase I/II studies – Renal, other Roche established / other clients Dr Shaun Holt Prof Richard Beasley Phase I/II – Respiratory, other GSK established / other clients Medical Research Institute of NZ

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Other Clinical Trials Groups Epidemiology, biostatistics, project & data (IT) management clinical trials – heart, stroke, other Beltas – CRO Services all phases, NZ regulatory. Focus European Biotechs Clinical schools – Auckland, Wellington, Christchurch, Dunedin

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NZ’s leading medical device company Products: Respiratory humidification, Obstructive sleep apnea Neonate incubators Operating theatre (patient warmers, nerve stimulators) NZX & ASX listed

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Neonatal brain monitor for intensive care in premature infants – prevention of brain injury (Cerebral Palsy) Developed by Professor Chris Williams, University of Auckland. BRM-2 brain monitor Owned by Tru-Test (NZX listed) CEO Dr Justin Vaughan Distrubution partners and investment

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ISEQ world’s first framework for integrating different data sources, while using “research agents” that update results as you are analysing Creates order-of-magnitude time saving, cuts down supercomputing power required to run genome-genome analysis. Biomatters creates software, to fill market-gaps in the biotechnology industry. Products ISEQ & Cheesecake Text mining tools solving some of hardest problems facing life Science researchers, bioinformaticists, IP analysts Products: Classifier, SureGene, SureChem, Entity Extractor NZ Centre of Excellence: Uni. Of Auckland/Agresearch Research areas: Genomics, Evolutionary Genomics, Conservation/Foresic Genetics, Genetic Epidemiology, Applied Bioinformatics, Application Dev..

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(cGMP) certified manufacturer of natural biochemicals - extracts from plant and animal raw materials. Products for pharmaceutical, dietary supplement, cosmetic, biotechnology, diagnostic and aquaculture uses. Include - (plants) Actinidin, D-Pinitol, Echinacea extract and ProenOthera® (animal) bile derivatives - cholic acid, deoxycholic acid and dehydrocholic acid (and salts), cartilage extract including chondroitin sulphate and other glycosaminoglycans, proteins, peptones and thymus extracts. Contact - Selwyn Yorke

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Serum, blood, other biologicals and organs from meat processing bovine, ovine, caprine, and cervine stock. Leading supplier of fetal calf serum. NZ accorded No. I status by the European Union in respect of BSE and related diseases By-products an important business sector for Richmond Richmond keen on partnerships to develop new product lines Suppliers to Invitrogen and Hyclone

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Animal blood products (serum and proteins) & custom made antibodies for use in therapeutic, cell culture, microbiology and immunology application Quality assured: produce products solely from donor sheep, cattle, goat Products: SeraPac, HaemoPac, ImmonoPac, PlasPac Markets: Asia, Europe, North America Signalomics platform - drug development and disease diagnotics– establishing signal pathway targets using high activity polyclonal antibodies produced for commercial supply in sheep. Prof. Peter Sheppard Symansis Ltd

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High through-put screening natural products from NZ terrestrial and marine microbes for control of Agriculture pests and diseases. Chemistry, protein analysis, toxicology and formulation Sensitive and highly miniaturised screens against a panel of agricultural test organisms representing a wide range of plant and animal pests and diseases Advanced flow cytometric capability in plant and mammalian cellular physiology Andrew Broadwell and Peter Wigley - Directors

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Other producers of animal vaccines in NZ include: Business subsidiary of AgResearch R&D Develops, markets and distributes vaccines Animal health products for sheep, dairy/beef, deer, horses, pigs, dogs and cats

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Animal health, animal welfare, biosecurity, conservation for sustainable pastoral farming productivity Research programmes: food safety & quality, spatial epidemiology, emerging diseases, wildlife health & conservation, reproductive management &diseases, locomotion & musculoskeletal rehabilitation, mycobacterial diseases, nutritional management animal production and diseases. Cost-effective, integrative (pasture-to-plate) applied research to Internationally recognized quality standards (GLP) Primary Sponsor: Pfizer Professor Grant Guilford

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Subsidiary of Fonterra Identification, discovery, commercialisation genes for improving milk production, composition, animal health, and pasture grasses Interdependent platforms based around bovine and forage genomics World's largest exporter of dairy products 13 billion litres of milk processed with 2 million tonnes of dairy products produced annually, 1,000 ingredient products to the international food industry Marketing & Innovation Group – Fonterra’s research and development group adding value to NZMP products.

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Food and Food components affect health at the molecular Genetic level by using nutritional genomic methods 1st Target - Crohn’s disease Collaboration, Auckland Uni., Hortresearch, Agresearch and Crop & Food Prof. Lyn Ferguson Discovery bioactives from milk for human health Therapeutic & dietary products from milk for conditions osteoporosis, infectious diseases and various inflammatory disorders, including asthma, inflammatory bowel disease,diabetes, and atherosclerosis JV Fonterra & University of Auckland partners Seeks partnerships for development IP

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Tatua Nutritionals division focused three key product areas– ingredients specialist nutrition, healthcare products; bionutrients customised biopharmaceutical applications Tatua Nutritionals’ specialty ingredients include spray dried milk proteins (caseinates, whey protein concentrates), protein hydrolysates and freeze dried biologically active proteins (lactoferrin and lactoperoxidase). Produces nutritional formulations, tablets and capsules containing bioactive ingredients. Novel therapeutics and diagnostics proteins discovered from decades of sheep breeding Parasites and disease: lead candidates to control parasites and selected diseases in livestock species through genetic diagnostics, vaccines and novel anthelmintics Muscle development: increasing production in intensive livestock production systems extending to human diagnostic and therapeutic applications targeting muscle growth disorders Reproduction:products control mammalian fertility by increasing ovulation or inducing reversible sterilisation

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BLIS - acronym for Bacteriocin like inhibitory substances - natural antibacterial peptides/proteins for the control of Streptococcal throat infection, chronic bad breath, dental caries, ear and other infections. BLIS K12 product throat guard - based on S. salivarius and Salivarian B Professor John Tagg, University Otago – 20 years R&D CEO Kelvin Moffat (ex Boots) Listed NZX. Licensing and distribution partners

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Biotechnology company - production and marketing A2 MilkTM and milk products Dr McLachlan correlation - A2 beta casein, natural milk protein variant with improved human health. Developed simple efficient (IP protected) means to incorporporate the protein in cows milk. CEO – Andrew Clarke. NZX listed. Licensing and distribution partnerships

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Bioactive products for health and wellbeing Extracts - deer velvet antler, botanical (phytoeostrogens and antioxidants), animal (aprotinin) and marine oils Aged related and womens health, sports recovery performance MAF and NZFSA certified - Free TSEs and Foot and Mouth disease CEO – Ross Keeley. AgResearch - key R&D provider Contracts, licensing and partnerships

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Pure NZ colostrum (powder, capsule, tablets CEO Trevor Lock Distribution partners www.purenz Botanical compounds for health. Enzogenol products Safe antioxidant extract from pine bark Int’l sales. Private Co. Partnerships and investors. CEO Larry Stenswick

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Canterbury and Nelson Nutraceuticals Cluster Botanical (Echinacea, red clover, mullein, St John’s wort, manuka oil, valerian, hawthorne, alfalfa, horopito, wheat and barley grass) Bee (propolis, pollen, venom, manuka honey) Marine (Greenshell mussel powder, shark cartilage, abolone powder, pacific oyster powder, shark liver oil, omega 3 fish oil) Other (deer velvet, hydroxyapatite, chondoitin sulphate, bovine cartilage, glandular extracts, blood products, emu oil) Contract Manufacturing : private label, drying, grinding, freeze drying, milling, blending, bottling/ labeling, encapsulating, tabletingExtraction - Water, Solvent, CO2, Alcohol, Countercurrent, Maceration, Cold Pressing, Contract growing and seed multiplication, Raw material suppliers, Research and Development/Consulting

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Natural Product Cosmetics (all natural ingredients) Skincare, colours cosmetics, women’s and men’s, oils, balms, soaps, ache & pain relief, hair care, health supplements No synthetic preservatives [paraben free] No harmful ingredients Herbicide, pesticide and GM free No animal ingredients or testing Bioactive ingredients Recycleable, reusable packaging Manuka oils, honey etc, scientific testing Distribution partnerships and joint ventures

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Apple, Kiwifruit, Berryfruit, Stonefruit New varieties and products Gene discovery: pest, disease and stress control, development, signalling, flavour, nutrition. Bioactives: nutrigenomics CRI formed 1992, 500 staff, R&D and commercial Partnerships Biomaterials, Pine tree breeding, genetics, DNA markers, wood quality, Flowering control

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BioProcessing: Natural Products - identification, extraction and processing for cosmetic, health supplement and biochemicals Biochemical technologies: carbohydrate chemistry, molecular structure analysis, separation technologies, organic natural product chemistry, chemical synthesis, fine chemicals, pharmaceuticals and agrochemicals GlycoSyn small molecule cGMP synthesis Carbohydrate Chemistry: design, synthesis and characterisation IRL Biopharm manufacturing secondary metabolites for biotech and pharma. CEO Nigel Kirkpatrick

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Marine organisms Bio-actives Biodiversity native animals and plants

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Bio-prospecting extreme environments Pharmaceutical, Forensic, Health, food, environment monitoring

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Life Science Ventures – Venture Capital fund focus on life sciences in New Zealand and Australia Agbiotechnology, Agriculture, Food Technology and Health Partners: Direct Capital, Celentis, Inventages, Queensland State Bill Kermode

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iGlobe Treasury Fund - backed by New Zealand and Singapore governments - one of the four Venture Investment Funds (VIF). Tony Bishop Endeavour Capital - develop globally competitive companies based on science and technology innovations (biotechnology, software and medical sectors) Neville Jordan No 8 Ventures – VIF technology fund Jenny Morel

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NZ Investments

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Dr Bret A M Morris Investment Manager - Biotechnology Investment New Zealand New Zealand Trade and Enterprise +64 9 919 9045

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