Australian biotechnology is a burgeoning success story

Australia’s biomedical capabilities

Biomedicine in Australia

The biomedical sector in Australia remains the strongest key area of biotechnology capabilities. Of the 427 biotechnology companies in Australia at the end of 2006, over 209 (49%) were operating in the human therapeutics field, 68 (16%) in agriculture and 55 (13%) in medical diagnostics. With the addition of 625 medical devices companies, Australia’s biomedical sector is well established. (Figures are taken from Hopper & Thorburn's BioIndustry Review 2007 – Australia and New Zealand.)

Australia’s international reputation in biomedicine builds on historic breakthroughs, including the creation of the bionic ear and being the first to purify and clone three of the major regulators of blood cell formation.

Australia has skills in many fields of biotechnology such as stem cell research and clinical trials. .

Australian capabilities in stem cell research are underscored in a report of the UK Stem Cell Mission to Australia in November 2006:

"The mission team concluded that based on its depth and breadth of scientific excellence in stem cells, clear legislative framework, aggressive commercialisation strategies and importantly its determination to accelerate basic and translational research towards to the clinic, Australia will continue to be a key contributor to the advancement of this exciting and challenging field for many years to come."

Click here to view the UK Stem Cell Mission report

A high number of clinical trial centres and timely completion of clinical trials are two key elements contributing towards Australia's competitive advantage in clinical trials. Click here for more on clinical trials.

Furthermore, a Clinical Trials and Research Providers Directory has been produced to assist companies to access Australian and New Zealand clinical trial sites and service providers. The directory is available through the Australia-New Zealand Biotech Alliance website: www.biotechalliance.org/clinicaltrials

Defining biomedicine

Biomedicine in Australia includes a wide range of biotechnology applications in the treatment and identification of human diseases from therapeutic treatments to diagnostics for the identification of diseases and vaccines to protect against them. It also includes services such as the production of GM animals, preclinical services, research products (e.g. DNA kits, data mining for drug discovery) and cosmetics. Medical devices are also included under the umbrella of biomedicines (e.g. electronic equipment and implantable medical devices).

Australia’s current biomedical capabilities encompass:

• diagnostics;
• medical devices;
• pre-clinical and clinical trials;
• therapeutics; and
• vaccines.

Drivers of biomedicine

Australia is faced with an ageing population and key community health issues including chronic diseases. Biotechnology has an ever-increasing role in responding to these challenges and producing outcomes from health and medical research. Companies and researchers are increasingly involved in cross sectoral technologies such as genomics, which is viewed internationally as a crucial future technology. A number of research organisations are exploring natural resources from Australia’s mega-biodiversity for new chemical entities that may lead to exciting discoveries in the medical sector.

Enhancing Australia’s biomedical capabilities

Australia’s biomedical capabilities are underpinned by a range of factors, or conditions, that support Australian medicine generally. These general factors include an excellent health care system and records, as well as world class medical research skills in universities, hospitals and other institutions.

Australia’s ability to innovate is another example. Australian scientists are internationally recognised for their novel and multidisciplinary approach to science, supported by a strong academic base and major research institutes. Examples of intellectual property developed by Australian organisations include Gardasil the cervical cancer vaccine, Aridol the asthma diagnostic and management tool, and Relenza the anti-influenza medication.

Collaboration is also an important factor in supporting biomedical capabilities. There exist significant partnerships between governments, medical research institutions, universities, and industry, including through the Cooperative Research Centres (CRCs) focused on health or medical research. A number of recent breakthroughs have come from the medical science and technology CRC sector. For details click here.

There is also significant biodiscovery focus through institutions such as the Australian Institute of Marine Science (AIMS).

Natural biodiversity is seen as a key factor underpinning biomedicine. Australia is one of the world’s 17 megadiverse countries, and is well placed to capture new chemical entities from its natural products research.

AIMS possesses one of the world’s largest publicly owned collections of biotic extracts for bioactive chemical discovery, covering some 20,000 marine macroscopic and microscopic organisms from around Australia. The Bioactive Molecule team uses samples from this library to identify novel chemicals of interest, and is playing a key role in the global race to find new treatments and alternatives in the fight against cancer.

Biomedical sectors

The largest product area within biomedicine is therapeutics, with 49% of core biotech companies focused in this area. This level of company activity substantiates Australia’s biomedical capabilities in therapeutics.

Within the therapeutics sector, areas of significant capability include immunology, oncology, infectious diseases (e.g. HIV, Hepatitis B), metabolics and diabetes, allergy and respiratory diseases, stem cell research, inflammatory diseases, cardiovascular diseases, infertility, neurology and pain, nutraceuticals, urology, and tropical health and medicine.

While therapeutics (and specifically oncology therapeutics) is a focus for the largest group of listed biotech companies in Australia, capabilities in diagnostics, vaccines and medical devices are evidenced by substantial company activity in these areas.

Major Australian biotech partnerships in 2006-07

A number of major biotech and pharmaceutical companies and research organisations around the world continue to show strong interest in forming partnerships with Australian companies and research organisations. Among recently signed collaborations are:

• Cytopia and Novartis (Switzerland): Cytopia signed a global licence and R&D collaboration deal with Novartis to develop orally active, small molecule therapeutics for the prevention of transplant rejection and the treatment of autoimmune diseases.
• Biota and Boehringer Ingelheim (Germany): Biota signed a collaboration and licensing deal with Boehringer Ingelheim to develop nucleoside analogues for the treatment of hepatitis C infections.
• Evogenix and the National Institutes of Health (US): Evogenix signed a cooperative R&D agreement with the NIH for the clinical evaluation of Evogenix's new anti-cancer antibody therapeutics by NIH researchers.
• Psivida and Pfizer (US): Psivida signed collaborative research and licensing agreement with Pfizer for the development of drug delivery technologies in ophthalmic applications.
• Walter and Eliza Hall Institute and Genentech: The WEHI signed an exclusive global collaboration deal with Genentech to discover, develop, manufacture and commercialise a new generation of broad spectrum cancer therapeutics.

Government support initiatives

Government policy is a major supporting factor with health a key focus in the National Research Priorities. This focus is helping to guide future R&D directions following agreement by all governments in Australia on specific national health priority areas set out by the National Health & Medical Research Council (NH&MRC).

Health Ministers have endorsed seven national health priority areas – asthma, cancer control, cardiovascular health, diabetes mellitus, injury prevention and control, mental health, arthritis and musculoskeletal conditions.

The Australian Government, through the 2007-08 budget, committed $485.8 milllion to enable clinical and research facilities to improve their capacity to undertake quality work into the causes, diagnosis and prevention of disease.

Other key government policy initiatives for the medical sector include the Pharmaceuticals and Medical Devices Action Agendas. These initiatives and programs for the medical sector are in addition to the more generic, national programs for industry, such as the $1 billion Commercial Ready program and the extended 175% R&D tax concession.
 

Emerging capabilities in biomedicine

Oncology is the focus of the majority of listed biotech companies in Australia. There are also a growing number of public biotech companies that highlight Australia’s emerging capabilities in cell and tissue engineering, with the emergence of companies with research interests in stem cells, cell-based vaccines (e.g. dendritic cell vaccines);tissue replacement; and repair or regeneration of organs.

Drug delivery technology is another emerging area for Australia, with opportunities in marketing through international collaborations. A range of capabilities in which major changes are forecast over the next five to ten years are noted below, under the phases of the value chain.

Discovery stage

Australia’s biomedical sub-sector is developing capabilities in research into microbial resistance. This research is particularly important not only in biomedical applications, but also across other areas of biotechnology. For example, research into resistance to antibiotics for bacterial infections and resistance against anti-fungal products is not only applicable to human health, but also in the agriculture and environmental sectors.

In the 2007-08 Federal budget, the Australian Government allocated $100 million to Princess Alexandra Hospital and University of Queensland to support a research and development facility for the development, testing and small-scale production of life-saving biopharmaceuticals.

The Australian Government is also providing a $10 million grant to assist in the establishment of a small-scale mammalian cell production facility. This will bridge the infrastructure gap in the national biotechnology manufacturing chain by providing the capacity to produce recombinant proteins using mammalian cells.The facility will allow drug developers access to small quantities of complex biological material for studies ranging from preclinical research to Phase III clinical trials. Click here for further information on the mammalian cell production facility.

In medical devices, discovery capabilities in biomaterials science are beginning to translate into the establishment of new companies. Australia is likely to develop further in the area of personalised medicine with biomarker discovery, and build on research capabilities in stem cells.

Development stage

The Australian Synchrotron in Melbourne was officially opened in July 2007, and provides infrastructure for advanced technology, with particular benefits likely across discovery and development of biomedical products and in the areas of nanotechnology, disease mechanisms and microbiology. Initial experiments commenced at the Synchrotron in April, with five of the nine beamlines becoming operational. Among the high priority five beamlines are beamlines that will support protein crystallography and advancement of IVF technologies.

There are strong prospects for the formation of more internationally competitive cancer research consortia, particularly for breast, colon, ovarian, prostate cancers and leukaemia.

More specifically, emerging capabilities in the development phase include tissue engineering (e.g. autologous primary cell cultures for tissue repair), niche areas of protein discovery techniques and prophylactic and therapeutic vaccine development (e.g. novel combinations or single shot vaccines and DNA based vaccines for autoimmunity, chronic infections and anti-biowarfare).

Preclinical stage

Building on existing capabilities in the preclinical phase, there is increasing sophistication and infrastructure in animal and other preclinical facilities, including transgenics in Australia. For example TetraQ is the first contract research organisation in Australia to provide integrated preclinical services to the global pharmaceutical and biotechnology industries.

A further example of how Australia is building on existing capabilities in this area is the use of GM technology to produce an internationally competitive product, including supply through companies such as Ozgene.

Clinical trials stage

Emerging capabilities in clinical trials include:

• the use of applied stem cell therapy and cell therapy in tissue repair;
• wound healing for diabetes treatment;
• connective tissue engineering;
• neurodegenerative disease; and
• some cosmetic applications.

The ARC Research Network for Tissue Engineering has been established to coordinate research into tissue engineering which will help build capabilities. Further fostering of these capabilities is likely as governments, industry and relevant agencies look to a more national approach to streamlining approval of clinical trials. This should assist in highlighting the key issues and developing specific strategies and solutions as required.

Australia has multiple advantages as a venue for clinical trials. It has an exemplary record for meeting timelines and recruitment targets for drug trials. Each year there are around 700 clinical trials conducted across 2000 centres in Australia. Multinational companies like Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Quintiles, Roche and Servier have chosen to base clinical trials in Australia.

Major clinical trial centres in Australia include Cancer Trials Australia, Nucleus Network and the Queensland Clinical Trials Network.

Marketing stage

Marketing opportunities could be fostered by Australia’s proximity to Asia and the Pacific Rim and common interests in areas such as the treatment of tropical diseases. One area of opportunity is for countries affected by tropical diseases to collaborate with Australian researchers, including conducting clinical trials here, rather than in countries where the tropical diseases may be endemic.

Marketing opportunities in the future may also be helped by increased confidence in Australia’s biotechnology sector. Increased confidence is being assisted by the ASX / Ausbiotech Code of Best Practice for Reporting Guidelines. This Code aims to increase accountability of biotech companies to investors by providing better quality and more uniform information, especially in relation to intellectual property, clinical trials data and the outcome of major technical or clinical events. The Guidelines are based on the successful mining industry codes which have been developed over a 20-year period and which are used internationally.