Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 9, Num. 1, 1999

Journal in New Format for Year 2000 and Beyond

As part of the restructuring of the Australian Biotechnology Association and its new direction for the coming millenium, we have been considering the future role of this journal. Should it be solely a news journal, should it stay with its present 50:50 mix of science articles and news, should it be an industry journal for lobbying politicians, should it evolve into a magazine explaining the new technologies to the public, or should it cease to exist? A number of factors, such as staff time and cost, revenue and membership numbers all affect this decision. The following decision was taken, but it should be noted that it allows us a great deal of flexibility in its implementation during 1999.

Government Embraces Biotechnology in New Budget

The 1999-2000 Budget speech of 11th May 1999 by The Hon. Peter Costello, Federal Treasurer, announced major additional funding in health and medical research to be provided through the NHMRC. New funds of $M614 over six years are to be provided.

Parallel to this welcome initiative for medical biotechnology research are new initiatives in biotechnology.

The Federal Government is to establish the Office of the Gene Technology Regulator (OGTR) to regulate the application of gene technology. The OGTR will regulate research in and applications of gene technology that are not covered by existing regulators.The OGTR will operate under powers to be conferred through an intergovernmental agreement and associated Commonwealth, State and Territory legislation.

Australians Seek Facts on Gene Technology

Australians are sending a strong message that they want more information about gene technology and food, according to a national survey conducted by CSIRO.

New research into consumer attitudes suggests most Australians are willing to try gene- modified foods provided they can see clear benefits.

California-Australia Biotech Partnering Conference

Austrade have been very proactive in ensuring that there will be a strong presence from Australian companies at the California biopartnering conference this May.

The updated Program for the California-Australia Biotech Partnering Conference in San Diego is given below. On Day 1 we have arranged a compelling program of top speakers who will give their overview on finance, legal, partnering and commercialization issues facing bioscience companies today, and strategies to overcome them. Australia will be the focus of a special hour presentation, and as part of the BIOCOM breakfast panel on international opportunities. Australian biotechnology will very much be on the menu, thanks to the generous contribution of Florigene Limited. The rich, vibrant, purple colour of 1,000 Florigene Moonshadow flowers will grace the BIOCOM breakfast tables on May 12th.

Bio 99 is the world's largest biotechnology conference, and provides important US exposure and international networking opportunities. Conference information is on www.bio.org.

Net News - A Letter to Biz-Biotech

I would like to point out that the "GMO industry" is not against labelling. GIBiP (Green Industry Biotechnology Platform - http://www.gibip.org) an organisation representing 20 European companies active in plant biotechnology, supports labelling within the context of the Novel Food Regulation (258/97/EU) and the Council Regulation 1139/98, and support consumer choice. The industry position is that labelling is a food safety issue and that only those products should be labelled which contain foreign DNA or proteins.

Distinguished Medical Researcher Appointed to Key National Health Position

Federal Health and Aged Care Minister, Dr Michael Wooldridge, recently announced the appointment of Professor John Mathews as Head of the National Centre for Disease Control (NCDC) located in the Population Health Division of the Department of Health and Aged Care in Canberra.

Initiative to Develop Biotechnology Industries in North Queensland

The Parliamentary Secretary for Queensland's Department of State Development opened a workshop on developing a biotechnology industry in the region. The workshop was held on 16 March at the Australian Institute for Marine Science's Caper Ferguson laboratories near Townsville.

Dr Peter Murphy of AIMS marine bioproducts program said "This workshop is about creating knowledge-based industries for the twenty-first century in North Queensland. North Queensland's science expertise and the region's rich biodiversity can pave the way to development of biotechnology industries in the region. As a centre of biodiversity, particularly marine biodiversity, and with internationally recognised biotechnology research at AIMS and James Cook University, North Queensland is poised to attract biotechnology industries."

New Centre on Metals and Genetics Opens in Melbourne

The opening of the Centre for Cellular and Molecular Biology at Deakin University in February establishes a major international research centre for the study of the effect of heavy metals on human health.

Headed up by Professor Julian Mercer, a world-renowned leader in the field of the biology of copper, the centre also paves the way for a new course in human genetics that will be offered by the Faculty of Science and Technology next year.

World Wide Genetics Research Projects Established in Australia

Glaxo Wellcome recently announced that it has signed agreements with three separate Australian research centres to collaborate in the company's world wide program for uncovering the genetic basis of disease.

Australia-European Commission Joint Science and Technology Cooperation Committee

The fourth meeting of the Joint Science and Technology Cooperation Committee (JSTCC), established under the S&T Agreement between Australia and the European Community (EC), was held in Canberra on 3 March 1999.

Professor Jorma Routti, Director-General for Science, Research and Development, led the European Commission delegation. Dr Paul Wellings, Head of the Science, Technology and Innovation Division, Department of Industry, Science and Tourism, led the Australian delegation.

Australia Leads the World in Fisheries Management

Federal Agriculture, Fisheries and Forestry Minister, Mark Vaile, recently launched the Bureau of Rural Sciences (BRS) report, Fishery Status Reports 1998: Resource Assessments of Australian Commonwealth Fisheries, saying Australia continued to lead the world in fisheries management.

Membrane Technology in Food and Bioprocessing

An intensive two day seminar on the fundamentals and recent developments of Ultrafiltration in the Food and Bioprocessing Industries with Special Guest Presenter - Dr Munir Cheryan of the University of Illinois, USA

Moreland City Council Drops Genetically Engineered Food

Moreland City Council is set to become Victoria's first local government and Australia's second to oppose the use of genetically altered food. In its own services Council will work towards a service that is free of genetically altered food and encourage child care centres and other services to follow suit.

News from Malaysia

Kuala Lumpur, Malaysia has been selected as the venue for the 21st IUFRO (International Union of Forestry Research Organizations) World Congress from August 7-12, 2000. The theme of this important congress is Forests and Society : The Role of Research and 2000-3000 participants are expected to enjoy the varied and stimulating programme of plenary, sub-plenary and specialist meetings. The congress will focus on five main sessions : sustainable management of natural resources, forests and society's needs, changes in environment and society, cultural diversity in forest management, and the global vision of forest and society.

Typhoid fever remains as an important public health problem in many tropical developing countries, exacerbated in recent times by the appearance of antibiotic-reistant strains. Malaysian Biodiagnostics Research Pty. Ltd. (MBDR), Malaysia's first biodiagnostic company has recently announced the availability of a new, more rapid version of the diagnostic test kit for typhoid fever, TyphiDot, which they developed and marketed several years ago.

GLAXO WELLCOME

Australia passed another key milestone in the worldwide battle against the influenza virus today with the opening of the first manufacturing facility for the flu treatment, Relenza (zanamivir) at the Melbourne headquarters of Glaxo Wellcome Australia.

Relenza was recently recommended for approval by the Australian Drug Evaluation Committee for marketing in Australia, thus clearing the way for the treatment to be available on prescription throughout Australia during the coming winter.

BIOTA

Biota Holdings Limited has announced that the Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee has voted against recommending Relenza7 (zanamivir for inhalation) - a proposed new treatment for influenza type A and B - for FDA approval at this time. Relenza was invented in Australia in the 1980s and licensed to Glaxo Wellcome by Biota.

VIRAX

Virax has announced the signing of a Research Agreement with Macfarlane Burnet Centre for Medical Research. The agreement supports further research in monkeys into the application of the Company's Co-X-GeneTM technology for the treatment of HIV.

Monsanto Welcomes ANZFA Review

Monsanto Australia Limited recently welcomed the review of their application for the use of food products from cotton and soybean crops improved through the application of biotechnology.

DSM BIOLOGICS

As from January 1 1999 onwards, the new DSM Fine Chemicals group will operate under the following three trade names:

DSM Minera [formerly DSM Andeno (iodine/quinine)]

DSM Fine Chemicals' strategy can be characterized as `accelerated expansion", meaning that production capacity and sales should grow at a much higher rate than the market. This growth objective is to be realized through autonomous growth as well as through acquisions or alliances.

BRESAGEN

Australian Nobel Prize winner and 1997 Australian of the Year, Professor Peter Doherty, has been appointed to the Scientific Advisory Board of Adelaide Biotechnology company, BresaGen Limited.

FORBIO

ForBio, a specialist forest biotechnology company, is patenting several key genes derived from trees. These are thought to be the first tree genes patented in Australia from a gene discovery project.

AMRAD

AMRAD Corporation Limited (ASX:AML) and the Ludwig Institute for Cancer Research, have announced that rights to their respectively owned VEGF-B (vascular endothelial growth factor B) protein patents and technology have been licensed for collaborative development with Baxter Healthcare Corporation. AMRAD will be working with Baxter to investigate the VEGF-B protein as a possible new approach to treating patients with ischaemic heart disease, the leading cause of death in developed countries.

BioVentures Australia Commences Operations

Start-up Australia and research Corporation Technologies (RCT) announced recently the commencement of a joint venture, BioVentures Australia Pty Limited ("BioVentures Australia"), which will invest in life science and medical technologies originating in Australia.

Auckland's Genesis Research and Development has announced that it has entered into a long-term research collaboration with Stanford Rook Holdings, a London-based biopharmaceutical company. The collaboration centres on using Mycobacterium vaccae technology to develop an asthma vaccine.

Journal in New Format for Year 2000 and Beyond

As part of the restructuring of the Australian Biotechnology Association and its new direction for the coming millenium, we have been considering the future role of this journal. Should it be solely a news journal, should it stay with its present 50:50 mix of science articles and news, should it be an industry journal for lobbying politicians, should it evolve into a magazine explaining the new technologies to the public, or should it cease to exist? A number of factors, such as staff time and cost, revenue and membership numbers all affect this decision. The following decision was taken, but it should be noted that it allows us a great deal of flexibility in its implementation during 1999.

On Monday 26 April 1999 at a meeting of Directors and Office-Bearers of the ABA, it was agreed in principle to gradually move this journal from its present mix of news and scientific articles to a predomination of news and only occasional articles. The articles to be of biotechnology policy, consumer perception, surveys of biotechnology industries in Australia and the Pacific Rim (especially New Zealand), but not scientific articles except in exceptional circumstances. We plan to gradually implement this during the year and cancel the list of special features proposed for the remainder of 1999. We apologise for any inconvenience to authors.

The journal will remain with the same title "Australasian Biotechnology" and general external appearance, except that it will be reduced in page numbers from its current 64 pages. It will continue to appear every second month, and we will aim for 6 issues per year (with the exception of this year, 1999, where we have not published the January/February issue, as advised to you earlier). Reasons for this decision are as follows:

• the ABA is becoming more of an industry-oriented association and wants the journal to better reflect this
• comments from readers that they do not read the scientific articles generally
• suitable scientific articles are getting harder to find (hardly any voluntarily get submitted)
• advertising is declining probably largely in response to a decline in ABA membership in the last three years, and consequently, a smaller circulation
• finances of the ABA are not particularly healthy (the ABA has been refocusing over the last two years, and developing business plans and new directions, and this costs money)
• not enough available time of the voluntary editors
• the ABA secretariat is spending a disproportionate amount of time on the journal

So, as part of the restructuring and repositioning of the ABA, we have decided to make these changes to the journal. The evolution to a newly structured journal during 1999 provides all of us, including you the readers, with a wonderful opportunity to remold what I proudly think is a very good journal with a high international reputation, to an even better journal by the year 2000, more aligned with the current needs of our readers.

We are very mindful of our responsibilities to subscribers and advertisers (as well as to our readers) in introducing these changes. We will fully consider any situations where subscribers or advertisers feel disadvantaged by the changes. We fully expect all will be delighted and that all will benefit from the changes.

We have purposely not burdened readers in the past with questionnaires on the type of journal they want. However, now is your big opportunity to send your comments, criticisms, ideas, offers of help to the ABA (tel: (03) 95968879; fax: (03) 9596 8874; email: admin@aba.net.au . Let's really make this the journal you want! Finally, I draw your attention to our Issues paper by Paul Savage on page 47, which is very pertinent to our current journal discussions. It is reproduced from Chemistry in Australia, April 1999. It adds a number of additional reasons why we need to make significant changes to the journal at this time.

Martin Playne
Editor

Government Embraces Biotechnology in New Budget

The 1999-2000 Budget speech of 11th May 1999 by The Hon. Peter Costello, Federal Treasurer, announced major additional funding in health and medical research to be provided through the NHMRC. New funds of $M614 over six years are to be provided.

Parallel to this welcome initiative for medical biotechnology research are new initiatives in biotechnology.

The Federal Government is to establish two new agencies to ensure Australia realises the potential gains being offered by biotechnology: Biotechnology Australia (a Federal Government Initiative) and the Office of the Gene Technology Regulator.

These agencies will be the focal point for the policy and regulatory measures needed to facilitate the development of biotechnology.

Biotechnology Australia (BA) reports to a Council of five Commonwealth Ministers and will operate from within the Department of Industry Science and Resources. The Office of the Gene Technology Regulator (OGTR) will operate from within the Health and Aged Care portfolio and is intended to be overseen by both Commonwealth and State Ministers.

The Federal Government has committed $17.5 million to fund these two agencies and other related measures in the 1999 Budget.

The Federal Government has established Biotechnology Australia to help ensure Australia captures the benefits of biotechnology, while protecting the community and the environment from any risks.

Biotechnology Australia's tasks are to work closely with other Departments and stakeholders to:

• develop a national strategy for biotechnology;
• develop a public awareness program to provide information about biotechnology and gene technology;
• support training for developers and managers of intellectual property; and
• secure better access to genetic resources and gene collections.

BA's key task is to develop an overarching National Biotechnology Strategy to ensure Australia captures the benefits arising from the medical, agricultural and environmental application of biotechnology, while minimising costs and risks.

The development of this strategy will be overseen by a Council of Ministers on Biotechnology, consisting of: the Ministers for Industry, Science and Resources (Chair); Agriculture, Fisheries and Forestry; Education, Training and Youth Affairs; the Environment and Heritage; and, Health and Aged Care. The Council will be supported by a Committee of Secretaries from these departments.

Five cabinet ministers are involved in Biotechnology Australia: the Minister for Health Dr Michael Wooldridge, Senator Nick Minchin, Agriculture Minister Mr Mark Vaile, Environment Minister Senator Robert Hill, and Education Minister Dr David Kemp.

The strategy will build on the work started by the Biotechnology Task Force in the Department of Industry, Science and Resources, and other Commonwealth Departments on sectoral biotechnology agendas. Staff from other departments will be seconded to BA.

The strategy will be completed this year, following extensive consultation with industry and the community which will give all stakeholders an opportunity to contribute.

In the lead-up to these consultations, BA will issue a comprehensive Biotechnology Issues Paper to focus attention on the priority issues and explore the respective roles of government and the private sector.

Some of the issues to be addressed in this paper include: how to ensure Australia maximises its private and public sector investments in biotechnology research; what strategies need to be adopted to encourage greater commercialisation of biotechnology research; identification of impediments to private sector investment in biotechnology research; and, the effectiveness of Australia's present management of biotechnology intellectual property.

One of BA's other major tasks is to support a public awareness and information program to help the community understand the opportunities that biotechnology offers, as well as the ways in which any potential risks are handled. This program is scheduled to start later this year.

Community needs for an information program by government have been identified by consumer groups, educationalists, the science community and industry, and most recently by the Consensus Conference on Gene Technology in the Food Chain.

The Biotechnology Australia strategy should unite Australia's somewhat dispersed efforts in biotechnology, and be a shot in the arm to the whole sector. It will emphasise four areas that are critical to sustainable development of this vital sector:

• Regulation
• Education
• Protection of Intellectual Property Rights
• Commercialisation

The Federal Government is to establish the Office of the Gene Technology Regulator (OGTR) to regulate the application of gene technology. The OGTR will regulate research in and applications of gene technology that are not covered by existing regulators.The OGTR will operate under powers to be conferred through an intergovernmental agreement and associated Commonwealth, State and Territory legislation.

The OGTR's main task is to help realise the benefits of gene technology for the Australian community, industry and the environment, whilst ensuring human safety and environmental protection, through regulation that is timely, science-based, consistent with Australia's international obligations and takes account of ethical and socioeconomic concerns. The OGTR will operate from within the Department of Health and Aged Care.

The OGTR's functions will be to:

• regulate all aspects of the development, production and use of genetically modified organisms and their products, where no other existing regulatory body has responsibility, in accordance with principles agreed and enacted by all jurisdictions;
• work with regulatory bodies to ensure the consistent application of standards and harmonise assessments across all systems of regulation; and
• undertake or commission research in the area of risk assessment.

The regulatory framework for gene technology will draw upon existing legislation for the control of foods, therapeutic goods, agricultural and veterinary chemicals, and industrial chemicals as currently administered by the Australia New Zealand Food Authority (ANZFA), the Therapeutic Goods Administration (TGA), the National Registration Authority (NRA) for Agricultural and Veterinary Chemicals, and the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), respectively.

It will also involve new legislation to regulate GMOs and GMO products that do not fall within the mandate of existing systems. The system of regulation is being considered as a set of related elements covering import of GMOs and their products; research, regulation of GMO products, and post-release control mechanisms.

The OGTR will focus on gene technology safety and regulate products not covered by other national systems. The proposed OGTR will coordinate gene technology regulation in Australia in concert with existing schemes, by coordinating applications to the OGTR and being a focal point for inquiries about gene technology regulation.

The OGTR will also administer the new legislation and subsidiary bodies and committees. A key part of the OGTR will be the proposed Gene Technology Advisory Committee (GTAC), which will in effect be a continuation of the present Genetic Manipulation Advisory Committee (GMAC).

Other key functions of the OGTR will be to operate a central database or register of approved releases and products, and to provide a `shopfront' for proponents to assist in defining the regulatory pathways for GMOs and GMO products where more than one agency would need to issue regulatory approvals.

The government will also introduce significant new spending measures on R&D related to genetic and biological resources, and a coherent plan to ensure that they do not leave Australia. Overall it has committed more than $250 million annually to biotechnology research and development. This funding is distributed across a number of agencies including AusIndustry, universities, CSIRO, the Cooperative Research Centres and the National Health and Medical Research Council.

The OGTR should ensure ongoing public confidence in the products of biotechnology. Hopefully it will ensure that Australia does not have a tabloid newspaper inspired "Frankenfood" controversy, such as that which has recently exploded in Britain over genetically modified foods - amid accusations of improper influence by biotechnology companies on British regulatory bodies and institutes .

The coalition Cabinet initiatives are concrete evidence of the Government's commitment to future high tech industries, and ability to consult with its constituency. It provides hope that decisions which are vital to the future health, environmental steward-ship, and economic prosperity of Australians will be based on measured, well considered judgements rather than fear-mongering propaganda from special interest groups.

Source: David Tribe, ABA Director, and Martin Playne, Editor, based on Ministerial releases and other sources.

Australians Seek Facts on Gene Technology

Australians are sending a strong message that they want more information about gene technology and food, according to a national survey conducted by CSIRO.

New research into consumer attitudes suggests most Australians are willing to try gene- modified foods provided they can see clear benefits.

"But the overwhelming message from this sample of opinion was that people don't have enough information on gene technology or its use in food, and they would definitely like more," says Dr Katrine Baghurst, principal research scientist with CSIRO Human Nutrition.

Dr Baghurst will outline the findings of the national random survey to a conference on gene technology hosted by the Australian Academy of Science at the Maritime Museum in Sydney today. The results are based on 623 postal responses.

"The survey shows 47 per cent of respondents would be willing to try genetically modified foods, if they are of better quality and the same cost as ordinary foods - while 17 per cent said they were unwilling to try it."

But more than half of respondents (58 per cent) claimed they knew little or nothing about gene technology and its use in the food chain although most had heard vaguely about it.

"A key finding of this survey was that 81 per cent of respondents see a clear need for ongoing communication of information to the public about gene technology."

Dr Baghurst says it is interesting that this survey suggests most consumers still rate the issue of chemicals in the food chain as a much greater concern.

"It also indicated that 45 per cent consider continued scientific and technological innovation will deliver benefits that outweigh the risks, while 37 per cent are unsure and 17 per cent disagree."

Dr Baghurst said that it was interesting how the random survey had to a significant degree complemented the findings of the recent Consensus Conference on Gene Technology in the Food Chain, in which a citizen panel was carefully briefed on the issue by experts.

"The Consensus Conference, too, emphasised a need for better public information on this issue, yet it gave gene technology in Australia a cautious green light subject to proper regulation and public scrutiny."

"There is a message here for science, for industry and for governments. CSIRO is already working hard to make sure this information is more readily available."

California-Australia Biotech Partnering Conference

Austrade have been very proactive in ensuring that there will be a strong presence from Australian companies at the California biopartnering conference this May.

The updated Program for the California-Australia Biotech Partnering Conference in San Diego is given below. On Day 1 we have arranged a compelling program of top speakers who will give their overview on finance, legal, partnering and commercialization issues facing bioscience companies today, and strategies to overcome them. Australia will be the focus of a special hour presentation, and as part of the BIOCOM breakfast panel on international opportunities. Australian biotechnology will very much be on the menu, thanks to the generous contribution of Florigene Limited. The rich, vibrant, purple colour of 1,000 Florigene Moonshadow flowers will grace the BIOCOM breakfast tables on May 12th.

Day 2 is designed for real dialogue with qualified teams on development issues facing the Australian bioscience industry. Heller Ehrman White & McAuliffe will lead a strategy breakfast on regulatory and clinical trials issues for Australia. Intracel Corp. will lead an intensive session on about how to survive, how to grow, and how to be successful, from start-up to large company. They will conduct an interactive workshop on strategic partnering, and will provide essential materials and resources to participants, who are encouraged to send examples of what they need help with.

A panel on financing strategies will be lead by Ernst & Young, Macquarie Technology Investment Banking, Cooley Godward and Start-up Australia. International patent strategies and legal issues will be addressed by a panel of US, Australian and European experts from Griffith Hack and Heller

Ehrman White & McAuliffe. Participants will have the opportunity to obtain help with challenging issues during break-out consultancy workshops with the finance, legal and strategic partnering teams.

Austrade San Francisco will talk about how we can assist you in the US, with our contacts and ability to identify opportunities and research potential partners. Synergistic Media Network, the creators of the Biotech Beach, Biotech Bay, etc. map series, will lead a dynamic presentation on how the Internet is changing how biotech business is done, how the Internet can be used strategically, and the exposure they are creating for the Australian biotech industry on Biospace.com, the leading biotech website. A live webcast of the conference proceedings will be conducted on BioSpace.com.

Bio 99 is the world's largest biotechnology conference, and provides important US exposure and international networking opportunities. Conference information is on www.bio.org.

Confirmed exhibitors include Alchemia Pty Ltd, ANUTECH Pty Ltd, Australian Genome Research Facility, BioDiscovery Limited, Biotech Australia Pty Ltd, Bresagen Limited, CSIRO with Australian Institute of Marine Science, CSIRO Entomology, Clinical Network Services (CNS) Pty Ltd, Cytopia Pty Ltd, EnCompass Bioinformatics Pty Ltd, Ilexus Pty Ltd, Institute for Molecular Bioscience, Medica Holdings Limited, PanBio Pty Ltd, Queensland Government, The University of Queensland/UniQuest, and Victorian Government.

UNITED STATES:

California Senate Office of International Relations

Pfizer, Smith Kline Beecham and Monsanto

Heller Ehrman White & McAuliffe

Cooley Godward LLP

Synergistic Media Network Inc.

AUSTRALIA:

Federal Department of Industry, Science & Resources

New South Wales Innovation Council

Macquarie Technology Investment Banking

Ernst & Young

Florigene Limited

We hope to bring a full report to you in our next issue.

Net News - A Letter to Biz-Biotech

I would like to point out that the "GMO industry" is not against labelling. GIBiP (Green Industry Biotechnology Platform - http://www.gibip.org) an organisation representing 20 European companies active in plant biotechnology, supports labelling within the context of the Novel Food Regulation (258/97/EU) and the Council Regulation 1139/98, and support consumer choice. The industry position is that labelling is a food safety issue and that only those products should be labelled which contain foreign DNA or proteins.

I think it is important to note that the Novel Food Regulation has hardly been mentioned in the recent debates about GMO food. This regulation which came into force in 1998 regulates the introduction of food and food ingredients which have until now not been consumed to a significant degree within the Community. These novel foods and food ingredients could be GMO or non-GMO.

Since its introduction and transcription into national legislations, several Novel Foods (based on GM plants have been notified by producers and are currently under review. The Regulation foresees in the provision of an environmental risk assessment and the safeguarding against adverse effects on human health.

The regulation also provides for the labelling of foods and food ingredients to inform the final consumer in case such a food or food ingredient is no longer equivalent to a conventional food or food ingredient.

As Plant Biotechnology Industry we work closely with food processors to provide as much information as possible. However, at the end of the day it is the food processor or manufacturer which has the labelling responsibility and not the provider of the GM seed or plants.

The Novel Food Regulation was introduced in 1998 and has since been transcribed into national legislations. Since then, at national levels discussions and consultations have taken place and are still ongoing about the implementation of the Regulation at national levels. The main issues are the methods to be used for the detection of foreign DNA or proteins (this should be standardised) and the threshold values which will be allowed.

In anticipation of clear national rules on these issues, several food companies have started to label foods and food ingredients based on the known presence of foreign DNA or proteins.

As, with time, rules will be established on the measuring and thresholds, labelling will become commonplace.

The Novel Food Regulation regulates both GMO food and non-GMO food. It is interesting to consider that kiwifruit, starfruit, mangosteen, lychees etc, if introduced today into the community, would likely fall under the regulation and would be subject to risk assessments for human health and the environment. We regularly embrace novel foods and fruits which appear on the supermarket shelves and assume they are safe and non-allergenic without posing the same questions we pose regarding GM foods.

Edo Lin - Mycogen-Verneuil Biosciences

Distinguished Medical Researcher Appointed to Key National Health Position

Federal Health and Aged Care Minister, Dr Michael Wooldridge, recently announced the appointment of Professor John Mathews as Head of the National Centre for Disease Control (NCDC) located in the Population Health Division of the Department of Health and Aged Care in Canberra.

"Professor Mathews is a distinguished health professional who has wide experience in both medical research and public health and I am delighted we have been able to coax him from his present position as Foundation Director of the Menzies School of Health Research in Darwin to head up our national centre," Dr Wooldridge said.

"Professor Mathews started his medical career as a medical officer at Royal Melbourne Hospital after which followed a number of fellowships and appointments including research fellowships with the NHMRC, the University of Oxford, and research experience in New Guinea under the aegis of Sir McFarlane Burnet at the Walter and Eliza Hall Institute.

"Professor Mathews has been a lecturer and instructor in a number of disciplines. He is a Professor in the Department of Public Health at the University of Sydney, Professor at Flinders University of South Australia and has been Senior Associate of the University of Melbourne."

Dr Wooldridge said he was determined to see the National Centre for Disease Control emerge as a centre of excellence in population health prevention, surveillance and management of disease.

"The NCDC is unique in that it combines the national coordination for prevention and detection of diseases such as breast and cervical cancer, nutrition and lifestyle based illnesses and injury with the surveillance and management of communicable diseases such as HIV/AIDS, hepatitis C, vaccine-preventable childhood diseases, food-borne illnesses and new and emerging transmissible diseases," Dr Wooldridge said.

"The NCDC holds the key roles as the coordinator of national action in response to communicable diseases outbreaks and aims to be a leader in the development of best practice models and national public health policy.

Initiative to Develop Biotechnology Industries in North Queensland

The Parliamentary Secretary for Queensland's Department of State Development opened a workshop on developing a biotechnology industry in the region. The workshop was held on 16 March at the Australian Institute for Marine Science's Caper Ferguson laboratories near Townsville.

Dr Peter Murphy of AIMS marine bioproducts program said "This workshop is about creating knowledge-based industries for the twenty-first century in North Queensland. North Queensland's science expertise and the region's rich biodiversity can pave the way to development of biotechnology industries in the region. As a centre of biodiversity, particularly marine biodiversity, and with internationally recognised biotechnology research at AIMS and James Cook University, North Queensland is poised to attract biotechnology industries."

"AIMS has a Biodiversity Collection that is the result of a strategic push over the last ten years by a team of marine natural products scientists to create a source of novel compounds from the sea. There is a huge range of applications for marine bioproducts, including pharmaceuticals, seafood toxin testing, agrichemicals, sun-screens, environmental effects of pollutants, bioremediation, and industrial enzymes. This work has now paid off. Here in Townsville we now have world-class expertise in biotechnology."

James Cook University scientists are using biotechnology to improve plant productivity in tropical food crops, to investigate differentiation and development in animals, and to study the molecular details of the dengue fever virus in order to develop an effective treatment.

Dr Peter Isdale, AIMS Executive Manager of Business and Finance said "Many industries in the Townsville area either have a biotechnology focus, or could benefit from biotechnological approaches, including mariculture, mineral bioprocessing, waste recycling and management, and medical diagnostics. AIMS, James Cook University, The Queensland Manufacturing Institute and the Department of State Development have collaborated on the workshop initiative to facilitate a network of biotechnology industries in North Queensland."

Representatives from AIMS, James Cook University, the Queensland Department of State Development and their Biotechnology Task Force, the federal Department of Industry, Science and Resources, CSIRO, Queensland Manufacturing Institute, and biotechnology companies will participate.

New Centre on Metals and Genetics Opens in Melbourne

The opening of the Centre for Cellular and Molecular Biology at Deakin University in February establishes a major international research centre for the study of the effect of heavy metals on human health.

Headed up by Professor Julian Mercer, a world-renowned leader in the field of the biology of copper, the centre also paves the way for a new course in human genetics that will be offered by the Faculty of Science and Technology next year.

Before joining Deakin last year, Professor Mercer spent 18 years at the Murdoch Institute at Melbourne's Royal Children's Hospital where he led a team that isolated the gene involved in the fatal genetic copper disorder, Menkes disease. The discovery of this gene has revolutionised the study of the biology of copper, a metal which is essential for health and is associated with diseases of the brain including Alzheimer's disease, motor neurone disease and mad cow disease (bovine spongiform encephalopathy). His team has moved with him from the Murdoch Institute to Deakin and is continuing work on the project. Other staff members are studying the health effects of metals such as zinc, iron and arsenic.

The Centre for Cellular and Molecular Biology was opened by the Lieutenant Governor, Professor Adrienne Clarke (Director of the Plant Cell Biology Research Centre, University of Melbourne, and former Chairman of the CSIRO) on Friday, 26 February.

The Centre for Cellular and Molecular Biology is located at the Burwood Campus of Deakin University. This Centre is a major initiative by Deakin University and its location on the Burwood campus is part of the strategy of the University to concentrate its metropolitan activities to this site. The University has provided over a million dollars to fund the building of state-of-the-art Molecular and Cellular Biology laboratories and a further $400,000 was provided for essential equipment. In addition to this new equipment, the Centre incorporated another $400,000 worth of pre-existing equipment including an Optiscan Confocal microscope and a Varian atomic absorption spectrometer.

World Wide Genetics Research Projects Established in Australia

Glaxo Wellcome recently announced that it has signed agreements with three separate Australian research centres to collaborate in the company's world wide program for uncovering the genetic basis of disease.

Perth will host two of the centres. The first is based at the Australian Neuromuscular Disorders Centre, Queen Elizabeth II Medical Centre and headed by Professor Byron Kakulas. It is one of three key genetics screening sites Glaxo Wellcome is supporting world wide. The Centre will conduct DNA screening in a bid to identify genes associated with a number of diseases being investigated by Glaxo Wellcome.

The second centre in Perth is involved in the largest ever genetic study into asthma, a condition that affects more than 100 million people world wide, 2 million of whom are Australians.

Professor Peter Sly, Head of the Clinical Sciences Division at the TVW Telethon Institute for Child Health Research in conjunction with the Princess Margaret Hospital, will collect genetic and clinical data from 100 families in Perth. This will form part of an international network which aims to identify and locate the genes which alter the risk of suffering from asthma.

Families will be recruited through the Princess Margaret Hospital or through GP referrals in the Perth metropolitan area. The genetic and clinical information will be collated in a central data base and the results analysed to find regions of the genome that are altered in asthmatics.

"With over 800 families planned to be involved internationally, this will be by fare the biggest coordinated sample collection and gene screening effort ever in asthma," said Professor Peter Sly. "The comparative data we will be obtaining from family members who are unaffected by asthma are vital if we are to uncover the genetic clues to asthma."

The Genomics Research Centre at Griffith University is the third Australian centre with whom Glaxo Wellcome is collaborating. This collaboration will enable Associate Professor Lyn Griffiths and her team to greatly accelerate the search for the genes responsible for migraine.

The Centre has already localised two of the genes responsible to chromosome 19 and the human X chromosome - the latter explaining at least in part, the increased prevalence of the disorder in females. The aim now is to track down the location of other contributing genes as well as identifying the actual gene components of migraine.

Boost to local research

The Medical Director of Glaxo Wellcome Australia, Dr Mike Devoy, said the establishment of the three genetics collaborations is a boost to Australian scientific research and reinforces Glaxo Wellcome Australia's commitment to investing locally. The company is committing approximately A$4.5 million in Australia over the next 3 years to these programs.

"The goal of Glaxo Wellcome's genetics effort is to understand the genetic basis of disease and use this information to discover and develop new medicines. In addition, we are using genetics to get the right medicine to the right patient by correlating patients genetic information with their response to medicines. From this, we will be able to understand how to treat the disease better, both by using existing medicines more effectively, and by discovering new and better treatments for the disease," said Dr Devoy.

Glaxo Wellcome is a research-based pharmaceutical company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world, and to the health care providers who serve them. Glaxo Wellcome Australia contributes significant resources to scientific research and development in Australia.

Australia-European Commission Joint Science and Technology Cooperation Committee

The fourth meeting of the Joint Science and Technology Cooperation Committee (JSTCC), established under the S&T Agreement between Australia and the European Community (EC), was held in Canberra on 3 March 1999.

Professor Jorma Routti, Director-General for Science, Research and Development, led the European Commission delegation. Dr Paul Wellings, Head of the Science, Technology and Innovation Division, Department of Industry, Science and Tourism, led the Australian delegation.

The fourth meeting reviewed the achievements and events since the JSTCC last met in Brussels in July 1997. The relationship had entered a new phase when agreement was reached in October 1998 to amend the 1994 S&T Agreement. This allowed Australian researchers to cooperate in all EC thematic programmes of research and technological development and demonstration activities as well as the corresponding network activities. The previous Agreement had restricted Australian participation to six specific thematic areas of the EC's research activities.

Seven of the new EU level Research and Technological Development projects launched since July 1997 involve Australian researchers as full contractors or associated contractors. These projects are in the fields of Biomedicine, Environment and Climate, Telematics, Energy and Measurement Standards. This has brought the total number of known collaborative projects launched to 37.

The meeting reaffirmed the mutual benefits to be gained through international research collaboration and looked to the EC's Fifth Framework Program for Research and Development which commences this year as an immediate opportunity to progress the relationship through new projects.

The delegations agree that cooperation could be enhanced through the sharing of knowledge and information and agreed to further this through the wide dissemination of information on the Fifth Framework Programme in Australia and by making information on Australian research activities available to European research entities.

Following the success of the workshops already organised in the fields of photovoltaics and biotechnology, targeted workshops could be organised on other themes of common interest. In this respect the meeting endorsed the proposed workshop on Clean Coal Technologies to be held in Brussels during the first week of May, and the proposed Information Society Technologies Open Days in Sydney and Brisbane on 17 and 21 May respectively. It was agreed that the fifth joint meeting be held in Brussels in the year 2000.

Australia Leads the World in Fisheries Management

Federal Agriculture, Fisheries and Forestry Minister, Mark Vaile, recently launched the Bureau of Rural Sciences (BRS) report, Fishery Status Reports 1998: Resource Assessments of Australian Commonwealth Fisheries, saying Australia continued to lead the world in fisheries management.

"I'm pleased to see that of those fish stocks studied, the majority are being fished sustainable. This goes to show that Australia's investment in fisheries science and our progressive approach to fisheries management is paying off," Mr Vaile said.

However, the Minister cautioned against complacency and expressed concerned about overfishing, saying there was more work to be done to improve understanding of the dynamics of some fishery stocks. The BRS report provides an independent scientific assessment of the status of the Commonwealth's fishery stocks - managed on a day-to-day basis by the Australian Fisheries Management Authority (AFMA).

Of the main species or species groups covered in the BRS report, 12 are being fished sustainably; one is under-fished; the status of 13 is uncertain, and four (southern bluefin tuna, gemfish, school shark and tiger prawns) are over-fished.

"Those species that are considered `overfished' have management plans and strategies in place to rebuild stock levels. Industry is working with fish management authorities to ensure the sustainability of all stocks. Building on our strong domestic fisheries management performance, in the international arena Australia must continue to press for collective efforts to manage highly migratory stocks."

The Minister also pointed out that as a result of Australian efforts, the SBT Commission (CCSBT) responsible for the management of southern bluefin tuna, was again on track.

"Significant progress was made at the recent meeting in Tokyo on issues such as catches of countries outside of the CCSBT, trade certification and capacity and illegal activity," he said. "It's time for a more responsible world wide approach to the use of fishery stocks. We have the appropriate scientific expertise and management powers to regulate activities within waters under our control. What we must do is to continue to pressure for better international commitment to protect the future of fishery resources which migrate through our waters."

Copies of the report can be purchased from the Agriculture, Fisheries and Forestry - Australia Shopfront by calling (02) 6272 5550. Information on the report is also located at: www.brs.gov.au

Membrane Technology in Food and Bioprocessing

An intensive two day seminar on the fundamentals and recent developments of Ultrafiltration in the Food and Bioprocessing Industries with Special Guest Presenter - Dr Munir Cheryan of the University of Illinois, USA

Dates: October 1 & 2, 1999 Venue: University of Western Sydney Hawkesbury, Richmond, NSW

Enquiries: Jenny Carney Tel: (02) 4570 1455; Fax: (02) 4578 4100; Email: J.Carney@UWS.edu.au

Australian Academy of Science Overseas Grants

The Academy has advised us of its exchange fellowship and awards program for 2000 / 2001 for Japan, China, Korea, Taiwan, Europe, USA, Canada and Mexico. There is also separate information for studies in France. Information and application forms are available on the Internet at : http://www.science. org.au/internet/exchange/contscix.htm

Different conditions apply to the various awards, but generally they are for focussed short term visits, but not for attendance at conferences nor for postdoctoral training.

Moreland City Council Drops Genetically Engineered Food

Moreland City Council is set to become Victoria's first local government and Australia's second to oppose the use of genetically altered food. In its own services Council will work towards a service that is free of genetically altered food and encourage child care centres and other services to follow suit.

Cr Melanie Raymond says that while the federal government has allowed a twelve month delay in introducing improved food labelling standards, in the UK there are moves for tougher standards and full information about food quality.

"Councils, as major providers of food services for older people and people with disabilities in the community, have a duty to adopt an approach that is precautionary and responsible. We serve over 120,000 meals-on-wheels annually. For those not in a position to make an informed decision, such as infants in creches and those receiving meals-on-wheels, we must act responsibly.

"In the UK over 300 local councils have banned genetically altered foods and large supermarket chains and food manufacturers are also rejecting genetically altered foods," she said.

At a recent Council meeting, the Council resolved to become "GE" free as soon as possible, a move that will:

• Require council food supplies to seek guarantees from their raw material suppliers that products have not been genetically engineered;
• Avoid foods that are known to have been genetically altered and seek alternative sources;
• Educate and consult with Moreland's large food manufacturing base to encourage awareness and adoption of practices to avoid genetically altered food;
• Work with committees of management of local children's services to eliminate the use of genetically altered foods.

News from Malaysia

Kuala Lumpur, Malaysia has been selected as the venue for the 21st IUFRO (International Union of Forestry Research Organizations) World Congress from August 7-12, 2000. The theme of this important congress is Forests and Society : The Role of Research and 2000-3000 participants are expected to enjoy the varied and stimulating programme of plenary, sub-plenary and specialist meetings. The congress will focus on five main sessions : sustainable management of natural resources, forests and society's needs, changes in environment and society, cultural diversity in forest management, and the global vision of forest and society.

For enquiries about the scientific programme contact : Congress Scientific Committee, IUFRO Secretariat, c/o Federal Forest Research Institute, Seckendorff-Gudent-Weg 8, A-1311 Vienna, Austria, Tel : 431 8770151, fax : 431 8779355, email : iufroxxi.csc@forvie.ac.at .

For enquiries regarding organisational aspects and registration contact : IUFRO 2000 Congress Secretariat, Forest Research Institute of Malaysia (FRIM), Kepong, 52109, Malaysia, Tel : 603 6372135, fax : 603 6365687, email : iufroxxi@frim.gov.my . The Congress also has a web site at : http:/iufro.boku.ac.at/iufro/congress/c sc/

Improved version of typhoid diagnostic test

Typhoid fever remains as an important public health problem in many tropical developing countries, exacerbated in recent times by the appearance of antibiotic-reistant strains. Malaysian Biodiagnostics Research Pty. Ltd. (MBDR), Malaysia's first biodiagnostic company has recently announced the availability of a new, more rapid version of the diagnostic test kit for typhoid fever, TyphiDot, which they developed and marketed several years ago. Jointly developed by MBDR and Science University of Malaysia (USM), the rapid1-Hour New Typhidot test represents a significant improvement on the first generation test which took 3 hours to perform. MBDR hopes to work with the Malaysian Ministry of Health to replace the traditional Widal test with the new TyphiDot test by this year. Such a move would result in significant savings on the overall costs spent for the diagnosis of typhoid fever in government hospitals and laboratories in Malaysia. The test is also being marketed in other Asian countries, including Bangladesh, Pakistan, Sri Lanka and Vietnam. In terms of overall performance, MBDR has seen total sales of the TyphiDot test improve from RM 10,000 in 1995 to RM 800,000 in 1998 thus vindicating the efforts of the Malaysian Technology Development coprporation (MTDC) in promoting the commercialisation of promising indigenous technologies. Interested parties can contact Dr Ong Kok Hai at ongkh@imc.po.my

Tikki PangMalaysia

GLAXO WELLCOME

Australia passed another key milestone in the worldwide battle against the influenza virus today with the opening of the first manufacturing facility for the flu treatment, Relenza (zanamivir) at the Melbourne headquarters of Glaxo Wellcome Australia.

Relenza was recently recommended for approval by the Australian Drug Evaluation Committee for marketing in Australia, thus clearing the way for the treatment to be available on prescription throughout Australia during the coming winter.

Glaxo Wellcome Australia's Medical Director, Dr Mike Devoy, said the company plans to have Relenza available in pharmacies around the country from as early as May 1 this year. "We have worked hard to make Relenza, a product of Australian research, available to Australians ahead of any other country around the world this winter," Dr Devoy said. "We are pleased to have achieved this and look forward to working with the medical profession to ensure this new treatment provides maximum benefit for those who need it most."

The new Relenza production line was officially opened on March 12 by the Minister for Industry, Science and Resources, Senator the Hon. Nick Minchin. The facility will supply enough product for use in the Australian domestic market as well as the entire Asia Pacific Region.

The production facility, located at Glaxo Wellcome Australia's Boronia site in Melbourne, will be one of only two manufacturing sites worldwide and will also provide back-up supplies for Europe where the drug has also been approved for marketing.

Dr Devoy said the establishment of this local manufacturing facility is the realisation of a major opportunity for Australia to develop, market, manufacture and export Relenza around the world - an achievement all Australians can be proud of.

Relenza

Relenza is the first in a new class of compounds which work by blocking the action of the viral enzyme associated with influenza (neuraminidase), thus preventing the virus escaping from infected cells and spreading to healthy cells nearby. Neuraminidase inhibitors are effective against both influenza A and B viruses.

The drug is administered through an oral inhaler device which delivers the active ingredient directly and quickly to the site of infection in the lungs within seconds. This delivery route means that the potential for side effects is reduced because exposure to the rest of the body to the product is minimal.

Clinical trials conducted in Australia and overseas have demonstrated the benefits of Relenza in reducing the severity and duration of symptoms, accelerating patients' return to their normal lives and, in `high risk' patients, reducing complications and antibiotic use.

BIOTA

Biota Holdings Limited has announced that the Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee has voted against recommending Relenza7 (zanamivir for inhalation) - a proposed new treatment for influenza type A and B - for FDA approval at this time. Relenza was invented in Australia in the 1980s and licensed to Glaxo Wellcome by Biota.

"We are disappointed with the committee's decision," noted Dr Hugh Niall, Chief Executive Officer of Biota Holdings Limited. "Relenza is the first neuraminidase inhibitor considered by the FDA for approval. We believe that a series of international clinical trials have successfully demonstrated its ability to treat influenza. However, we are confident that Glaxo Wellcome will work with the FDA to resolve outstanding clinical issues and bring this important drug to market."

Many committee members recognised the difficulty of designing studies for this self-limiting disease. While they thought Relenza had a favourable safety profile and was a promising antiviral, they expressed reservations about efficacy in one of the three pivotal studies.

Dr Niall added, "Regulatory approvals in other major markets around the globe are being actively pursued. Recommendations for approval of Relenza in Australia and final approval for marketing and distribution in Sweden have already been received."

In a more recent announcement, Biota Holdings Limited has advised that its development partner, Glaxo Wellcome plc, has been notified by the US Food and Drug Administration (FDA) of their intention to continue the regulatory review of the application of the company's influenza product, Relenza (zanamivir), beyond the April 27th action date.

Under US law, companies pay a user-fee to the FDA with each drug application. In return, the FDA aims to complete the review of the application, by a specified date, which in this case was April 27th.

This extension will allow the company and the FDA more time to continue their review of the data on Relenza and follows discussions between Glaxo Wellcome and the FDA after the February 24th meeting of the agendy's Antiviral Drug Advisory Committee, which did not recommend approval.

Glaxo Wellcome has already received approval for Relenza in Australia and Sweden. Sweden is acting as the Reference Member State in the Mutual Recognition Process for the purpose of obtaining approval in the other countries of the European Union.

Biota Holdings Limited has advised that Glaxo Wellcome has received approval from the Medical Products Agency in Sweden to market Relenza (zanamivir) for the treatment of influenza A and B. In addition, Biota has been notified by the Australian Drug Evaluation Committee (ADEC) of its recommendation for approval to market Relenza for the treatment of influenza A and B. These are the first major steps in the world-wide marketing of Relenza.

Sweden will now act as the Reference Member State in the Mutual Recognition Process for the purpose of obtaining approval in the other countries of the European Union. Approvals in European countries are consequently expected to follow later this year.

Glaxo Wellcome is a research-based company whose people are committed to fighting disease by bringing innovative medicines and services to patients through-out the world and to the health- care providers that serve them.

Biota is an Australian listed company (BTA) based in Melbourne and engaged in the funding and management of a research and development program focusing principally on the discovery of new human pharmaceuticals for the treatment of viral respiratory diseases and cancer. The company's ADRs trade in the US on the pink sheets at a ratio of three shares to each ADR.

VIRAX

Virax has announced the signing of a Research Agreement with Macfarlane Burnet Centre for Medical Research. The agreement supports further research in monkeys into the application of the Company's Co-X-GeneTM technology for the treatment of HIV.

Dr David Beames, CEO of Virax Holdings said: "We believe this further research with Macfarlane Burnet Centre for Medical Research, a world renowned Australian medical research institution in the area of HIV research, will provide important supporting information for the regulatory approval submissions required for our HIV/AIDS clinical trial."

Dr Stephen Kent of Macfarlane Burnet Centre for Medical Research is directing the research. Dr Kent, with Dr David Boyle of CSIRO, Animal Health Division, and Professor Ian Ramshaw of the John Curtin School of Medical Research at the Australian National University, published results of research into a preventative HIV vaccine late last year. Dr Boyle and Professor Ramshaw are inventors of the Co-X-GeneTM technology.

HIV/AIDS Clinical Trial Update

Significant progress has been achieved in a number of essential areas regarding Virax's HIV/AIDS Phase I/IIa human clinical trial using the Company's Co-X-GeneTM technology. The therapeutic HIV/AIDS trial is the first of its type in Australia.

A detailed review and assessment of the preparatory work for the trial has been undertaken, with particular focus on manufacturing and safety issues. As a result of this work and related extensive scientific review, the vaccine formulation and manufacturing process have been markedly improved and the Company's ability to satisfy the necessary regulatory and safety requirements has been significantly enhanced.

The vaccines to be administered in the trial have been manufactured in Virax's own purpose-built GMP (Good Manufacturing Practice) facility. Quality testing of the products has commenced. Prior to commencement of the clinical trial, approvals must be obtained from three different regulatory authorities. Virax has already satisfied the requirements of the first of these authorities.

The actual timing of clinical trial commencement is dependent on completion of the regulatory approval process. The Company anticipates that the clinical trial will commence no earlier than the fourth quarter 1999.

Virax Holdings Limited, based in Melbourne, is a publicly listed (ASX:VHL) biotechnology company engaged in the discovery and development of immunotherapeutics for the treatment of HIV/AIDS, cancer, infectious and autoimmune diseases.

Virax's business strategy is to identify and in-license promising early stage bio-technologies, conduct R&D followed by early stage clinical trials to demonstrate commercial value and then to partner with major bio-pharmaceutical companies to complete clinical trials and commercialisation.

Monsanto Welcomes ANZFA Review

Monsanto Australia Limited recently welcomed the review of their application for the use of food products from cotton and soybean crops improved through the application of biotechnology.

Monsanto Public Affairs Manager Nic Tydens, said biotechnology in agriculture was giving improved yields, lower costs and more sustainable farming in a number of countries around the world. "In Australia, cotton farmers are reaping the benefits of Monsanto's INGARD cotton which is genetically enhanced to be resistant to caterpillar pests and has reduced the usage of insecticide sprays by up to 50%. The improved soybean crops, grown in the USA, Canada and Argentina are giving higher yields while reducing cultivation and erosion", Mr Tydens said.

The Australia New Zealand Food Authority (ANZFA) is assessing foods from these crops according to the new Food Standard A18 to regulate foods produced by gene technology.

ANZFA has recently reviewed comprehensive information about the safety, nutrition and composition of food derived from these soybeans and cotton crops and in both cases no potential public health and safety concerns were identified.

"The new regulation by ANZFA will give confidence to consumers that the products of biotechnology will be assessed thoroughly in Australia. These crops have already been evaluated and approved by food regulators in a number of countries including the US, UK and Japan, which served as interim approval. Now the Australian Government has put in place a food regulatory system that will allow Australia to share in the environmental, economic and nutritional benefits biotechnology is bringing to agriculture and the food industry", Mr Tydens said.

DSM BIOLOGICS

As from January 1 1999 onwards, the new DSM Fine Chemicals group will operate under the following three trade names:

DSM Minera [formerly DSM Andeno (iodine/quinine)]

DSM Fine Chemicals' strategy can be characterized as `accelerated expansion", meaning that production capacity and sales should grow at a much higher rate than the market. This growth objective is to be realized through autonomous growth as well as through acquisions or alliances.

DSM Fine Chemicals' strategy is to become the partner of choice for innovative life science companies based upon:

Superior technology toolbox;

Optimal production facilities;

Service throughout the product life cycle.

The DSM Fine Chemicals business group is a major supplier of key intermediates for the life science industries, produced on the basis of a close relationship with customers.

DSM Fine Chemicals also produces a range of standard products, advanced (bio)intermediates and active (biological) ingredients. The products are sold world-wide for use in (bio-)pharmaceuticals, agrochemicals, dyes and pigments, flavour and fragrances, and many other markets.

BRESAGEN

Australian Nobel Prize winner and 1997 Australian of the Year, Professor Peter Doherty, has been appointed to the Scientific Advisory Board of Adelaide Biotechnology company, BresaGen Limited.

Professor Doherty, who shared the 1996 Nobel Prize for Medicine with Professor Rolf Zinkernagel of Switzerland for his work on the immune defences of cells, will participate in the regular overview of the scientific work carried out by BresaGen.

BresaGen, based at Thebarton in Adelaide, is involved in the development and production of new pharmaceuticals to combat such illnesses as cancer and in transgenic animal research.

Dr John Smeaton, BresaGen's Managing Director, said the appointment of Professor Doherty was a major boost for the company and a recognition of the importance of its work, particularly in new drug development.

Professor Doherty, who now works at the St Jude Children's Research Hospital in Memphis, Tennessee, and Professor Zinkernagel made their Nobel-winning discovery while collaborating at the John Curtin School of Medical Research at the Australian National University in Canberra between 1973 and 1975. Professor /doherty became the fourth Australian to win a Nobel Prize in the field of medicine, after Lord Howard Florey in 1945, Sir Macfarlane Burnet in 1960 and Dr John Eccles in 1963.

A revolutionary anti-cancer drug under development by South Australian biotechnology company BresaGen Limited, has been injected into a human subject for the first time.

A breast cancer patient aged in her 50s has undergone a course of injections designed to test the safety of the drug as part of a Phase I clinical trial being conducted at the Royal Adelaide Hospital.

The drug, a GM-CSF antagonist known as E21R, could be highly effective against certain types of myeloid leukaemias and solid tumours, such as breast cancer. E21R is a modified form of a natural human hormone involved in blood cell development.

Laboratory studies show it works by binding onto receptors found on cancer cells, resulting in cell death. E21R is more specific against certain types of cancer cells than drugs currently used in chemotherapy.

E21R is being developed by BresaGen under exclusive licence from Medvet Science Pty Ltd and the project is funded in part by a three year, Australian Federal Government R&D Start grant, with expenditure by BresaGen matched dollar for dollar by the Federal Government.

The Phase I clinical trial coincides with BresaGen being informed that Medvet Science would be awarded a patent for the drug in the United States, a step which ensures BresaGen retains exclusive rights to the product for the next 20-25 years.

Patents have already been issued in Australia and New Zealand and are also being sought in Europe and other territories.

Dr Meera Verma, the General Manager of BresaGen's Protein Pharmaceutical Division, said that as part of the Phase I trial, 18 end-stage cancer patients would be injected with E21R, with successive groups of patients receiving higher doses as the trial proceeded.

"While the Phase I trial is primarily a safety study, it is possible that some patients may benefit from the drug during the trial," she said. "If the Phase I trial shows E21R has no significant toxicity problems, the drug will then enter Phase II clinical trials which will examine its effectiveness."

E21R was initially discovered at the laboratories of Professors Angel Lopez and Mathew Vadas at the Hanson Centre for Cancer Research, part of the Institute of Medical and Veterinary Science (IMVS) in Adelaide. Dr Ian Olver, the Clinical Director of the RAH Cancer Centre and the Principal Investigator for the Phase I trial, said the trial would take most of 1999 to complete. He said the Phase II clinical trials would specifically test the drug's effect on both myeloid leukaemia and breast cancer.

FORBIO

ForBio, a specialist forest biotechnology company, is patenting several key genes derived from trees. These are thought to be the first tree genes patented in Australia from a gene discovery project.

ForBio is filing provisional patents on for one separate genetic sequences from eucalypts and pines. Eleven of the sequences control fertility and flowering time whilst the remaining thirty are integral to the way a tree deals with stresses such as salinity.

The patenting of genes for ForBio is part of its program to secure rights to genes of commercial value in forestry. With over 10% of the eucalypt genome covered, ForBio has already sequenced about 10,000 genes from eucalypts and pines.

One of the world's most pressing environmental problems is the decrease in land quality. Large areas of Australia and other continents are affected by high salinity, heavy metal contamination, cold, drought, flooding and low nutrient soils.

Having control of genes that allow plants to tolerate such stresses is of great commercial importance to ForBio. It also complements ForBio's existing program of breeding salt tolerant trees, the first of which were planted in Australia's Murray Darling Basin last year and are growing well in saline soils.

Understanding the genes that control flowering in plants is a highly competitive area of research around the world. ForBio has a powerful position worldwide in the reproductive control of trees through its existing patients and gene licenses. ForBio's gene discovery project aims to strengthen its position. Uses of reproductive control include making trees sterile and inducing early flowering. In the case of sterile trees, more energy is diverted into making more wood.

Also, with sterile trees, it is possible to add `foreign' genes to the plant without the risk of gene escape through interbreeding with native trees. Examples of `foreign genes' are those that are added to give herbicide or insect resistance to trees.

Early flowering accelerates breeding, shortening the time between generations. This is essential to foresters looking to quickly and efficiently improve forest performance in order to supply the world's timber and fibre needs.

ForBio's gene discovery program, whereby it finds and catalogues all the genetic material in eucalypts and pines, started about eighteen months ago. Part of its program is in collaboration with the US multinational Dupont. Its main focus is on eucalypts.

AMRAD

AMRAD Corporation Limited (ASX:AML) and the Ludwig Institute for Cancer Research, have announced that rights to their respectively owned VEGF-B (vascular endothelial growth factor B) protein patents and technology have been licensed for collaborative development with Baxter Healthcare Corporation. AMRAD will be working with Baxter to investigate the VEGF-B protein as a possible new approach to treating patients with ischaemic heart disease, the leading cause of death in developed countries.

This major agreement follows AMRAD's and Ludwig's recent announcement of a collaboration with RPR Gencell for the development of the VEGF-B gene for gene therapy applications, highlighting the significant international interest and investment in cardiovascular therapy, particularly in respect of VEGF-B.

The VEGF-B gene expresses or produces a protein that has also shown promise as a potential therapy for cardiovascular disease. The protein, known as AM133, has been separately licensed, and is the subject of the collaboration with Baxter.

The agreement provides for AMRAD and the Ludwig to share up to US$22 million, which encompasses licence fees and milestone payments, in addition to any royalties from the sale of any resulting products. AMRAD will also collaborate in planning and overseeing development of the VEGF-B protein to facilitate commercialisation of products for ischaemic coronary and vascular disease.

Mr John Grace, AMRAD Managing Director, said: "The VEGF-B protein project is a very important collaboration for us. This agreement provides AMRAD with the best opportunity to accelerate the development of AM133, which has great potential as a new weapon in the fight against heart disease in Australia and elsewhere. One primary consideration in partnering with Baxter was the company's leadership in research and technologies related to recombinant proteins, particularly Baxter's Recombinate7 brand of recombinant Factor VIII, a genetically engineered blood-clotting therapy for people with haemophilia A. Baxter also maintains a leadership in technologies for advanced stages of cardiovascular disease, through the company's Cardio Vascular Group. We are confident that the agreement with Baxter is the best approach to helping this new potential therapy achieve clinical as well as commercial success," said John Grace.

Two teams working independently discovered and characterised VEGF-B. One team was based at the Queensland Institute of Medical Research (QIMR), an AMRAD member institute, working in collaboration with scientists at AMRAD. The other team consisted of scientists based at the Stockholm branch of the Ludwig Institute for Cancer Research, working jointly with researchers from the University of Helsinki. Further research on characterising VEGF-B is in progress at AMRAD's Burnley laboratories and at the Ludwig.

BioVentures Australia Commences Operations

Start-up Australia and research Corporation Technologies (RCT) announced recently the commencement of a joint venture, BioVentures Australia Pty Limited ("BioVentures Australia"), which will invest in life science and medical technologies originating in Australia.

BioVentures Australia will work in partnership with researchers and research institutions to identify, evaluate, protect, develop and commercialise inventions. In addition to providing project funding, BioVentures Australia will add value to the technology by providing project management, commercial expertise, product development experience, patent strategy and legal support. In most cases, the value added to technologies will be realised through licensing or sale to industry. Some projects will advance to the company formation stage at which point BioVentures Australia will seek coinvestors.

Announcing the venture, George Jessup, managing director of Start-up Australia said: "BioVentures Australia brings together a major international player in technology commercialisation with an active local venture fund manager. This provides an opportunity for inventors and researchers to develop their technology and product further in Australia and ultimately maximise the value of their technology in the international market place."

Start-up Australia is managing the new venture. Start-up Australia will source deals, conduct due diligence, manage the investments and secure exits. RCT has initially allocated up to $10 million to this venture and will provide value-adding expertise in science, patent strategy, drug development and commercialisation.

In announcing their investment, Gary Munsinger, president of RCT stated: "We have been impressed by the quality of technology available in Australia and have been aware of the activities of Start-up Australia for some time. It was a natural progression, as we expand our international presence, to join forces with an experienced manager, Start-up Australia."

Stephen Robinson, director of Start-up Australia noted: "The investment by RCT is a vote of confidence in the fund management skills of Start-up Australia and in the deal flow potential in Australia. BioVentures Australia will allow us to invest in technologies at a pre company formation state. We are continuing to raise funds for the Start-up Australia Fund, which will invest at the later stages of development. We expect this will make the Start-up Australia Fund more attractive to local investors."

Auckland's Genesis Research and Development has announced that it has entered into a long-term research collaboration with Stanford Rook Holdings, a London-based biopharmaceutical company. The collaboration centres on using Mycobacterium vaccae technology to develop an asthma vaccine.

Both Genesis and Stanford Rook have been undertaking research into asthma for some time, and each recognises the benefits of pooling their complementary skills and technologies. Earlier this year Genesis announced the start of clinical trials for its asthma vaccine at the Wellington Medical School.

"This collaboration should significantly reduce the development time for our joint asthma programme, and extends our ability to use the technology in other diseases in the future. I am really enthusiastic about the added benefits that can be gained from this combined scientific research," said Jim Watson PhD, Chief Executive Officer of Genesis.

While the incidence of serious infections has declined in many developed countries, asthma has become increasingly common. The allergic disorder can emerge when a change occurs in the balance between white blood calls, known as Th cells. Since 1994 Genesis has been actively engaged in immune disease research, searching the genome of the Mycobacterium vaccae microbe for gene products that have the potential to change this balance of power among Th cells.

Genesis has also received considerable interest in its clinical results using Mycobacterium vaccae technology for a psoriasis vaccine, undertaken with a United States biotechnology partner Corixa Corporation.

Stanford Rook is extensively involved in research programmes using Mycobacterium vaccae technology for the treatment in asthma, tuberculosis and cancer.

Genesis in Global Forestry Venture

Auckland's Genesis Research and Development Corporation has announced that it has signed a letter of intent to contract with a world-leading forestry biotechnology joint venture. The joint venture, to be established by Fletcher Challenge Forests, International Paper, Monsanto Company and Westvaco Corporation, will produce and market tree seedlings to improve forestry health and productivity for the forestry market worldwide.

Genesis will provide the joint venture with intellectual property in the form of patents and its forestry genomics database, together with ongoing genomics research capabilities. In return, Genesis will receive payment for its intellectual property, ongoing royalties from the sale of seedlings incorporating any current or new Genesis technology, and payment for ongoing scientific services.

Genesis and Fletcher Challenge Forests have been active partners since 1995. During this time Genesis used its biotechnology expertise to identify and understand many key biological functions of commercial forestry trees. Genesis' research has resulted in one of the largest inventories of forestry genomic knowledge in the world.

The combined knowledge of the joint venture companies will significantly reduce the time needed to develop improved tree varieties compared to traditional tree breeding programmes. It will allow trees to be planted that have higher growth rates, lower fibre production costs and which contribute to healthy forest ecosystems. These improvements will enable forest landowners to meet the growing demand for wood products while strengthening their ability to manage forests in a sustainable manner.

Genesis is an unlisted public biotechnology company based in Auckland, New Zealand. Genesis was formed with the express intent of using genomic technology to develop health products, and to apply the same technology to economic opportunities in plant based primary industries. Genesis works with corporate partners wanting to use gene technology to make significant changes to their industry. Genesis' health strategy focuses on immune diseases. Its plant strategy started with a forestry programme four years ago; this is now the most extensive forestry genomics and molecular biology programme in the world.

More information from: James D. Watson, Chief Executive, Genesis Research & Development Corporation, 64 9 373 5600, j.watson@genesis.co.nz

Note: Forbio Inc. - Removed from listing 22/03/99 pursuant to listing rule 17.11 at the request of the Company.
(reference: Shares, May 1999, p61)

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Copyright 1999 Australian Biotechnology Association Ltd.