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Allens Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.


Feature article: Grants and Concessions – Australian State and Territory Governments

In brief: Patent Attorney and Lawyer Dr Rob Silberstein provides an outline of some of the available grants and concessions offered and/or supported by Australian State and Territory governments.

In our 6 September 2006 edition of Biotech News, we provided an overview of some of the financial and related contributions that the Australian Federal Government seeks to make to the research and development (R&D) community. In this article, we focus on such contributions offered and/or supported by Australian state and territory governments.

We remind our readers that this is only an overview. It is by no means exhaustive, and we encourage our readers to look into the kinds of grants for which they may be eligible to gain a thorough understanding of the eligibility requirements, currency of and commercial issues derived from, such grants.

New South Wales

BioBusiness Program

The objectives of this program are to help develop world-class export-oriented products, services and businesses; support the biotech technology pipeline to take basic research through development to commercialisation; and promote leadership and training. Businesses that meet the participation criteria may be provided with dollar-for-dollar funding.

For non-research establishment costs and high-growth business programs, funding is limited to a maximum combined total of $75,000, per individual firm, or group of associated businesses. There are a number of activities that are not funded, including research costs, proof of concept, prototyping, product design and testing, clinical and field trials; staff salaries, capital expenditure, and the cost of website establishment.

To meet the core criteria for BioBusiness programs, companies must be: New South Wales based; operate as a for-profit company with significant private ownership; operate in a biotechnology sector as defined by the BioFirst strategy; and be already in the market, or have a product/project being developed for commercialisation, or be involved in basic, strategic or applied research with demonstrable commercial potential.

There are a number of components to the BioBusiness programs, with each component providing funding (and/or other forms of assistance) to be applied to different aspects of an eligible company's business activities. Some of these components have the following titles: Non-Research Establishment Costs, High Growth BioBusiness, Proof of Concept, Professional Leadership and Development, Fostering connections between Investors and Biotechnology Sector, and BioFirst Biotechnology Precinct.

New Export Opportunities Program (Department of State and Regional Development)

This program targets high potential and emerging markets for New South Wales goods and services. It typically assists trade missions and market visits overseas. Assistance can be tailored to focus on the special needs and interests of biotechnology and medical devices firms. Assistance can come in a range of forms, including business matching, appointments and other in-market services, preparation of pre-approved specialised marketing materials, freight on non-commercial quantities of samples, and interpreter services.

Technology Diffusion Program (Department of State and Regional Development)

This program assists small and medium firms to accelerate their adoption of appropriate new technologies. The program supports New South Wales businesses with their technology needs by organising and funding a range of activities under the following titles: Technology Awareness Groups, Systems and Technologies Diagnostics, Design Diagnostics, Cleaner Production, Benchmarking, Technology Implementation Groups, Technology Awareness Events, and Self-Help Tools.

BioBusiness BioLink Program

This program assists biotech research institutions with IP mining, commercialisation, entrepreneurship and the attraction of venture capital. Biolink was created through a partnership of medical research organisations to provide world's best practice business development services to more than 1200 researchers in Sydney and throughout NSW.

BioLink benefits industry by establish a 'one stop shop' for surveying and accessing well-characterised and protected technology, as well as providing professional business interface negotiations. It benefits researchers through its pro-active program for IP audits, IP protection, strategic international marketing and new business creations. BioLink is designed as an inclusive framework and all life science research entities in the state are eligible to join.

Small Business Expansion Program (Department of State and Regional Development)

This program assists business owners to grow their business by providing a range of services, including free business development consultations, seminars and workshops, group programs and one-on-one consultancies.

A one-on-one group consultancy may provide eligible businesses with a subsidy to offset the cost of employing private sector consultants to establish a growth path for the businesses.

Queensland

BioStart Fund (VC funding) (Department of Innovation and Information Economy)

This initiative aims to stimulate the growth of the Queensland biotechnology industry. It is designed to encourage and support young start-up companies by providing them with early stage funds to progress their research to a proof of concept level. BioStart will provide funding to research projects, which are at the 'proof of concept' stage of developing commercially valuable technologies.

Applicants must be able to demonstrate that: the proposed project in is the field of biotechnology; it is at the 'proof of concept' stage; the applicant has the ability to own or control IP relevant to the proposed project; the applicant has, or is prepared to, incorporate a company; and the applicant has, or is planning to, establish its principle place of business in Queensland.

Innovation Start-up Scheme (Department of Innovation and Information Economy)

This program assists highly innovative, early-stage technology companies to commercialise their newly developed products. The Queensland Government provides up to $80,000 (including GST) to successful applicants via a competitive, rounds-based grounds program. Applicants are required to match funding on a 80:20 basis (government:private). An additional $5000 is available on the same basis to recipients who complete all milestones successfully and within the agreed timeframe, to assist in the preparation of applications for Commonwealth grants or private venture capital.

Queensland Industry Development Scheme (Department of State Development)

This scheme aims to help establish companies to innovate, expand and employ more people. It assists companies that wish to: be competitive globally, develop export markets, attract investment, adopt new technology, develop innovative products and services, or develop environmental management plans.

Assistance is provided on a dollar-for-dollar basis, for a minimum of $5000 to maximum of $50,000 per project. Assistance over $50,000 will be considered on a case-by-case basis.

Queensland BioCapital Fund (VC Funding)

This is a $100 million dollar venture capital fund specialising in biotechnology. It will be managed by the Queensland Government's fund management arm, the Queensland Investment Corporation. The fund will be a closed-end fund with a life of 10 years.

Smart State Fellowships (to be incorporated into the Innovation Skills Fund)

These Fellowships support the Queensland Government's investment in leading edge research facilities by funding talented early career researchers, working in leading Queensland-based research teams. This program is designed, among other things, to: retain the talents of promising early career researchers in Queensland; attract outstanding researchers nationally and internationally; grow mutually beneficial linkages between research and industry; and support research which will benefit the future economic and social development of Queensland.

The Queensland Government is providing up to $150,000 in grant funding per Fellowship, which is been matched by research organisations and industry cosponsors, totalling $300,000 over three years per Fellowship.

Smart State Health and Medical Research Fund

The fund provides Queensland hospitals, health services and independent medical research institutes with the support needed to continue with the world-class research they are undertaking.

The fund comprises two streams:

  • Operational Support Program
    Funding support is provided for the operational costs of research undertaken by Queensland independent health and medical research institutes on a competitive basis, between 10 cents and 25 cents per dollar received elsewhere by the applicant organisation.
  • Queensland Clinical Research Fellowship Program
    Funding provides fellowships for early-career and experienced clinical researchers to be employed in Queensland hospitals and health services. Four fellowships will be appointed each year. Funding is matched from other industry, Commonwealth and overseas sources.
teQstart Investment Fund

teQstart is managed by a Queensland Government-owned company, teQstart Pty Ltd, through an independent board of directors. It funds technology research projects at the 'proof-of-concept' stage so that developed intellectual property can reach an investment ready position. Successful applicants receive the necessary investment to move to the next stage of commercialisation.

Queensland Entrepreneurs (Department of Innovation and Information Economy)

Queensland Entrepreneurs provides mentoring to aspiring entrepreneurs as they journey toward commercial success. It facilitates networking, mentoring and investment through access to business executives, 'angels' and services provides, as well as successful entrepreneurs.

South Australia

Bio-Arc Program (BioInnovation SA)

This program enables emerging and established South Australian biotech companies to become industry partners in Australian Research Council (ARC) linkage grants. Bio-Arc will provide up to $25,000 cash per year for two years to biotech companies that would be unable to participate in the Linkage project without financial support. Companies can apply to Bio-Arc to provide financial assistance for projects that will achieve key milestones and contribute to the growth of the company and/or assist with the commercialisation of biotechnology by that company.

Bio Innovation SA Grants

Bio Innovation SA operates a number of key fund initiatives, including:

  • Commercial Development Initiative
    This initiative assists commercialisation of South Australian bioscience technologies originating from public sector organisations, including universities, hospitals and research institutes. Applications can be submitted at any time. Grants of up to $50,000 can be used for such activities as proof-of-concept research, IP advice and market research.
  • Business Development Initiative
    This initiative assists South Australian bioscience companies to develop their businesses. Grants of up to $50,000 can be used for a range of activities. The initiative is open to start-up and early-stage South Australian biotechnology companies. Applications can be submitted year-round and are reviewed according to merit criteria, which include the feasibility and commercial viability of the activities in the commercial expertise and skill of the management team.
  • Commercial Infrastructure Fund
    This fund provides a maximum of $250,000 to help South Australian bioscience companies to buy equipment that has the potential to assist them with generating revenues and attracting investment.
  • Research Infrastructure Fund
    This fund is designed to facilitate the establishment of research service facilities/organisations to serve the needs of the bioscience community. Service providers should be located within publicly funded research organisations, however commercially operated organisations and privately funded research organisations are considered on a case-by-case basis. The program provides funding for staff positions within the facilities or for the purchase of major pieces of bioscience equipment that could benefit both bioscience research and industry sectors.
  • Commercial Management Grant
    This grant provides funding of up to $150,000 to support the employment of commercial managers within the eligible organisations, hospitals and universities. It is provided on a dollar-for-dollar matching basis.
  • Entrepreneur-in-Residence Program
    This program assists companies with product development, corporate strategies and capital raisings.
Business Development Initiative (BioInnovation SA)

The purpose of this initiative is to assist groups that wish to form biotechnology companies meet the costs of company formation and business planning for their company. Maximum funding available is $30,000.

AIB Labs Infrastructure Fund (BioInnovation SA)

This is an initiative between BioInnovation SA, South Australia's three universities and key bioscience research institutes. The key objectives of the project include: increasing the impact of research and development by facilitating access to leading edge technology expertise and major equipment infrastructure; maximising funding for current and future strategic infrastructure investments; and implementing and supporting effective management and an accredited quality systems at AIB Labs facilities and other key technical service facilities.

Funding for the AIB labs is provided by BioInnovation SA through its Research Infrastructure Fund (discussed above).

Tasmania

Enterprise Growth Program

This program provides grants to eligible Tasmanian companies to overcome impediments to business growth by assisting with, for example, improving processes and systems, managing the introduction of new technology and human resources, accessing market opportunities, identifying and resolving supply change issues, or undertaking market planning.

Grants of up to $10,000 are available, generally on a dollar-for-dollar basis. Payment is made in arrears based on pre-approval and the satisfactory completion of the project.

Research Partnerships Program

This program supports collaboration projects between Tasmanian-based enterprises and local and other research institutes. It aims to support the development of innovative products, processes or services that have the potential to be commercialised. It will also support the adoption of a new technology by industry. Grants of up to $150,000 are obtainable, based on legibility. If interested in submitting an expression of interest for further rounds of this program (not yet committed) contact should be made with the Research Partnerships Program Project Officer.

Tasmanian Innovations Program

A range of financial assistance is provided to help commercialise innovative products, processes and services. These include:

  • Early Stage Commercialisation Assistance
    Up to $20,000 is available on a two-for-one dollar basis for direct costs incurred in commercialising a product.
  • Mentoring Assistance
    Up to $20,000 is available on a three-for-one dollar basis to engage an appropriate mentor or coach to provide guidance and advice, or business and human development activities to further commercialise a new product.
  • Commercialisation Assistance
    Up to $150,000 is available on a two-for-one dollar basis for direct costs incurred in commercialising a product.
©-STAR Award

This award recognises a Tasmanian science and technology company or individual for its preliminary success in commercialising a science and technology product, process or service. Judges look for entries that demonstrate technologies with a clear commercial potential and are particularly interested in contestants who can demonstrate that some progress has already been made towards commercialisation, although this is not essential. The winner receives a specialised trophy and $5000. Five finalists will each receive a specialised certificate.

Victoria

Export and Innovation Programs – Agenda for New Manufacturing (Department of Innovation, Industry and Regional Development)

The Agenda identifies export growth as a key factor in Victoria's future prosperity. Another recognised key success factor is accelerated innovation. Export Programs are provided to encourage more manufacturing companies to export, grow and facilitate collaborative export initiatives. Innovation Programs are provided to encourage manufacturers to evaluate new technology options and demonstrate new technologies to other Victorian manufacturers.

  • Export Program 1: First Step Exporter
    This program helps export capable manufacturers research new market possibilities and support them in their efforts to explore offshore opportunities. Funding support of up to $10,000 (50 per cent subsidy) is available to be used against associated expenditures. Subsidies are limited to eligible expenses, including commissioned market research, economy class travel, promotional material, and trade fair participation.
  • Export Program 2: Going Global
    This comprises a business review to help new exporters accommodate the rapid changes required to their business as a result of rapid export growth, or to support initiatives for significant growth in their current exports. Funding support of up to $15,000 (50 per cent subsidy) is available to be used against expenditures associated with a consultancy or short-term resourcing support.
  • Export program 3: Collaborative Export Marketing
    This program seeks to explore new models for groups of firms (minimum three) including industry associations, supply chains sets, and project-based networks to participate in international activities, such as group marketing approaches and group technology marketing applications. The program supports work on joint export initiatives and bidding for major international projects. Funding support of up $30,000 (50 per cent subsidy) is available to be used against expenditures associated with a consultancy or short-term resourcing to develop and/or implement a group export marketing strategy. Subsidies are limited to eligible expenses, including, consultant services, professional services, commissioned market research, economy class travel, and preparation of promotional material.
  • Innovation Program 1: Technology Evaluation
    This program aims to encourage high growth potential companies or industry groups to identify and fast track the evaluation of technology for advancement. Funding support of up to $20,000 (50 per cent subsidy) is available to be used against associated expenditures. Indicative costs include: third party research, training, plant preparation and trials, and implementation report development.
  • Innovation Program 2: Technology Demonstration
    This program supports the costs of developing awareness activities which showcase how new technologies have been successfully implemented. Funding support of up to $20,000 (50 per cent subsidy) is available to be used against expenditures associated with demonstrating the process of implementing a new technology. Indicative costs include: installation, training, technical assistance, and marketing or publicity costs associated with the uptake or demonstration of the technology.
Grow your Business Program (Department of Innovation, Industry and Regional Development)

This program is a flexible new funding and support program that provides advice, referral and assistance to innovative Victorian companies. The model typically begins with the provision of information and referral services at the direct request of a business. The need of further assistance is identified, and eligible businesses can apply for a grant to engage the services of an independent specialist to undertake a Business Strategic Review and/or create a Business Development Plan. For the Business Strategic Review, a grant of 75 per cent up to a maximum of $4000 is available. For the Business Development Plan, a grant of 50 per cent up to a maximum of $7,00 is available. Also available are group/networking/supply chain program grants of 75 per cent up to a maximum of $15,000.

Technology Commercialisation Program (Department of Innovation, Industry and Regional Development)

This program aims to increase the rate of commercialisation of science and technology ideas and supports the growth of new high-technology businesses, products and services in Victoria. The Victorian Government has contracted 12 private sector service providers to provide high quality, professional business support and tailored development services to start-up technology companies.

The Venture Capital Access Program (Department of Innovation, Industry and Regional Development)

This program helps start-up technology companies commercialise their operations and grow. It is funded by the Department of Innovation, Industry and Regional Development and administered by the Victorian Employers Chamber of Commerce and Industry. Twice a year, a limited number of Victorian companies are selected to receive up to $50,000 worth of business mentoring, completed over 12 months, in addition to training at a leading US or European business university. Eligible businesses must have been trading for less than three years, have developed a product which has global application, and own the intellectual property in the product.

Western Australia

Western Australian Government Centres of Excellence Scheme

The Centres of Excellence in Science and Innovation Program aims to encourage, catalyse or leverage opportunities to expand and enhance Western Australia's science and innovation capability and performance. Investment from this program is available to support and facilitate research excellence in existing and proposed scientific endeavour, with a significant base in Western Australia.

It is intended that once established, Centres become powerful attractors of further investment from both the private and public sectors and function as nationally and/or internationally competitive centres of research excellence.

Western Australia currently invests in some 40 centres. Co-investment of net cash by proponents is a requirement. Additional commitments by proponents of existing (in-kind) resources are also valued and necessary in establishing an appropriate scale for a viable Centre. Moreover, a minimum level of combined net cash and in-kind co-investment of $3 for every $1 of State investment is required and all co-investment items proposed maybe subjected to independent audit.

Business Innovation Development Scheme (Small Business Development Corporation, Western Australia)

This scheme supports eligible Western Australian small businesses wishing to commercialise an invention or new technology, to access private-sector advice and expertise. Support is only provided to projects where the product or process is in the pre-commercialisation stage. The following specific assistance is provided to successful applicants:

  • Stage 1: Initial Assistance
    Up to 20 hours of consulting to evaluate the commercial potential idea and develop an action plan detailing what private sector advice and expertise will be required to assist in the commercialisation process.
  • Stage 2: Consulting
    If the applicant is recommended for further assistance after stage 1, a contribution of up to $5000 is available towards the costs of engaging external expertise to commercialise the invention/technology.
  • Stage 3: Mentoring
    Optional free follow-up mentoring is provided through the Business Enterprise Centres upon completion of the financial contribution for 12 months.
Export Ready (Small Business Development Corporation, Western Australia)

This program supports eligible small businesses and individuals to qualify for state and Commonwealth export assistance programs. It provides an evaluation of the commercial potential of the business; a basis for business growth; access to free private sector advice; and an evaluation of the export potential of the business; determination of the critical success factors for exports; and the basis for a project brief to engage an export planning consultants.

Market Access Program – Indian Ocean Region (Department of Industry and Resources)

This program is designed to assist non-government Western Australian businesses to embark on initial entry into the markets of the Indian Ocean Region. Services provided typically include (but not be restricted to) introductions to, and qualifications of, buyers, market research, visit program arrangements, advice on market selection, strategic business advice and follow-up services.

Australia Capital Territory

Canberra Business Development Fund

This fund is to designed to provide eligible businesses located in the Canberra region with a source of capital funds through equity investments. It typically invests in early-stage companies that require capital to expand their business operations. Monies invested are intended to assist the companies to accelerate their expansion strategy by providing working capital for a combination of activities, such as expanding sales in current or new markets; increasing production capacity; or undertaking further product development.

The fund is a joint venture between the ACT Government and Australian Capital Ventures Limited. Companies seeking investment capital are encouraged to contact the Fund Manager, Australian Capital Ventures Limited, to discuss eligibility and other requirements.

All business proposals must meet the following criteria: the business must be located in or have a reasonable business connection with the Canberra region; the proposal must be for an existing business that has reported sales or, alternatively, has developed a proven prototype that is being trialled for commercialisation; and there must be a sound plan for business expansion growth.

Companies that meet the elegibility criteria will be assessed against a wide range of evaluation criteria depending on the nature of the proposal, including, product differentiation, market attractiveness, barriers to market entry, management capabilities, and potential exit strategies and retinal investment.

Other sources of funding in the ACT

Research into funding opportunities available to research and development businesses in the Canberra region appears to direct enquiries to various Commonwealth Government-funded grants, such as for example the 'Commercial Ready Program'. Readers are encouraged to contact appropriate sources in the Australian Capital Territory and/or Commonwealth Governments for clarification on issues regarding possible funding for research and development businesses in the ACT. We also refer readers to our earlier published article on Commonwealth Grants and Concessions (6 September 2006).

Northern Territory

Regional Economic Development Fund

The purpose of this fund is to assist with the development of business and capabilities in all regions of the Northern Territory. All funding is subject to approval of the Minister for Regional Development. Preference is given to applications where 50 per cent of the funding is provided by cash or in-kind support provided by the applicant or by other sources, such as the Commonwealth Government, private enterprise or philanthropic organisations.

Grants of up to $25,000 may be available and variations may be negotiated. However, there may be occasions where funding offers are less than was requested, and funding will not be recurrent unless at the Minister's discretion.

Grants will be available to bring regional economic development concepts to the 'ready for business' stage. All applications that are designed to deliver positive regional economic development outcomes will be considered. Applications should be aligned with Northern Territory Government priorities.

Funding can be applied to: the total cost of the project (subject to there being 50 per cent financial and/or in-kind support from the applicant or from other funding partners); recurring maintenance or operational costs of facilities (eg rent, services charges, and administration); projects that have already been completed and/or have outstanding debts; fund-raising, promotional or charitable events; projects that may have a negative impact on existing businesses or may compete with other commercial activities in the local area; wages and salaries; and assets.

Incorporated bodies and/or legal entities may apply for this funding. Applications will be accepted from not-for-profit community organisations/groups based in the Northern Territory. Applications involving private enterprise organisations will be considered where it can be clearly demonstrated that benefits will accrue to the wider community.

To apply, potential applicants should contact the Program Manager by phone on (08) 8999 5133.

Other sources of funding in the NT

Research into funding opportunities available to research and development businesses in the NT region appears to direct enquiries to various Commonwealth Government-funded grants, such as the 'Commercial Ready Program'. Readers are encouraged to contact appropriate sources in the Northern Territory and/or Commonwealth Governments for clarification on issues regarding possible funding for research and development businesses in the NT. We also refer readers to our earlier published article on Commonwealth Grants and Concessions (6 September 2006).

For further information please contact Dr Trevor Davies on +61 2 9230 4007.

Company news

In brief: Regular news from the biotech industry.


Apollo's diabetes breakthrough

25 September – Apollo Life Sciences announced that it has successfully lowered blood glucose levels in diabetic rats with oral insulin, using its proprietary oral delivery technology, OradelTM. Oral feeding of diabetic rats with OradelTM insulin resulted in reduction in blood glucose levels in responder animals of up to 80 per cent which persisted for longer than 6 hours. Generally the stomach's digestive acids usually destroy insulin before it can be absorbed by the body. However, Apollo's formula overcomes this problem with a protective coating. Currently diabetes patients require up to 1500 insulin injections a year to manage their conditions, but these findings suggest that needle-free insulin for diabetes treatment may be a reality in the near future.

[Source: Company Announcement]

AstraZeneca opens two major scientific laboratories

18 September – AstraZeneca has opened two major scientific laboratories in the United Kingdom (UK), adding to the company's significant investment in the region. The first building opened was AstraZeneca's Cancer Research Area building that cost over £60 million. Research at this laboratory is expected to increase AstraZeneca's candidate drug output in oncology to compliment the company's existing cancer medicines. The second building that was opened was the Biology Building that cost over £16 million. This building will be used to assess the safety of drugs across a range of several disease areas.

[Source: Company Announcement]

EvoGenix successfully tests osteoporosis treatment

19 September – EvoGenix Ltd announced that it has completed independent pre-clinical efficacy testing of EGX-010. EGX-010, a protein that prevents bone loss, is a modified version of the natural protein, osteoprotegerin which regulates the build up and break down of bone in the body. EvoGenix used its EvoGeneTM optimisation technology to modify the oesteoprotegerin protein in order to avoid side effects associated with the interference of cancer cell surveillance. Following the completion of human trials, EGX-010 could be used to treat conditions which attack and weaken bone, including osteoporosis, bone cancer and Paget's disease. Independent studies have tested EGX-010 which has proved to be highly effective in preventing abnormal breakdown of bone. EvoGenix have now begun discussions with potential licensees who would complete the development of the product, including clinical testing and commercialisation.

[Source: Company News]

Glivec® receives additional EU approvals

19 September – Novartis announced it has received additional European Union approval for Glivec® to include patients with rapidly progressive form of leukaemia and hard-to-treat solid cancer tumour. According to David Epstein, President of Novartis Oncology, 'Understanding the targets against which Glivec® works has led to the unique opportunity to treat two rare diseases that have Glivec®-sensitive pathways.' The new indications demonstrate how cancers and diseases of different origin and locations share common molecular characteristics that can often respond to the same targeted treatment. Glivec® targets the activity of abnormal proteins called tyrosine kinases that play important roles within certain cancer cells. Submissions in the EU for three other rare diseases remain under review.

[Source: Company Announcement]

GSK invest in French vaccine manufacturing facility

29 September – GlaxoSmithKline (GSK) announced that it is to invest more than €500 million in its vaccine manufacturing plant in France to increase production capacity in formulation, filing, freeze-drying and packaging to meet growing worldwide demand for paediatric and adult vaccines. This facility will contribute to the production of many of GSK's new vaccines including those involved in the prevention of cervical cancer, meningitis and influenza. The new site will house a freeze drying plant which will transform vaccines from a liquid into a solid powder - thereby enhancing the shelf-life and stability of a number of vaccines. This new site forms part of GSK's strategy to increase its capacity to supply vaccines across the globe by developing a unique manufacturing network, based on three major 'hubs' in Europe, North America and Asia. The French site expected to be operational in 2011.

[Source: Company Announcement]

GSK licences flu treatment to Chinese company

28 September – GSK announced it has signed a licensing agreement with Simcere Pharmaceutical Group of Nanjing, granting them the right to manufacture and sell the anti-viral treatment zanamivir in China, Indonesia, Thailand, Vietnam and all least developed countries. Zanamivir is the active ingredient in GSK's Relenza®, which was developed by GSK under license from Biota Holdings Ltd. This agreement with Simcere is intended to expand the available supplies of zanamivir in areas of the world that may be in the front line of a possible influenza pandemic.

[Source: Company Announcement]

Mayne Pharma to be acquired by Hospira

20 September – A leading global hospital products company, Hospira Inc. and Mayne Pharma Ltd announced that the companies have entered into an agreement for Hospira to acquire Mayne. Under the terms of the agreement Mayne shareholders will receive AUD$4.10 per outstanding ordinary share, leading to a total equity consideration of approximately AUD$2.6 billion. Christopher Begley, chief executive officer of Mayne, said 'this combination will create the leading generic injectable pharmaceuticals company in the world - delivering unparalleled value to the global healthcare system ...' Mayne Pharma which has grown rapidly over recent years, expects to continue to grow under the ownership of Hospira which is expected to provide access to great resources, particularly in the United States market. The transaction is expected to be completed by the end of the current calendar year.

[Source: Company Announcement]

New epilepsy indication for Lamictal®

25 September – GSK announced that the United States Food and Drug Administration (FDA) have approved a new use of the anti-seizure drug Lamictal® for the treatment of Primary Generalized Tonic-Clonic (PCTC) epilepsy. PGTC are the most common type of generalized seizures that usually occur without warning and are associated with wide-ranging physical and behavioural changes with potentially life-threatening complications. This new use marks the fifth FDA approval of Lamictal in epilepsy making it one of the few antiepileptic drugs that is effective in a broad spectrum of seizure types.

[Source: Company Announcement]

New initiative to improve access to anti-malarial drug

29 September – Novartis announced an immediate reduction in the average price of antimalarial medicine Coartem® in an attempt to improve access to this important malaria therapy in low income regions, particularly Africa. In Africa alone, a child is estimated to die every 30 sections of malaria. This gesture has been aided by the improved supply situation for the natural ingredient artemisinin. The average price per treatment is US$1 compared to the prior level of US$1.57. Countries will now be able to treat twice the number of children under the age of five with the same amount of funds.

[Source: Company Announcement]

Pfizer's Anti-Smoking pill Champix® approved in Europe

29 September – Pfizer Inc. announced that the European Commission (EC) has approved their novel anti-smoking medication Champix®. Prior research has shown that the combination of behaviour counselling and drug therapy is often more effective as health interventions than attempting to quit unaided. Accordingly Pfizer have marketed Champix® as an 'aid' to smoking cessation making it available with a patient support plan which smokers can customize to address their individual behavioural triggers as they try to quit smoking. The approval of Champix® was based on a comprehensive clinical trial program including four pivotal trials involving approximately 4000 cigarette smokers. This medication received United States Food and Drug Administration approval in May 2006.

[Source: Company Announcement]

Pfizer commits funds to address gaps in clinical treatment of malaria

20 September – Pfizer announced a US$15 million commitment to help close critical treatment gaps in malaria for patients in Senegal, Ghana and Kenya. This commitment is part of a collaborative effort to address global health issues that is run through the Clinton Global Initiative (CGI). Pfizer will partner with both governmental and non-governmental organisations to help develop and strengthen programs for the effective treatment and management of malaria. According to Malaria experts the greatest barrier to care is the tendency for patients and caretakers to not seek and complete proper treatment regimens. Many patients rely on traditional medicines and herbs or take painkillers to ward off the symptoms. Through this five year initiative, Pfizer will provide grants and expertise to support programs that improve patient's understanding of appropriate treatment and patient care.

[Source: Company Announcement]

Pfizer enter licensing agreement with Quark Biotech

26 September – Pfizer Inc announced that they have entered into an agreement under which Pfizer acquires an exclusive worldwide license to Quark's novel human gene RTP-801 and to molecules that modify its expression or function. RTP-801 is involved in the development of pathologic blood vessels which accelerate the progression of age-related macular degeneration (AMD), the leading cause of blindness in the developed world. Pre-clinical models suggest that AMD can be treated by blocking the expression of the RTP-801 gene through RNA interference. Financial terms of the deal were not disclosed.

[Source: Company Announcement]

Sanofi pasteur begins bird flu trial

19 September – The vaccines business of the Sanofi-Aventis group, Sanofi pasteur has as part of the FLUPAN collaborative research project funded by the European Commission, begun the first clinical trial of a new generate H7N1 pandemic vaccine. The H7N1 vaccine was produced using the PER.C6® cell-based technology. This is an alternative production process that is expected to offer advantages over traditional manufacturing methods. The clinical trial in question is the first to assess the safety and ability to generate an immune response of a split, inactivated prototype pandemic H7N1 vaccine produced on cells.

[Source: Company Announcement]

Serono SA acquired by Merck KGaA

21 September – Merck KGaA announced that is has entered into an agreement with the Bertarelli Family, majority shareholders in Serono SA, to purchase their Serono shares. Assuming the deal is closed as expected, Merck will hold 64.5 per cent of the capital of Serono and 75.5 per cent of the voting rights. According to Michael Roemer, Chairman of the Executive Board of Merck, 'This acquisition transforms Merck's Pharmaceuticals business and creates a leading position in the world of biologic medicines.'

[Source: Company Announcement]

Xyzal® co-promotion agreement between Sanofi-Aventis and UCB

25 September – Sanofi-Aventis and UCB announced that they have entered into an agreement to co-promote Xyzal® in the United States. Xyzal® is a once-daily antihistamine indicated for symptomatic treatment of Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis and Chronic Idiopathic Urticaria in adults. Under the terms of the agreement, Sanofi-Aventis will make an upfront payment to UCB and milestone payments at certain stages in the development and commercialisation of the drug. Profits will be shared between the two companies.

[Source: Company Announcement]

BioTip: Ownership of inventions

Under Australian patent law, although any person or legal entity can apply for a patent, that person or entity is required to file a Notice of Entitlement before the patent application is accepted confirming how their title to the invention was derived from the inventor(s). Title to an invention can be derived in a number of ways, including contract of employment or by assignment. Determining ownership is not always straightforward, particularly where an inventor is employed by more than one employer or an inventor holds an academic appointment in one institution while being employed by another. Whatever the situation, it is imperative that the chain of title to the invention to the applicant is demonstrable.

Upcoming Allens event

Your invitation to AAR drinks during AusBiotech 2006

Are you attending AusBiotech 2006 in Sydney during November?

If so, why not take time out from the conference to come and meet AAR's Biotech team on Monday 20th November at 6.00 pm.

We invite you to join us for drinks at AAR's Sydney offices while enjoying spectacular views of Sydney Harbour.

For your invitation, all the details about our function and the RSVP date, see www.aar.com.au/pubs/bt/10oct06/invite.pdf (214KB PDF)

We hope to see you in Sydney!

Events

Information on the latest conferences

See conferences in: October | November

October

Australasian Clinical Research: Collaborating to do it Right
Monday 23 – Wednesday 25 October
Mercure Hotel
Brisbane, Australia

November

NEW BioBusiness Summit 2006
Thursday 9 – Friday 10 November
New Delhi, India
http://ficci.com

NEW NanoBiotech World Congress
Thursday 16 – Friday 17 November
Boston, United States

NEW AusBiotech 2006: Bridging Innovation and Investment
Sunday 19 – Wednesday 22 November
Sydney Convention & Exhibition Centre, NSW

For further information, please contact:

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