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Biotech News 10 August 2006

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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 Federal Government

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 the Australian Federal Government.

Researching the financial and related contributions that the Australian Federal Government seeks to make to the research and development (R&D) community reveals a vast number of grants, concessions, awards and the like.

This article provides an overview of some of these. Readers should note that this is only an overview provided to give an insight into the kinds of financial and related contributions that the Federal Government makes to the R&D community. It is by no means exhaustive. Allens Arthur Robinson encourages Biotech News readers to look into the kinds of government 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.

Australian Research Council Linkage Grants

The Australian Research Council (ARC) offers 'Linkage – Projects' grants to support R&D that involves risk or innovation. 'Linkage – Projects' support collaborative research projects between higher education researchers and industry. Also available under this scheme is Australian postgraduate awards industry, Australian post-doctoral fellowships industry and linkage industry fellowships. The amount of funding provided depends on the applicant's capacity to obtain the required industry partner(s) contributions.

Commercialising Emerging Technology

Commercialising Emerging Technology (COMET) helps customers commercialise innovation by raising capital from business angels or venture capital funds, borrowing money, licensing, and joint ventures or strategic alliances. COMET assistance is typically available for early-growth stage companies, spin-off companies, and individuals. COMET engages private sector business advisors across Australia to assist successful applicants to become ready for and to engage in commercial activities, also providing financial assistance.

Commercial Ready

This is a competitive merit–based grant program supporting small and medium enterprises. Commercial Ready aims to encourage the growth and successful innovation of Australian companies, increase the international competitiveness of Australian businesses, foster greater collaboration between industry and research institutions, and generate national benefit for the Australian economy. Grant payments are claimable for eligible expenditure incurred on or after the project commencement date, which cannot be before the date the commercial ready application is accepted by AusIndustry.

Cooperative Research Centres Program

The Cooperative Research Centres (CRC) program supports research partnerships between the public sector and the private sector. CRCs are intended to convert research results into commercial products and services or transfer new know-how into industry or other stakeholders.

Health and medical research – overhead infrastructure support

This is 'additional funding' to be used primarily to assist independent medical research institutes that are awarded National Health and Medical Research Council (NHMRC) research grants, with overhead infrastructure costs. This funding provides up to 20 cents for every dollar awarded for research to independent medical research institutes by the NHMRC. This funding is intended to assist institutes to meet costs, including providing facilities such as libraries, computing centres, animal houses and herbaria. The purchase, hire and maintenance of equipment, telecommunications, and salary and services for support staff can also be contributed to by the additional funding.

Innovation Investment Fund

The Innovation Investment Fund program (IIF) is designed to promote the commercialisation of Australian R&D, through the injection of venture capital into small, high-tech companies in their seed, start-up or early expansion stage. The contribution involves a fund manager providing equity financing and managerial advice to investee companies. In return for the provision of capital, the fund manager acquires a part-ownership of the company and usually a seat on the board of directors. At least nine innovation investment funds are currently active, with Allen & Buckeridge and Neo Technology Ventures specialising in innovation and communications technology, GBS and Startup being dedicated to the Bioscience sector, CM Capital combining information technology and life science expertise, and AMWIM, Foundation, Momentum and Nanyang having a general investment focus.

International science linkages

This funding is geared toward building linkages between Australian researchers and firms to access international science and technology. It supports high-quality collaborations between Australian scientists and international partners on leading-edge science and technology. To date, this program has supported almost 270 new research collaboration partnerships, 170 new strategic alliances between institutions, and 34 science and technology agreements with 21 countries.

National Collaborative Research Infrastructure Strategy

This funding is geared to provide researchers with major research facilities, supporting infrastructure and networks necessary for world-class research. It follows the major program of investments provided under Backing Australia's Ability through the Systemic Infrastructure Initiative (SII) and the major national research facilities (NNRF) program.

Pharmaceuticals Partnerships Program

This program (also known as P3) provides grants to companies to increase their pharmaceutical R&D in Australia. The program is running to 30 June 2009 with a third application round commencing in the second half of 2006. This round provides grants for up to two years (1 July 2007 to 30 June 2009). P3 grants are 30 per cent of the company's annual increase in eligible R&D expenditure above its base level of expenditure. The maximum grant that a company can receive is $10 million. Eligible pharmaceutical R&D activities include basic pharmaceutical research through to clinical trials needed for drug registration, as well as supporting activities that are directly related to the conduct of R&D activities.

Pre-Seed Fund (VC Funding)

This program encourages the private sector to take a more active role in funding and managing the commercialisation of research from universities and Australian government research agencies such as CSIRO, ANSTO and others. Alan & Buckeridge, GBS Venture Partners, SciVentures and Starfish Ventures have been selected to invest in projects or companies spinning out from universities or Australian government research agencies. GBS Venture Partners are specialising in life sciences, Alan & Buckeridge in information and communications technologies, and SciVentures and Starfish Ventures in a broad range of technologies. The managers will acquire an equity interest in each project or company, and will provide management and technical advice to develop the commercial potential of the technology. The maximum investment in any project or company is $1 million.

Eligible companies must be commercialising research and be controlled by, or be using intellectual property that is at least 50 per cent owned by, a university, a public sector research agency or qualifying researcher. They must be incorporated and operate substantially in Australia and must have not generated any sales revenue. Applications are made by approaching the fund managers directly.

Research Infrastructure Block Grants Program

This program helps higher education institutions meet the overhead costs they incur when carrying out research projects supported by the ARC, the NHMRC and other national competitive research granting agencies. The amount of Research Infrastructure Block Grant (RIBG) funding provided is set at 20¢ for each dollar of Australian competitive research grant income earned by institutions.

R&D tax offset (if public ownership less than 25 per cent)

This concession is an Australian Government initiative seeking to increase the level of R&D being conducted by Australian companies. It enables companies to deduct a certain percentage of eligible expenditure incurred on R&D activities from assessable income when lodging tax returns.

Export Market Development Grants

The purpose of the Export Market Development Grants (EMDG) is to encourage small and medium-sized Australian businesses to develop export markets. The grant reimburses up to 50 per cent of expenses incurred on eligible export promotional activities, less the first $15,000.

TradeStart

This is a national network of export assistance offices in partnership between Austrade and a range of local private and public sector organisations throughout Australia. Austrade and TradeStart offer a package of free services designed to assist small and medium-sized Australian companies to develop their businesses overseas and to make their first export sale.

Tradex

This is an Australian Government scheme providing up-front exemptions from customs duty and GST on imported goods that are intended for direct export or imported goods that are used, lost or wasted in the manufacture of other goods that are later exported. Normally, importers of goods destined for export later on would have to pay duty and GST at the time of import. Under Tradex, duty and GST are exempted up-front, potentially delivering significant cash flow advantages.

NHMRC grants, scholarships and awards

Careers Development Awards / Careers Awards

The NHMRC provides a vast array of career development awards including Clinical Career Development Awards, Health Career Development Awards and Partnership Career Development Awards, among many more.

Enabling grants

The enabling grants scheme is designed to underpin the current NHMRC funding system by strengthening the research base in particular areas. It is intended to assist Australian researchers, providing support for scientific facilities and/or activities to enhance the national health and medical research effort. The facilities and/or activities must have the full support of a relevant administering institution.

Equipment grants

NHMRC provides funding for equipment grants to support competitively funded medical research. The funding is allocated on a pro rata basis to administering institutions according to their share of the total funding awarded by the NHMRC for research in the applicable year.

Industry Fellowships

These Fellowships seek to foster closer interaction between Australian researchers and high technology industries. They target researchers with a track record of research excellence and commercial interest to spend up to two years in industry (in Australia or overseas), followed by two years at a research institution in Australia.

Program grants

These grants provide support for teams of researchers to pursue broadly based collaborative research activity. There is a high level of competition for the program grant funding and successful applicant teams have a very high record of achievement in research. Applicants must demonstrate to the peer review panel that they are capable of conducting research at an internationally competitively level.

Project grants

A project grant is a funding agreement with an eligible Australian institution to enable an individual researcher or a group of researchers to undertake a scientific investigation. Advertisements inviting applications for project grants support appear in the press and by electronic notification to Australian research institutions in December each year. There are several types of project grants available.

Scholarships

The scholarship scheme supports outstanding Australian health and medical graduates early in their career. There are a wide variety of scholarships including, the Medial and Dental Postgraduate Research Scholarships, the Pharmacy Guild Postgraduate Scholarship, Training Scholarships for Indigenous health research, among others.

Strategic awards

These awards support health and medical research in areas which have been identified as a priority and for which there is an unmet need for targeted funding. Strategic award types are varied and numerous including, the Ageing Well, Ageing Productively Program Grant, the Australian-European Union Health Research Grants, and the Diabetes Vaccine Development Centre Grant, among others.

Training (Post-Doctoral) Fellowships

These fellowships provide opportunities for Australian researchers to undertake research that is of major importance in its field and that will benefit Australian health. Categories of fellowship award are varied and include Australian Training Fellowship for Aboriginal and Torres Strait Islanders Health Research, Australian Clinical Research Fellowship, and Industry Fellowship and Travelling Award for Research Training, among others.

Company news

In brief: Regular news from the biotech industry.

Antisense granted patent in Japan

29 August – Antisense Therapeutics Ltd (ANP) announced that the Japanese Patent Office has granted a patent that protects the company's lead compound ATL1102 until 2019. This follows similar protection granted in the United States (US) and Australia. ANP has an exclusive license to ATL1102 from its collaboration partner Isis Pharmaceuticals Inc. in the US. ATL1102 is a second generation antisense inhibitor of integrin alpha-4 and is currently in phase-2 clinical trials as a treatment for multiples sclerosis (MS). The compound has also shown positive effects in a number of animal models of inflammatory disease including asthma. ATL1102 is also covered by other Isis Pharmaceuticals antisense technology and manufacturing patents and applications to which ANP has a world-wide license.

[Source: Company Announcement]

AtCor makes sale to US Pharmaceutical Company

31 August – ASX listed, AtCor Medical Holdings Ltd announced that it has completed an agreement with a United States (US) based pharmaceutical company to supply their SphygmoCor® systems for a US multi-centre clinical trial. SphygmoCor® is a system that measures central blood pressure non-invasively. The total value of the contract is US$1.48 million. According to Ross Harricks, chief executive officer of AtCor, 'This order is further evidence of growing pharmaceutical research sector adoption of central pressure data as a key to determining the true cardiovascular impact of new drugs.' The SphygmoCor® system has the potential to allow companies the ability to make better informed decisions earlier in the drug development process.

[Source: Company Announcement]

BioDiem join race to develop bird flu vaccine

30 August – Melbourne based pharmaceutical development company BioDiem Ltd announced that is has signed a cooperative research and development agreement with the United States Centres for Disease Control and Prevention (CDC) to develop a cell culture candidate vaccine against avian influenza H5N1. The co-operative research will generate, characterise and evaluate live attenuated cold-adapted influenza vaccine candidates against influenza A H5N1 viruses. This research is in line with the view of experts at the World Health Organisation who believe that a live vaccine may offer better and broader protection in the event of a pandemic outbreak. Further, a live attenuated influenza vaccine may also allow for a single dose of a smaller amount of vaccine to provide meaningful protection, compared with currently available inactivated vaccines which would mean more people could be vaccinated.

[Source: Company Announcement]

Biopharmaceutical production plant in Germany

29 August – Merck KGaA announced that it is planning a €190 million biopharmaceutical production plant at its headquarters in Darmstadt, Germany. The plant will be used to manufacture the latest generation of biologically active ingredients for the treatment of cancer. Initially the plant will mainly produce Erbitux®, a monoclonal antibody to which Merck acquired the rights to develop and Market outside the United States and Canada from ImClone Systems Inc. Erbitux® acts as a treatment for colorectal and head and neck cancer and is the company's top selling pharmaceutical product. Chairman of the Executive Board, Dr Michael Roemer indicated that Darmstadt was chosen as the site of this production plant due to the excellent infrastructure, highly qualified workforce, internationally acclaimed academic environment and central geographic location. Production is expected to commence in 2010.

[Source: Company Announcement]

ChemoCentryx and GSK enter into alliance

24 August – GlaxoSmithKline (GSK) and ChemoCentryx Inc. announced a worldwide strategic alliance to discover, develop and market novel medicines for the treatment of a variety of inflammatory disorders. The alliance which will be conducted through GSK's Centre of Excellence of External Drug Discovery (CEEDD), provides the company with access to one of the broadest pipelines of chemokine based therapeutics. The CEEDD's role is to formulate multiple risk/reward – sharing alliances. ChemoCentryx will receive an upfront payment of US$63.5 million. Further, assuming successful development and commercialisation ChemoCentryx stands to earn up to US$1.5 billion in milestone payments. ChemoCentryx will be responsible for the discovery and development of small molecule drug candidates targeting four specific chemokine and chemo-attractant receptor targets. GSK will have exclusive options to license each product for further development and commercialisation on a worldwide basis. The agreement includes Traficet-EN®, a drug candidate that is in the late stage of development for the treatment of inflammatory bowel disease.

[Source: Company Announcement]

CogState announces first agreement with Lundbeck

23 August – ASX listed, CogState announced that it has signed an agreement with Danish pharmaceutical company H. Lundbeck A/S for use of its cognitive testing services in a clinical trial. The total value of CogState's contracted future revenue exceeds A$2.3 million.

[Source: Company Announcement]

CyGenics acquires stake in DNAPro

1 September – Australian tissue banking and cell therapy company CyGenics Ltd announced that is has disposed of its wholly owned subsidiary, Cell Sciences Pty Ltd in exchange for a 20 per cent stake in DNAPro. DNAPro is a Malaysian company engaged in manufacturing and trading biopharmaceutical products including the hepatitis B, anti-cancer and anti-AIDS vaccines. CyGenics will have a representative on DNAPro's board and it is expected that this arrangement will provide the CyGenics group with enhanced access to the Malaysian healthcare market and enable cross-selling and licensing of DNAPro's products via CyGenics' international network.

[Source: Company Announcement]

European approval for Exjade®

30 August – The European Commission (EC) has granted approval for Exjade® as a new treatment to help patients with transfusional iron overload in all European Union (EU) member states. Exjade® is the only oral iron chelator to provide continuous chelation coverage with a single daily dose thereby overcoming the current cumbersome infusion via pump treatment. Iron chelation is often necessary to prevent potentially life-threatening complications of excess iron in patients who receive regular blood transfusions owing to diseases such as thalassemia and sickle cell anaemia.

[Source: Company Announcement]

GSK's relenza receives European approval

24 August – GlaxoSmithKline (GSK) announced that it has received approval from European Regulators in 15 EU countries for use of its anti-viral Relenza® in the prevention of influenza A and B in adults and children 5 years of age and above. Relenza® is already approved in Europe and the United States for the treatment of Influenza. According to David Stout, President Pharmaceutical Operations, 'This approval is a significant step forward as it provides the medical community in Europe with another option to prevent and treat seasonal influenza enabling governments to prepare for a potential flu pandemic.' GSK has committed over US$2 billion to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza®.

[Source: Company Announcement]

MediGene agree to acquire Avidex

30 August – Biotechnology company, MediGene AG announced that it has signed an agreement to acquire privately held biotechnology company Avidex Ltd. This acquisition enables MediGene to diversify and broaden its drug pipeline with several drug candidates to treat cancer and autoimmune disease. This includes the lead drug RhuDex® that is being developed as an oral disease modifying and anti-arthritic agent. Several drug candidates are expected to originate from the innovative monoclonal T cell receptor technology platform that Avidex part owns. The purchase price offered was approximately €50 million to be paid for in the form of MediGene shares. Avidex will remain in Oxford and will be operated as a subsidiary of MediGene. According to Dr Peter Heinrich, chief executive officer of MediGene this acquisition makes their portfolio 'one of the strongest among the European biotech companies.'

[Source: Company Announcement]

Pfizer wins Norvasc patent challenge

1 September – Pfizer announced that a United States (US) federal court has upheld the company's US patent covering amlodipine besylate, the active ingredient in Norvasc. Norvasc is the world's most prescribed branded medicine for treating hypertension and was challenged by generic manufacturer, Synthon Pharmaceuticals. The judge ruled that the patent was infringed by the generic manufacturer's product and prohibited Synthon from launching a generic version of amlodipine until September 2007.

[Source: Company Announcement]

Sanofi extend research collaboration with ImmunoGen

1 September – ImmunoGen Inc. announced that Sanofi-Aventis has exercised its right to extend the term of its research collaboration with them. ImmunoGen will receive committed research funding from Sanofi-Aventis until 31 August 2008, but are no longer obligated to present Sanofi-Aventis with new targets for antibody-based anticancer therapeutics. ImmunoGen is now free to use new targets it discovers to develop its own proprietary products. Following the completion of this collaborative agreement, Sanofi-Aventis will need to license the right to use ImmunoGen's maytansinoid TAP technology for antibody targets that were not part of the research collaboration.

[Source: Company Announcement]

Two avian influenza vaccine candidates finalised

24 August – ASX listed, Imugene Ltd has successfully completed laboratory development of two avian influenza (H5N1) vaccine candidates. The candidates are now ready for challenge trials in chickens to confirm efficacy. The vaccines utilise Imugene's Adenoviral Delivery Vector technology to deliver the necessary genetic material necessary to stimulate the immune system. The two vaccine candidates differ to meet commercial requirements. Broiler birds require immunity early in the bird's life, but the protection need only be short term given birds reach market weight by approximately 45 days of age. Whereas layer birds require longer lasting immunity. Accordingly the vaccine developed for layer birds uses two antigens to elicit both antibody and cell-mediated immunity. In contrast the broiler vaccine uses a single antigen. The vaccine candidates were developed using genetic material produced in Europe.

[Source: Company Announcement]

BioTip: Authorship versus inventorship

Inventorship on a patent application is not the same as authorship on a scientific paper. Inventors are persons who made an inventive contribution to the invention claimed in one or more claims in a patent/application. Although deciding who may have been an inventor can be difficult, particularly if a team has been involved with development, naming inventors correctly on a patent application is essential. In the United States, for example, a patent may be held invalid if inventors were named incorrectly on the application.

Events

Information on the latest conferences

See conferences in: September | October

September

BIO Japan
Wednesday 13 September – Friday 15 September
Osaka, Japan

ClubBio2006: 'Breaking the Barriers'
Thursday 21 September – Friday 22 September
Hyatt Regency Resort, Sanctuary Cove
Gold Coast, Queensland
http://www.ausbiotech.org

Mergers and Acquisitions in Biotechnology
Tuesday 12 September
Lion Hotel
North Adelaide, Australia
http://www.ausbiotech.org

An Introduction to Commercialisation
Friday 8 September
National Neurosciences Facility
Carlton South, Victoria
www.ausbiotech.org

Biomarkers Summit
Tuesday 26 – Wednesday 27 September
Prague, Czech Republi

October

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

For further information, please contact:

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