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Regular news within the Australian biotech industry.

Agenix appoints new Managing Director

11 December – Mr Mark Carnegie has resigned from the Board of Directors of Brisbane-based biotechnology company Agenix Ltd. Mr Carnegie had been a Director of Agenix since November 2000. Agenix's CEO, Mr Donald Home, took over the role of Managing Director, effective 12 December 2002. Mr Ravindran Govindan, Executive Chairman of Agenix, says 'Don Home's 14 years experience as a Senior Executive for Abbott Laboratories has been extremely valuable since joining Agenix in June 2001. This change will place greater responsibility on Don in driving Agenix's commercialisation'.

[Source: Company Announcement]

Australian Cancer Technology moves towards anti-cancer vaccine commercialisation

12 December – Following encouraging results from the Phase Ib/IIa clinical trial of anti-cancer vaccine Pentrix® at Sydney's St Vincent's Hospital, Australian Cancer Technology Ltd (AustCancer) is engaged with various parties evaluating the vaccine. AustCancer Managing Director Dr Alistair Cowden says the vaccine should be 'Deal ready' by early 2003. According to Dr Cowden, 'the response to the Pentrix® trial results from potential partners has been very encouraging. Our task now is to select the commercial option that will give Pentrix® the best possible chance of achieving its full potential and deliver the most value to AustCancer shareholders'.

[Source: Company Announcement]

Autogen completes first step toward NASDAQ listing

10 December – Australian biotechnology company Autogen Ltd has successfully completed its first step towards a NASDAQ listing, with its Level One American Depository Receipt programme declared effective by the US Securities and Exchange Commission. Autogen is now preparing to lodge a Form 20-F with the SEC as part of the ADR Level Two programme. The Level Two programme is a US listing with US GAAP and full SEC compliance, which enables the Autogen ADRs to be traded on the Small Cap NASDAQ market. The New York-based President of Global Markets capital Corporation, Mr Mark Saunders, says 'Autogen's research programmes, including its work in the areas of obesity and diabetes, coupled with its existing collaborations with US and European institutions, will stand it in good stead in the US market'.

[Source: Company Announcement]

Benitec to collaborate with Garvan Institute on diabetes

12 December – Benitec will collaborate with Sydney's Garvan Institute of Medical Research to investigate the role of specific genes in Type II diabetes. The project will involve Benitec's proprietary gene silencing (RNAi) technology. The aim of the research is to determine the function of specific genes and their role in glucose metabolism and insulin action. The company hopes the project could identify new gene and gene product targets for the development of drugs for Type II diabetes. The company will provide specially designed DNA constructs which will target and silence suspected diabetes genes identified by the Garvan Institute. The collaboration agreement grants Benitec commercial rights to any new intellectual property arising out of the collaboration. The agreement also allows Benitec to develop gene silencing or RNAi-based therapies for the gene targets.

[Source: Company Announcement]

Bionomics and University of Melbourne publish key epilepsy research

3 December – A study into a gene which causes epilepsy conducted by scientists from Adelaide-based biotechnology company Bionomics Ltd and The University of Melbourne is now complete. The results, which have been published in the US science journal, Proceedings of the National Academy of Science, validate an essential part of Bionomics' discovery platform, ionXTM. The study found fundamental molecular deficits in epilepsy patients. Research team leader Dr Steve Petrou says the study will lead to a better understanding of the causes of epilepsy and clears the way for the discovery of new classes of epilepsy drugs. According to Bionomics' CEO Dr Deborah Rathjen, 30 per cent of epilepsy sufferers do not respond to existing drug treatments.

[Source: Company Announcement]

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Bresagen happy with proposed export ban

5 & 11 December – Bresagen Ltd has welcomed the Senate's passing of the Research Involving Human Embryos and Prohibition of Human Cloning bills (see Government News). However, the company was initially concerned that Senator Boswell's moves to ban the export of stem cell lines and stem cell products via changes to the customs regulations could prevent Australian researchers from playing a leading role in this scientific area. Bresagen is a leader in stem cell research and has already developed four research embryonic stem cell lines in the US, registered with the National Institute of Health. Bresagen's Vice President, Clinical Development, Dr Chris Juttner, said 'Bresagen is ready to develop therapeutic stem cell lines in Australia and we have developed relationships with IVF clinics to do this. But an export ban could make this work worthless.' However, Bresagen has now been informed by the National Health and Medical Research Council that the export of embryonic stem cells or the products of embryonic stem cells will not be prohibited. The regulatory changes will prevent the export of whole embryos. Bresagen says these changes will not hamper the development of embryonic stem cell based therapies in Australia for export.

[Source: Company Announcements]

Comquest pays University of Queensland A$1m from research commercialisation

6 December – Comquest Pty Ltd has paid the University of Queensland A$1m from the commercialisation of technology developed at UQ's Centre for Magnetic Resonance. Comquest, formed in 1991, has been responsible for overseeing marketing and commercial activities flowing from a A$5.2m research programme to develop magnetic resonance at the CMR. This is Comquests' second payment, UQ having received A$1.5m in February 2001.

[Source – University of Queensland Media Release]

CSL's Swiss subsidiary wins US FDA review of 12 per cent liquid IVIG

10 December – The US Food and Drug Administration has accepted for review ZLB Bioplasma AG's supplemental biologics licence application for a 12 per cent liquid formulation of Immune Globulin Intravenous (Human) (INVIG). ZLB is the fully-owned Swiss subsidiary of Australian-based CSL Ltd, acquired by that company from the Swiss Red Cross in 2000. The news follows the FDA's recent acceptance for review of ZLB's Rh(D) Immune Globulin. CSL expects both products to be available to US patients by 2004, subject to favourable review by the FDA. The company emphasises, however, that licences are yet to be issued.

[Source – Company Announcement]

Global Health to collect and transmit information about adverse drug events

9 December – The Health Solutions Division of Working Systems Solutions Ltd, Global Health, has closed an agreement to trial the secure collection, transmission and notification of suspected adverse drug events to the Therapeutic Goods Association via the Internet. Handwritten, voluntary notifications from GPs documenting suspected adverse drug events have already been collected by the TGA for more than 28 years. The Adverse Drug Reaction project was developed by the University of Ballarat's Collaborative Centre for eHealth. Global Health had previously been selected by the CCeH to trial the secure ordering and receipt of pathology results across the Internet, which should go live later this month.

[Source – Company Announcement]

Gradipore wins US Gradiflow patent

4 December – Gradipore has been granted a new US patent for its breakthrough separations platform, Gradiflow, which covers the removal of biological contaminants such as viruses and bacteria. Gradiflow purifies proteins and removes viral and bacterial pathogens simultaneously, which will enable pharmaceutical manufacturers to reap the economic benefits of fast, high-yielding manufacturing processes, reduced processing costs, and improved product safety and quality. Global CEO and Vice Chairman of Gradipore, Mr Robert Lieb, says: 'Securing this patent is a significant event because it paves the way for the commercial licensing of the Gradiflow technology for viral removal applications'. It also strengthens Gradipore's IP relating to the removal of prions associated with Creutzfeldt-Jakob disease.

[Source – Company Announcement]

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Medica subsidiary, Cytopia, reports encouraging data from prostate cancer treatment trials

12 December – Melbourne-based drug discovery company Cytopia Pty Ltd, a 79 per cent owned subsidiary of Medica Holdings Ltd, has announced promising data from initial animal trials of a treatment for late-stage prostate cancer. After only two weeks of treatment, preliminary data shows reductions in tumour size of up to 50 per cent relative to untreated control animals. Cytopia's CEO Dr Kevin Healy says the company has lodged three new patent applications 'to protect the novel molecules that have shown this encouraging proof of efficacy against the advance (hormone-refractory) stage of prostate cancer'.

[Source – Company Announcement]

Novogen subsidiary, Marshall Edwards, starts Phase II phenoxodiol trial

10 December – Marshall Edwards Inc, a subsidiary of Novogen Ltd, will start a Phase II clinical trial of its novel anti-cancer drug, phenoxodiol, in women with recurrent ovarian and fallopian cancers. The trial will be conducted at the Yale University School of Medicine and will initially involve about 40 women for whom chemotherapy has already proved unsuccessful. The trial will evaluate the ability of phenoxodiol to halt tumour growth or to shrink tumours.

[Source – Company Announcement]

Panbio releases new glandular fever test

13 December – Panbio Ltd has released a new glandular fever test, based on a patented peptide. Panbio gained approval to sell its glandular fever test in the US earlier this year. The new test offers improved differentiation of past infection. The company plans to continue developing its range of tests for the Epstein-Barr virus, which causes glandular fever. Panbio Vice President Strategic Marketing, Mr Nick Thliveris, says 'the release of the new test strengthens Panbio's push into the broader domestic and international diagnostics market'.

[Source – Company Announcement]

Polartechnics lists SolarScan® with FDA

4 December – Polartechnics has listed SolarScan® as a Class 1 device (lowest risk level) with the US FDA ahead of schedule. The listing will allow the company to market SolarScan® in the US and will position SolarScan® as an instrument capable of monitoring images of suspicious pigment skin lesions and providing melanoma diagnostic assistance to doctors. The company expects to enter the US market in 2003.

[Source – Company Announcement]

Proteome Systems to collaborate with Nestlé

13 December – BioTech Capital Ltd has announced that its portfolio company Proteome Systems will conduct collaborative research with the Swiss Nestlé group to study sugars attached to proteins found in milk. BioTech Capital says the agreement validates the group's expertise and technology platforms related to the study of proteins and how sugars modify their behaviour.

[Source: Company Announcement]

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Psiron exercises Vapotronics option following resignation of Chairman; signs drug delivery agreement with Canon for Vapotronics IP

11 & 17 December – Psiron Ltd has exercised its call option to acquire 70 million ordinary shares in Vapotronics from Mr Vogas, who has resigned from the Board of Vapotronics. This represents just under 40 per cent of the outstanding capital. Psiron's Chairman, Mr Stephen Jones, has replaced Mr Vogas as Chairman of Vapotronics.

In a separate announcement, the company indicates it has entered into a major biotech deal with Canon Inc of Japan, with the signing of a memorandum of understanding. Under the agreement, Canon is to be granted an exclusive, worldwide licence over Vapotronics IP over inhaled drug delivery. Psiron recently acquired a majority holding in Vapotronics. Terms of the agreement include a US$1m fee upfront and royalties of 0.5 per cent on all device sales. Additionally, Psiron will receive 10 per cent of the royalties Canon receives from pharmaceutical companies. Final agreements are expected to be executed by April next year.

[Source: Company Announcement]

Sirtex's SIR-Spheres® enter Europe; wins European patent

9 & 10 December – Sirtex Medical Ltd's SIR-Spheres® have been used in Europe for the first time. A patient with advanced secondary liver cancer was treated recently at the Leicester General Hospital, a principal treating hospital for the University of Leicester. The news follows regulatory approval in October 2002 for Sirtex to market the product in the European Union. The company is rolling out its technology throughout Europe, targeting the UK, France, Germany and Belgium.

In a separate announcement, the company indicates it has been granted a European patent entitled 'Controlled Release Preparation', relating to the company's controlled release microspheres, which are used to direct particular chemotherapy drugs to cancers.

[Source – Company Announcement]

Solbec Pharmaceuticals completes human mesothelioma cell lines study

10 December – Solbec Pharmaceuticals Ltd has announced the completion of its review of the effect of SBP002 on an expanded range of human mesothelioma cells. The study was conducted by the Department of Medicine at the University of Western Australia. The first part of the study investigated the effect of SBP002 on five human mesothelioma cell lines. Next, SBP002 was compared with current treatments for mesothelioma. The third part of the study is currently confidential because it is the subject of a new patent application. The study confirms that SBP002 is effective against all five human mesothelioma cell lines tested. It is more effective at killing the mesothelioma cells than gemcitabine and docetaxel, which are therapeutic compounds currently used to treat mesothelioma.

[Source – Company Announcement]

Virax opens new Vector Construction Unit

12 December – Virax Holdings Ltd has opened a new Vector Construction Unit at the School of Biomedical Sciences at Monash University. Virax CEO, Dr David Beames, says: 'By establishing a VCU we now have greater control of the process for new product development'. Dr Beames says vectors are a fundamental component of Virax's immune-based therapies and the ability to produce them will enable the company to expand its product pipeline more quickly. Virax previously outsourced vector construction.

[Source – Company Announcement]