 |
| About Bioline | All Journals | Testimonials | Membership | News |
|
||||||
|
||||||
Australasian Biotechnology, Vol. 10 No. 1, 2000, pp. 10-15 BIOTECH BUSINESS Code Number: au00006
Horticulture biotechnology firm, Florigene, is being acquired by agricultural chemicals company, Nufarm, which recently changed its name from Fernz. Nufarm, which is listed on the ASX, will pay about $2 million for a 90.1% holding in Florigene, following the recent approval of the deal by Florigene shareholders. Florigene, which is launching new versions of its blue carnation in Japan and the US, has spent approximately $45 million on R&D since 1985. The investment arm of the Melbourne-based Pratt Group, Thorney Holdings, is purchasing an 8% holding in the listed biotechnology investment company, Medica Holdings Ltd. The acquisition is part of a $4.5m rights issue to raise funds for accelerated research and further biotechnology investments by Medica. Thorney Holdings is taking up two million shares and one million options in Medica to acquire approximately 8% of the company, in conjunction with a renounceable pro-rata rights issue to existing Medica shareholder. Medica's Managing Director, Dr Kevin Healey, said the funds raised would enable Medica to accelerate its anti-inflammatory drug discovery program at Cytopia Pty Ltd, of which it owns 85%, and to make an additional three or so investments this year. Medica has also recently completed the acquisition of an initial 31% holding in Brisbane-based Xenome, investing up to $2 million over the next 18 months. Medica plans to increase its ownership to 50% by the end of the year. Pharmaceutical R&D firm, Biota Holdings, has announced its first profit, recording a net income of $4.5 million on revenues of $8.9 million for the half year to December. This compares with a loss of $3.3 million for the same period last year. Total revenues for the half year included royalty revenues of $2.8 million, licensing revenues of $4.7 million, interest income of $1.1 million, and a START grant of $139,000. R&D expenses totalled $4.1 million as compared to $3.8 million for the same period in 1998. A significant part of the income for the period was derived from a milestone payment from Glaxo Wellcome of $3.4 million following the US FDA approval of Relenza and a signing fee of $1.1 million from Daiichi Pure Chemical Co. Ltd, Biota's distributor of Flu OIA in Japan. Biota is due to receive an advance royalty payment from Glaxo Wellcome of approximately $4 million in the second half of the fiscal year. Biota's R&D expenditures are expected to increase in the second half of the year mainly due to the increased level of research expenditure relating to BTA 188, the Company's project in development for the treatment of rhinovirus (common cold). Other projects under way include the development of a treatment for Respiratory Syncytial Virus (RSV) and second generation influenza therapies. However CEO, Dr Hugh Niall, said that the company still expected to record a profit for the full year. Biota is now concentrating on viral respiratory diseases and either licensing out or terminating non-core projects. Work on a potential treatment for diabetes and an anti-cancer therapy conducted in collaboration with CSIRO will be continued by CSIRO subject to approval by the Boards of Biota, CSIRO and the IR&D Board, and there have been early stage discussions with a potential commercial partner. In addition, Biota and the Howard Florey Institute have agreed on a plan to develop and commercialise their joint Alzheimer's project. Biota will phase out its direct financial support of the project but will assist the Florey Institute in identifying a commercial partner and will receive a royalty based on sales of any drug arising from the project. Pharmaceutical company, Novogen Limited, has announced an operating loss for the half year to December 31 of $5.63 million, a 23% improvement on the $7.53 million loss for the corresponding period in 1998. Managing Director, Christopher Naughton, attributed the reduced loss to the fact that Novogen had now established an international support and marketing infrastructure to manage the rollout of its products. Sales revenues for the period increased 37% to $12.36 million. LISTING TO SUPPORT ALZHEIMER'S DRUG Biotechnology company, Prana Biotechnology, is planning to list on the ASX and raise $8m in funds through a public offer. The funds raised will be used primarily to accelerate the development of therapeutics forage-related diseases, particularly Alzheimer's disease. The technology which Prana is developing for both the diagnosis and treatment of Alzheimer's disease has emerged from research conducted at the Massachusetts General Hospital, the University of Melbourne, the Mental Health Research Institute of Victoria and the Biomolecular Research Institute. The scientific principles underlying the technology have applications for developing treatments for a number of other diseases including Prion diseases (Creutzfeldt-Jakob disease or Mad Cow disease), Parkinson's disease, Amyotorophic Lateral Sclerosis (Motor Neuron disease), Cataracts and Tardive Dyskinesia. The Executive Director of Prana Biotechnology is Professor Colin Masters, Professor and Head of the Department of Pathology at the University of Melbourne and Chief of Neuropathology, and Director of Research Laboratories at the Mental Health Research Institute of Victoria. Progen Industries Limited has announced an $11 million fund raising through the issue of shares to institutional investors. Proceeds from the placement will be used to further the development of the company's anti-cancer drug PI-88, an angiogenesis (blood vessel growth) and metastasis (cancer spread) inhibitor, and continued expansion of Progen's product research pipeline. The Phase 1b trial of PI-88 in cancer is under way and the company is planning Phase II trials. Newly listed Adelaide-based biotechnology company, BresaGen Limited, has reported a loss of $1.15 million to the half year to December, its first six months as a listed company. Half-year revenue from sales of its human growth hormone and veterinary product, EquiGen Injection, exceeded the prospectus forecasts of $500,000 for the full year, with revenues for the first six months amounting to $580,000. Total revenues for the company in the six month period were $1,441,000. Amongst the developments for Bresagen over the past six months are acquisition of intellectual property from the University of Adelaide in the field of cell therapy; a contract with Nextran Inc to carry out further work aimed at cloning pigs as part of the development of xeno-organs for human transplantation purposes; and continuation of Phase I clinical trials of the anti-cancer drug E21R. Biological separations company, Gradipore Limited, has reported a $3 million loss for the half year. The company has attributed the result primarily to increased spending on research and development in the Gradiflow and Medical Applications Divisions, together with start-up costs associated with the launch of Gradipore's precast electrophoresis gel range, GradiGels, over the internet. Gradipore reported sales of $3.97 million for the half year, compared with $2.9 million for the same period in 1998. Sales in both the Haemostasis and GradiGels divisions of the company are expected to grow in the next half following granting of clearance by the US Food and Drug Administration (FDA) to market the GradiLeiden V product in the USA, and the international launch of GradiGels over the internet. Gradipore expects the Gradiflow division to record small sales of the Babyflow instrument in this financial year, with increased sales following from the international launch in FY2001. Earlier this year, Gradipore raised $13.27 million from investors including institutions at $5.90 per share. The company's shares have since surged to close to $10 on rumours that a major agreement is to be signed with a large US medical care company. Adelaide-based gene research company, Bionomics Limited, listed on the Australian Stock Exchange in mid-December, after raising $7 million at 40 cents a share in the initial offering. Bionomics will initially be developing research that emanates from the laboratory of Professor Grant Sutherland at the Women's and Children's Hospital in Adelaide and from work led by Professor Sam Berkovic at the University of Melbourne. The Women's and Children's Hospital, The University of Melbourne and the Institute of Medical and Veterinary Science in Adelaide are being contracted to undertake the R&D work, with the aim of identifying and mapping genes which could play a key role in the treatment of epilepsy and breast cancer. Mr Ainsworth said the Bionomics team was enthusiastic about the challenge of adding substantial shareholder value and further developing the company's leading edge genetic research into both diseases. "The success of the offering gives us the capital to roll out our operations strategy to fund increased research work under licence and service agreements including funding additional scientists and establishing laboratory infrastructure," he said. Bionomics reported a net loss of $0.36 million in the half year to December on zero sales. AMRAD SELLS DRUG DISCOVERY BUSINESS AMRAD Corporation Ltd has sold its its wholly owned subsidiary AMRAD Discovery Technologies (ADT) to ExGenix Ltd, a company established for the purpose by a group of Australian based investors led by Rothschild Bioscience Unit (Australia). Under the terms of the sale AMRAD will receive $4m in cash, a convertible note of $4m and 5 million shares (about 23.8% equity) in the new company. In addition, AMRAD holds 1.2m options in ExGenix Ltd. ExGenix will continue ADT's work of discovering potential sources of pharmaceutically-active compounds from the biota of selected parts of Australia and South East Asian Regions. ADT interfaces with two key Australian genomics centres: The Cooperative Research Centre (CRC) for Discovery of Genes for Common Human Diseases, and the Genetic Epidemiology Unit within the Menzies Centre for Population Health Research in Tasmania. ADT is the commercialising partner in the CRC and has first right to all research outcomes from the Centre. In other news, AMRAD has announced an agreement with DevCo, a United Kingdom based virtual pharmaceutical company focusing on neuroscience, to develop one of AMRAD's lead drug discovery compounds, AM36, as a potential treatment for stroke patients. AM36 is a novel compound with combined antioxidant and neuronal sodium channel blocking actions that emerged from a four-year AMRAD-funded program with the Departments of Pharmacology and Chemistry, Monash University. Under the terms of the agreement DevCo will design, carry out and fund the development program up to and including proof of principle Phase II studies in patients. On completion of Phase II studies, AMRAD has the right of first refusal to either buy back worldwide rights or to share in commercial proceeds generated by DevCo. AMRAD has retained the right to market the drug in Australia and New Zealand. A recent study published in the prestigious international journal Stroke found AM36 protects against death of neurones in the brain and motor function impairment, even when administered up to three hours after the onset of the stroke event. AMRAD has also recently announced that it has obtained clearance from the Therapeutic Drugs Administration to commence clinical trials with two of its compounds - AM336 for treatment of uncontrollable severe pain and AM365 for treatment of Hepatitis B virus infection. GENE SHEARS FIGHTS OFF PATENT CHALLENGE Gene Shears Pty Ltd has successfully fought off a patent opposition in Europe by Ribozyme Pharmaceuticals, a NASDAQ-listed biotechnology firm, securing European patent coverage of its proprietary hammerhead ribozyme technology. Under European patent laws, patents are subject to a review period during which an opposing party may challenge the granted patent on a variety of grounds. Patent application for the Gene Shears technology was originally filed by CSIRO in 1987. Gene Shears is now owned by CSIRO and the French seed firm, Groupe Limagrain Pacific Pty Ltd, and is licensed to Groupe Limagrain Holding and Johnson & Johnson Research Pty Ltd. The technology is currently in phase 1 clinical trials in Australia and the US as a potential gene therapy for HIV, and research is well advanced by Groupe Limagrain into applications of ribozymes in the agricultural and food industries. The Cooperative Research Centre for Vaccine Technology (CRC-VT) has reached an agreement with CSL Limited, Australia's largest pharmaceutical company, to expand the effort to develop a vaccine to prevent infectious mononucleosis - the debilitating disease known to many as glandular fever. According to the Director of the CRC-VT, Professor Michael Good "The agreement with CSL Limited is important because it significantly increases our chances of making an effective EBV vaccine. It means that Australia will be set to benefit from he commercialisation of the CRC's intellectual property," he said. "This news comes at an important time for our Centre, a transition period in which we can confidently look to the future, with the support and commitment of the Commonwealth Government. We have been successful in our application for a further seven years of funding from the Commonwealth. This means we can promise a further seven years of vaccine research, based in Queensland," said Professor Good. A group of senior managers of Biotech Australia and other investors has formed an investment company, Human Therapeutics Ltd, which has bought out Biotech Australia Pty Ltd from its parent company, Hoechst Australia Ltd. NEW R&D PROJECT FOR AQUACAROTENE AquaCarotene Ltd is establishing an R&D project to investigate a possible treatment for prostate cancer based on a natural anti-cancer agent, lycopene, extracted from AquaCarotene's Dunaliella Salina marine algae. The project will also explore creating and extracting natural essential neutraceuticals from Dunaliella Salina for application in aquaculture feeds used for salmon, trout and prawn farms. Aquacarotene Limited has set up a subsidiary, Natural BetaCarotene (Australia) Pty Ltd (NBA) to act as the operational manager of the R&D project, which will be undertaken as a joint venture with research company, AgGene Australia Ltd. Aquacarotene Ltd listed on the Australian Stock Exchange in January this year. AquaCarotene is currently in negotiations with a Chinese corporation which has expressed strong interest in AquaCarotene's product in regards to possible product supply arrangements, . Members of the Chinese company visited Western Australia in late 1999, to inspect AquaCarotene's operations, and to engage in further negotiations. Further information on the web at www.aquacarotene.com AMRAD has announced an agreement with Ares-Serono, one of the world's leading biotechnology companies, with a view to developing a novel treatment for infertility. Under the terms of the agreement, AMRAD has licensed to Ares-Serono certain patent rights and technology pertaining to recombinant LIF (Leukaemia Inhibitory Factor). Ares-Serono is initiating development of LIF in the field of reproductive health and will be supplied by AMRAD with pharmaceutical grade LIF. AMRAD is presently developing the same protein for neuromuscular diseases under the name AM424. A growing body of experimental and clinical data suggests a possible role of LIF in the process of embryo implantation. "The causes of female infertility are multiple and in many cases difficult to ascertain," said Dr. Silvano Fumero, Senior Executive Vice President, Research & Pharmaceutical Development at Ares-Serono. "Embryo implantation is one of the major causes of pregnancy failure. Addressing embryo implantation by the administration of an exogenous agent is a novel approach in assisted reproductive technology (ART)". John Grace, Managing Director of AMRAD, said that AMRAD was excited about working with Ares-Serono, the world leader in the treatment of infertility. Ares-Serono has made an undisclosed payment to AMRAD. Total payments of up to US$16 million will be due based on the achievement of certain development milestones and Ares-Serono will pay royalties to AMRAD based on eventual sales of LIF pharmaceutical products. Ares-Serono is a leading biotechnology company, headquartered in Geneva. Its 1999 sales totalled US$1.054 billion. AMRAD is developing AM424 for diseases of nerves and muscles, and is currently conducting a Phase II clinical trial in Australia. LIF was originally discovered at the Walter and Eliza Hall Research Institute based in Melbourne. New Zealand biotechnology company, Genesis Research & Development, has announced that its psoriasis vaccine, PVAC(tm), had passed a major milestone. Genesis and its development partner Corixa Corporation (NASDAQ: CRXA), a US vaccine-based biotechnology company, has received clearance from the US Food and Drug Administration (FDA) to initiate Phase II clinical trials to further study PVAC treatment of patients with moderate to severe psoriasis. Psoriasis affects up to 100 million people worldwide. PVAC, a derivative of Mycobacterium vaccae (M. vaccae), is an immunomodulatory product for treatment of psoriasis. It will be produced for the US IND (Investigational New Drug application) studies at Corixa's facility in Hamilton, Montana. Genesis and Corixa will conduct three random, placebo-controlled studies in the United States, Brazil and the Philippines. "This is an extremely important milestone, both for Genesis as a company, and in the development of PVAC as a novel therapeutic for managing psoriasis," says Dr Jim Watson, Chief Executive of Genesis. "What's exciting for Genesis is that we have now taken PVAC, a discovery we made ourselves and developed in collaboration with Corixa, over a considerable hurdle in the world's most stringent regulatory process. Getting approval to begin Phase II trials represents the culmination of five years laboratory and clinical work and six months of regulatory processes." To undertake this process with a discovery that we made ourselves is unusual - often companies purchase the original intellectual property that they take through the testing cycle. The success to date of our partnership with Corixa demonstrates the commercial potential of Genesis' discovery and partnership-based approach to building and retaining a portfolio of intellectual property." Psoriasis is characterised by chronic inflammatory lesions with red, scaling plaques, and is believed to be caused by immune attacks from the body's own T-cells. The disease affects an estimated one to three per cent of the world's population. There are approximately five million people in the US with psoriasis, with an estimated 30 per cent having a moderate to severe form of the disease. In August 1999, Genesis announced that Japanese pharmaceutical company Zenyaku Kogyo has agreed to purchase limited rights to PVAC, for multi-year license, research and development in Japan. Genesis and Corixa retain exclusive rights for the rest of the world. Zenyaku Kogyo was the first party outside of the development partners to make a commitment to PVAC on the strength of its commercial potential. Australian plant biotechnology and horticultural company, Technico, will invest $5.2 million in establishing a production facility for its advanced seed potato technology. The technituber plant will produce seeds for China's potato growers who annually produce 44 million tonnes of potatoes. The technology permits the rapid multiplication of miniature seed potatoes. Similar facilities have been established by Technico in Australia, the US and Mexico. Technico's Managing Director, David McDonald, said that the China facility would have the ability to produce 10 million seeds a year, and already contracts are in place for half this quantity. Technico is also completing a similar seed facility in India. It has formed a close relationship with the Pepsico snack food division, Frito Lay. Technico won the 1998 Australian technology award for excellence in the development of agri-biotechnology. FLINDERS LICENSES DNA SAMPLING TECHNOLOGY Flinders Technologies Pty Ltd, the technology commercialisation arm of Flinders University, has signed a deal with Whatman plc covering the commercialisation and marketing of the FTA processing system for DNA invented by Associate Professor Leigh Burgoyne of Flinders University. The FTA system is based on a solid matrix for safely and conveniently handling DNA samples rather than working with DNA in solution. This enables more efficient collection, transportation, storage and processing of samples for DNA analysis. FTA sample collection cards kill dangerous microorganisms that could be in blood, and 800 DNA samples a day can be processed automatically, compared with a handful using traditional methods. FTA has broad applications in research, diagnostics, environmental science, forensics and DNA data-base markets. The Australian Institute of Marine Science has signed an agreement with Australian company, Sunscreen Technologies Pty Ltd, to develop a sunscreen based on a molecule derived from coral. The sunscreen, codenamed 855, is structurally unlike compounds in current use. It has shown high efficiency in absorbing and dissipating UV radiation in the UV-B region of the spectrum. Tests to date show the compound has low allergenic activity, and can be synthetically produced. Under the terms of the commercialisation deed, STPL will provide up to several million dollars in venture capital to secure a global industrial partner from the pharmaceutical industry to help complete the development and regulatory approval of the sunscreen's use and bring the compound into full-scale production. AIMS has licensed the worldwide rights to use the patented sunscreen to STPL. STPL is an Australian technology company backed by investment funds from HIH Insurance, one of Australia's largest general insurers, and a small group of investors led by Stephen Gellert. Sunscreen 855 (as well as its manufacture and use) is a fully protected invention following a lengthy patenting process. After 10 years of development, the international patent was issued last November. Food Science Australia is undertaking a collaborative research project with US food technology firm, Flow International Corporation, to explore the use of ultra high-pressure (UHP) as an alternative to heat-treatment (pasteurisation) or chemical preservatives, with the aim of creating foods which retain their fresh characteristics but have the shelf-life of a processed food. Project leader, Dr Martin Cole, said traditional methods of a food preservation such as pasteurisation and use of chemical preservatives tended to alter qualities of food such as colour, flavour and nutrition value. High-pressure technology involves placing the food in a water medium and subjecting it to pressures of 100 to 800 megaPascals, killing the food-poisoning microbes as well as bacteria that cause the spoilage of food. "The beauty of this technique is that, because food contains water, which is relatively incompressible, it causes minimal damage to actual food itself - only the bugs. The result is a food which retains most of the features of fresh produce, but keeps longer and is safe to eat." Dr Cole said. Initially, the work will focus on using pressure as a way to treat acidic foods like jams, fruit juices and sauces, as well as refrigerated products such as meats and seafood, because these are easily preserved using pressure techniques. Later, Dr Cole says, the team plans to explore the use of pressure to replace sterilisation or canning of foods such as fruits and vegetables. There are several challenges to overcome. Some enzymes which cause foods to spoil are very resistant to pressure, and the presence of oxygen residues in the food can also lead to spoilage. As a result it may be necessary to combine pressure with other techniques, such as cool storage and hygienic packaging to attain the best results. Food Science Australia will conduct the research using a UHP unit manufactured by Flow International, which will be the first of its kind in Australia. The UHP unit will allow Food Science Australia to work with companies in Australia to evaluate the potential of this new technology to their businesses. Flow International Corporation has 41 ultrahigh-pressure units in operation or on order. Currently, they are being used by food companies in the United States, Japan and Europe to produce seafood, meat, fruit and juice products. Listed biomedical company, Autogen, has invested an estimated $600,000 to purchase a gene-screening technology that has the ability to measure more than 30,000 genes at a time. Autogen's R&D director, Professor Greg Collier, said that the company would be able to accelerate its work in the obesity and diabetes field because of the new equipment. The equipment will be housed at Deakin University's microarray laboratory at Geelong where about 40 people are working on Autogen projects. PEPTECH AND BIOTECH AGREE TO MERGE Sydney-based biotechnology firm, Peptech Ltd, and Biotech International have reached agreement on a $64 million deal to merge the two companies. The merger is to be accomplished by an offer by Peptech of 8.75 new Peptech shares for every 10 Biotech shares. The Executive chairman of Peptech, Michael Cohen, said that the aim of the takeover is to build an Australian biotechnology company of significant size. Peptech has reported a net loss for the year ending September 30 of $874,000, compared with a net loss of $25.1 million in 1998. Biotech chairman, David Fawcett, has announced plans to retire on completion of the merger with Peptech. Biotech International Limited has reported sales of $11.24 million for the first half of the financial year, up 41% on last year's first half sales. Profit for the half year, before amortisation of brand names, was $0.86 million compared with $0.21 million for the previous corresponding period. Operating profit for the half year after amortisation was $0.593 million. The balance sheet at 31 December showed $7.546 million of borrowings including $4.773 million attributable to the pharmaceutical business and net group debt of $6.2 million. Biotech International also announced last month that it had increased its holding in Lozenge Pty Ltd, the parent company of Biotech Pharmaceuticals Pty Ltd (BPL), to 60.5 per cent. Following the merger of BII's pharmaceutical operations with BPL in July 1999, BII held 47% of the stock in BPL's parent company. BPL manufactures a range of pharmaceutical and neutraceutical products and provides contract development, testing and manufacturing services to the human and veterinary health care community. In another investment, Biotech International has increased its holding in Biopool International Inc from 7.41% to 7.77%. Biopool International develops, manufactures and markets test kits used to assess blood clotting and bleeding disorders, evaluate various risk factors for developing cardiovascular disease, as well as controls used to monitor and measure the presence of drugs of abuse. The combined group will hold a portfolio of technologies, including patented drug release technology for reproduction and behaviour control in companion animals, and for the treatment of human sex hormone-dependent diseases, especially prostate cancer; diagnostics based on technology relating to clotting diseases and chronic inflammatory conditions; patented monoclonal antibodies for the diagnosis of Tumour Necrosis Factor; antibodies for the diagnosis of inflammatory prostate disorders; patented chemicals for tissue fixation for research and diagnostic applications; a patented monoclonal antibody being developed for use in detecting blood clots; and a range of patented natural compounds with potential use in nutraceutical and cosmaceutical applications. As at 10 March, Peptech was entitled to just over 19 million shares, equivalent to about 17.5% of Biotech's 115 million shares. The offer has been extended to 31 March. Following the recent acquisition of AMRAD Biotech by Chemicon International Inc for $14 million, the new business will now operate under the name of Silenus Labs Pty Ltd. The sale is part of AMRAD's strategy to rationalise the business so as to focus on the pharmaceutical R&D business, including the development of three lead products. Under the sale agreement, Chemicon will purchase the assets of the AMRAD Biotech business including: plant and equipment, trademarks, patented technology, licences and agency agreements and assume related liabilities. Silenus will incorporate the range of biotechnology and life science products formerly marketed by AMRAD Biotech and the same Australian staff will continue to operate the company and serve the Australian market. Chemicon is located in California and began in 1981. It supplies high quality immunological reagents, immunodiagnostics and molecular biology products to the biotechnology industry. The Silenus range of monoclonal and polyclonal antibodies, with its established reputation of quality, will continue to form an integral part of the Silenus manufactured products portfolio. Other focus areas are cell biology, molecular biology and epitope tagging. These products will continue to be developed and manufactured on-site at the Silenus facility in Melbourne. Silenus will continue to distribute and support a range of quality imported agency lines which are complimentary and synergistic to our core product range. In conjunction with our manufactured products, these agency lines allow Silenus to offer a comprehensive range of research and diagnostic tools for life science laboratories. TRIAL PROGRESS FOR CARDIAC DRUG Listed pharmaceutic company, Novogen Ltd, has completed in-vitro laboratory studies on its new cardiovascular drug, NV-04, which have demonstrated the drug's potential to control blood vessel relaxation, to modify vessel wall biochemistry and to display anti-oxidant properties. Novogen hopes that NV-04, derived from Novogen's patented phenolic compound technology, will provide the first drug to address the underlying disease processes which lead to heart attack and stroke rather than treating symptoms which precede these events. Novogen's Research Director, Professor Alan Husband, said that the powerful vasoactive and anti-oxidant properties for NV-04 made it a perfect candidate as a new drug to improve cardiovascular function by controlling blood pressure and reducing atherosclerosis. Studies of NV-04 have been undertaken under contracts with the Baker Medical Research Institute, the Howard Florey Institute of Experimental Physiology and Medicine and the Heart Research Institute, with funding assistance of $3.75 million from an R&D Start grant. Novogen will now embark on the next stage of development which involves laboratory animal testing. In another recent development, Novogen has received approval for its anti-cancer drug, NV-06, to begin Phase 1 clinical trials. The initial trial, to be conducted at a public hospital in Sydney, will provide preliminary pharmaco-kinetic and tolerability data on the intravenous form of the drug. NV-06 is a synthetic version of a human phenolic hormone discovered by Novogen scientists that has demonstrated significant anti-cancer activity in the laboratory against human cancer cells including breast, prostate, large bowel and leukaemia cancers. Novogen is currently developing the compound for the treatment of prostate cancer. Novogen has been awarded a $2.79 million R&D Start grant to assist in the development of NV-06. Novogen has also recently announced findings from a new phase II clinical study of its dietary supplement for menopause, Promensil, that the supplement significantly alleviates severe cyclical mastalgia. Mastalgia, or fibrocystic breast disease, affects around one in four Australian women, causing painful swelling of the breast in association with the menstrual cycle. Novogen has been awarded a patent claim for therapeutic benefit of isoflavones for cyclical mastalgia by the US Patent Office. New Test for Rapid Blood Clot Diagnosis Biotech International Limited has launched a new rapid D-dimer test for the diagnosis of blood clot conditions, through its subsidiary, Agen Limited. The new rapid test expands the range of D-dimer tests sold by Agen. D-dimer is a molecular sub-unit found in blood clots and Agen was the first company in the world to offer D-dimer testing, based on its patented D-dimer specific monoclonal antibody, 3B6. Rapid diagnosis and early medical intervention are key factors in the successful treatment of life threatening blood clots. The new test, named "Simplify D-dimer", is easy to use and provides a blood clot status result within 10 minutes, using a single drop of the patient's blood. Launched in Australia last week, the product will be introduced to European market in mid-November. Executive Director of Biotech International, Roman Zwolenski, expects the company will achieve significant sales of the Simplify D-dimer product within the next few months from Australia and Europe. "Each year 10 million people in Western Europe and the US suffer from life threatening blood clots in leg veins. For about 600,000 of these the clot will travel to the lungs and tragically some 100,000 will not survive. Agen Biomedical, a subsidiary of Biotech International, has commenced legal action against the US Biopool International Inc for infringement of the D-Dimer patent owned by Agen. Biotech International has taken up a 8.9% stake in Biopool whose stock is listed on the OTC bulletin board in the USA. Biopool has not been licensed to use the D-dimer test and Biotech International's Chairman, David Fawcett, said that the company is "fully committed to protecting its key intellectual property". Copyright 2000 - Australasian Biotechnology |
| |||||||||
