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China's OTC Market • Non Bactericidal Antibiotics • Eiffel's New SCF Facility

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China's OTC Market • Non Bactericidal Antibiotics • Eiffel's New SCF Facility www.asiabiotech.com Industry Watch Australia Eiffel’s New SCF Facility in Operation iffel Technologies Limited (ASX:EIF), the Australian drug re-engineering company, has officially Elaunched its new development facility in Sydney’s Macquarie Park. The new facility will house a pilot plant which is designed to address the engineering development and issues faced when transferring laboratory scale processes to a commercial manufacturing environment. The plant is also capable of producing batches of re-engineered drug products at larger scale (around 100 times larger than can be made at research scale) to About Eiffel Technologies support later-stage product development activities. Eiffel Eiffel’s focus is on improving the performance and delivery is using its proprietary supercritical fluid (SCF) of currently approved pharmaceuticals. The companies technology, used to produce nanoparticles of therapeutic scientists have collectively 50 years experience in the agents, to develop new versions of existing modification and re-engineering of pharmaceutical pharmaceuticals to improve their performance. compounds and are at the forefront of supercritical fluid research. The company’s development program focuses on developing and improving drugs in a range of therapeutic Eiffel sponsors continuing research in pharmaceutical areas, particularly diabetes and asthma, and one of the processing at its Pharmaceutical Re-engineering Facility, key areas for the company is the development of an located at the University of NSW. Pharmaceutical inhalable form of insulin to potentially replace injections development and scale-up activities are conducted at the for diabetes patients. The search for an effective insulin Company’s headquarters in North Ryde, Sydney, Australia. product that can be delivered without injection has been a goal of diabetes researchers for many years – with as many as 13 major international companies have active Contact Details: programs aimed at bringing an inhaled product to the Eiffel Technologies Limited market, which is expected to be commercialized as early Address: 3 Innovation Road, PO Box 1412, as late 2005. Macquarie Center, The development team has screened over 30 drugs North Ryde NSW 2113, Australia which are currently on the market to investigate their Tel: +61 2 9805 0022 potential to be improved by re-engineering with Fax: +61 2 9805 0044 supercritical fluid technology. Novel particle production Email: [email protected] processes have been developed for over half of these URL: www.eiffeltechnologies.com.au drugs. Eiffel also has collaborative development agreements with a number of prominent pharmaceutical and drug delivery companies, and is in discussions with companies who can potentially contract manufacture commercial quantities of the re-engineered drugs. Eiffel’s managing director Christine Cussen explained, “We would typically partner with a large international pharmaceutical company to bring a re-engineered drug to market. With this new facility we are now able to offer them a more complete technology package, covering both the product and a proven process to manufacture it.” 1360 APBN • Vol. 8 • No. 24 • 2004 www.asiabiotech.com Industry Watch Non Bactericidal Antibiotics arlier in December, researchers at the University of New South Wales (UNSW) reported that furanones isolated from seaweed Delisea pulchra* can interfere E with the switching on of cholera** bacteria virulence factors, which are responsible for the development of the disease. Instead of eradicating the pathogens or inhibiting growth, which are common approach by conventional antibiotics, furanones was observed to hinder bacterial signals transmission. “This is very exciting as these are the first antimicrobials of their type that have been shown to be effective,” commented Dr Diane McDougald, a senior research associate at the Center for Marine Biofouling and Bioinnovation. Scientists believe that furanones may be effective against a range of bacteria which “have communicative system”, such as tuberculosis, golden Staph infections and other food poisoning bacteria. Many bacteria rely on quorum sensing (signaling system) to determine whether the size of population is sufficient to activate the behavior change and start infecting the host (e.g. attach to cell surface). Owing to the extensive use of antibiotics in the past decade, antibiotic-resistant bacteria has become a growing global concerns and making drug therapy for diseases (such as tuberculosis, gonorrhea and malaria) less effective. Currently, about 70% of bacteria that caused infections in hospitals are resistant to at least one of the common drugs used to treat infections. Furanones’ mode of action could be a solutions to certain drug resistant strains since there is no selection pressure on the microbes to develop resistance. From this perspective, furanones has the potential to be either a stand alone therapy targeting at bacterial colonization or in combination with existing treatments to enhance drug efficacy. At the moment, the laboratory findings are indicating that Vibrio cholerae is sensitive to furanones and the bacteria fail to switch on the virulence factors in the presence of furanones. The team has now extended the experiments to tissues cultures and mice models. UNSW researchers Prof Kjelleberg and Prof Steinberg discovered the unique behaviors of furanones in 1990s and the synthetic version of the compounds have been made. A separate company Biosignals Ltd (ASX:BOS) has been set up to serve as the commercializing counterparts of selected compounds (including furanones) identified at UNSW Center for Marine Biofouling and Bioinnovation. * Delisea pulchra is a red algal species of seaweed found at the Sydney’s Botany Bay. It produces furanones to prevent bacteria from forming biofilms on its leaves. ** Global cholera incidence recorded between 110,000 and 200,000 per annum, with fatality reported at 5,000 per annum. WHO believes that the actual figure is likely to be higher. Infections via Vibrio cholerae contaminated waters and food are common. 1362 APBN • Vol. 8 • No. 24 • 2004 www.asiabiotech.com Industry Watch “This outcome is an early stage demonstration of the potential of furanones in human treatments and substantially enlarges Biosignals potential,” said Michael Oredsson, BOS CEO and MD. “The core target human application appears to be as a class of antibiotics that may sidestep bacterial resistance. ... The core success of furanones is minimizing the seemingly intractable problem of bacterial resistance. Biosignal has copied a mechanism in nature that has effectively negated bacteria for about a million years.” On 17 December, BOS received a AUD1.4 million (US$1.05 million) START grant in support of its anti-bacterial extended wear contact lenses using its unique furanone technology from Australian Government via AusIndsutry START grant program. The project, with the involvement of biomaterial specialist: the Ian Wark Researche Institute throughout 2005, aims at preventing eye infections and hopes to benefit the 100 million contact lens wearers. About Biosignal Ltd Biosignal listed on the ASX in April 2004 to commercialize a novel anti-bacterial technology. The first applications are reducing risks of infection from contact lenses and treating aquaculture equipment as an effective and environmentally friendly anti- fouling. Contact Details: Biosignal Ltd Contact Name: Rohan McDougall, General Manager Address: Suite 145, Level 1, National Innovation Center, Australian Technology Park, Eveleigh NSW 1430, Australia Tel: +61 2 9209 4126 Fax: +61 2 9209 4306 Email: [email protected] URL: www.biosignal.com.au About AusIndsutry START Grants The R&D START program provides over AUD700 million (US$532 million) pver the next four years for companies to undertake industry R&D and related activities. The objectives of R&D START are to: - Increase the number of company R&D projects with high commercial potential - Foster innovation in Australian businesses - Foster greater commercialization of outcomes from R&D projects - Foster R&D projects by companies working together or working with research institutions APBN • Vol. 8 • No. 24 • 2004 1363 www.asiabiotech.com Industry Watch C-Pulse Heart Device Testing Progressing unshine Heart Inc (ASX:SHC) announced the second successful short-term implantation of its C-Pulse heart assist device in a patient with heart failure, S with four other heart failure patients to undergo similar intra-operative testing of the device still. An implantable mechanical heart assist device powered by an external driver/ controller/power supply unit, the C-Pulse has been specifically designed to address many of the limitations of current mechanical heart assist devices. The device was tested on a 65-year-old male heart failure patient during surgery for coronary artery bypass grafting – the C-Pulse was tested and removed before the completion of bypass surgery. Previously, the device had been tested in six patients requiring coronary artery bypass surgery who did not have heart failure, the results showing that the first trial showed a 64% increase in blood flow to the heart muscle with counter- pulsation (under the action of the C-Pulse) and a 31% reduction in stress on the wall of the left ventricle of the heart. Stress on the ventricle wall is a major contributor to heart failure. Dr William Peters, SHC’s medical Director, was pleased with the results of the latest test. “The performance of our device
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