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www.asiabiotech.com Industry Watch Australia Aspect Medical Systems and Brain Resource Company Partners in MCI Study A spect Medical Systems Inc has agreed to fund The Brain Resource Company (BRC) to conduct a clinical study aimed at developing markers for Mild Cognitive Impairment (MCI). More than 80% of patients with MCI develop Alzheimer's disease within ten years, at a rate of 10% to 15% of patients per year. Estimates are that in addition to the four million Americans with Alzheimer's, another eight million suffer from MCI. This is becoming of increasing concern to the medical fraternity given the aging population. Aspect is recognized as a global market leader in brain monitoring, having developed the first clinically proven and commercially available direct measure of the effects of anesthetics and sedatives on the brain. This technology has been used to assess more than 12.2 million patients and is utilized in more than 68% of the best hospitals with operating rooms in the U.S and is available in more than 160 countries. Of particular importance, earlier this year Aspect and Boston Scientific Corporation announced a strategic alliance to develop brain monitoring technology for diagnosing and treating depression and alzheimer's disease. BRC is particularly pleased to have been selected by Aspect to contribute to this component of the alliance. BRC is to receive A$500,000 to conduct this study. About Aspect Medical Systems Inc Aspect Medical System’s was founded in 1987 to develop technology that could measure a then unknown element of patient status — the direct effect of drugs and disease on the brain. Today, Aspect is recognized as a pioneer and global market leader in brain monitoring, having led the way to develop proprietary technologies that directly measure these effects and ultimately improve the quality and cost effectiveness of patient care. Aspect’s premier product (Bispectral Index (BIS) technology) became the first clinically proven and commercially available direct measure of the effects of anesthetics and sedatives on the brain. About BRC The Brain Resource Company provides a comprehensive methodology to assess brain and body function. BRC has set up the world's first standardized international database which brings together an unprecedented breadth of data. This includes: personal history; neuropsychological tests (memory, attention etc); electrical brain-body function (speed of information processing); brain structure; and genetics coupled with new ways of analyzing the brain. BRC's standardized methodology is currently employed in over 50 sites in six countries (USA, Europe, South Africa, Australia) by a wide range of users. 1250 APBN • Vol. 9 • No. 23 • 2005 Contact Details: Aspect Medical Systems Inc Address: 141 Needham Street, Newton, MA 02464 +617 559 7000 Tel: +617 559 7400 Fax: [email protected] email: Contact Details: Brain Resource Company Address: PO Box 737, Broadway NSW 2007, Australia +61 2 9211 7120 Tel: +61 2 9211 2710 Fax: [email protected] Email: www.asiabiotech.com Industry Watch Australia Mesoblast and Cordis Collaborate on Adult Stem Cell Heart Trial A ustralian adult stem cell company, Mesoblast Limited announced that Cordis Corporation, a Johnson & Johnson company, will join forces in its upcoming adult stem cell Pilot Cardiac Clinical Trial through an agreement with Mesoblast’s American affiliated company, Angioblast Systems Inc. Mesoblast’s chief scientific adviser, Professor Silviu Itescu, said that the collaboration would be the world first clinical use of the latest Biosense Webster Inc cardiac injection catheter technology for cell delivery. “This is a significant endorsement of the clinical potential of our proprietary adult stem cell technology,” Professor Itescu said. The principal investigator of the Pilot Clinical Trial at Newcastle’s John Hunter Hospital, Dr Suku Thambar, will use the Biosense Webster NOGA XP catheter technology to deliver the proprietary adult stem cells directly into the damaged heart muscle of up to ten patients suffering from severe multivessel coronary artery disease. ““The advantage of this latest technology is the speed with which will allows us to assess viable heart muscle where cells can be accurately delivered,” Dr Thambar said. “This should maximize the potential benefit of adult stem cells for patients with ischemic heart disease, while providing clinicians with a user-friendly method to deliver the cells”. Mesoblast executive chairman, Mr Michael Spooner, said there was substantial international interest in Mesoblast’s imminent clinical trials and platform technology. “Mesoblast’s strategy is to have the strongest possible approach to commercializing our technology by working closely with global dominant players in our areas of interest. The relationship with the Johnson and Johnson companies, Cordis and Biosense Webster, is indicative of this strategy. Importantly, under this agreement we will retain all of our Intellectual Property rights associated with our platform adult stem cell technology and will remain free to pursue all commercial options,” Mr Spooner said. APBN • Vol. 9 • No. 23 • 2005 1251 www.asiabiotech.com Industry Watch About Cordis Corporation Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology, including the drug eluting Cypher stent. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of people who suffer from vascular disease. About Biosense Webster Biosense Webster Inc, a Johnson & Johnson Company, pioneered electrophysiology (EP) diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools. As the leader in navigation systems, Biosense Webster's technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. About Mesoblast Ltd Mesoblast Limited is a publicly listed Australian biotechnology company committed to the development of novel treatments for orthopedic conditions, including the commercialization of a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage. Mesoblast has the worldwide exclusive rights for a series of patents and technologies that have been developed over more than ten years and which relate to the identification, extraction and culture of adult mesenchymal precursor cells (MPCs). The technology has achieved outstanding results in pre-clinical in vivo studies in the regeneration and repair of large bone fractures. Mesoblast has acquired a 33.3% interest in Angioblast Systems Inc, an American company developing the platform MPC technology for the treatment of cardiovascular diseases, including repair and regeneration of blood vessels and heart muscle. 1252 APBN • Vol. 9 • No. 23 • 2005 Contact Details: Cordis Corporation Tel: +800 781 0282 Fax: +215 325 4183 URL: www.cordis.com Contact Details: Biosense Webster Inc Address: 3333 Diamond Canyon Road, Diamond Bar, CA 91765, U.S.A. Tel: +909 839 8500 Fax: +909 468 2905 Contact Details: Mesoblast Limited Address: Level 39, 55 Collins Street, Melbourne 3000, Australia Tel: +61 3 9639 6036 Email: [email protected] URL: www.mesoblast.com www.asiabiotech.com Industry Watch Australia Apollo Life Sciences Begins Sale of Human Cell-expressed Proteins Globally A pollo Life Sciences announced that it will begin the sales of human cell-expressed proteins into the global research reagents market. Apollo is the only company in the market offering a range of proteins expressed exclusively from human cells rather than from traditional bacteria, insect or rodent cells. The market for protein reagents, used in experimental research, includes researchers in universities, pharmaceutical companies, research institutes and hospitals. Worldwide annual sales of protein reagents are estimated to be worth US$400 million per annum, with an annual growth rate of 15%. Apollo’s proteins, which are distinctive because they have human attachments (post translational modifications). They perform like proteins found in the human body. Proteins expressed in bacteria, insect or rodent cells have different attachments. As a result of this, they behave differently, both in experiments and in the human body. This can influence their effectiveness as therapeutics. Apollo’s proteins will enable scientists to extend research in new directions and advance understanding of many diseases and human biological functions. “Apollo’s proteins will allow researchers in Australia and around the world to perform many experiments that they have previously been unable to do by allowing them to better simulate human effects and therefore better predict clinical trial outcomes,” said John Priest, Apollo’s chairman and chief executive officer. “Commercializing these proteins has in the past been technically very difficult,” said Dr Alan Watts, Apollo’s scientific director. “Apollo has developed some proprietary processes which enable it to produce these proteins commercially. We are going to market with a starting range of 50 proteins and ten protein detection kits and we are on track to continue extending the product range. Twenty more proteins are in advanced development. Entering this market is strategically important for Apollo because it offers the advantages of R&D reagents’ low regulatory barriers to entry and high margins, enhanced by low cost distribution industry practices,” said Mr Priest. About Apollo Life Sciences Apollo Life Sciences is an Australia-based biopharmaceutical company which is creating, manufacturing and marketing next-generation therapeutics based on natural human proteins to protect and improve human health. These advanced proteins are used to treat a wide range of disorders associated with disease and aging. Apollo’s proteins are expressed from human cells and are expected to offer therapeutic advantages in terms of safety and effectiveness because they more naturally mimic proteins in the human body. Apollo also has a human-expressed protein-based topical therapeutic treatment for psoriasis in a Phase 1b clinical trial. The trial has progressed successfully through the first two stages and completion of the final stage is scheduled for 20 December 2005. Analysis and results of the trial are expected to be finalized in the first quarter of 2006. Contact Details: Apollo Life Sciences Limited Addrees: Apollo Life Sciences Limited, Level 1, 147 Queen Street Beaconsfield NSW 2015 Tel: +61 2 9310 1800 Fax: +61 2 9699 8615 Email: [email protected] URL: www.apollolifesciences.com APBN • Vol. 9 • No. 23 • 2005 1253 www.asiabiotech.com Industry Watch India Wockhardt Introduces Hepatitis A Vaccine into Indian Market W ockhardt Ltd has introduced its new generation hepatitis A vaccine in the markets in south India. The vaccine is made available in collaboration with China-based Zhejiang Pukang Biotechnology Company Ltd China. The drug is being launched in Kerala, Karnataka and Tamil Nadu recently. According to Wockhardt, a consignment of 50,000 vials of the live attenuated vaccine produced from H-2 strains, to be sold under the brand name ‘Biovac’ are being airlifted from China and will be available in all cities throughout China. The vaccine provides a protection for 15 years and also offers the convenience of a single dose for both children and adults. It can be administered subcutaneously in the dermatoid region of the arm. The response from the medical professionals regarding this vaccine has been overwhelming and the first batch of the 50,000 vials would last four to five months. The immunogenicity and tolerability of the vaccine were confirmed after clinical trials on 200 children at KEM hospital in Pune. Wockhardt had also been permitted by the Union Government to advertise the product and has chalked out a strategy to create awareness among the medical professionals. The international vaccine was first developed by Dr. Mao, who is the main investor for the vaccine. Over 120 million people had been administered the vaccine so far. About Wockhardt Ltd Based in India, Wockhardt is a global, pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine: globalisation and biotechnology. It is distinguished by a strong and growing presence in the world’s leading markets, with half of its revenue coming from Europe and the United States. Wockhardt’s market presence covers formulations, biopharmaceuticals, nutrition products, vaccines and active pharmaceutical ingredients. 1254 APBN • Vol. 9 • No. 23 • 2005 Contact Details: Wockhardt Ltd Address: Wockhardt Towers, Bandra-Kurla Complex, Bandra (East), Mumbai - 400 051, Maharashtra, India. Tel.: + 91 22 2653 4444 Fax: + 91 22 2653 4242 Email: [email protected] URL: www.wockhardt.com www.asiabiotech.com Industry Watch India Transgene Biotek Develops Oral Delivery of Insulin and Hepatitis B Vaccine T he Hyderabad-based Transgene Biotek Ltd has collaborated with the pharmacology division head, Dr Prakash V Diwan at the Indian Institute of Chemical Technology to develop oral delivery platforms for insulin and hepatitis B vaccine. The pre-clinical trials on oral delivery of insulin and hepatitis B have demonstrated positive results. The drug is to be administered in liquid form as oral drops. This new invention will help the diabetic population, showing not only the reduction of blood glucose levels compatible to that of the injectable insulin but also the clinically significant plasma insulin levels lasting up to 24 hours. This is a significant achievement since the sustainable plasma insulin levels up to 24 hours implies the possibility of reducing the frequency of insulin doses resulting in high patient compliance and better management of diabetes. With the pre-clinical trials providing the necessary data, the management has initiated steps to take it to the next stage of clinical trials in India and Europe simultaneously. Similarly, the pre-clinical trials on oral delivery of hepatitis B vaccine have demonstrated the generation of anti-body titres to a single dose of oral delivery comparable to that of injectable hepatitis B vaccine. The company claims to be the first to have developed this technology to deliver hepatitis B vaccine through oral route. Oral administration of this vaccine which provides the easy administering of the vaccine to the infants and children, combining with cost reduction, shall be a major factor in the disease control of this viral infection across the world. With the pre-clinical trial data providing exciting results, the management is in discussions with one of the biggest pharma companies in the world to out-license the oral delivery of insulin as a first step. Contact Details: About Trangen Biotek Transgene Biotek is a public limited company and one of the first biotech companies in India. Products in the pipeline include a quadrivalent meningococcal meningitis vaccine that is in the final stages of human clinical trials in Africa, and various therapeutic proteins in collaborations with other companies Transgene Biotek Ltd Address: 68, 69 & 70, IDA Bollaram, Anrich Industrial Estate, Medak District – 502 325, Andhra Pradesh, India +91 8458 279103 Tel: +91 8458 279755 Fax: [email protected] Email: APBN • Vol. 9 • No. 23 • 2005 1255 www.asiabiotech.com Industry Watch Japan Peruseus Proteomics’s Background P eruseus Proteomics (PPMX) was founded in February 2001 as a biotech venture company that develops, manufactures and distributes antibody-based therapeutics, diagnostics and life science research products using proprietary antibody production technology with high affinity and specificity in the area of mainly lifestyle-related diseases and cancers. PPMX is the first biotech venture company to emerge from the Japanese government’s Millennium and Focus 21 Projects. Since April 2003, PPMX has been involved in a national research project called “BioNanochip for the Analysis of Protein Interactions” sponsored by the New Energy and Industrial Technology Development Organization (NEDO). As a member of this project, PPMX functions as the developmental partner for the generation of high-quality antibody-based therapeutic and diagnostic products to improve and extend life expectancy. Japan’s Bioventures Today —Peruseus Proteomics Inc Peruseus Proteomics’s Business PPMX develops, manufactures and distributes antibody-based pharmaceutical, diagnostic and life science research products using proprietary protein expression technology and processes. The company’s three core businesses are the development of antibody-based therapeutics, antibody-based diagnostics and antibody research reagents. Fig.1 Monoclonal antibody production process. 1256 APBN • Vol. 9 • No. 23 • 2005 www.asiabiotech.com Antibody-based Therapeutics Antibody-based Diagnostics Antibody Research Reagents Industry Watch PPMX utilizes a careful screening and selection process to identify highly functional monoclonal antibodies as potential seed compounds for use in disease therapeutics. By selecting the antibody that has the function of cytotoxic activation of cancer cells, PPMX develops therapeutics targeting various cancers, namely liver, pancreas, urinary bladder, kidney, uterus cancers and brain tumor. PPMX also develops small molecular compounds drugs through the analysis of biological information typified by protein localization, complex formation and modification which could be obtained by utilizing nuclear receptor antibody with high affinity and specificity. PPMX develops high sensitivity monoclonal antibodies for use in diagnostic kits capable of detecting novel disease biomarkers at a level and precision that far surpasses current diagnostic methods. Currently four types of diagnostic kits are in the final stages of development. PPMX aims to realize a customized medicine by developing diagnostic markers which can accompany treatment drug for cancer. PPMX offers a number of high quality research monoclonal antibodies, directed against the nuclear hormone receptors and epigenetic markers, for use in a variety of research applications, including western blot, immunohistochemistry and immunoprecipitation. PPMX has successfully created and commercialized all of the 48 nuclear receptor antibodies. Peruseus Proteomics’s Technology PPMX produces various highly functional antibodies and applies them in the development of therapeutic and diagnostic products. There are two core techniques that are used in producing antibodies with high affinity and specificity. Budded Baculovirus (BV) Expression Technology Budded Baculovirus (BV) Expression Technology is the technique to display large amount of target protein in their native structure on the surface of Budded Baculovirus, a type of virus only found in insects. The technology was developed by Professor Takao Hamakubo at the Laboratory for System Biology and Medicine (LSBM), a division of the Research Center for Advanced Science and Technology (RCAST) at the University of Tokyo. PPMX holds its exclusive license. It is often crucial to express target molecules in their native structural conformation in the process of producing antibodies with high affinity and specificity for use in therapeutic and diagnostic applications. Peptide or protein expressed by E. Coli are normally used for target protein expression. However, this method does not always reflect the native structure and function. By using BV Expression Technology, the native structure and function are well maintained even for complicated membrane proteins like GPCR and it is superior as immunogen. APBN • Vol. 9 • No. 23 • 2005 1257 www.asiabiotech.com Industry Watch Monoclonal Antibody Production Technology The antibody production process involves injection of the expressed target protein as an antigen into the mouse to produce antibody that attaches to the antigen by its immune function. It is, however, often difficult to produce functional antibodies against the desired target proteins due to immunotolerance of the animals used. PPMX has developed, in collaboration with LSBM, a variety of techniques to overcome immunotolerance to the target antigen, while simultaneously manipulating the immune response to produce monoclonal antibodies exhibiting high functionality. The research and development team at PPMX has more than 20 years of experience in producing monoclonal antibodies with reputations of their high quality. Market Overview in Japan Antibody-based Therapeutics Antibody-based Diagnostics Nuclear Receptor Antibodies 1258 APBN • Vol. 9 • No. 23 • 2005 Biopharmaceuticals include vaccines, antibody-based pharmaceuticals and interferon targeting various cancers, infections and autoimmune disorders. The global biopharmaceutical market in 2004 was approximately 4 trillion yen with an annual increment of 17%, with the antibody-based pharmaceuticals accounting for 25% of the market with an annual increment of 50%. The market size of Japanese biopharmaceutical in 2004 was approximately 348 billion yen, of which 8.1 billion yen was antibody-based pharmaceuticals. The discovery of various cancers and other disease-related antigens and the innovation of antibody producing technique contribute greatly to the increase in development of vaccines and antibody-based pharmaceuticals. The market for anticancer on which PPMX focuses was approximately 377 billion yen in 2004 in Japan, and it is expected to increase to 415 billion yen by 2006. The market size of in vitro diagnostics in Japan in 2004 was approximately 320 billion yen, of which 138 billion yen was antibody-based diagnostics with an increase of 3.8% from previous year. The market for the antibodybased diagnostics in Japan for 2005 is expected to be around 142 billion yen, an increase of 2.5% from 2004. The current market size of the cancer diagnostics is estimated at approximately 40 billion yen. The world market for drugs targeting nuclear receptors accounts for 10–15% of the entire drug market. The research on drugs targeting nuclear receptors for treatment of life-style related diseases is gaining more attention as these nuclear receptors are transcription factors playing a role of on-off switch for genes, and are thus extremely important as targets. As its life style is getting more westernized, Japan is said to have approximately 7 million hypertension patients, 2.3 million diabetes patients, and hyperlipemia patients that are approximately 40% of the total populations. These symptoms have close relationship with the occurrence and the progression of Japan’s top three killer, cancer, stroke and cardiac diseases if left untreated. As the number of patients of such life style-related diseases increase, the demand for such drugs is expected to rise sharply. www.asiabiotech.com Industry Watch Peruseus Proteomics’s Partnership Through a partnership with CMIC Co Ltd PPMX announced on September 27, the establishment of a highly sensitive method for determining the blood protein PTX3, a promising new marker for predicting the risk of arteriosclerosis. This method makes it possible to identify vascular inflammation at an early stage. PPMX plans to launch a research reagent kit in Japan and overseas. In addition, together with CMIC, it will develop a full-scale test service for universities and other research institutions, general practitioners and pharmaceutical companies. The two companies will develop an in vitro diagnostic and target to obtain approval by 2008. There is an increasing trend globally in licensing out the technologies by bio ventures to pharmaceutical giants at the early development stage of a product. Such tie-ups are still extremely rare in Japan, however, PPMX is more open for tie-ups with pharmaceutical giants at the early stage of development. * This article is contributed by JAIC Asia Holdings Pte Ltd as a part of collaboration with World Scientific Publishing Co Pte Ltd. Contact Details: Peruseus Proteomics Inc. Address : 4-7-6 Komaba, Meguro-ku, Tokyo, 153-0041, Japan Tel : +81 3 5738 1705 Fax : +81 3 3481 5760 Email : [email protected] URL : www.ppmx.com APBN • Vol. 9 • No. 23 • 2005 1259