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Australia EvoGenix and CSL Partner on Antibodies

ntibody therapeutics company, EvoGenix Ltd, had entered a Technology Collaboration agreement with CSL Ltd. EvoGenix will apply its proprietary Atechnologies to antibody products selected by CSL from its pipeline. The collaboration is designed to generate superior antibodies that are more effective as human therapeutics. CSL will have the right to commercialize the products. EvoGenix will receive royalty payments as therapeutics emerging from the collaboration reach the market. Under the terms of the agreement, EvoGenix will receive research payments to carry out work on CSL’s products. Each project carries a success payment for the achievement of project goals, as well as milestone payments as the product advances through the subsequent stages of clinical testing and regulatory approvals. The agreement marks the growing interest of Australian healthcare companies in the dynamic antibody sector, which is seen as the source of many of the future blockbuster drugs. Dr Andrew Cuthbertson, CSL’s Chief Scientific Officer commented, “CSL has identified antibody therapeutics as a focus of its expanding product pipeline. We are delighted to access key technologies which can accelerate development of our antibodies as effective treatments through this collaboration with EvoGenix. “ Dr Rob Crombie, VP for Business Development with EvoGenix, noted “We are looking forward to a highly productive relationship in developing these projects with CSL. As Australia’s leading healthcare company, and with their track record of success in taking biopharmaceuticals to the market, CSL is ideally placed to accelerate antibodies emerging from the collaboration through to becoming successful products.” This is the second major collaboration EvoGenix has made to exploit its proprietary antibody development technologies. The first was signed with pharmaceutical giant GlaxoSmithKline late last year. EvoGenix expects to utilize its proprietary technologies in additional selected relationships over the next few years.

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About EvoGenix EvoGenix Ltd has established leading technology capabilities for creating high value antibody therapeutics. The company exploits its capabilities through technology collaborations with partner companies, It also develops in-house wholly-owned antibody products. The EvoGenix technology converts a research-stage antibody, which is often produced in mice, into a high potency therapeutic suitable for long term administration to patients. This is a key value-creating step in antibody development. EvoGenix is progressively building company value by assembling a portfolio of short and longer term revenues resulting from products successfully generated in technology collaborations. At the same time, it is progressing its internal product pipeline with current products aimed at the treatment of osteoporosis, lung cancer, melanoma and respiratory infections. These will be out-licensed prior to the clinical stage to meet the existing high demand for new antibody products in the pharmaceutical industry.

About CSL CSL Ltd is a global specialty biopharmaceutical company that develops, manufactures and markets products to treat and prevent serious human medical conditions. CSL has substantial manufacturing facilities in Europe, the USA and Australia. The CSL Group operates globally through its Human Health businesses. CSL’s Human Health business includes the operations of ZLB Behring, CSL Bioplasma and CSL Pharmaceutical, as well as our global new product development activities.

Contact Details: CSL Ltd Address: 45, Poplar Rd, 3052, Victoria, Australia URL: www.csl.com.au

Evogenix Ltd Contact Person: Dr Merilyn Sleigh, CEO Address: Level 2, 37 Bligh Street Sydney NSW 2000 Tel: +61 2 8257 3393 Fax: +61 2 8257 3399 Emai: [email protected] URL: www.evogenix.com

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Australia Minomic’s Business

inomic is a global leader in biomarker identification. The company’s focus is on developing biomarkers exhibited in early and well established disease states. MIn pathology and disease, proteins in the body tissue are modified and secreted in the body fluids. Minomic has the full complement of state-of-the art procedures to allow them to develop highly predictive screening kits based on these biomarkers in body fluids such as blood, urine and tears. Minomic’s expertise in proteomic analysis of tears and urine and small sample volumes positions them at the forefront of non-invasive diagnostic technology. There are several benefits of biomarker tests over traditional tests. These benefits include: • Used with high degree of accuracy at very early stages of disease. • Used to measure disease progression or remission during treatment. • Used to understand pharmacotherapy efficacy, toxicity and theranostic assaying. • Rapid test, used non-invasively, on small volumes of sample and in the hands of general practitioners or nurses.

Minomic’s Background Minomic started in April 2002 with a turnover of approximately A$ 30,000 (US$22,000) and currently,its turnsover is A$ 1 million (US$0.74 million). The changes in its performance have arisen from the fact that the company successfully markets its products and services in Australia and Asia Pacific. It market its products to both broad based industry and to pharmaceutical and biotechnology businesses. Dr Brad Walsh founded the company with financial and in-kind assistance from four other founders. Two key technology partners, Waters Corp and Perkin Elmer Life and Analytical Sciences (both US listed companies) provided financial help and supplied equipment to establish the laboratory and technology platform. These partners believed in the vision of Minomic’s founders and remain partners. The company’s core business has been protein biomarker discovery from the outset with an initial focus on diabetes type 2 and its complications. Another academic partner is Professor Mark Willcox from the Institute of Eye Research.

Awards Minomic recognises the advantages of maintaining a profile in the marketplace. For a relatively young company, Minomic has already been the recipient of a number of prestigious awards including awards from Business Review Weekly and Frost & Sullivan.

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2003: Appointed the PerkinElmer Asia Pacific Center for Excellence in Proteomics 2004: Admitted to the Australian Technology Showcase 2005: Winner of “2005 Best Investment Pitch” for the On-the-Spot Investment Competition 2005: Finalist 2005 BioFirst Commercialization Award 2005: Frost & Sullivan Entrepreneurial Company Award 2006: BRW Upstarts 2006 Awardee

Minomic’s Market The global market for diagnostics is large with molecular diagnostics making up 3% market share. Molecular diagnostics was approximately US$3.1 billion in 2000 and is expected to be worth US$8.5 billion in 2008 and US$12billion in 2010. This growth is driven by the availability of new diagnostic methodology, the aging population, the explosion of the middle class and improved health care in countries such as India and China. Minomic, with its ability to identify and test reliably for biomarkers of diseases such as cancer and diabetes, is a company that is in a niche and growing market with few rivals. Its technology has major opportunities for rapid product range extension in diseases where traditional tests are limited or inadequate. Minomic currently has three core research and operational areas. These are; • Non-invasive diagnostic test using urine for Type 2 diabetes. • Non-invasive diagnostic test using urine for prostate cancer. • Partnering with biotechnology companies with specific biomarkers for clinical trials in pharmacotherapy, safety and efficacy. Minomic believes that the potential sales for the Minomic diabetes diagnostic product is US$15 million per annum and the potential sales for Minomic Prostrate Cancer diagnostic product is US$12 million per annum. With current estimates for successful drug development hovering in the US$900- million to US$1.7 billion range, the implications of finding relevant markers to predict toxicity, efficacy, and treatment outcomes are profound. Identifying such markers facilitates earlier go/no-go decisions in drug development. By understanding who is likely to respond to which drug, biomarkers can change the risk/benefit ratio for patients in clinical trials by enriching the population of patients who will benefit, as well as reducing the likelihood of adverse events. With smaller enrolments, faster trials, and higher success rates, companies can expect a greater market share for successful drugs, and physicians will have clearer guidance on better drug choices for their patients.

Minomic’s Technology Minomic has two business streams: i) Contract research division in the development of customized diagnostic tests for pharmaceutical and biotechnology companies . ii) The development of diagnostics kits (Type 2 Diabetes and Prostate Cancer). At the core of these two business streams are the skills and expertise around a platform

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of proteomics technology. No other biomarker discovery company has such a range of capabilities and resources. The company’s MiNavigator technology platform allows them to remove many of the significant bottlenecks that have slowed the expansion of proteomics. It uses proprietary recipes and methods that in the hands of our world-class scientists give results that are hard to match in the industry. These solutions are an important part of our core competence and are comprehensive, global, large scale and rapid. The development of this platform has led to the production of two proprietary products, MiPrep for efficient sample extraction and MiSpecies for data analysis.

Minomic’s People Brad Walsh—CEO Brad has 20 years in the business and has been associated with proteome technology since its inception. He structured the first high throughput proteome facility including staffing, design and fit-out of the laboratories. He also set up the business systems used to run the facility and managed the operations and contract activities of the facility. He has worked on commercialization of diagnostics since 1985 and proteome technology since 1996.

Geoff Randall—Business Director Geoff has over 20 years scientific instrumentation and consumables company experience in both the analytical and life science markets. He had the operational responsibilities for both Australia and South East Asia, then the company expanded into divisional responsibilities for Asia Pacific, including India for accountability of regional profit and loss as well as the formulation and implementation of corporate strategy and marketing plans. Mr Randall was also a member of a management team that was successful with the listing of a scientific company on the ASX and went on to grow that business during the 1980s.

Ashok Jairath—Finance Director Ashok has over 25 years of experience in various aspects of accounting and financial management ranging from auditing, public practice, taxation and as a financial controller in a major US financial institution in a European regional role and in Australia. Ashok’s banking experience provides him with a sound grounding in risk management with particular emphasis on project management, venture capital and liquidity management. His public practice experience complements his role in day-to-day financial management of the company with particular focus on statutory and regulatory requirements.

Stuart Craig—Chairman Stuart is a professional business manager/CEO who has been involved with business start-ups and turn-arounds through PricewaterhouseCoopers, over the past three years. As a CEO over the past thirteen years, he has consistently worked with autonomy on major business development and change, creating and turning around businesses and management teams to produce profitable entities. He has extensive international business experience in multiple industries such as service; capital equipment leasing; industrial consumer product manufacturing ; distribution; sales and marketing; high tech areas of data communications and biotechnology.

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Scientific Team A highly focused project team uses the MiNavigator platform to discover and commercialize biomarkers. Minomichave built a company that is populated with intelligent and talented people who have a passion for their work. The staff have a minimum experience of a Bachelor of Science and many have Honours, Masters and as well as PhD’s. All of them have been trained in proteomics over several years both in the company and in their previous employment.

Minomic’s Future Our aim is to generate value in the company in two ways: i) revenues from licensing deals of the diagnostic kits to potential pharmaceutical partners, who have strength in diagnostic market, for the development and commercialization phase. ii) revenues from contract services to large pharmaceutical and biotechnology companies undertaking clinical trials. Minomic is currently seeking research and investment partners and welcomes any enquiries.

Contact Details: Minomics Contact Person: Mr Brad Walsh Tel: +61 2 8977 9050 Email: [email protected] URL: www.minomic.com

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Japan

Japan’s Bioventures Today OMAb Pharma K.K.

OMAb’s Background MAb Pharma K.K. (“OMAb”) is a Japanese drug development venture company established in August 2004. It was jointly established by two Japanese companies, Medical & Biological OLaboratories Co, Ltd (“MBL”) and OncoTherapy Science, Inc. (“OTS”). MBL was the first antibody manufacturer founded in Japan in 1969, and it successfully went public in February 1996. In its earlier days, MBL focused on the development and production of antibodies to plasma protein. MBL currently offers more than 3,000 kinds of antibodies specific to cytoskeletons, oncogene products, and proteins related to signal transduction. OTS is a drug development company targeting oncogene and oncogene products. It was established in April 2001 with the aim to commercialize the research achievements by Professor Yusuke Nakamura, the director of Human Genome Center, the Institute of Medical Science, the University of Tokyo. Based on the joint research with the Institute of Medical Science, the University of Tokyo, OTS’s goal is to find almost all types of cancer related genes. OTS went public in December 2003 and became the fifth genome venture to be listed after AnGes MG, Inc., TransGenic Inc., Medinet Co., Ltd., and MediBIC. OMAb was set up to efficiently develop many prospective drug candidates MBL and OTS have. OMAb currently focuses on the development and commercialization of antibody-based therapies, especially for cancer. Currently, the treatments for cancer are mainly a combination of surgical removal of the cancer cells, radiation therapy and chemotherapy. All of these methods inevitably put much burden to patients’ bodies. Chemotherapy, especially, causes severe adverse effects as it kills other healthy cells in addition to cancer cells. Antibodies, on the other hand, are generally harmless as they are able to recognize target molecules more sterically and selectively. Therefore, OMAb is aiming to develop antibody-based drug as new cancer therapies in order to minimize patients’ burden.

OMAb’s Management One of the reasons that OMAb is gaining the industry’s attention is its management, especially Mr Kensuke Tomita, CEO of OMAb. After graduating from the Faculty of Pharmaceutical Science, the University of Tokyo, Mr Tomita first joined Sankyo Co., Ltd in 1974. He subsequently joined Eli Lilly Japan K.K. and Rorer Japan, Inc. He became a director of Rhone-Poulenc Rorer Japan Inc. (current Sanofi-Aventis K.K.) in 1994. He joined RPR Gencell, a gene therapy and cell therapy business section of Rhone-Poulenc Rorer in April 1995 and became VP and General Manager for Asia Pacific region. In June 2000, he became CEO of AnGes MG, Inc., the first bioventure from Osaka University to be listed on Tokyo Stock Exchange Mothers Section. Having been inspired by the mission to “win the battle with cancer” advocated by Professor Yusuke Nakamura from the University of Tokyo, Mr Tomita joined OTS in May 2002 and became CEO in April 2003. With considerable working experience in several big pharmaceutical companies, Mr Tomita is one of the leading businessmen in gene therapy field. Understanding the importance and the difficulty of constructing the operating base for bio-venture companies, Mr Tomita leads OMAb with the strong team of experienced doctors, drug developers, and licensing personnel.

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OMAb’s Business Lately there are many bioventures which further develop the basic study achievements sought at universities to license to pharmaceutical companies. However, most of the pharmaceutical giants prefer to license in candidates that are at later stage of clinical trials to avoid high development risks. Therefore, it is necessary for these venture companies to conduct a part of or all of the clinical trials, but most of the companies have difficulty to carry out such trials. Clinical trials require both staff experienced in trials and staff specialized in the specific drug candidates. Unfortunately, most venture companies are facing much difficulty recruiting these professionals, as these professionals tend to stay in big pharmaceutical companies. OMAb, on the other hand, has successfully selected and introduced very promising molecular-targeted drug candidates and experienced staff from the listed companies, MBL and OTS. OMAb possesses a number of drug candidates. OMAb has already identified several potential drugs from candidates obtained from MBL’s subsidiary, Institute for Antibodies Co., Ltd. (“IFA”), universities, research institutes and other bioventures in addition to MBL and OTS. These candidates have high potential for approval as, according to U.S. FDA’s study released in 2005, approximately 45% of monoclonal antibodies in phase I trials can be successfully approved as compare to merely 8% of new chemical entities can be approved.

Universities, OTS MBL IFA Research Institutes, Bio Ventures

Drug Candidates

OMAb Pharma Antibody-based Drug Development

OMAb Pharma Big Pharmaceutical Companies Manufacturing & Sales Manufacturing & Sales

Fig.1 OMAb Business Scheme

Antibody-based Drug The main characteristics of antibody-based drugs are as follows:

1. High efficacy and low adverse effects Having been able to recognize target molecules more selectively, antibody-based drugs are expected to be highly effective. Antibodies are serum protein found in normal human bodies. Therefore, their characteristics are well known, and are generally non-poisonous. They have high specificity against antigens, are thus unlikely to harm other cells. Antibodies are also able to have multiple reaction mechanisms such as inhibition of proliferation signals, activation of apoptosis signals, activation of the complement dependent cytotoxicity (CDC), and activation of the antibody- dependent cell-mediated cytotoxicity (ADCC).

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2. Suitable for cancer treatment As antibody-based drugs act only on cancer cells, the treatment is less invasive to patients than conventional cancer drugs that act on the whole body. Therefore, they are expected to raise the survival rates of the patients. In Japan, cancer drugs were allowed to be marketed upon completion of phase II trials in the past. However, the legislation has been passed in April 2006 which requires submission of patient survival rate data in phase III trials in order to bring the drugs to market. This change came after U.S. and European countries started to focus on the condition of cancer patients after the treatment for the development of cancer drugs.

3. Applicable for customized medicine As antibody-based drugs are able to target specific molecules, they can be used as customized medicine where they are selectively administered to patients who are highly expressing the target antigen.

Market Overview for Antibody-based Cancer Drug Research and development of cancer drug is one of the most active areas among all the pharmaceutical developments. Among approximately 1,000 kinds of new drugs, more than 40% of all are said to be cancer drug. The global cancer drug market has doubled in the five years from 1996 to 2000 and is expected to hit $45 billion by 2010. There are currently 19 antibody-based drugs approved by the US Food and Drug Administration (FDA), and six drugs are under phase III trials. The antibody drug market in Japan has been showing a steady growth in the past several years. It was 13.5 billion yen in 2004 and is expected to hit 60 billion yen by 2015, approximately 4.4 times of the sale in 2004. For antibody-based cancer drugs, anti-HER2 antibody drug has been marketed for the treatment of breast cancer in Japan and other countries, and anti-EGFR antibody and anti-VEGF antibody have been marketed for the treatment of colon cancer in the U.S. and other countries. However, the applications of these drugs are still very limited to certain cancer types, and the need to develop new types of drugs is high. In Japan, the popular antibody-based cancer drugs sold are Rituxan, marketed by Chugai Pharmaceutical Co., Ltd., and Herceptin marketed by Zenyaku Kogyo and Chugai Pharmaceutical Co., Ltd. The global sale of Rituxan exceeds 260 billion yen and for Herceptin, more than 100 billion yen. Only a limited number of antibody-based cancer drugs has been approved in Japan, however, Avastin, already being marketed in the US, is expected to proceed to the application for approval in 2006.

3000

2500 Herceptin 2000 Gleevec 1500 Rituxan

Million $ Avastin 1000 Iressa 500

0 1999 2000 2001 2002 2003 2004 Year

Fig.2 New Antibody-based Cancer Drug Sales

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OMAb’s Future OMAb plans to pursue in-house development of multiple drugs by using the management’s personal network such as Mr Tomita, Dr Okimura, Chief Operationg Officer of OMAb, and Dr Tsurushita, Director of OMAb, who used to work in U.S. company, Protein Design labs, Inc.(current PDL BioPharma Inc.). In addition, OMAb plans to strengthen its pipelines with other bio ventures in order to obtain more promising antibody-based drug candidates for further development in the future.

This article is contributed by JAIC Asia Holdings Pte Ltd. as a part of collaboration with World Scientific Publishing Co Pte Ltd.

Contact Details:

OMAb Pharma K.K. Address: 3-2-1 Sakado, Takatsu-ku, Kawasaki-shi, Kanagawa, 213-0012 Japan Tel: +81 44 820 8251 Fax: +81 44 820 8252 Email: [email protected]

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Japan

Immunodiagnostic Systems Signs Marketing and Sales Agreement with Medical & Biological Laboratories

mmunodiagnostic Systems Holdings (IDS), a leading producer of diagnostic testing kits for the clinical and research markets, has signed a Marketing and Sales Agreement Iwith Japan-based Medical & Biological Laboratories Company Limited (MBL). More details such as the financial terms have not been disclosed. MBL, based in Nagoya, Japan, is a company engaged in the research, development, manufacturing and marketing of in vitro diagnostics and basic research reagent, together with the marketing of related automated instruments and devices. Under the terms of the agreement, MBL gains exclusive Japanese marketing rights to IDS’s current non-radioactive in vitro diagnostics products in Vitamin D, bone Specific alkaline phosphatase, PTH and IGF-I, with tartrate-resistant acid phosphatase 5B to be added later, after completion of clinical validation. MBL is also licensed to distribute IDS’s products used only for research, comprising rat- and-mouse specific markers for bone and growth researchers in the pharmaceutical industry and universities throughout Japan. IDS designs, develops, manufactures and markets immunoassay kits, and is particularly active in the field of bone & mineral metabolism. It also has growing presence in the field of growth factors. IDS also works closely with Summit Pharmaceutical International (Tokyo) in developing its presence in the Japanese market. Osteoporosis is a skeletal disease observed with reduced bone strength resulting in the increase risk of bone fracture. Measuring bone-related markers has the clinical efficacy in evaluating the risk of fracture and in monitoring response to therapeutic treatment. Osteoporosis in the Japanese population has reached 450,000 (diagnosed patients in 2002), with an estimated patient population reaching 12,000,000 (including non-diagnosed patients), as the ageing population increases. On his return from Nagoya last week, Dr Roger Duggan, Managing Director of IDS, said: “Our existing business in Japan has been very rewarding, and to find such a prestigious partner as MBL to bring a substantial number of additional IDS products to the Japanese market now and in the future is good news indeed. We anticipate our relationship with MBL will grow still stronger as we go forward.” Mr Katsuhiko Nishida, President and CEO of MBL, said: “IDS product portfolio is positioned to complement the existing MBL products and it is our honour to have such powerful partner to work with. We highly expect this partnership to lead us into a new dimension for MBL, not only for the entry into new market in Japan but also for the constructive and productive long-term relationship to achieve mutual success.”

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About IDS Immunodiagnostic Systems Limited (IDS) is a dynamic company dedicated to the development and provision of innovative assays for use in clinical and research laboratories worldwide. From a modest sales and distribution operation established in 1977, IDS has become not only a developer and manufacturer in its own right, but also nurtures technology development externally, in British universities and research institutes. The company is focused on sustaining its position as a fully integrated In Vitro Diagnostics (IVD) company, building and maintaining capability in de novo product design, development, manufacture and global marketing.

About MBL For in vitro diagnostics, MBL is dedicated to the development, production, and marketing of immunological diagnostic reagents, especially for autoimmune diseases which capture 80% of the Japanese domestic market of autoimmune diagnostic reagents. In addition, MBL is actively involved in the identification, product development, and in-licensing of novel markers in the areas of rheumatoid arthritis and cancer markers through genetic manipulation and antibody technology.

Contact Details: IDS Ltd Contact Person: Dr Roger Duggan, Managing Director Address: Boldon Business Park, Boldon, Tyne and Wear, NE35 9PD, England Tel: +0191 519 0660 Email: [email protected] URL: www.idsltd.co

MBL Ltd Contact Person: Katsuhiko Nishida, President & CEO Address: 15B Constitution Way, Woburn, MA 01801, USA Tel: +781 939 6964 Fax: +781 939 6963 Email: [email protected] URL: www.mbl.co.jp

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Japan

Vical and AnGes MG to Collaborate on Allovectin-7®

ical and AnGes MG Inc. announced a collaborative agreement for Vical’s Allovectin-7® cancer immunotherapeutic. Under the agreement, AnGes will Vprovide up to US$100 million in ongoing clinical trial funding and future sales- based milestones as Allovectin-7® is successfully commercialized. Vical retains exclusive marketing rights for Allovectin-7® in the United States and the rest of the world outside of specified Asian countries, for which AnGes received exclusive rights. Through a scheduled series of cash payments and equity investments totaling US$22.6 million, including an initial equity investment of US$6.9 million, AnGes will fund the Phase 3 pivotal trial of Allovectin-7® to be conducted by Vical in the United States in accordance with a Special Protocol Assessment (SPA) completed with the U.S. Food and Drug Administration (FDA). Vical has made significant preparations for timely initiation of the Phase 3 trial, and will be actively recruiting additional clinical sites at the annual meeting of the American Society of Clinical Oncology. AnGes will pay Vical royalties on product sales in the specified Asian countries, plus the above-mentioned milestones as defined sales levels are achieved. Vical will pay AnGes tiered royalties based on defined sales levels in the United States, and fixed royalties on rest-of-world sales. Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7®. “We have established a mutually beneficial relationship last year with AnGes in the angiogenesis field,” said Vijay Samant, President and Chief Executive Officer of Vical, “and we believe the Allovectin-7® agreement expands our opportunities for success. Now that we can advance this key program mitigating the financial risk of independent development, we are eager to begin the Phase 3 trial of Allovectin-7® as soon as possible.” “We are pleased with our ongoing relationship with Vical and being able to further strengthen the strategic relationship between us in the field of gene therapy,” said Ei Yamada, President and CEO of AnGes MG, “and through this new arrangement we see great potential to bring Allovectin-7® into the Asian market for melanoma and other cancer indications. We believe our new partnership will yield further collaboration and substantial benefits for both parties in the future.”

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About Vical Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company has developed certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs.

About AnGes MG AnGes MG Inc is a biopharmaceutical company founded in December 1999. It focuses on innovative discoveries by researchers of Osaka University. The company specializes in research and development and practical application of DNA-based therapeutics. The company, along with its subsidiaries, is engaged in developing three new medicines: HGF genetic medicine which improves blood circulation by regenerating blood vessels, NFkB decoy which controls various inflammations, and HVJ envelope vector for non- viral drug delivery and discovery.

Contact Details: Vical PLS Address: 10390Pacific Center Court San Diego, California 92121-4340 Tel: +858 646 1100 Fax: +858 646 1150 Email: [email protected] URL: www.vical.com

AnGes MG Address: 4F, Saito Bio-Incubator, 7-7-15, Saito-asagi, Ibaraki, Osaka, 567-0085 Japan Email: [email protected] URL: www.anges-mg.com

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Singapore

GlaxoSmithKline Strengthens Asian Presence with New S$300M Vaccine Plant

laxoSmithKline (GSK), one of the world’s leading vaccine manufacturers, is set to strengthen its presence in Asia with the establishment of its first vaccine Gmanufacturing plant in Singapore set to be operational in 2010. The plant is Singapore’s first primary vaccine facility and GSK’s largest vaccine investment in Asia. The new vaccine plant is GSK’s biggest vaccine investment in Asia and will be the first such facility in Singapore. The company will spend more than S$300 million over the next four years, in the first phase of development of the plant dedicated to the primary production of paediatric vaccines. Building work, which has already started, will be phased over a number of years with a view to ensuring maximum manufacturing flexibility. More than 200 jobs will be created to support this facility. Built on a 85,000 square meter plot of land, the new state-of-the-art facility will include high-tech production buildings, as well as support buildings such as administration offices, meeting rooms, quality control laboratories, power plants and a warehouse. It is also designed to allow for future site expansion. GSK intends to boost its employees skills by sending key personnel for training in its manufacturing plants in Belgium, Germany and Hungary. Once operational, the new plant will be the center of GSK’s bulk polysaccharides and conjugates production worldwide, and will play a pivotal role in the production of pediatric vaccines to meet global demand. The new facility will manufacture GSK’s innovative conjugate vaccine that provides protection against Streptococcus pneumonia and Non-typeable Haemophilus influenzae, two important pathogens responsible for serious illness among children. GSK’s multiple combinations of new meningitis conjugate vaccines also will be produced at this facility. Patrick Florent, Senior Vice President, Global Industrial Operations, GSK Biologicals, said, “GSK has enjoyed a presence in Singapore since 1959, even before Singapore became an independent nation. We view ourselves as residents, not tourists and this view underscores our long-term commitment to Singapore. We chose to develop our new vaccine plant, also our largest vaccine investment in Asia, in Singapore, due to its excellent infrastructure, highly-qualified workforce, superb geographical location and strong government commitment to the biomedical sciences sector. The new plant emphasizes our long-term commitment to Singapore and to the Asia-Pacific region, and Singapore remains an attractive location for any future investment for GSK.”

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Dr Hans L. Bock, GSK Biologicals’ Vice President and Director of Clinical R&D and Medical Affairs, Asia-Pacific, Australasia, China/Hong Kong & Japan, said, “Vaccination provides freedom from disease for millions of children and adults worldwide. We see the vaccination of children as particularly important, as it forms part of the foundation to build disease immunity in the community. Nearly nine out of 10 doses of vaccines we distributed last year were paediatric vaccines. Our goal is to improve the quality of life of people everywhere, by making quality vaccines available to every person who needs them. With the new plant, and with our innovative vaccines in the pipeline, we believe we will take this quest to a higher level.”

About GlaxoSmithKline and GlaxoSmithKline Biologicals GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. GSK Biologicals, the vaccine division of GlaxoSmithKline, is one of the world’s leading vaccine manufacturers. GSK Biologicals is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Biologicals employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. GSK Biologicals is also developing innovative immunotherapy compounds to treat cancer patients. In 2005, GSK Biologicals distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and developing world, an average of three million doses a day. In the next five years, GSK Biologicals expects to launch five major new vaccines: an HPV vaccine targeting cervical cancer, a vaccine against rotavirus-induced gastroenteritis (now licensed in 41 countries in addition to the European Union markets), a vaccine to prevent pneumococcal disease, an improved flu vaccine for the elderly, and several meningitis combination vaccines.

Contact Details: GlaxoSmithKline Biologicals Contact Person: Elizabeth Hernandez Tel: +65 6232 8134 Email: [email protected] URL: www.gsk.com

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Singapore

Kalbe Farma Sets Up R&D Base in Singapore to Focus on Drug Development of Biopharmaceuticals

ndonesian-listed pharmaceutical company, PT Kalbe Farma Tbk. (Kalbe Farma), the largest in , officially opens its office for research coordination and Ilicensing in Singapore recently. The company focuses on research and development of biopharmaceuticals (medicines manufactured using biotechnology) and other innovative products as well as diagnostic tools. Known as Innogene Kalbiotech Pte Ltd (Innogene), it is a wholly owned subsidiary of Kalbe. Innogene aims to specialize in oncology, intensive care, therapeutic and preventive vaccines. Mr Johannes Setijono, CEO of Kalbe Farma, said: “With Innogene, Kalbe Farma will be the regional pioneer to leverage cutting-edge technology and enjoy the first mover advantage to introduce breakthrough medicines worldwide. This, in turn, will enable us to stay committed to our long-term objective of delivering better quality of life to people around the world through the betterment of their overall health.” “With Innogene based in Singapore, we are confident that the island-state’s favorable biomedical ecosystem and existing state-of-the-art infrastructure will help us fast-track our R&D processes. We also hope to leverage Singapore’s high-caliber workforce, respect for intellectual property rights and the country’s trustmark for positive work ethics and quality to consolidate Innogene’s positive standing in the world market. We also target to take the company public eventually and Singapore’s status as a renowned financial hub will be to our advantage,” added Mr Setijono. To advance its vision to become a leading biopharmaceutical company, Innogene also collaborates with other local and international companies, researchers and institutions to acquire, develop and patent innovative pharmaceuticals and diagnostic products for the global market. They include Fraunhofer-Gessellschaft, Europe’s largest applied science organization to develop affordable diagnostic kits for Hepatitis C, Canada’s YM BioSciences Inc to develop nimotuzumab also known as hR3 for treating brain tumor and Recombio, a Swiss company to develop a cancer vaccine, IE10, for the treatment of non small cell lung carcinoma and breast cancer. Innogene is also working with Singapore’s Lynk Biotechnologies to develop and license out innovative products for application in different therapeutic classes.

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Dr Rikrik Ilyas, Director of Innogene Kalbiotech, said: “Currently, we are working towards developing and patenting lactate-based pharmaceuticals globally from Singapore. The focus indications are for post-cardiac surgery and traumatic brain injury. The post-cardiac surgery indication was launched last month in and will soon be submitted for registration in Singapore. Launches in more countries in Asia are expected within the coming years. The traumatic brain injury indications have completed the proof of concept stage and are now pending clinical trials in the USA. We are also working on the clinical development of an antibody (a biotech drug designed to resemble human antibody) that inhibits cancer cell growth and IE10 in Singapore. We hope to launch and market both cancer therapies in Singapore and regionally in 2007 and 2010 respectively.” In addition to being the center that coordinates clinical trials and research activities, Innogene will also be the office for licensing activities which manages the application and commercialization of patents worldwide. Currently, Innogene is looking at a staff strength of 12 including scientists, clinical technicians and administrative staff. The Singapore subsidiary is supported by advisors located in the USA and France as well as ad hoc experts of different therapeutic disciplines.

About Kalbe Farma Kalbe Farma was founded in 1966 and has since been committed to improving the overall health of people for better quality of life. The company’s three core businesses are healthcare, food and packaging for pharmaceutical products and consumer goods. Headquartered and publicly-listed in Jakarta, Kalbe Farma now owns 14 per cent of ’s pharmaceutical market. It was listed in 1991. Kalbe Farma has offices in , , , the , Singapore, , and and employs more than 12,000 staff.

Contact Details: Kalbe Farma Address: Kawasan Industri Delta Silicon Jl. MH Thamrin Blok A3-I Lippo Cikarang, Bekasi 17550 Indonesia P.O. Box 371, Bekasi 17037 Tel : +6221 89907333 Fax : +6221 89907360 URL: www.kalbe.co.id

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Singapore

MerLion Pharma and ICES Inks R&D Partnership to Boost Singapore’s Biotechnology Industry

he Institute of Chemical and Engineering Sciences (ICES), a research institute under the Agency for Science, Technology and Research (A*star), signed a research Tcollaboration agreement with MerLion Pharmaceuticals Pte Ltd to synthesize and develop novel molecules, based upon naturally derived compounds, for anti-tumor drug therapies. The agreement was signed by Dr Tony Buss, President and CEO of MerLion and Dr Keith Carpenter, Executive Director of ICES. Under the terms of the agreement, ICES will design and synthesize compounds based on natural product leads for possible use as anti-tumor agents in humans. New compounds generated in ICES can be further modified and optimized in MerLion, which has significant medicinal chemistry expertise in the optimization of the pharmacological, toxicological or metabolic properties of natural products. The World Health Organization estimates that there are approximately 11 million new incidences of cancer around the world every year, therefore research into new forms of cancer treatment constitutes a critical medical need. The principle discovery methodology of many modern drugs focuses on the drug’s interaction with specific proteins in the body. Many cancer inducing pathways consist of a series of interactions between such complex molecules. Naturally occurring compounds, which are produced by organisms such as microbes (bacteria, or fungi) or plants, have an ability to specifically interfere with such highly complex interactions. This makes them therefore an ideal starting point for the design of new pharmaceutical substances. There is a recognition across the industry that natural products represent a crucial strategy for the modulation of such protein: protein interactions. Dr Tony Buss, President and CEO of MerLion commented, “We recognize the expertise and skills that ICES continues to develop within Singapore. The institute works with academic and industry leaders from across the world and has excellent chemistry capabilities. It is a significant benefit that ICES is able to link its synthetic chemistry skills with MerLion’s natural product chemistry knowledge and biological understanding. I am sure that collaborations such as this can play important role in the biotech success of Singapore”. Dr Keith Carpenter commented that, “We are excited to work with MerLion on this project which is both rewarding and meaningful for both parties. By sharing our facilities and research expertise and by bringing their extensive natural product chemistry knowledge and biological understanding in this partnership, we are confident that it will contribute to the development of Singapore’s biotech industry.”

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About MerLion Pharmaceuticals MerLion Pharmaceuticals is a Singapore-based, privately held company, engaged in natural product based drug discovery that focuses on discrete R & D collaborations with research organizations possessing novel, validated targets in key therapeutic areas. Formed in 2002, the company works in partnership with an impressive number of large pharmaceutical and biotech companies worldwide. MerLion Pharma has a strong pipeline of pre-clinical candidates displaying novel chemistry and modes of action. It plans to accelerate development of these compounds towards the clinic whilst maintaining a productive discovery engine, supplying new leads and candidates via collaboration and independently.

About Institute of Chemical and Engineering Sciences (ICES) Institute of Chemical and Engineering Sciences (ICES) is a member of the Agency for Science, Technology and Research (A*STAR). Established in 2002, ICES’ mission is to develop scientific knowledge, R&D manpower and technological capabilities to support future and current needs of Singapore’s chemical, biomedical and process engineering industries. The research program covers chemistry and chemical engineering science, combined with advanced analytical characterization and measurement to develop state of the art technology for the petrochemical, general chemical, fine chemical and pharmaceutical industries.

Contact Details: ICES Contact Person: Ms Hera Adam Tel : +65 6796 3894 Fax: +65 6873 4805 Email: [email protected] URL: www.ices.a-star.edu.sg

MerLion Pharmaceuticals Pte Ltd Contact Person: Mr Chris Molloy Tel: +65 6829 5606 Fax: +65 6829 5601 Email: [email protected] URL: www.merlionpharma.com.

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Singapore

Philips Inaugurates Asia Pacific’s First Medical Learning Center

hilips Medical Systems, a division of Royal Philips Electronics, has opened Asia Pacific’s first Learning Center for advanced medical diagnostics equipment training Pin Singapore. The Learning Center offers training programs designed around the needs of healthcare technicians and customers. It will offer its services to engineers, sales engineers and application persons. It will also provide medical knowledge of the most advanced medical diagnostics equipment and their operation. The Learning Center is 37,000 sq feet and is the largest of its kind in the Asia Pacific region. It is equipped with the most sophisticated medical diagnostics such as cardiovascular X-ray, general X-rays, computed tomography (CT), scanner, magnetic resonance imaging (MRI), ultrasounds systems and patient monitoring. The center will provide more than 4000 training days during 2006 and increase over 6000 days over the next two year. Courses are also conducted in Mandarin and Japanese to suit the needs of engineers from China and Japan. Outside Singapore, the company has two other medical training centers, one at its home base in Netherlands and the other in Cleveland, US. The Learning Center in Singapore which cost about ,12 million euros, is equipped with eight lecture rooms, 20 laboratories and an auditorium that can seat 98 people. “The Singapore Learning Center has been established in response to out rapid expansion and success in the Asia Pacific region where we are benefiting from double- digit growth rates over the past couple of years. The opening of the Center reinforces out commitment to advancing healthcare in Asia Pacific. The Learning Center is aligned around our brand promise “Sense and simplicity” and is a reflection on how one makes advanced technology simple and easy to experience,” said Mr Jouko Karvinen, CEO, Philips Medical Systems. “The Center allows us to address a long pending requirement of this region, access to a facility providing education and training in the skills and expertise required to operate technologically advanced high-performance diagnostics equipment. Good healthcare solutions will improve patient care. At the same time, they will keep healthcare costs under control. Singapore serves as an ideal location for the center as it is in the heart of Asia Pacific, as well as a vibrant medical hub in the region. The Singapore Government (EDB) has also shown keen interest to cooperate with local industries and has a strong focus to develop Singapore into a knowledge based society. We believe the local and regional medical communities will benefit from the easy access to our knowledge base in diagnostics technology and healthcare innovations,” added Mr Karvinen.

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“I am very pleased that Philips Medical Systems has chosen Singapore as the location for its first and only learning center in Asia Pacific,” said Mr Philip Yeo. “The center will provide training for Philips’ staff and customers in the region using the latest medical equipment. It will reinforce our efforts to develop Singapore as the Biopolis of Asia, with strong regional linkages and networks. In addition, the center will also enhance Singapore’s capabilities in advanced imaging equipment, a key enabler for our emphasis on translational research.” Philips is one of the top three global medical systems providers and is ranked number 2 in patient monitoring and number 2 in medical diagnostics imaging globally. Philips Medical Systems accounts for 20% of the group’s turnover.

About Philips Medical Systems A leading supplier of diagnostic imaging and patient monitoring devices, Philips Medical Systems delivers one of the world’s most robust portfolios of medical equipment for faster and more accurate diagnosis and treatment. The Philips’ product-line includes best-in- class technologies in X-ray, ultrasound, magnetic resonance, computed tomography, nuclear medicine, PET, radiation oncology systems, patient monitoring, information management and resuscitation products, as well as a range of training and education services. Philips Medical Systems has long provided the equipment and technologies that are on the cutting-edge of the healthcare market. Founded in 1896, when Philips manufactured the first x-ray tubes for medical applications, Philips Medical Systems is well positioned to transform the healthcare possibilities of tomorrow into the realities of today.

Contact Details: Philips Medical System Address: Philips Medical Systems Singapore Philips Electronics Singapore Pte Ltd 620A Lorong 1 Toa Payoh Singapore 319762 Tel: +65 6882 4776 Fax: +65 6255 4853 URL: www.philips.com

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