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 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 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.

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“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 lived up to all expectations,” he said. “The implantation was straightforward and took only 15 minutes. With the C-Pulse in place, the patient had increased blood flow to the heart and improved heart function as a consequence. And importantly, there were no complications.” Investigators at Auckland City Hospital are currently seeking suitable patients for both this short term trial and a long term human clinical trial, while Sunshine Heart is also actively recruiting further clinical trial centers for long term human clinical studies to support a CE Mark application.

About Sunshine Heart Inc Sunshine Heart is an international company focused on the development of an innovative cardiac assist device to treat patients in moderate to severe long term heart failure (an estimated 1.8 million patients in the US alone). These patients constitute a large and under-served market segment and provide a significant market opportunity for the Company.

Contact Details: Sunshine Heart Inc Contact Name: Andrew Blunden, CFO/Company Secretary 2A River St, Birchgrove, NSW 2041, Australia Tel: +61 2 9818 7913 Fax: +61 2 9818 7915 Email: [email protected] URL: www.sunshineheart.com

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Mesoblast Boosted by Successful Closing of IPO

ustralian biotechnology company Mesoblast Limited has announced the successful closing of its US$16 million Initial Public Offer (IPO), which opened on 1 December A2004 and closed on 8 December 2004. Mesoblast is dedicated to the commercialization of world-leading adult stem cell technology. Prof Silviu Itescu, Mesoblast’s founder described how the company’s strategy to commercialize stem cell technology developed by scientists at the Hanson Institute and the Institute of Medical and Veterinary Science in Adelaide has been endorsed and identified this technology as having a number of significant commercial and technical advantages. Mesoblast has the worldwide license to develop and commercialize this technology for orthopedic applications, including the repair of bone fractures and regeneration of cartilage for knees and for vertebral discs in the back. “Mesoblast can isolate mesenchymal precursor cells, a type of adult stem cell population that can efficiently generate new bone, cartilage and blood vessels, at up to 1000-fold purer levels than existing and competing technologies,” Itescu explained. Mesoblast’s strategy is to minimize corporate costs and intelligently outsource final product development to world leading institutions. The company also has plans to buy a 33.3% stake of Angioblast Systems Inc, an American corporation that owns the underlying adult stem cell technology platform. Angioblast is commercializing the technology for cardiovascular applications, including the repair and regeneration of heart muscle, and growth of new blood vessels for cardiac disease, peripheral arterial disease and skin ulcers. “Our principal goal is to gain Investigational New Drug approval from the FDA within the next two to three years. Throughout our development program we intend to crystallize shareholder value by constantly meeting specific short-term goals and milestones. Moreover, we will actively seek out opportunities to develop strategic partnerships with major international corporations at points in time that will maximize shareholder value.” Mesoblast Chairman Michael Spooner said.

About Mesoblast Limited Mesoblast Limited is an Australian biotechnology company committed to the global commercialization of a unique adult stem cell technology for orthopedic applications. The technology has achieved outstanding results in the regeneration of bone and cartilage in pre-clinical studies.

Contact Details: Mesoblast Limited Contact Name: Julie Meldrum Address: Level 1, 843A Glen Huntly Road, Claufield South, VIC 3162, Australia HP: +61 419 228 128 Email: [email protected] URL: www.mesoblast.com

APBN • Vol. 8 • No. 24 • 2004 1365 www.asiabiotech.com Industry Watch China China’s Changing IPR Landscape

hina is quick to realize the importance of a well-defined Intellectual Property Rights (IPR) to protect its pharmaceutical industry, and has been C taking a proactive role in improving and enforcing its IPR system. In September 2004, the World Health Organization (WHO) concluded that China’s has “an independent regulatory system and a relatively comprehensive legal system” after assessing China’s existing drug regulatory capacities. The inaugural implementation of Patent Law took place in 1985, the legislation only protects inventions in the formulation process, medical devices and apparatus. In addition, no patent are to be granted to pharmaceutical products/substances obtained by chemical extraction. However, things changed in 1992 after China held IPR talk with US, and this has led to the revision of Patent Law. Under the new system, all pharmaceutical inventions are eligible for patent protection up to as much as 20 years. The system also covers Trademark Law, Pharmaceutical Administration Law as well as other administrative protection regulations. This revision has seen a 91% surge of drug patent applications in 1993, leading to 2,415 cases. The number of applications peak in 2000, recording at 8,564 cases. This year, Chinese authorities have worked with several foreign pharma giants (such as Pfizer, Eli Lily, GlaxoSmithKline, and Bayer) in kerbing fake drug manufacturers, forfeiting up to US$8 million worth of counterfeit drugs. According to Zheng Xiaoyu, Head of the State Food and Drug Administration (SFDA), China has paid great attention to tackle the issue of counterfeit drugs. In 2003, 994 fake drug manufacturers and distributors were ordered to cease operations, and US$60 million worth of counterfeit drugs and facilities were seized. 276 cases were referred to judicial system and 217 registration certificates for medical devices and 134 medical devices manufacturing licenses were withdrawn. Currently, domestic players have not realized the significance of IPR and this may have disadvantaged the domestic pharmaceutical manufacturers. Close to 90% of the local manufactureres are mostly surviving on “mimick formulation” manufacturing strategy, replicating others’ invention. With the strengthening of IPR, these players have to find a quick in order to stay in the game. According to statistics, some 21% of the patent protection applications on western medicine inventions were filed by domestic players between 1992 and 1997. Observers pointed out that local traditional Chinese medicine (TCM) manufactureres are also likely to encounter IPR challenge as overseas pharma players (especially from Japan, South Korea, and US) are quitely applying for patent for their TCM invention, and the number of applications is on the rise since 1994. On the contrary to the growing number of foreign patent applications — from 2 cases in 1985 to 12 by 1997, China’s local research institutes and enterprises are showing signs of slowing patent silings. He Xiaodong, an official from the State Administration of Traditional Chinese Medicine, also noted that foreign institutes and pharma players are investing more efforts in acquiring TCM IPR in recent years. He foresees that it would be necessary to draft an IPR specific for TCM in future.

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Investment Hotspot: China’s OTC Market

ultinational pharmaceutical companies have been channeling substantial amount of investment into China’s over-the-counter (OTC) market in recent Myears, focusing on manufacturing and marketing of prescription drugs. In 2003, Germany Merck KgaA injected US$12 million in Shanghai last year to explore the OTC market; Roche is also confident about the market and forecast an annual market growth at 50%, and projected a sales target of US$120 million in 2008. ’s largest non prescription drug producer — Advanced Pharmaceutical Co Ltd HK — collaborated with Alpharma (Foshan) Pharma to established an OTC business in China. According to Paul Lau, Novartis China Branch President, sales in China Mainland hit US$137 million in 2002, up 13.8% from previous year, and it anticipates that market to grow at a healthy rate of 20-30% per annum in the next five years. Earlier in 2004, Novartis has plans to invest a total of US$14 million for expansion in China, including the setting up of production facility in Changping (Northern Beijing) to triple the production output and broaden the variety of products. Novartis expects the expansion to complete before 2007. The investments are driven by two distinct advantages, (1) large population and (2) existing medical insurance system. The increasing individual disposable income, together with the improved policies and regulations on prescription and non prescription drugs, China is forecast to have the fastest growing OTC market in the world, with sales likely to exceed US$7 billion by 2005. The present Chinese medical insurance system covers some of the OTC drugs, and patients are able to reimbursed for these OTC drugs. This system will take some time before aligning with the international standard, commented Hu Shengyu, Vice President, China Nonprescription Medicines Association (CNMA). Local bulk/prescription drug manufacturers are also busy expanding their shares of the OTC market. For example, North East General Pharma Factory launched new OTC business – Kanglinuo to exert presence in the OTC market in Q4 2003; and Xi’an Lijun Pharma (already in prescription drug sector, products include Lijunsha and Duobeisi) added Weikoujia (vitamin C effervescent ) to strengthen its grip of the OTC market shares. In general, the current Chinese OTC market players fall into four major categories, (1) Traditional multinational OTC drug producers, such as Xi’an Janssen, Bristol-Myers Squibb China, Sino-American Tianjin Smith Kline & French Laboratories Ltd. (2) Well known multinational drug producers but new to Chinese OTC market, this includes Merck and Novartis. (3) Local companies, notably the established prescription drug players: Number Six Factory of Hayao Group, Topsun Group, Guangxi Jinsangzi Pharma. (4) Other companies, an interesting sector quietly taken up by a few disinfectant and oral care products manufacturers to service the under-developed segment of the OTC market. At the moment, 70% of the market are local players while foreign players fill up the remaining 30%, with individual brands and fixed group of supporters. To date, there is no dominating brand among the local brands in the market. In addition, the absence of customer loyalty will be a challenging task ahead for local players to address. Nonetheless, branding and market awareness would be an immediate task for all in order to remain competitive in the game.

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India

Matrix Laboratories Close to Inking Landmark Contract Manufacturing Deal

atrix Laboratories is close to striking a deal with an unnamed US- based generic pharmaceutical firm for contract manufacturing of the MAmerican company’s 27 products on an exclusive basis. The deal is seen as a landmark in contract manufacturing because the business deals agreed between Indian firms and companies from abroad have traditionally been for specific products only. In a long term agreement, the Matrix can stand to gain from the bringing of entire manufacturing activities based in the US into India — with revenue figures projected to run into the millions each year. The ambitious collaboration is part of Matrix’s long-term strategy to enter into similar comprehensive contract manufacturing deals with companies from Europe and the US. While there will be no restriction on Matrix regarding the launch of generic formulations in its domestic market, the deal will however prohibit the company from filing any abbreviated new drug applications (ANDAs) in the future. In fact, Matrix has started launching its new formulation manufacturing business. The additional revenues from contract manufacturing agreements will serve as a jumping off point to fund a proposed capacity expansion plan for its bulk plants. The company has four plants for bulk drug manufacturing and is planning to almost double capacities over a three-year period.

About Matrix Laboratories Matrix Laboratories Limited is a public limited company listed on the major stock exchanges in India and is engaged in the manufacture of Active Pharmaceutical Ingredients (APIs) and Intermediates. The development and manufacture of quality intermediates, bulk actives have been critical to the company’s success in delivering innovative and affordable products for both the domestic as well as international markets.

Contact Details: Matrix Laboratories Limited Address: 1-1-151/1, 4th Floor, Sai Ram Towers, Alexander Road, Secunderabad 500 003, India Tel: +91 40 2770 0363 Fax: +91 40 2770 0343 Email: [email protected] URL: www.matrixlabsindia.com

APBN • Vol. 8 • No. 24 • 2004 1369 www.asiabiotech.com Industry Watch

Novartis Contemplates Setting up Research Base in India

wiss-based Novatis AG is seeking to set up a research center in India to complement the R&D activities the company already has in Europe and the US. S Along with China, India figured as one of the potential places for Novartis’ R&D base in because of the increasing quality of the researchers, though drug regulations and control, including patent protection, will be a chief factor behind the decision. Novartis Chairman Daniel Vasella is impressed by the development of intellectual property rights in China, but lamented that the implementation was not consistent. Cost concerns are also high on the agenda. “Costs are being driven down and down, mostly by China. Also India, but mostly China,” Vasella said during a recent visit with Novartis’ Executive Committee to Mumbai. But it’s still the issue of regulation standards that concern Novartis. The recall of Vioxx by US-based drugmaker Merck has drastically changed the landscape of drug controls. Tighter regulation in the pharmaceutical industry in Asia is perhaps now inevitable. Vasella also said that he was excited about India’s pool of scientists and researchers and the company will be looking for collaborations with Indian pharmaceutical companies. Novartis has intention to beef up its generic arm Sandoz to make it more competitive, and is always looking around for acquisitions and collaboration opportunities. No merger plans is on the cards though – for the moment. Novartis has existing tie-ups with Indian companies including Nicholas Piramal India Ltd., Torrent Pharmaceuticals, Dr Reddy’s Laboratories and Biocon.

About Novartis Novartis is a world leader in the research and development of products to protect and improve health and well-being. Novartis was formed in 1996 from the merger of the Swiss companies, Ciba-Geigy and Sandoz.

Contact Details: Novartis India Ltd Address: Royal Insurance Building, 14, J Tata Road, Mumbai 400020, India Tel: +91 22 2282 3434 Fax: +91 22 2282 2246 URL: www.novartis.com

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Japan Sosei US Subsidiary Focuses on CNS Therapy Development

hrough a new deal with Mitsubishi Pharma, Sosei has acquired an exclusive worldwide license to develop and commercialize a small molecule compound T (SON-216) targeted for attention hyperactivity disorder (ADHD). And with the pharmaceutical platform achieved by the inking of this new deal, Sosei also announced the incorporation of Kosei, Inc, its fully owned subsidiary, in the US. Kosei will be focused on developing new treatments for disorders of the central nervous system (CNS). Sosei is confident that the US is ideal for the pursue of CNS compounds as therapeutics as the Americans had been at the forefront of CNS research in recent years. Based in New Jersey, Kosei will be led by Yuzo Tarumi, currently Sosei’s board director. The company has also initiated a recruitment program to search for appropriate staff to manage its development projects in the US. Sosei acquired the SON-216 compound from Kosei as part of its unique drug reprofiling platform strategy and will use the development of the drug as the basis for increasing the company’s presence in the US. Apparently, SON-216 has a favourable safety profile and substantial supporting data package which enables SON-216 to be fasttracked into the clinical stage of development for ADHD. Launched in Japan in 1987, the compound (bifemelane hydrochloride) has been on the market for 11 years and is shown to be well tolerated and effective for the treatment of cerebrovascular related psychiatric symptoms. Sosei has exclusively licensed SON-216 from Mitsubishi Pharma to develop, manufacture and commercialize for ADHD, under the related patents – with an option to use for other indications. Mitsubishi retains the co-promotion rights to SON-216 in Japan though. SON-216 may be developed into a non-stimulant product to treat CNS diseases including ADHD. The latter has been described as a behaviour disorder characterized by ongoing inattention and/or hyperactivity-impulsivity occurring in several settings and more frequently and severely than is typical for individuals in the same stage of development. Shinichi Tamura, Sosei’s CEO described his company as having the strategic aim of expanding into the US for some time, and the collaboration with Mitsubishi had come at an opportune time for their development plans.

About Sosei Co Ltd Sosei is a leading Japanese biopharmaceutical company with significant expertise in drug development. It was founded in 1990, by Shinichi Tamura the ex-CEO of Genentech Japan, and is now capitalizing on its extensive global network established over the past 14 years in its successful technology transfer business.

Contact Details: Sosei Co Ltd Address: 4F Ichiban-cho FS Bldg, 8 Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 Japan Tel: +81 3 5210 3290 Fax: +81 3 5210 3291 Email: [email protected] URL: www.sosei.com APBN • Vol. 8 • No. 24 • 2004 1371 www.asiabiotech.com Industry Watch

Latest Pharma Merger: Dainippon and Sumitomo

n news of yet another major merger in the Japanese pharmaceutical sector, drug manufacturers Dainippon Pharmaceutical has bought up Sumitomo I Pharmaceuticals to form a merged entity that not only has the stronger potential to ward off competition in the saturated Japanese market, but one that is also large enough to make headways into the global market. The deal is expected to be completed by October next year. The two companies believe the merge will drive up their R&D activities with enhanced profitability and competitiveness. It combines the complementary focus shared by both companies, and the new firm is set to have a broader and expanding pipeline with products falling into five key therapy areas: cardiovascular, central nervous system, diabetes, infectious disease and respiratory. Other future businesses will still include the licensing of products and M&A programs to boost the product pipeline. But the focus will be on in-house development of products and the licensing of products from smaller players to source products. In terms of domestic ethical drug sales, the new entity will likely rank among Japan’s top ten pharmaceutical companies and hold the potential to develop several blockbuster drug products over the next few years. In the past, these two companies have relied heavily on licensing products to achieve sales growth. Sumitomo’s antipsychotic drug, SM-13496, is in Phase II clinical trials in the US, as well as SMP-114, a potential treatment for rheumatoid arthritis, in Europe. On the other hand, Dainippon has several drugs in development: an antidiabetes drug in the late stages of clinical development; the aldose reductase inhibitor AS- 3201, which is in preparations for Phase IIb studies in the US and Canada; and the antidementia drug AC-3933, which is in Phase II trials in Europe and Phase I in Japan. Small-scale pharmaceutical companies in Japan are increasingly looking to mergers as a way to stay competitive in the market. The consolidation of Dainippon and Sumitomo follows several mergers that had made the news as well, and it seems to present a quick solution to the problem of declining sales faced by Sumitomo. On the brighter side, Dainippon will almost double its revenue when it absorbs Sumitomo Pharmaceutical.

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About Dainippon Formed in 1897, Dainippon has set forth a corporate vision to build from the strengths of our past progress and make even greater progress as we look toward our bicentennial anniversary. We aim to contribute to people’s health and quality of life throughout the world by manufacturing the best quality pharmaceutical products, then moving forward through research and development to create even greater value.

Contact Details: Dainippon Address: 2-6-8 Doshomachi, Chuo-ku, Osaka 541-8524, Japan Tel: +81 6 6203 5307 Fax: +81 6 6203 5307 URL: http://www.dainippon-pharm.co.jp/english/

About Sumitomo Pharmaceutical Sumitomo Pharmaceuticals has marketed various new drugs for diseases for which there had been no effective remedies. The company strives to continue contributing to medical progress and to assist in maintaining and developing healthy lifestyles among today’s society through the research and development of innovative and effective new drugs.

Contact Details: Sumitomo Pharmaceutical Address: 12-2, Kyobashi 1-chome, Chuo-ku, Tokyo 104-8356, Japan Tel: +81 3 5159 2500 Fax: +81 3 5159 2945 URL: www.sumitomopharm.com

APBN • Vol. 8 • No. 24 • 2004 1373 www.asiabiotech.com Industry Watch

Eisai Targets on Anti-Hepatitis Drug Market in China

isai has in-licensed an anti-hepatitis B agent, generic name clevudine, from the South Korea-based company Bukwang Pharm, hence obtaining the E exclusive right to develop, manufacture and market clevudine in 10 Asian countries other than South Korea. In South Korea, Bukwang is already in the process of conducting Phase III clinical trials. Clevudine is an antiviral agent for treatment of hepatitis via DNA polymerase inhibition. Hepatitis B is a serious disease with high incidence in the region, especially in China. Clevudine provides a new option for hepatitis B treatment by its powerful antiviral effect. For the treatment of hepatitis B, antiviral agent, interferon, or liver protective agent are used. When plasma virus concentration is high, antiviral agent or interferon are used to control the level of virus. In this case, treatment may take a long time. Banking on its pharmaceutical expertise and experience in product development, Eisai will be developing the compound in countries in the region, aiming at the filing of new drug applications for approval principally in China. The company expects a powerful and continuous antiviral effect to be achieved from the development of Clevudine. Its mode of action is antiviral via HBV DNA polymerase inhibition. As a research-based pharmaceutical company with research facilities in Japan, US and Europe, Eisai mainly develops drugs based on novel natural compounds. The company’s main expertise areas are however in the development of treatment through neurology and gastroenterology.

About Eisai Co Ltd A company with a rich tradition of providing healthcare to patients, Eisai is engaged in the development, manufacture, and distribution of prescription and OTC pharmaceuticals, diagnostic products, and pharmaceutical production equipment. The company also has an extensive network of research centers across the globe.

Contact Details: Eisai Co Ltd Address: 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan Tel: +81 3 3817 5120 Fax: +81 3 3811 3077 URL: www.eisai.co.jp

APBN • Vol. 8 • No. 24 • 2004 1375 www.asiabiotech.com Industry Watch

Singapore Zimmer Targets at Asian Aging Population

ith medical technology advancements and developed healthcare systems, people are living longer, with higher expectations of a better W quality of life. In addition, improved economic well-being enables older people to lead independent, active lives. Zimmer is committed to helping these people, by providing effective solutions to restore mobility and relieve the pain of arthritis and traumatic injuries. The company aims to develop, produce and globally market orthopedic products and services that repair, replace and regenerate, thereby improving the quality of life for orthopedic patients. Zimmer has facilities and offices around the globe and in 1982, the company registered a business office in Singapore, as Zimmer Pte Ltd (ZPL). ZPL serves Singapore and markets in the Asia region, focusing mainly on Australia, New Zealand, Korea, Taiwan, China, Thailand, India and of course, Singapore. “Our main business activities in Singapore are marketing and distributing orthopedic implants, instruments and related equipment. Currently, the biggest market is Australia and New Zealand, however the greatest potential in the near future is China,” said Stephen Ooi, President of Zimmer’s Australasia operations. In 1987, ZPL introduced Innovative Cementless Hip and Knee joint implants to Singapore. Within a year, the product had gained market leadership, through focused surgeon education programs and high quality. These training programs, together with better technologies and surgeon skills have greatly improved the quality of surgical outcomes of joint replacements. Joint replacement products are needed for the surgical replacement of worn out or diseased joints, caused by osteoarthritis and rheumatoid arthritis, which are prevalent in elderly people. “Zimmer sells mainly joint replacement implants, implants for the treatment Contact Details: of trauma conditions of the bone, spinal implants and related equipment. Our Zimmer Inc bestselling products are the joint replacement implants, especially for knee Address: PO Box 708, replacements,” said Ooi. “In 2003, the total sales for ZPL was US$13 million, 1800 West Center which does not include the revenues of the other subsidiaries managed by our Street, Warsaw, regional office in Singapore.” IN 46581-0708, USA Over the past several years, ZPL has expanded its finance, distribution, Tel: +1 800 613 6131 marketing and materials functions, to support markets in the region. Future plans Fax: +1 574 372 4988 for ZPL are to further strengthen its regional functions, to include surgeon URL: www.zimmer.com education investments, setting up of regional learning centers, and direct clinical research/outcome and product development activities to tap the expertise in the region. The Zimmer Corporation has a long history of innovation. It has made significant investments into orthobiologics research, as it views that this will be a key part of the future of orthopedic care. In order to further enhance the company’s ability to provide quality, cost-effective products and services, Zimmer has formed numerous partnerships with healthcare providers around the globe. “We see ourselves supporting the complete continuum of orthopedic care for the patients to enhance their quality of life,” said Ooi. “Our Singapore office is a key strategic regional operation that will position the company well to strengthen our business leadership in the region. Singapore is an ideal geographic location with a good, stable, clean and efficient government and environment that supports business investments.”

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ES Cell Receives Million Dollar Grant

he US National Institutes of Health (NIH) has given a Singapore-based stem cell company a grant of US$1 million to help it build up its capabilities. ES T Cell International, one of only a handful approved to supply human embryonic stem cells to researchers who want US federal grants, has emerged as a major supplier over the last two years. The money would be given out over a period of three years. It has provided its human embryonic stem cell lines — colonies of the unprogrammed cells — to 150 laboratories all over the world, he said. The company owns six of the 22 cell lines or colonies currently listed on the NIH human embryonic stem cell registry. This is the second time NIH has pumped money into the company. Two years ago, NIH gave it US$400,000, as well as the green light to provide these sought-after cells to researchers worldwide. The company has about 70 researchers and collaborators here as well as in Holland, Australia and Israel, and has more than 250 patents pending or granted in the field. It is creating new cell colonies, which are not nourished by animal cells, the conventional method being used now. This means that they can eventually be used in trials involving people because there will be no danger of transmitting animal diseases. It aims to start clinical trials by 2006.

About ES Cell International Pte Ltd ES Cell International Pte Ltd (ESI) is a regenerative medicine company and a world- leading provider of products and technologies derived from human embryonic stem (hES) cells. ESI owns six of the nineteen hES cell lines currently listed on the US National Institutes of Health (NIH) Stem Cell Registry. ESI can supply hES cells, associated reagents, and comprehensive training to researchers, worldwide.

Contact Details: ES Cell International Pte Ltd Address: 11 Biopolis Way, # 05-06 Helios, Singapore 138667 Tel: +65 67749533 Fax: +65 67745077 Email: [email protected] URL: www.escellinternational.com

APBN • Vol. 8 • No. 24 • 2004 1377 www.asiabiotech.com Industry Watch

Tai wan

Combing to be Regional Vaccine Manufacturing Center

aiwan is taking another step to up its stakes in the vast Asia Pacific pharmaceutical market. With a budget of US$180 million from the T Council for Economic Planning and Development (CEPD), the Taiwanese Government is embarking on a 10-year program to make Taiwan the regional center for vaccine manufacturing. According to details of the proposal, US$60 million will be set aside for acquiring new manufacturing facilities and US$120 million for procuring the vaccines to be produced by these plants. The initiative is to provide incentives for drug companies and investors — both in Taiwan and from abroad — to form business alliances to build pharmaceutical production facilities in Taiwan. GlaxoSmithKline Inc (GSK), Kuo Kwang Biotech Co Ltd and Formosa Plastics Group have all expressed interest in the plan. Government research institutes will also be looking for foreign companies to help boost local development in the field with a built-operate-transfer, or BOT, project to produce flu vaccines. Once their plan is put into action, said Chong, The National Health Research Institute (NHRI) will serve as the coordinating unit for national projects ranging from lab tests and personnel training to exploiting cutting-edge vaccine technologies. NHRI has also secured a US$36-million government budget to expand its manufacturing facilities and research databases, putting particular emphasis on non-commercial vaccine products. More than simply benefiting from the business advantages of the vaccine plan, it is also considered a viable safeguard against a vaccine shortage on the island. The Taiwanese population is especially vulnerable to the outbreak of diseases because the island does not fall under the protective umbrella of the World Health Organization (WHO), hence prompting fears of inadequate supply of vaccines during an influenza pandemic, one of the many contagious diseases that may spread easily. The ultimate objective is to produce up to 2 million doses of flu vaccines each year for local consumption — and that Taiwan would be able to produce its first vaccine within the next seven years. In the case of a seasonal flu outbreak, Taiwan will then be free of any worry about vaccine shortages in the future, explained Health Minister Chen Chien-jen to stress on Taiwan’s pressing need to develop its own vaccination capabilities. In 2000, NHRI launched a two-year project on which the Academia Sinica’s Institute of Biomedical Sciences contributed to the research and development of a vaccine for Enterovirus 71, which is expected to hit the market in the near future, after animal trials are completed. The NRHI is currently researching vaccines for dengue fever and Japanese encephalitis as well.

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