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www.asiabiotech.com Company News Australia Starpharma to Conduct Animal Trials on Vaginal Microbicide Clover Secures HiDHA Oils Supply Contract to UK Starpharma Ltd., based in Melbourne, Australia, is being fully funded by the US National Institutes of Health (NIH) to conduct trials on a gel’s ability to prevent HIV/ SIV and chlamydia infection in macaque monkeys. Australian listed functional food ingredient company, Clover Corporation Ltd., has recently secured a contract to supply its HiDHA (DHA — Docosahexaenoic acid) oils for use in Heinz Farley infant formulas in the UK. The gel contains a compound known as SPL7013 and is being developed as a topical vaginal microbicide for application by women before sex to provide broadbased protection against infection by sexually transmitted diseases (STDs). Starpharma is currently preparing an Investigational New Drug application to submit to the US Food and Drug Administration (FDA) for Phase I testing of the SPL7013 gel in humans. SPL7013 will be the first dendrimer-based nanostructure approved for human testing. As dendrimers are a totally new class of compounds, Starpharma has to pioneer all aspects of the regulatory development of its drugs, which are being referred to as “Nanodrugs”. In previous trials, SPL7013 has been shown to be effective against a range of STDs, including HIV, herpes, hepatitis B and chlamydia. Recent studies conducted by the Division of AIDS Research in the US National Institute of Allergy and Infectious Disease (NIAID) have shown that SPL7013 protects cells from infection by a range of HIV-1 and HIV2 strains isolated from HIV patients. Due to the high potency exhibited by the compound against the clinical isolates of HIV, it has been selected to advance to NIHsupported trials for the prevention of HIV/SIV infection in monkeys. Another study will be conducted to study the prevention of chlamydia infection. This study will initially examine the safety of SPL7013 following multiple intravaginal applications and will then assess its ability to prevent chlamydia infection. Starpharma Ltd., a wholly owned subsidiary of Starpharma Pooled Development Ltd., is a biopharmaceutical company focused on the development and application of dendrimer nanotechnologies as drugs against major diseases. 348 v6n10-pt1 The contract is to supply 43 000 kilos of HiDHA rich oils for a twelve-month period commencing March 2002. According to Clover’s executive chairman, Mr Hamish Drummond, the contract would generate some A$2 million (US$1.08 million) in sales revenue for Clover. Clover has developed a prominent position in long chain polyunsaturates (LCPs), Omega-3 (DHA) and Omega-6 (GLA) oils. LCPs, and especially DHA, are essential for good health but are not widely available in the modern diet. Mr Drummond added, “This UK-based infant formula product coupled with the recent announcement that the FDA has approved the use of DHA in infant formula will lead to the use of these essential fatty acids in infant formula products throughout Europe and other parts of the world.” Research has confirmed that adding DHA to infant formulas enhances brain and eye development in babies in the same way breast milk does naturally. The human brain undergoes rapid growth during the first 12 months of life, with DHA crucial to maximizing development and cognitive abilities. Clover has developed a prominent position in long chain polyunsaturates (LCPs), Omega-3 (DHA) and Omega-6 (GLA) oils. Research has shown that LCPs, and especially DHA, are essential for good health but are not widely available in the modern diet. Clover’s products are based on the richest natural source of DHA, tuna fish oil. Clover sources this DHA from South Pacific tuna fish, a sustainable clean source of tuna stock. APBN • Vol. 6 • No. 10 • 2002 348 5/14/02, 9:58 AM Company News China GlaxoSmithKline Completes Business Integration in China GlaxoSmithKline appears in the China market with a whole new stance as it rounds up its business integration in China. The company’s business and market strategy has been determined and in this month the new management ranking would implement its market strategy in China. The company aims to be the overlord in China’s medicine industry. Last year, GlaxoSmithKline invested in both Tianjin GlaxoSmithKline Co. Ltd. and Suzhou GlaxoSmithKline Co. Ltd., the total investment amounting to US$0.218 billion. GlaxoSmithKline said that the merger of Glaxo and Smithkline not only complements its business in China, but also strengthens the company’s competitiveness in China. After the completion of integration, GlaxoSmithKline’s first action in the China market is to cooperate with Switzerland pharmaceutical giant Novartis to market the latter’s Lamisil (terbinafine hydrochloride tablet) in China through the company’s Tianjin branch, which is good at overthe-counter (OTC) market. Tianjin GlaxoSmithKline recently held a press conference in Beijing to announce that it would march into the OTC market. It said that in the Chinese OTC market, the company has accumulated effective management and operation experience and possesses a strong marketing team. In 2001, GlaxoSmithKline achieved sales of US$29.5 billion and profit before tax of US$8.8 billion. Among which pharmaceutical sales accounted for US$24.8 billion with new products representing 22 percent of total pharmaceutical sales. GlaxoSmithKline has over 100 000 employees worldwide. Of which more than 40 000 are in the sales and marketing area, consisting the largest sales force in the industry. The company hires more than 42 000 employees working at 107 manufacturing sites in 40 countries and employs over 16 000 staff for R&D. Refrigerators, freezers and transport containers for the medical sector Gold Safety Standard features • History of abnormal data stored in relation to alarm • Alarm tests • RS 485 interface • Door opening alarm • Self-diagnosis • Door looking device • Forced-air refrigeration • Digital temperature display • Audible and visual alarms • Alarm system with a backup power supply of at least 48 hours in case of power failure • Key-operated power switch • Remote alarms • Safety thermostat • Guaranteed operation with an outside temperature between 10°C and 43°C • Special insulation • Stainless steel cabinet • Automatic opening and closing of the door Dometic Private Limited • 10 Toh Guan Road, #10-02 TT International Tradepark • Singapore 608838 Tel. : 6795 3177 • Fax : 6862 6620 Email : [email protected] • www.dometic.lu APBN • Vol. 6 • No. 10 • 2002 v6n10-pt1 349 5/14/02, 9:58 AM 349 www.asiabiotech.com Company News GSK and Gilead Sign Licensing Agreement for Hepatitis B Drug in Asia US-based Gilead Sciences Inc. and GlaxoSmithKline have recently announced the signing of a licensing agreement for the rights to commercialize adefovir dipivoxil, Gilead’s investigational antiviral for the treatment of chronic hepatitis B, in Asia, Latin America and other territories. Under the agreement, Gilead will retain rights to adefovir dipivoxil in the US, Canada, Eastern and Western Europe, Australia and New Zealand. GSK will receive exclusive rights to adefovir dipivoxil solely for the treatment of hepatitis B in all countries outside of the Gilead territories, the most significant of which include China, Korea, Japan and Taiwan. Adefovir dipivoxil is in Phase III development by Gilead for the treatment of chronic hepatitis B. Dosed as one oral 10 mg tablet (once daily), adefovir dipivoxil belongs to a novel class of drugs called nucleotide analogues, which are designed to work by blocking HBV DNA polymerase. In these markets, GSK plans to develop adefovir dipivoxil for patients with chronic hepatitis B who are naive to therapy as well as for those patients who have developed lamivudine-resistant HBV. GSK has agreed to pay Gilead an up-front licensing fee of US$10 million, and Gilead is entitled to receive additional cash payments of up to US$30 million upon achievement of certain milestones. GSK also will pay Gilead an undisclosed royalty on net sales of adefovir dipivoxil. GSK will have full responsibility for development and commercialization of adefovir dipivoxil in the covered territories. Adefovir dipivoxil is in Phase III development by Gilead for the treatment of chronic hepatitis B. Dosed as one oral 10 mg tablet (once daily), adefovir dipivoxil belongs to a novel class of drugs called nucleotide analogues, which are designed to work by blocking HBV DNA polymerase, an enzyme involved in the replication of HBV in the body. Adefovir dipivoxil is an investigational compound and has not yet been 350 v6n10-pt1 determined safe or efficacious in humans. Gilead has recently filed a New Drug Application for adefovir dipivoxil with the US Food and Drug Administration and a Marketing Authorization Application with the European Medicines Evaluation Agency. “Adefovir dipivoxil will be a valuable addition to our portfolio,” said Mr. Howard Pien, president of pharmaceuticals international at GlaxoSmithKline. “We hope adefovir dipivoxil will offer a valuable new treatment option to physicians and will help improve the quality and duration of life of millions of hepatitis B patients across Asia, Latin America and other international areas.” For the treatment of chronic hepatitis B, GSK also markets Zeffix in 50 countries worldwide, including China (as Heptodin), the US (as Epivir-HBV) and Europe. More than 200 000 patients have been treated with Zeffix since its first launch in November 1998. With total 2001 sales of US$148 million, Zeffix is currently the only licensed oral antiviral treatment for chronic hepatitis B worldwide. Tianjin Tasly Steps into Biopharmaceutical Field China’s Tianjin Tasly Pharmaceutical Co. Ltd. has recently entered into an agreement with the Chinese Academy of Military Medical Sciences on the technology transfer and development of a Class I biological new drug named genetically engineered uPA (plasminogen activator). u-PA, also called recombinant human urine plasminogen activator, is indicated for thrombolic cerebro-cardiovascular diseases. Tasly will invest a total of US$18 million on the development and production of the drug in collaboration with the Chinese Academy of Military Medical Sciences. Tianjin Tasly, one of the fifteen largest enterprises in Tianjin, is a famous traditional Chinese medicine company. Its major product is Compound Danshen Drop, a leading drug in the treatment of cardiovascular diseases. Through this cooperation, the company has diversified its product scope into biological and chemical drugs. APBN • Vol. 6 • No. 10 • 2002 350 5/14/02, 9:58 AM Company News Nova BioGenetics Receives Chinese Approval for Antimicrobial Hand Gel positioned to capture a significant share of the local market.” BioShield Technologies Inc. has recently announced that Nova BioGenetics, an affiliate company of BioShield, has received approval from China’s State Drug Administration (SDA) for the country’s first antimicrobial hand gel using Bioshield’s technology. Befar incorporates alprostadil, a drug well recognized for treating ED, with the NexACT® transdermal delivery technology. Befar is manufactured in China and marketed in China and Hong Kong by NexMed’s Asian licensee. Through Nova BioGenetics and BioShield’s partnership with MegaStar Universal Ltd., Megastar has been very active in formulating, testing and creating China’s first antimicrobial hand gel. In clinical studies conducted in China, Befar exhibited two advantages over the currently marketed oral ED medication — faster onset time and minimal side effect profile. Initial marketing of the product in China and Asia has produced significant demand and medical acceptance for the product as it mitigates the vast majority of the bacteria and fungi that typically create viral illnesses. BioShield Technologies Inc. is a Georgia, US based antimicrobial and antiviral company. Its core business is committed to the discovery, development, marketing and sale of surface-modifying antimicrobial and anti-viral products. Its antimicrobial technology is a revolutionary alternative to conventional sanitizers, disinfectants, or biocides primarily because it kills bacteria, and viruses, including HIV, on contact and can remain active for extended time periods. Dr. Mo further added, “During 2002, we anticipate additional approvals and filings in various international markets.” In the US, NexMed is conducting its Phase III clinical development programs for AlproxTD. The multi-center trials will enroll up to 2500 patients with mild to severe ED. NexMed has completed a Phase II multi-center take home study with its Femprox ® topical treatment for female sexual arousal disorder. NexMed Inc. is an emerging pharmaceutical and medical technology company with a product development pipeline of innovative topical drug treatments based on the NexACT transdermal drug delivery technology. Hong Kong India NexMed’s Alprox-TD Launched in Hong Kong US-based NexMed Inc., a developer of innovative topical treatments based on its proprietary drug delivery technology, has recently launched a proprietary cream treatment for erectile dysfunction (ED) called Alprox-TD® in Hong Kong under the trademark Befar®. NexMed has been selling the treatment in China since July 2001. In November 2001, NexMed and its Asian licensee filed a New Drug Application with the Health Sciences Authority for approval to market Befar in Singapore. Dr. Y. Joseph Mo, president and chief executive officer of NexMed, commented,“We are excited about the potential of Befar in Hong Kong, a small but lucrative market. We believe that as the first approved topically-applied ED treatment, Befar is well GlaxoSmithKline’s Indian Subsidiary to Source for Raw Materials GlaxoSmithKline Pharmaceuticals (GSK), the global pharmaceuticals company, will soon commence sourcing of raw materials like viles, syringes and bottles from its Indian subsidiary. GSK has sourced from India raw material such as ranitidine and sulphamethoxazole for many years. However, it is unlikely that formulations will be sourced out from India in the near future on account of regulatory issue. APBN • Vol. 6 • No. 10 • 2002 v6n10-pt1 351 5/14/02, 9:58 AM 351 www.asiabiotech.com Company News A company spokesperson said, “Though, the manufacturing facilities of GSK in India are undoubtedly world class producing formulations of international quality, we need to significantly enhance our manufacturing efficiencies to further up the global manufacturing competitiveness of our facilities.” It is now globally accepted that the Indian pharmaceutical industry manufactures many items (from the raw materials) required by the industry as per international specifications and quality. Thus, many international pharmaceutical companies are actively contemplating sourcing for raw materials from India. Headquartered in the UK and with operations based in the US, GSK is one of the industry leaders, with an estimated seven percent of the world’s pharmaceutical market. It also has leadership in four major therapeutic areas — anti-infectives, central nervous system, respiratory and gastro-intestinal/ metabolic. Socrus Launches NDDS for Cipro in Intramuscular Dosage Form Indore-based Socrus Pharmaceutical Ltd. has recently pipped other Indian pharmaceuticals firms by coming up with a novel drug delivery system (NDDS) for ciprofloxacin (cipro) in an intramuscular (IM) dosage form. Socrus has filed for both the local and American patents for this NDDS and is scouting for a partner to license it out. This is the world’s first NDDS for cipro in an IM dosage form. Socrus plans to obtain the US Food and Drug Administration approval through the joint efforts of licensing, manufacturing and a marketing partner. Cipro, scheduled to go off-patent by December 2003, is currently available through the oral route in tablets or intravenous (injectible) route globally. Usage of cipro was earlier brought into sharper focus following the anthrax scare in the US. Cipro administered through the oral/ intravenous route absorbs into the body slowly, 352 v6n10-pt1 leading to delayed relief. Intravenous infusion also calls for hospitalization as its administration of 100ml/200ml is done drop by drop. As against this, the patient given an IM injection gets quicker relief and also needs no hospitalization. However, according to analysts, injectibles in cipro account for only 5–10 percent of the US$1.8 billion global market. Indian giant Ranbaxy had earlier licensed the exclusive development and worldwide rights for its oncea-day cipro in tablet form to Bayer AG in a US$50 million deal, plus the royalty. Cadila to Make Presence Felt in Dermatological Market The Ahmedabad-based pharmaceutical company Cadila Pharmaceuticals Ltd. is set to increase its presence in the dermatological sector. Mr. R. Sahni, senior vice president of marketing for Cadila, revealed that the company is proposing to enter the Rs876 crore (US$179 million) topical dermatological market in a big way in the near future. Cadila has thus far concentrated on the oral dermatological segment that mainly constitutes drugs such as antibiotics, anti-allergics and steroids. The range of topical dermatological products identified by Cadila include exclusive and latest molecules for two chronic skin problems namely acne and psoriasis. In the acne market, which is broadly divided into prescription oriented molecules and cosmetic OTC preparations like Clearasil, CPL is launching the latest retinoid Adapalene, hailed as a breakthrough molecule in both the treatment and prophylaxis of acne. The company proposes to launch the drug next month. As for the psoriasis market, Crosslands has been the sole player in a monopoly market. The company imports the molecule Calcipotriene in its finished form from Denmark-based Leo Pharmaceuticals and markets it in India. However, Cadila would be importing the raw material for the drug and making it in India. Cadila is also exploring the possibility of entering the oral acne treatment sector later this year. Mr. Sahni said, “We have not been able to do this so far as the sole molecule for this, isotretinol, which though available in the international market, is fraught with serious side effects specially if taken by pregnant women.” APBN • Vol. 6 • No. 10 • 2002 352 5/14/02, 9:58 AM Company News Japan Takara Bio Sets up Organic Produce Operation to Develop Health Foods Takara Bio Inc. has recently announced that it will set up an agricultural biotechnology branch on Yakushima Island, southern Japan to produce organic plants and herbs for the development of health foods. To kick off, Takara will be producing health foods from extracts of ashitaba (Angelica Keiskei), a unique celery-like vegetable. Research by Takara has shown that ashitaba contains many substances that can prevent cancer, as well as large quantities of elements that stimulate nerve growth factors (NGF). NGF stimulate the growth and development of neurons in the central and peripheral nervous systems and are promising for the prevention and treatment for the degeneration of peripheral nerves, which can lead to senility and diabetes in the elderly. The new branch will be located at a 210 000 square meter site in Kamiyaku-cho on Yakushima Island, a World Heritage Site. Takara will purchase the land five years after the establishment of the branch. In addition, Takara will build a “Healing Village”, where people may refresh their mind and body by farming in the beautiful natural environment of Yakushima. Takara is already creating an agricultural biotechnology branch in Fukushima prefecture, northern Japan. With a similar climate to the Tokyo region, Fukushima is an ideal site for organic health food production and vegetable-processing. Takara Bio Inc., based in Shiga, Japan, is divided into three divisions: DNAtech, which develops technology and equipment for research into genomics and proteomics; BIOMedi, which develops biotechnology applications in geneand cell-based diagnostics and therapies; and AgriBIO, which concentrates on agricultural biotechnology. Aventis and Fujisawa to Cooperate in Marketing of Synercid Injection Aventis Pharma Ltd. and Fujisawa Pharmaceutical Co. Ltd. have jointly announced that they have formed an alliance to market the streptogramin antibiotic, Synercid® Injection. In recent years, the strong resistance of vancomycinresistant Entercoccus faecium (VREF) to the glycopeptide antibiotic vancomycin has become increasingly problematic, especially in Europe and the US. VREF has also been reported in Japan since 1996, although the number of cases remains small. Composed of quinupristin and dalfopristin, Synercid Injection is the world’s first injectable streptogramin antibiotic. It exhibits strong antibiotic activity against VREF and is approved and marketed in over 30 countries worldwide. Created and developed by Aventis and composed of quinupristin and dalfopristin, Synercid Injection is the world’s first injectable streptogramin antibiotic. It exhibits strong antibiotic activity against VREF and is approved and marketed in over 30 countries worldwide, including the UK and the US. Aventis received a Japanese import license in January 2002. Aventis and Fujisawa are already cooperating in the marketing of the anti-allergic Intal® and the glycopeptide antibiotic Targocid Injection®. The two companies have agreed to form the alliance for the marketing of Synercid in Japan, taking into account the nature of Synercid as a drug for the treatment of such specialized diseases as VREF infections. Under this agreement, Fujisawa will be the sole distributor of Synercid Injection in Japan, and Aventis will possess the license to import. Fujisawa plans to launch Synercid in the summer of this year. Fujisawa Pharmaceutical Co. Ltd. produces and markets pharmaceuticals, medical equipment and supplies, home care business, chemicals and animal health products. The company is one of Japan’s largest drug makers, with its main strength in antibiotics. APBN • Vol. 6 • No. 10 • 2002 v6n10-pt1 353 5/14/02, 9:58 AM 353 www.asiabiotech.com Company News Eisai Announces Phase III Clinical Trial Results for Vascular Dementia Drug Eisai Co. Ltd., based in Tokyo, Japan, has recently released the results of the second of two phase three clinical trials conducted in the US and Europe by Eisai Inc. involving vascular dementia (VaD) for Aricept®. The new data reinforces earlier findings that demonstrated treatment with Aricept significantly improved cognitive function with vascular dementia compared with placebo in the double-blind study. There are no approved treatments for this condition yet. VaD is the second most common form of dementia, accounting for up to one-third of all diagnosed dementia cases in the US. The prevalence of VaD increases with age and, as the number of people in the US age 65 and older is expected to grow to 69.4 million by the year 2030, VaD can be expected to be a growing healthcare issue in society. The 24-week double-blind randomized study involved patients who received daily doses of 5mg Aricept, 10-mg Aricept or placebo. The study included 603 men and women with VaD. All participants took one or more medications, with over 80 percent receiving medication to prevent strokes. Patients who received 5 or 10 mg of Aricept showed significant improvement in their cognitive function compared to those taking placebo. Evaluation of global function also revealed significant improvements for patients at the 5 mg dose of Aricept doses compared to patients who received placebo. Improvement for patients on the 10-mg dose was not significantly better than placebo. Overall adverse events in VaD patients treated with Aricept did not differ significantly in frequency compared to Alzheimer’s disease patients. As expected and consistent with the drug’s known mechanism of action, side effects related to the digestive system (including diarrhea and nausea) 354 v6n10-pt1 occurred more frequently in Aricept treated patients than placebo treated patients. Of the 125 patients who discontinued the study, 89 did so due to an adverse event. Aricept is an acetylcholinesterase inhibitor. It increases a neurotransmitter in the brain, acetylcholine serving to improve the symptoms associated with Alzheimer’s disease. Aricept has been launched in over 50 counties worldwide including Japan, the US, the UK, Germany and France. Eisai Co. Ltd., established in 1941, is a leading pharmaceutical manufacturer specializing in ethical drugs. Prescription drugs account for about 90 percent of sales and are led by Aricept, the firm’s top seller that treats Alzheimer’s disease. Marubeni Chicken Plant Ordered to Shut Down Marubeni Chikusan Corp. has recently been ordered by Japan’s Fair Trade Commission (FTC) to cease production over its intentional mislabeling of some 1700 tons of chicken during a three-year period from 1999. According to the FTC, the mislabeling was conducted at the company’s nine offices, including Sendai and Osaka. Marubeni Chikusan Corp., a unit of trading house Marubeni Corp., is the second major meat processing company to receive an FTC order in relation to false labeling charges. In March, Tokyo-based Snow Brand Foods Co. became the first to receive such an order. The company sold 700 tons of Brazilian chicken labeled as domestic chicken to 80 mass retailers between April 1999 and February this year. During the same period, it sold 1000 tons of ordinary chicken as special brand-name chicken. The FTC order also requires the firm to place advertisements in newspapers and elsewhere to apologize for its actions and to reveal all facts. In March, Marubeni Chikusan admitted that its branch office in Sendai passed off chicken imported from Brazil as higher-priced domestic chicken. It was revealed that the company falsified descriptions of 5–8 tons of imported chicken each year during 1999 and 2001. Its president Mr. Hitoshi Nishizono recently admitted to the Japanese agricultural ministry that the illegal labeling practices might also have occurred at other offices. APBN • Vol. 6 • No. 10 • 2002 354 5/14/02, 9:58 AM www.asiabiotech.com Company News Korea business partners worldwide. Medi-Hut International’s Tussle with KFDA Medi-Hut International, a joint venture between Medi-Hut Co. Inc. of the US and a Korean international distributor of medical supplies, has recently suffered a setback. Export sales of the company’s medical syringes and other products to overseas markets have been affected by obscure regulations of the Korean Food and Drug Administration (KFDA). Until now, KFDA still refuses to issue the “Certificate of Free Sales” which certifies that a “firm is authorized to manufacture medical devices under the Pharmaceutical Affairs Law, and the item(s) is permitted to be freely sold in domestic and overseas markets” to Medi-Hut. Overseas import firms are only familiar with the name “Medi-Hut International”. There is thus a discrepancy between the company name that appears on the cer tificate (“Hangook Medi-Hut”) and the name known by its business partners. As this certificate is required as proof by some importing countries, Medi-Hut’s export sales performance is potentially threatened. When Medi-Hut first registered with KFDA as a foreign-invested company in Korea, the company gave its legal name as “Hangook Medi-Hut” in Korean characters on the “Certificate of FDI Company Registration”, although the name Medi-Hut International also appeared in English on the same document. As Medi-Hut’s main business is outside of Korea, the company has used only the name Medi-Hut International for all its promotional materials, packaging, letterheads, etc. As a result, overseas import firms are only familiar with the name “Medi-Hut International” from day-to-day business dealings. There is thus a discrepancy between the company name that appears on the certificate (“Hangook Medi-Hut”) and the name (“Medi-Hut International”) known by its 356 v6n10-pt1 In the past, the application form as well as the actual certificate were issued only in the Korean language; and herein lies the root of the problem. The KFDA insists that the English certificate should carry the phonetic translation of the company’s legal Korean business name, or in this case, “Hangook Medi-Hut”. KFDA’s argument is that by adhering to the phonetic translation of a company’s name, further confusion can be avoided in the event that another company establishes a business named “Medi-Hut International” (in Korean characters), though such a scenario is highly unlikely due to copyright infringement laws. KFDA’s reluctance to grant the certification can destroy Medi-Hut’s credibility with its clients, and may also cause lucrative business ties to be severed. Malaysia Top Glove to Set up Eighth Plant near Shanghai Malaysia’s world-leading glove manufacturer Top Glove Corp. Bhd. plans to set up its eighth plant near Shanghai to produce PVC gloves. Dr. Lim Wee Chai, chairman and managing director of Top Glove, said that construction of the plant is targeted to begin by the end of this year. The company would invest about RM11.4 million (US$3 million) to add another 12 dipping lines upon completion of its first phase. Top Glove currently has six plants with 58 dipping lines, which now produce about 3.6 billion pieces of gloves a year. Five of the plants are in Klang and Ipoh, Malaysia while one is in Phuket, Thailand. The company is also starting construction of its seventh plant in Hatyai, Thailand next month. The plant would be completed by end of this year and provide another 20 dipping lines within a year. According to Dr. Lim, Top Glove would have an additional 40–50 dipping lines from its Hatyai and Shanghai plants in the next three years. The two plants would produce about three billion pieces of gloves a year. He said that with this scale, Top Glove would be one of the world’s top three latex glove manufacturers by next year. It is currently in the world’s top five and targets to be APBN • Vol. 6 • No. 10 • 2002 356 5/14/02, 9:59 AM Company News number one by 2005. Top Glove Corp. Bhd., established since 1991, is one of the world’s leading manufacturers and exporters of high quality latex examination, nitrile, surgical, household and industrial gloves based in Malaysia. Over the years, it has expanded to a production capacity in excess of 300 million pieces of gloves permonth or 3.60 billion pieces of gloves per year. Chemical Company of Malaysia to Focus on Pharmaceuticals Chemical and fertilizer firm Chemical Company of Malaysia Bhd. (CCM) is planning to turn its pharmaceutical businesses into the main source of income in the near future. Mr. Lim Say Chong, managing director of CCM, said that the company sees much better long-term potential from its newly developed pharmaceutical businesses. Its wholly owned subsidiary Upha Corp. (M) Sdn. Bhd. and CCM Pharma, which manufactures and retails pharmaceutical products, manage the group’s healthcare business. The pharmaceutical businesses brought CCM a pre-tax profit of RM5.6 million (US$1.5 million) last year, down from RM5.9 million (US$1.6 million) the previous year. Mr. Lim said that the decline is a temporary hiccup, as steps have been taken to rationalize and consolidate the manufacturing sector as well as strengthen its distribution and brand building effort. The company is looking at building more brands of pharmaceutical products and increasing the number of its Prima Health retail centres. For greater access to the latest medical research, the company has since 1997 invested in US-based Impax Laboratories Inc. and Cardiome Pharma Corp., which develop and commercialize specialty, generic branded pharmaceuticals. Mr Lim said, “CCM has a 14 percent stake in Impax and six percent in Cardiome. We have the exclusive rights to distribute the products from both companies in this part of the world except for Japan and Taiwan.” Philippines Monsanto Philippines Harvests Bt Corn Monsanto Philippines has recently harvested Bt corn in its field trial site in Pangasinan, Philippines. This is one of the eleven trials conducted in various parts of the Philippines during the dry season cropping. The harvesting is strictly supervised by the Bureau of Plant Industry and is also witnessed by representatives from other national and local government agencies. The members of the Scientific and Technical Review Panel of the National Committee on Biosafety of the Philippines also monitored the harvesting. According to Mr. Ronald G. Cabangbang, product development executive of Monsanto, two Bt corn varieties are field tested in the area. These are Yieldgard 818 and YieldGard 838. These Bt corn varieties are specifically evaluated for resistance to Asian corn borer and compared with commercial corn hybrids. Results confirmed the effectiveness of the Bt corn varieties in controlling Asian corn borer infestation. Unlike traditional varieties of corn, Bt corn exhibits healthier plants, undamaged stalks, and cleaner cobs. The benefit of the Bt technology in protecting yield is clearly demonstrated. Data from the Pangasinan field trial, including those in the other ten trial sites for dry season evaluation of Bt corn, will be released soon by Monsanto. Singapore Air Products Installs First Cryogenic Abatement System in Singapore Air Products and Chemicals Inc. has recently completed the installation of a cryogenic solvent recovery system at Schering-Plough’s new manufacturing plant in Singapore. The Cryo-Condap® system, to abate volatile organic compounds from the pharmaceutical manufacturing process, is the first of its kind in Singapore. Air Products has over 70 of this system installed worldwide to cater for a APBN • Vol. 6 • No. 10 • 2002 v6n10-pt1 357 5/14/02, 9:59 AM 357 www.asiabiotech.com Company News range of industries including fine chemicals, pharmaceutical and refrigeration recycling. development in relation to drugs and genome based diagnostics. The system works on a basis of cryogenic condensation. Its uses liquid nitrogen in a heat exchanger to cool down a waste gas stream. The solvent can then be separated from the waste gas stream and either is re-processed for use in the manufacturing process or disposed of, depending on the characteristics of the solvents and regulatory requirements. The BioEnterprise Asia (BEA) Group is a consortium of life science enterprises dedicated to identifying, nurturing and managing the development of innovative new technologies and high growth enterprises in healthcare, the life sciences and related technology areas.␣ The carrier gas is then “virtually solvent free” and can be safely dispersed into the environment. In this process, up to nine different solvents are treated. A spokesman of the company said, “We have worked closely with Schering-Plough to develop, build and deliver the hi-tech recovery system on budget and within a very short space of time — ready for the anticipated mid-year opening of their new plant. Our cryogenic team is dedicated to delivering bespoke systems which provide the most efficient environmental solution to meet legislative demands now and in the future.” Air Products and Chemicals Inc. is the world’s only combined gases and chemicals company. It is a market leader in the global electronics and chemical processing industries, and a longstanding innovator in many industrial markets, including coatings, adhesives and ployurethanes. BioEnterprise Asia and Ocimum Biosolutions to Jointly Set up R&D Facilities BioEnterprise Asia, based in Singapore and Ocimum Biosolutions have recently signed a Memorandum of Understanding (MoU) in Hyderabad, India to form a joint venture called Ocimum BioEnterprise Labs. The MoU is exchanged between Dr. Gurinder Shahi, CEO of Bioenterprise Asia and Ms. Anuradha Acharya, CEO of Ocimum Biosolutions Ltd. Ocimum BioEnterprise Labs will set up R&D facilities at the ICICI Knowledge Park in India. Areas of interest will include technology and product 358 v6n10-pt1 Dr. Shahi said, “BioEnterprise Asia recognizes the tremendous untapped potential of scientific insight and nascent technologies in India.” The␣ BEA Group currently include Lynk Biotechnologies in the proteomics and drug development arena and Asia Pacific Genomics in the genomics arena and others in the areas of medical device and biomedical IT, surfactants and specialty biomaterials and bioinformatics and molecular modeling arenas. Ocimum Biosolutions is a life sciences research and development company with focus on bioinformatics and contract research services with operations both in the US and India. Ocimum Biosolutions has its US Headquarters in Indianapolis, Indiana. The Indian arm of Ocimum Biosolutions is located in Hyderabad. The company’s primary focus is to be a one-stop destination for bioinformatics consulting needs and also on development of key ready-to-use bioinformatics software modules, contract research and training. Taiwan US Criticare Expands Partnership with Taiwan BioCare US-based Criticare Systems Inc. has recently expanded its partnership with Taiwan’s BioCare Corp. to include the distribution and service of Criticare’s products in China and Taiwan. BioCare is a subsidiary of the Koo’s Group, the second largest company in Taiwan. The agreement calls for Criticare Systems Inc. labeled product to be manufactured in Taiwan and China by BioCare, who will now be responsible for complete sales and service APBN • Vol. 6 • No. 10 • 2002 358 5/14/02, 9:59 AM Company News in those countries. BioCare currently manufactures a major percentage of Criticare’s products in Taiwan. This is being expanded to a new 300 000 square feet facility, shared with other Koo’s Group subsidiaries near Shanghai, China. Criticare’s President Mr. Emil Soika stated, “We expect this arrangement to open opportunities for significant growth that could not be unlocked through a traditional international sales network.” “BioCare has proven to be a valued high quality partner with astute insights into the emerging Asian markets. We believe that this strategy will dramatically improve Criticare’s business potential in these markets.” Criticare is an international medical device company headquartered in Waukesha, Wisconsin, US. It designs, manufactures, and markets cost-effective patient monitoring systems and noninvasive sensors for a wide range of hospitals and alternate health care environments throughout the world. Invested by Grand Pacific Petrochemical Corp. of the Koo’s Group, which is one of the most influential enterprises in Taiwan, BioCare Corp. is one of the largest biomedical device manufacturers in Taiwan. The company dedicates its professionals to developing products and services worldwide. Rules & Regulations AstraZeneca, with a research facility at Brisbane’s Griffith University, has a collection of more than 40 000 mainly rainforest plants, insects, fungal samples and marine organisms gathered under deals with the governments of Queensland, Papua New Guinea, China and India. As part of the arrangement, a royalty stream is guaranteed to Griffith University should any products develop from AstraZeneca’s on-campus research. The Queensland Museum and Brisbane Herbarium as collectors will receive 15 percent of the royalty. Under licensing agreements with the governments of Western Australia and Queensland, BioProspect is systematically collecting thousands of native plants for screening. After testing the chemistry of 400 trees in the Atherton Tableland area of Northern Queensland, BioProspect discovered a naturally occurring insecticide, which it is now developing. Under the deal, BioProspect has to use Queensland facilities and services to develop the discovery and ensure as much spin-off as possible goes back to the state of origin. The Australian government is yet to introduce new regulations covering bio prospecting. The deal agreed to in The Hague requires companies or collectors seeking information from indigenous peoples to secure “prior informed consent’’ beforehand. The international meeting wants nations to pass this and other agreed guidelines for bio prospecting into law. Australia Companies to Need License for Bio-prospecting A recent meeting in The Hague has agreed on guidelines for national licenses to access genetic resources. This will allow poor countries to make money from drugs and other new products synthesized from their indigenous plants. At least three Australian organizations are reported to be racing to gather massive collections of Australian plants, insects, marine life and other organisms before the voluntary agreement is adopted. These are the Perth-based company BioProspect, multinational drug and agrochemical company AstraZeneca, and the Australian Institute of Marine Sciences. India Small Firms Seek More Time to Implement GMP Recognizing funding constraints of India’s small pharmaceutical units, a panel working on India’s drug and pharmaceutical policy has recently suggested that the deadline to implement World Health Organization’s (WHO) good manufacturing practices (GMP) be extended by one year to 31 December 2004. It has also suggested that the small scale industry (SSI) units be given financial assistance to bring them up to par with international GMP requirements. APBN • Vol. 6 • No. 10 • 2002 v6n10-pt1 359 5/14/02, 9:59 AM 359