KPMG, Watson Pharmaceuticals, Tui, Dunkin' Brands: Intellectual Property Bloomberg- Jun 9, 2011 China's drug market is primed for "explosive growth," making its pharmaceutical companies attractive takeover targets for drugmakers about to lose patents on their most popular medicines, according to KPMG LLP. Products worth more than $30 billion will lose patent protection this year, leading more drugmakers to consider buying or joining with companies in China, the world's third-biggest drug market, according to a KPMG report released yesterday. The report said that large pharmaceutical companies are turning away from traditional mergers that boost margins and reduce costs, and are looking for unconventional acquisitions such as firms that have unique uses for drugs, according to the report. "The pharmaceutical market will experience explosive growth in the coming years," KPMG said, adding that the expansion would be fueled by rapid environmental, economic and social changes that follow urbanization. "The industry now feels there is a better business model in zeroing in on the end customer rather than on bulk manufacturers of generics." As an example, KPMG mentioned Nasdaq-listed SciClone Pharmaceuticals' purchase of NovaMed Pharmaceuticals Inc., a China-based specialty company, in April. NovaMed has a portfolio of 18 drug products spanning major therapeutic areas including oncology, cardiovascular disease and central nervous system disorders. China's pharmaceutical market is predicted to grow at least 25 percent this year, according to U.S.-based research firm IMS Health. Pfizer Inc. (PFE) on June 3 unveiled plans for a potential joint venture with Zhejiang Hisun Pharmaceutical Co. to produce branded and low-cost generics, as it seeks revenue sources before it loses U.S. patent protection in November for Lipitor, the cholesterol medication. Lipitor was the world's best-selling drug last year with $10.7 billion in sales. KPMG also said foreign companies investing in China risk running afoul of new Chinese laws, such as the 2008 PRC Anti- Monopoly Law, as well as other laws such as the U.S. Foreign Corrupt Practices Act and the recently enacted U.K. Bribery Act. Compliance can be difficult due to China's lack of transparency in transactions and less-than-complete business records to support corporate payments, KPMG said. "It becomes even more murky and ambiguous in the health- care, medical device, and pharmaceutical sectors given the significant use of distributors, agents, and other third- parties," the report said. The law may see those groups as part of the company, but they don't typically "have the internal controls in place to adequately maintain their own books and records," KPMG said. Pay-for-Delay Drug Deals Said to Be Target for Rule at FTC The U.S. Federal Trade Commission is considering using its rule-making power to stop so-called pay-for-delay deals between brand-drug manufacturers and makers of generic medicines after failing to get judges or Congress to act, three people familiar with the process said. FTC Chairman Jon Leibowitz, pushing to abolish these deals, is studying how the agency could prohibit brand-name manufacturers such as Cephalon Inc. (CEPH) and Sanofi Aventis SA from paying generic-drug makers such as Watson Pharmaceuticals Inc. (WPI) to drop patent lawsuits that might get generics to market faster, the people said. The people declined to be identified because the decision-making process isn't public. Leibowitz estimated in an interview May 3 that the deals cost consumers about $3.5 billion a year in higher prescription drug prices by slowing the introduction of generics. A rule to block certain patent settlements would be unusual for the FTC because it would involve antitrust rather than consumer protection and it could be made on the agency's own initiative under its basic statutory authority rather than at Congress's specific direction, said Bert Foer, president of the American Antitrust Institute in Washington. Efforts by the FTC to challenge the settlements in federal courts have failed and Congress hasn't moved to outlaw them. The settlement amounts are confidential, Peter Kaplan, an FTC spokesman, said by e-mail. Generic drugs account for 78 percent of all retail prescriptions in the $307.4 billion-a-year U.S. pharmaceuticals market, according to the IMS Institute for Healthcare Informatics. Consumer spending on generic drugs is growing as patents expire and patients choose lower-cost options, IMS said on its website. The FTC may try to issue the rule under an expedited procedure it hasn't often used, the people said. One precedent was in 1971, when the FTC passed a rule that required labeling octane content at the gas pump. "Any potential attempt by the FTC to move forward unilaterally with such a rulemaking would be unprecedented," said Sean Heather, executive director of the global regulatory cooperation project at the U.S. Chamber of Commerce. "The 'if you don't at first succeed try, try, and try again' approach to policy making by an independent agency isn't appropriate." In recent years, the FTC has slowed its rule-making, partly as a result of procedures, set up under a 1975 law, that Liebowitz has described as "cumbersome." Final rules under this process take almost seven years on average to implement, said Jeffrey Lubbers, a professor of administrative law at American University in Washington. The FTC hasn't initiated any new rules under this system since 1980, he added. Drug company lobbyists say the settlements can benefit consumers when brand-name drugmakers allow generic equivalents to get to market before patents expire. "Patent settlements have never prevented competition beyond the patent expiry, and generally have resulted in making lower-cost generics available months and even years before patents have expired," said David Belian, a spokesman for the Generic Pharmaceutical Association, a Washington-based trade group whose members include Mylan Inc. and Anchen Pharmaceuticals Inc.
Thursday, June 9, 2011
Vincristine Sulfate(1mg/mL,1mL)納入基準必要藥品
行政院衛生署中央健康保險局公告100.06.09健保審字第1000027843號 主旨：公告新增藥物Vincristine Sulfate 1mg/mL,1mL注射劑為不可替代之必要藥品，並自中華民國100年08月01日生效，如附件。依據：全民健康保險藥價基準及全民健康保險藥價基準必要藥品及罕見疾病用藥「尊重市場價格」之執行原則。
Recall of GlaxoSmithKline's French-made Augmentin powder for syrup 156mg/5ml
2011-06-09 Hong Kong (HKSAR) - The Department of Health (DH) today (June 9) ordered GlaxoSmithKline Limited (GSK) to recall from its consumers an antibiotic manufactured in France for paediatric patients, Augmentin powder for syrup 156mg/5ml (HK-24658), as the detection of a plasticiser, Diisodecyl phthalate (DIDP) has raised both safety and quality concerns. A spokesman for DH said, "In view of the latest development in Taiwan's plasticiser incident, the DH has enhanced its surveillance on pharmaceutical products containing flavouring agents." Referring to the detection of plasticiser in Augmentin in Taiwan in particular, the spokesman explained, "Augmentin is an antibiotic for the treatment of bacterial infections. In Hong Kong, there are two Augmentin products containing flavouring agents, both of which are registered under GSK by the Pharmacy and Poisons Board, namely Augmentin powder for syrup 156mg/5ml manufactured in France, and Augmentin powder for syrup 457mg/5ml manufactured in the UK. Both are for use in children. Samples were submitted earlier on to the Government Laboratory (GL) for plasticiser analysis." The spokesman went on to reveal that, "On testing, the GL found DIDP in the French-made Augmentin powder for syrup 156mg/5ml at a level of 18ppm. This is two times Europe's specific migration limit for DIDP for food contact materials. Plasticisers were not otherwise detected in the other samples tested." "DIDP's safety in man is not well established. However, data on animal studies suggested that long-term consumption of DIDP at high level may affect the liver. It is a fact that the DH has not received any report of adverse events related to the product, but GSK has failed to demonstrate the safety of the tainted product to our satisfaction. The threat to public health cannot be ruled out as this stage," the spokesman added. "Moreover, there could also be the issue of the selling of a drug not of the nature, substance or quality demanded by the purchaser here, meaning that the Public Health and Municipal Services Ordinance (Cap. 132) might have been contravened. The maximum penalty involved here is a fine of $10,000 and three months' imprisonment. In any case, DH will refer the whole matter for the Department of Justice's legal advice after having completed our investigation," the spokesman continued. The spokesman cautioned patients who are currently using the above drug for treatment to consult their attending doctors or pharmacists as soon as possible and to not just stop using the drug abruptly. "Otherwise, there could be implications on both the courses of the diseases under treatment as well as antibiotic resistance development here," the spokesman warned. In connection, anyone who has taken the drug and is either in doubt or feeling unwell also ought to seek professional advice from healthcare providers. "Meanwhile, DH will continue to monitor the Taiwan incident, investigate the present incident and keep track of the present recall besides maintaining enhanced vigilance on pharmaceutical products with flavouring agents," the spokesman stated. Source: HKSAR Government
「醫療器材之臨床試驗設計與GCP查核重點」研討會
June 9th, 2011財團法人醫藥品查驗中心將於2011年6月14日(星期二) 上午8:30至12:00，假張榮發基金會國際會議中心1001會議廳（台北市中山南路11號10樓）舉辦研討會，主題為「醫療器材之臨床試驗設計與GCP查核重點」研討會，特別榮幸邀請到Dr. Neil Fearnot擔任主講，Dr. Fearnot目前為 Cook Group Incorporated副總裁，具有豐富的跨國醫療器材臨床試驗執行經驗，並曾多次獲邀協助衛生署進行國內醫療器材GCP查核。本次研討會的重點為醫療器材臨床試驗設計，GCP實地查核重點及實際案例分享。本次研討會不收取任何費用，歡迎產學研醫藥各界踴躍參與，即日起開始接受報名，名額有限，為免向隅，敬請及早上網報名。詳細活動內容和報名方式，請見查驗中心網頁活動公告。若有任何問題請電洽：查驗中心陳竣瑋， TEL 2322-4567 轉909， E-mail：a005cwchen@cde.org.tw Date/Time：June 14, 2011 Venue：張榮發基金會國際會議中心1001會議廳 Language：English; Host：Department of Industrial Technology, Ministry of Economic Affairs; Organizer：Center for Drug Evaluation (CDE) Registration：http://www.cde.org.tw
Agenda
| Time | Topic | Speaker |
| 8:30 – 9:00 | Registration |
|
| 9:00 – 9:10 | Welcoming Remarks |
|
| 9:10 – 10:10 | Design of Clinical Trials for Medical Devices | Dr. Neil Fearnot |
| 10:00 – 10:30 | Break |
|
| 10:30 – 11:30 | GCP Inspection and Case Studies | Dr. Neil Fearnot |
| 11:30 – 12:00 | Q&A | Dr. Neil Fearnot |
Targeted drug for lung cancer patients approved for subsidy
2011/06/09 17:52:18 The Central News Agency Taipei, June 9 (CNA) The Taiwan Lung Cancer Society applauded the government's recent decision to subsidize targeted therapy for patients suffering from certain types of lung cancer. A press conference was held after the Bureau of National Health Insurance announced that pulmonary adenocarcinoma patients with the EGFR gene mutations or metastasis can qualify for a subsidy for the drug gefitinib beginning this June. Gefitinib is a drug used in the treatment of certain types of cancer. The Taiwan Lung Cancer Society (TLCS) said the move is expected to benefit an estimated 2,500 local patients per year. "More and more people are suffering from lung cancer in Taiwan, and the launch of the subsidy program is welcoming news, " said Yang Pan-chyr, the Dean of National Taiwan University's College of Medicine. Perng Reury-perng, a TLCS member and a doctor at Taipei Veterans General Hospital, said that gefitinib, when compared with chemotherapy, was proven more effective in treating pulmonary adenocarcinoma, the most common type of lung cancer among Taiwanese people. About 44 percent of the lung cancer cases in the country are pulmonary adenocarcinoma, Perng said. Gefitinib comes in a tablet form and has very few side effects, he said, allowing patients to lead a normal social life and extend their life expectancy. Without government subsidy, the average patient would have to pay about NT$1 million (US$ 31,250) per year for gefitinib treatment. In Taiwan, lung cancer was the leading type of cancer for women, and the second most common form of cancer among men, in 2009. That year, the disease claimed 7,951 lives.
陸港澳遊客赴台健檢 2010年產值2億1000萬新台幣!
台觀光醫療 鎖定陸港澳客 2011/06/09 （中央社記者王曼娜香港9日電）為推廣台灣觀光醫療，9家台灣醫療業者今天在香港國際旅遊展上賣力推銷觀光醫療行程，希望吸引更多香港、澳門及中國大陸遊客赴台接受健康檢查、整型及疾病治療。由台北世界貿易中心主辦、香港台北貿易中心承辦的「台灣觀光醫療形象館」，9日在香港會議展覽中心舉辦的國際旅遊展覽會上展出，以「健康風尚、樂活遊寶島」為主題，邀請台灣北中南9家醫療業者參展，並推出客製化醫療旅遊行程，期望吸引港澳及大陸遊客參加。台灣觀光醫療團團長、新光醫院總經理洪子仁表示，近年來藉由參加香港旅遊展活動，不僅吸引港澳居民到台灣進行健康檢查、醫療美容及疾病治療，也吸引越來越多大陸居民，尤其北京、廣東、江蘇等地居民，赴台進行高階健檢及醫療美容。他說，陸港澳遊客赴台健檢、醫療美容及疾病治療的人數，從2009年的4700人次，增至2010年的9800人次，為台灣醫療業帶來的產值，從2009年的1億2000萬新台幣，增至2010年的2億1000萬新台幣。洪子仁預料，開放大陸居民赴台自由行後，以每年18萬人計算，估計每年吸引2000至9000名自由行陸客赴台參加醫療觀光。出席同一場合的行政院大陸委員會香港事務局局長楊家駿表示，大陸居民赴台健檢已是常態，尤其高階健檢深受大陸高官歡迎，曾有大陸官方赴台旅行團參加每人要價人民幣5萬元以上的健檢項目。一旦落實陸客自由行後，相信會有越來越多大陸居民赴台健檢。此外，經濟部駐港機構、遠東貿易服務中心主任陳光丕，香港台北貿易中心總經理劉錫威以及高雄醫學大學附設中和紀念醫院國際醫療中心主任林成龍，分別在會上介紹台灣醫療觀光特色及優勢，並鼓勵陸港澳居民參加相關行程。
Talk of the Day -- Hospitals suspend use of Augmentin amid panic
2011/06/09The Central News Agency Local newspapers reported Thursday that major hospitals around Taiwan have suspended the use of the GlaxoSmithKline Plc (GSK) -produced antibiotic Augmentin over plasticizer contamination concerns. According to media reports, mild levels of the banned chemical di-isodecyl phthalate (DIDP) were detected in the Department of Health (DOH) tests on GSK's Augmentin, commonly used to treat bacterial infections, particularly in children. Since a local TV news channel reported Tuesday that Augmentin bought at local pharmacies contained DIDP -- a substance often used in the production of plastics to make it more flexible -- quite a few parents have asked doctors not to prescribe the drug for safety concerns. TVBS said Tuesday laboratory tests show that the Augmentin purchased at local pharmacies contained 14.8ppm (parts per million) of DIDP, while a strawberry-flavored Augmentin syrup often prescribed for children at local clinics was found to contain 18.1 ppm of DIDP. In response, the Taiwan branch of GSK said that all the company's products on the Taiwan market met the standards of Good Manufacturing Practices and had been certified by Taiwan's health authority before entering the market. DOH tests show GSK's Augmentin contains 9-13.7 ppm of DIDP, levels that officials said pose no health risks to humans. The following are excerpts from the local media coverage of the issue: China Times: GSK, a leading global pharmaceutical, biologic, vaccine and consumer healthcare company headquartered in London, said it has no plans to pull Augmentin from pharmacy shelves at the moment. Hospital administrators and medical practitioners said the government should push the healthcare company to explain why the banned chemical was detected in its product. They also asked health authorities to conduct an across-the-board examination of all pediatric drugs to alleviate public panic over plasticizer contamination that has gripped the country since mid-May, when another toxic, phthalate-based plasticizer, DEHP, was detected in a variety of food and beverage products. Kang Jaw-jou, director-general of the Taiwan Food and Drug Administration (TFDA) under the DOH, said Wednesday that although the levels of DIDP detected in Augmentin were limited and could be translated to about 2 micrograms (mcg) in each dose -- an amount unlikely to harm human health, his agency will still ask GSK to produce proof showing it has not wittingly or maliciously adulterated its antibiotic with the banned substance. GSK argued that powdered ingredients used in Augmentin syrup were made in the United Kingdom and that the DIDP levels detected are far lower than the levels seen as harmful or dangerous in the United States or the European Union. Insisting that Augmentin remains a safe prescription medicine, GSK said it is investigating how and why DIDP made its way into the product in the first place. "We are waiting for the examination results from an independent and impartial third party," it added in a statement. Meanwhile, Kang said that as some phthalate-based plasticizers can help maintain density and functions of a specific drug in humans, major advanced countries such as the United States have not barred their use in some pharmaceuticals.Of the more than 20,000 drug certificates issued by the DOH, more than 80 have been issued to pharmaceuticals containing two other phthalate-based plasticizers -- DBP or DEP -- Kang said. (June 9, 2011) United Daily News: Kang said Wednesday that the DOH will not order GSK to recall Augmentin for the time being and that hospitals can decide on their own whether to suspend their use of the antibiotic. All major local hospitals, including National Taiwan University Hospital, Veterans General Hospital, Mackay Memorial Hospital, Shin Kong Wu Ho Su Memorial Hospital, Cathay General Hospital and Tri-Service General Hospital have suspended the prescription of Augmentin.
繼藥技中心 萊特先進再次攜手工研院!
工研院抗腸炎及類風濕性關節炎植物候選藥物技轉萊特先進公司 2011/06/10 經濟日報【台北訊】國內植物新藥布局全球市場再添一頁。由工研院研發的「抗類風濕性關節炎候選藥物DLS-03」與「抗腸炎候選藥物DLS-01」兩項新藥與技術平台，日前宣布技轉給萊特生進生醫公司（以下簡稱萊特公司），其中抗腸炎新藥DLS-01預計明年申請FDA人體臨床試驗（IND），該公司目前手中已有四種技轉植物新藥待送IND，未來若全數「出手」，銷售金額將是數百倍計算。
工研院生醫所所長邵耀華表示，DLS-03／技術平台與DLS-01 ／技術平台兩項研發成果，在經濟部的科專支持下，由工研院中草藥技術團隊自上千種不同中草藥萃取物與分萃物中，篩選出具有效抑制人體發炎因子，而且可以口服的兩項新藥，未來兩大技術平台將延伸開發出其它如抗痛風、骨質疏鬆症、乾癬、中風，甚至是癌症等中草藥新藥，潛力看好。萊特公司董事長江滄炫指出，植物新藥向來為公司開發產品主軸，加上植物藥治療慢性病如腸炎與類風濕性關節炎已是未來國際新藥研發趨勢，針對未來國際市場規劃布局，不同技術開發階段公司皆有機會導入技術移轉或共同開發策略，現已積極擘劃國際技術媒合網絡。萊特公司吳先民總經理表示，該公司今年年初參與BioAsia 會議，多家國際藥廠已表達對DLS-01與DLS-03興趣，並進行接洽。本月更將前往美國華盛頓舉辦的Bio International Convention，建構各大藥廠技術移轉通路，洽談合作機會。邵耀華說，目前對於腸炎治療，僅採用抗腸炎蛋白質西藥，一支針劑花費上萬元，不僅患者負擔大，藥效也有限。抗腸炎植物候選藥物DLS-01，兼具製程簡易、價格便宜、使用劑量低、可口服、無明顯副作用多項優點。目前已完成動物試驗，預計最快7至8年上市。至於類風濕性關節炎，目前治療類風濕性關節炎最有效的當屬生物製劑-恩博，病人一年藥費高達50萬元，即使有健保給付，但條件嚴苛，又要限制用藥頻度。這項抗類風濕性關節炎中草藥DLS-03，因具快速取得高純度單一天然化合物製程、使用劑量低、副作用低等優勢，未來上市可增加病患接受度。據了解，已有兩三家國際大藥廠對DLS-01抗腸炎植物新藥有興趣，熟悉國際藥品市場「生態」的萊特公司，早以擺好陣式等候這些大買家上門，至於未來在哪一個階段出手，獲得美國FDA核准進入人體臨床試驗，就如同拿到藥品上市的「入場券」，是一項重要指標。因為從IND到第二期人體臨床試驗，產品的價值將翻了六倍，如果到了第三期人體臨床試驗再出手，就再翻六倍，萊特手中擁有四項植物新藥等著「敲」國際藥品市場大門，將是目前最具發展潛力的業者。而萊特公司先前與藥技中心合作技轉的抗憂鬱症植物新藥，最快近期內就可以知道能否順利IND。
Activists urge tighter plasticizer controls
Taipei Times ; Jun 10, 2011Environmental groups, academics and victims of plasticizer-contaminated products yesterday urged the government to impose stricter regulations on plasticizers by making them a category-one toxic substance. Democratic Progressive Party Legislator Tien Chiu-chin (田秋堇) said that only manufacturers with deep pockets could afford to inspect all of their products, while small vendors and the public could only become the victims. Joining the group at the legislature, a juice vendor from Yilan County surnamed Huang (黃) said he had been selling drinks for more than 10 years, but the exposure of potentially harmful chemicals in food additives had caused a dramatic drop in sales of about 90 percent. "I used to have a good reputation with the neighbors, but now they are afraid to come after learning of the plasticizer incidents," Huang said. "I feel bad for doing harm to my neighbors, but I have nowhere to ask for help." The government should control the sources of plasticizers, Tien said, adding that a mechanism akin to the EU's Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) should be adopted in Taiwan to control the use of the substances. Holding up a bottle of dioxin-polluted dirt collected at the mouth of the Dadu River (大肚溪), Wu Jen-pang (吳仁邦) of Tainan Community University said dioxins and toxic heavy metal pollutants would not be so easy to acquire if the government enforced stricter regulations to control them at source. Wu Kuen-Yuh (吳焜裕), a professor at National Taiwan University's Institute of Occupational Medicine and Industrial Hygiene, called on government agencies to hire more officials with a background in toxicology to control the growing number of chemical substances used in various products. In addition, Herlin Hsieh (謝和霖) of the Taiwan Watch Institute said the government should ban polyvinyl chloride and polyvinylidene chloride packaging, which is still often used in plastic wrap to keep food fresh. A ban on using the substances in household plastic wrapping has been passed by the legislature, but amendments proposed by the Environmental Protection Administration (EPA) will have to wait until 2013 to be implemented and commercial-use wrapping will be excluded from the regulations, Hsieh said. During a press conference in the afternoon, the EPA announced that seven types of plasticizers, including di(2-ethylhexyl) phthalate, or DEHP, would be added to the list of category-one substances (substances that are not readily degraded and that are likely to bioaccumulate and pollute the environment or endanger human health) and category-two substances (substances with carcinogens or affecting fertility) under the Toxic Chemical Substances Control Act (毒性化學物質管理法), while eight would be added to the list of category-four substances (chemical substances that may pollute the environment or endanger human health). The official announcement followed a meeting by specialists at the EPA's Toxic Chemical Substance Consulting Committee on June 1. The EPA said a decision had been made concerning a REACH-type mechanism and that following an official announcement, manufacturers would have a grace period of up to one-and-a-half years to adapt to the new policies. The EPA will hold a public hearing in the near future to gather more opinions before drafting an amendment to the regulations.
塑化劑風暴將不大範圍延燒至製藥界!
5藥廠12藥品「中塑」 已主動回收 2011-06-09台灣醒報 衛生署今天表示，包括汎生、中化、瑞安、三能化學、人人藥廠，主動回報有12項藥品，疑似使用昱伸、賓漢公司汙染原料，這5家藥廠表示為了民眾的安全，已主動進行回收，值得欣慰。 衛生署日前發函台灣區製藥工業同業公會，請製藥界自行清查原料，今天獲得回報證實有5家藥廠中塑。食管局長康照洲今天表示，藥廠必須證明未使用昱伸及賓漢的塑化劑產品，如果衛生署日後查出藥廠欺瞞，將依藥事法懲處。這12種藥品，分別為汎生的「每鞭達挫錠」、「口舒樂藥膏（安西諾隆）」；中化的「益胃片」、「泰利美寧糖漿」；瑞安的「固骨密加強型口服溶液用粉劑」；三能化學的「三能爽達含錠」、「三能免風熱液」、「三能爽達感冒液」、「三能蓋風感冒液」；人人的「胃液」、「"人人"甲狀腺錠」、「咳嗽糖漿」。
掌握全球醫電市場行銷與商機！
2011/06/10-台北訊 DIGITIMES中文網 21世紀的科技發展，是一個跨領域應用科技研發的世代，醫療服務與數位科技的整合，為傳統醫療電子帶來了革命性的改變，醫療電子與醫療服務資訊化，正是此一跨領域應用科技發展的代表！本次研討會由工研院、台灣區醫材公會共同合作，配合2011年台灣國際健康暨醫療展，於6/23(四)假台北世貿中心2樓，舉辦「醫療器材國際行銷與營運研討會」；活動邀請具備國際醫療器材銷售的廠商，分享海外市場行銷經驗，並由專業分析師針對國內相關產業群聚提供市場情報資訊與分析。期望透過本次活動，促進國內業者密切聯繫與合作發展，共同開闢國際市場。活動詳情請上活動官網查詢：http://college.itri.org.tw/SeminarView1.aspx?no=56110015&msgno=307771
行政院一等功績獎章背後的代價?!!
追出塑毒汙染 政院重獎楊技正 【2011/06/10 聯合報】衛生署食品藥物管理局楊姓技正追根究柢，揪出全球第一件黑心塑化劑汙染食品案，行政院長吳敦義昨天在行政院會頒發一等功績獎章表揚，並發廿萬元獎金；衛署也記楊姓技正兩大功，依法晉級一級，並頒發一個月俸給六萬多元。吳揆表示，今年三月，楊姓技正執行加強取締偽劣假藥專案時，意外發現可疑訊號，抽絲剝繭分析卅多種原料、包材，主動查到益生菌含塑化劑，發掘真相、鍥而不捨的精神，足為全體公務人員楷模。楊技正獲獎後，依舊低調，不願露面，加班到晚上七點多，昨天僅透過食藥局，傳真一張手寫稿給媒體：「大家好，很榮幸能獲得功績獎章及獎金之殊榮，非常感謝大家對檢驗工作者的認同與支持，讓大家有個乾淨的食品環境。」食藥局主秘羅吉方說，楊技正昨天領完獎回辦公室，就把獎章收起來，沒有秀出來。行政院廿萬元獎金，加上衛生署加發一個月薪水約六萬多元，食藥局同事對楊說：「很補喔！」除了獎金，楊技正任職食藥局廿六年，去年才升技正，晉一級後，由八職等第五級升到第六級，明年可望跳到九職等。她是國內檢驗人員，首位領到行政院一等功績獎章。黑心塑化劑存在多年，楊技正何以能查出異樣？羅吉方透露，藥品檢驗比食品檢驗嚴苛，楊技正受藥學訓練，當她看到益生菌有塑化劑，比他人敏感，「她心想，都在查橡皮擦有沒有塑化劑，更何況食品？」激起她查到底的決心。日前有周刊在台北醫學大學校友資料，查到楊技正名字，並在報導中寫出她名字，是否造成她困擾？食藥局局長康照洲說：「多少有一點！」不過，楊仍照常上下班，也沒戴口罩或帽子，不怕被認出，「又不是歷史人物吳鳳。」人事行政局局長吳泰成表示，馬政府上任後獲頒一等功績獎章者，包括行政院前副院長朱立倫、衛生署前署長葉金川、楊志良、前副署長張上淳、疾管局前局長郭旭崧、長庚兒童醫院院長林奏延、國光生技董事長詹啟賢、教育部體育司前司長王俊權及國防部軍醫局前局長范保羅等九人，楊姓技正是第十位，也是唯一獲贈行政院長廿萬元獎金者。
台灣東洋病毒抗癌藥物!
東洋生技將重啟大陸版圖深化布局 【2011/06/09 經濟日報】台灣東洋（4105）9日於股東會上宣布，今年起將專攻抗癌藥物並重啟大陸版圖，全力投入新藥研發及通路布局，並於10年內完成「病毒抗癌藥物」研發；法人估，由於大陸獲利可觀，加上紫杉醇銷售挹注，東洋今年營收成長可望突破二成。東洋董事長林榮錦表示，由於轉投資公司智擎的抗癌新藥，「奈米微脂體喜樹鹼製劑」（PEP02），成功授權給美國Merrimack Pharmaceuticals藥廠，其中簽約金1,000萬美元已經入帳，今年起可望轉虧為盈。因此，東洋可以把心力全部專注於抗癌新藥的研發上；林榮錦用「重新啟動大陸版圖」，似乎表示東洋未來的事業中心將在大陸。
東洋紫杉醇進入歐洲市場
5月營收／東洋3.3億新高 【2011/06/10 經濟日報】東洋（4105）受惠於轉投資公司智擎生技及大陸子公司業績看旺，該公司（9）日公布5月合併營收3.3 億元，創下歷史高點。此外，昨日多家生技類股公布5月營收，美吾華（1731）、喬山（1736）、旭富（4119）也同步成長。東洋表示，5月合併營收約3.3億元，主要受惠於轉投資公司智擎簽約金入帳，及大陸子公司今年業績看旺。此外，東洋原本預定年底才出貨的抗癌藥紫杉醇，於今年6月搶先進入歐洲市場，目前東洋藉由和德國當地藥廠合作，東洋負責製造，並賺取權利金以及製造費用，法人預估今年至少可認列約1.4億元的稅前盈餘。東洋目前發展病毒抗癌新藥，已送申請專利，預估在今年底前通過核准。東洋董事長林榮錦表示，目前病毒抗癌藥業界尚無人研發，東洋此次手筆可望獨步全球，並在10年內研發完成獨占市場。分析師表示，在抗癌藥獲利部分，以目前東洋已出貨的紫杉醇為例，其作用為阻斷癌細胞分裂，而受阻斷死亡。
塑毒基金可行性高嗎?
檢視塑毒 食品業要主動2011-06-10 中國時報 【鄭博文／高雄市（副教授）】 法規早有明文規定，有害人體的添加劑是不能加入食品中的，但不肖業者昧著良心將有毒添加劑放入食品增加賣相及口感，嚴重影響到民眾的健康，期盼消保官也能與消基會結合，向這些黑心業者進行集體求償，將其黑心「謀利」所得成立一基金，協助無辜的受害者進行長期健康追蹤監測。目前塑化劑涉及產品類別似乎越來越多，恐怕政府相關單位一時之間也無法立即做全面檢驗。因此個人呼籲台灣所有食品業者能將自己的謀利之心放下，全面檢視自己進料紀錄，若有昱伸及賓漢以及其中下游供應者的進料紀錄，應主動下架並回收本身產品，再重新檢視自己的進料安全並做好檢驗工作，確保無疑人體健康再重新推出上市，如此才能讓民眾放心購買食用。在食品安全事故中，廠商主動下架並回收是處理食品危險管理的不二法門，過去美國「泰力諾」（Tylenol）止痛藥在一九八二年發生被下藥的中毒事件，當時廠商強生公司主動將所有產品下架回收，雖然當時蒙受一些損失，但同年十一月重新包裝後再上市，其銷售率比中毒前十月份的銷售率上升二○％，顯示強生公司在處理危機事故贏得消費者的信任。另外，台灣統一保健飲料也曾發生遭千面人下毒事件，統一公司當年也二話不說全面下架回收保健飲料並銷毀，統一的明快作法同樣也贏得國人對該公司的信任。
雄獅杏林積極佈局兩岸觀光醫療
台灣醫美翹楚聯手 艷驚瀋陽2011-06-10 旺報 瀋美先鋒陸客自由行即將開放，由台北世貿中心精心規畫的「台灣觀光醫療形象館」（右圖），鎖定大陸金字塔消費族群，期能透過台灣高階健檢與尖端醫療，讓他們深刻認識台灣價值。參展的亞立山大集團別出新裁，打出護士裝美女行銷。瀋美先鋒陸客自由行即將開放，由台北世貿中心精心規畫的「台灣觀光醫療形象館」，鎖定大陸金字塔消費族群，期能透過台灣高階健檢與尖端醫療，讓他們深刻認識台灣價值。參展的亞立山大集團別出新裁，打出護士裝美女行銷。 2011年瀋陽台灣名品展昨天登場，由台北世界貿易中心特別規畫的「台灣觀光醫療形象館」，首度在大陸試水溫，鎖定大陸中高端族群。台北世貿中心副祕書長黃文榮指出，觀光醫療是服務業的一種，台灣擁有很好的服務業，又有很優秀的醫療品質，相信商機無限。雄獅集團雄獅杏林事業公司總經理顏子欽不諱言指出，陸客自由行正是行銷台灣高度價值的最佳利器，也是台灣發展醫療觀光，走上國際化的機會。他估計，醫療觀光由於鎖定的是中高端大陸商務客，帶動的商機應是一般觀光旅遊商機的1.5倍，而台灣擁有優秀的醫療品質加上台灣在服務業的發展利基，「台灣很有機會」。
首度以形象館展出 陸客自由行即將在月底開放，台北世貿中心特別在瀋陽台灣名品展中規畫「台灣觀光醫療形象館」，邀請台灣12家優質醫療服務廠商與觀光旅遊業者參展，這是台灣觀光醫療首度以形象館方式在東北展出。引人矚目的是，配合陸客自由行即將開放，由雄獅旅遊加上康聯、亞立山大整形等健檢美容中心業者，特別針對遼寧喜愛台灣風情、重視健康與美麗的大陸民眾，也在展場推出多項套裝觀光旅遊行程。像是「漂亮愛台灣，玩美女人，北台灣時尚都會5日之旅」，標榜的是在參觀台北故宮及逛台北101享受購物趣時，可進行頂級紓壓及美白淨白、回春療程等，費用1萬8千元人民幣；還有「台灣深呼吸，活力有氧吧，東台灣樂活農家8日旅」等多項觀光旅遊套裝行程。
沒有藥味 只有咖啡香 康聯營業處資深經理錢芸霞指出，像康聯走的是高端健檢中心，陸客來到此館可以了解台灣的「沒有藥水味、只有咖啡香」的高階健檢及尖端醫療，更可同時體驗廠商提供的美容服務。更可同時體驗由台灣首富郭台銘為公司高階健檢提供的富豪級健檢服務。另外，台灣擁有與國際同步的染料雷射、脈衝光、高頻電波刀與果酸換膚技術，在二氧化碳與鉺雅鉻雷射除斑手術方面的成就，更造福無數愛美女性，在短短5天內就可以找回青春與美麗，相較大陸的美容醫療技術，先進很多。顏子欽說，大陸觀光客來台已達400萬人次，但目前開放的團進團出，並未真正把台灣價值發揮出來，但結合醫療的觀光醫療，可將台灣先進醫療服務業技術發揮出來，可讓陸客更深層認識台灣。
觀光求量 更要求質 他認為，陸客自由行的開放，給了台灣醫療觀光產業帶來契機，同時也是到了考慮台灣價值是否應用另一種方式行銷的時候，畢竟以台灣地狹人稠的情形，台灣追求的觀光客不該只是量，而是質。他說，由於會重視健康、追求美麗的多屬大陸中高端消費族群，而台灣醫療品質比大陸進步，且開放自由行後，許多大陸客來台想走主題式旅遊，結合服務業醫療觀光是可提高品質的服務，更可發揮台灣的高價值，讓大陸重新評價台灣。也因此，如果可以抓住此契機，商機無限。康聯也透露，大陸中高端工作壓力大、競爭高，睡眠檢測很受大陸高階商務人士喜愛。另外，一般提到美甲，大多數人聯想到的是指甲美化服務。但顏子欽指出，其實問題指甲的矯正及改善，也是專業美甲十分注重的領域，這部分也頗吸引大陸貴婦青睞。不過，亞立山大整形美容集團執行長特助鄭孝威也提醒，台灣醫療觀光雖具有潛力，但相關配套措施不足，比如來台醫療觀光陸客的回診、親屬陪同來台等簽證問題，將是台灣發展醫療觀光產業的致命傷。
友華生技科專: 長效口服劑型
友華生技蔡正弘︰明年成長啟動年 2011/06/10 〔自由時報〕雖然旗下品牌也被塑化劑波及，不過友華生技（4120）董事長蔡正弘表示，雖對公司有影響，但應該只是短期效應，公司計畫未來產品都將收回自己生產，不再委外代工，估計未來2、3年公司在新藥、嬰幼兒產品的成長性最高，明年是另一波成長的啟動年。由於友華去年每股獲利超過3元，但只配發0.7元股利，昨天被股東質疑，蔡正弘對股東表示，由於藥品的研發費用都拉很長，加上今年必須再興建一個倉儲，所以要保留現金，為了明後年的獲利，希望股東能忍耐。蔡正弘說，子公司友霖生技的雲林新廠已經通過衛生署查核，應該近期可以取得TFDA的PIC/S GMP認證，而且現在歐、美藥界聯盟也鼓勵學名藥設廠、研發，因此友霖兩項長效劑型口服用藥已取得經濟部工業局「業界開發產業技術計畫」，將積極出口，另外友霖也已經與世界級藥品公司簽訂製造合約，等新廠年底設備移入，明年就可以開始生產出貨。除了友霖之外，友華今年也有多項新藥上市，包括吸入性的氣喘用藥、新一代的糖尿病用藥，上市後都創造頗佳的獲利，還有治療帕金森氏症的新藥，也計畫在第三季上市，至於其他新藥包括胰臟癌、頭頸癌等與國際大廠共同開發的產品，也陸續展開臨床試驗。蔡正弘指出，目前旗下幾個事業部表現都有達成公司內部設定的預算目標，其中營養保健品部門今年將揮別去年台灣出生率低迷的影響，下半年動能將顯現。
友華董事長蔡正弘策略佈局說明 極力擺脫塑化劑風暴!
友華蔡正弘：未來3年，新藥、嬰幼兒產品動能最強2011-06-09 【時報】友華(4120)今日舉行股東會，承認99年度結算表冊及盈餘分配案，去年稅後淨利2.7億元，每股盈餘為3.42元，每股將配發現金股利0.7元。董事長蔡正弘表示，今年各部門表現都不錯，未來2-3年最看好新藥、嬰幼兒產品的成長，他說，新藥持續開發中，未來成長動能值得期待；看好大陸市場，奶粉產品已西進一年多，未來成長動能大。對於近期市場關注的起雲劑，他說，兒童綜合維他命、紫蘇益兒壯及開味益菌酵素等五項產品是委託「王子製藥」代工，其少量水果粉原料不慎使用受污染之起雲劑，第一時間已下架回收並停止出貨，營收影響很小。不過，他強調，以後不會在將產品委託他廠代工，自己做才能掌控，未來雲林新廠通過TFDA認證，就會自己生產相關產品。子公司友霖生技醫藥近日已獲衛生署查核，近日應可取得TFDA的PIC/S GMP認證。過去經濟部工業局鼓勵藥廠發展新藥，僅提供新藥補助款，現在也鼓勵發展學名藥，蔡正弘表示，友霖自行開發的兩項長效劑型口服用藥，已取得經濟部「業界開發產業技術計畫」補助核准。友華首季營運表現佳，合併營收10.6億元、年增9.6%；毛利率42.4%，增加2.46個百分點；稅後淨損益9990萬元，年成長46%。每股稅後盈餘1.18元，較去年同期增4成。該公司表示，新台幣升值有利毛利率表現，產品組合持續改善，都是主要因素。蔡正弘表示，今年各部門表現都好，希望今年營運能優於去年。展望未來，新上市的產品有吸入式的氣喘用藥、新一代的糖尿病用藥，治療帕金森氏症的新藥則預計第三季上市，為營收帶來另一層契機。胰臟癌、頭頸癌等新藥產品，相關的臨床試驗也陸續順利開展中。蔡正弘表示，未來2-3年，西藥的表現會更好，成長動能強勁。營養保健品中的嬰幼兒產品，去年、今年結婚人數大增，預期新生兒人口下半年將明顯增加，下半年營運動能不錯。另外，嬰幼兒產品已進軍大陸一年多，目前在江蘇、浙江、廣東等地區設立辦公室，僅銷售羊奶粉，主打卡洛塔妮品牌，考量收款問題，目前採逐省拓點、產品線逐步增加的穩紮穩打的方式，蔡正弘表示，大陸市場龐大，未來成長動能強勁。
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