KY康聯上市後首役 要併下游通路【2011/10/04 經濟日報】大陸前三大肝藥通路KY康聯（4144）執行長李欣表示，康聯將於5日在台上市，目前手握7億元銀彈，將於三到六個月內先整併二家大陸下游藥業通路，未來將聯合台灣學名藥廠如神隆、南光、美時、台耀等業者往上游整併，打造學名藥銷售航母艦隊。 李欣表示，正在籌備設立台灣分公司，預定11月以前正式營運。該公司也和大陸合作夥伴浙江仙琚、天津醫藥等洽談藥物銷售合作，計有18個品項，目前已進入最後階段。李欣表示，目前肝藥「代丁」銷售占康聯營收八成，市場規模約人民幣1,000億元（約新台幣4,790億元）。由於此市場已進入紅海狀態，康聯正積極切入其他品項。他以正在發展的呼吸系統用藥為例，雖僅占營收5%，但以大陸慢性肺阻塞狀況嚴重的情形來看，未來市場潛力大。
Tuesday, October 4, 2011
懷特PIC/S植物新藥廠
懷特 新癌藥年底上市【2011/10/05 經濟日報】懷特新藥（4108）昨（4）日表示，該公司治療癌症過程中重度疲憊症新藥「血寶」，目前正在進行醫院通路接洽，公司內部預估年底前可成功上市。此外，懷特將在本月11日，到大陸參加中國國際生物科技展（Bio China），並與歐洲生技大廠接洽「咳寶」授權事宜。懷特昨日股價以31.6元作收，下跌0.4元；該公司昨日公布9月營收，約1,400萬元，月增率5.7%；今年累計前三季營收約1.1億元，年增率75%。 懷特表示，目前該公司新藥血寶，歷經12年努力，終於在去年通過台灣食品暨藥物管理局（TFDA）核准，是目前台灣本土公司唯一被台灣藥物檢驗通過核准上市的新藥。 據了解，血寶目前正進行衛署核准的第四期臨床試驗，包括用於改善第三及四期非小細胞肺癌患者，接受傳統化療時的臨床反應與疲憊症 (生活品質)的輔助治療，並布局緊密醫院通路接洽，預估年底前將可以順利上市。法人指出，懷特為了量產血寶，日前斥資數億元興建台灣首座符合國際醫藥品稽查協約組織（PIC／s）與美國食品藥物管理局規範的「無菌植物新藥精製廠」，年初才剛完工，預計要生產該項新藥。 懷特表示，除了血寶以外，懷特旗下尚有包括咳寶、糖寶、骨寶及暈寶等新藥，其中咳寶、骨寶都已經完成臨床二期試驗；咳寶正規劃進入臨床三期，而骨寶則正進行臨床二期分析報告。 值得注意的是，懷特目前正規劃將咳寶等新藥，以授權的方式與國外大廠合作生產，其中「咳寶」已經受到歐洲某生技大廠青睞，雙方已經初步獲得共識。懷特表示，該公司將參加10月11日舉行的中國國際生物科技展，屆時也會和有意合作的歐洲生技大廠，洽談新藥授權事宜。
研華開發智能醫療大樓
研華與中山醫學大學打造智能醫院【2011/10/04 聯合晚報】工業電腦廠研華 (2395)今天與中山醫學大學附設醫院共同宣布將於10月中正式啟用中山醫學大學附設醫院台中汝川醫療大樓，且該醫療大樓也將成為全台首座智能院區，研華總經理何春盛表示，今年台灣醫療照護系統營收將倍增，歐洲市場業績也年增70%~80%。
如何降低化療對懷孕中胎兒影響!
卵巢癌切除、化療 生下健康兒 【2011/10/03 聯合晚報】一邊懷孕，一邊接受化療，會影響到寶寶健康嗎？31歲邱小姐第一次產檢做超音波時，意外發現卵巢腫瘤。懷孕21周時，接受切除手術，接著又做了4次化療，讓人擔心孩子安危。所幸最後母子均安，男嬰體重3200公克。懷孕化療 最怕寶寶脫毛掉髮 台北馬偕醫院婦產科主治醫師翁嘉穗指出，懷孕期間合併化學治療時，最擔心的就是血球低下發生的感染問題，新生兒如被化療藥劑感染，也會出現脫毛、掉髮等現象。 臨床顯示，懷孕35周就應停止施打化療藥物，為確保胎兒的健康，醫療團隊趕在邱小姐預產期兩個月前，完成第四次化療，希望降低化療對於胎兒的影響。 邱小姐第一次產檢超音波時，發現左邊卵巢長出一個20乘於15公分的腫瘤，體積大小與胎兒差不多。初步檢驗結果顯示，腫瘤屬於惡性卵巢癌。她隨後轉診至台北馬偕醫院。翁嘉穗表示，由於腫瘤巨大，且為掌握化療時間，立即安排外科手術，順利切除左側卵巢腫瘤及輸卵管。術後一周，邱小姐接受第一次化療，且持續回院，完成另三次的化療療程。化療期間，為求胎兒健康，她強迫自己進食，少吃澱粉類食物，多吃肉類和蔬果。 怕傷寶寶 媽媽生產不打止痛針 翁嘉穗說，邱小姐相當勇敢，原以為胎兒不保，但得知可以邊化療、邊懷孕時，高興地哭了起來。儘管生產時身體相當虛弱，但她擔心止痛針會傷害到寶寶，寧可忍受產痛，也不願打針。 最後她在9月30日順利產下男嬰，體重3200公克、身長50公分。寶寶出生後，活動力及身體各項檢查結果正常，也開始吸吮母乳，媽媽的身體恢復情況也相當好。翁嘉穗指出，卵巢癌早期不易發現，患者都以為只是腸胃不適。直到腫瘤增大，病人才開始出現下腹脹痛、噁心嘔吐、食欲不佳等症狀。孕期中發現卵巢惡性腫瘤並同步治療的個案相當少見，但只要病人身體狀況允許，與醫師好好配合，仍可保母子平安。
More people receiving vaccination shots: CDC
October 4, 2011 CAN PRECAUTION:The CDC said 280,000 people received flu vaccination shots between Saturday and Monday, already 60,000 more than in the same period last year. More people have been more willing to go to hospitals to receive free seasonal flu shots so far this year than last year, the Centers for Disease Control (CDC) said yesterday, four days after the vaccination program for this year began. Of the 2.66 million free influenza shots available for high-risk groups, 220,000 were used between Saturday and Monday, CDC Deputy Director Shih Wen-yi (施文儀) said. This represents 60,000 more vaccinations than in the same period last year, Shih said. If the vaccination rate remains high over the next couple of months, there would not be any free shots available for the general public after high-risk groups are vaccinated. Last year, free shots were given to the general public during the winter season because of a relatively low vaccination rate among those most at risk of catching the flu. High-risk groups include people 65 years of age or older, nursing home residents, people with rare diseases or serious illnesses, children aged six months to 10 years, medical staff and people working in the livestock sector. Those not on the priority list but who work among potentially high-transmission groups are urged to get vaccinated at their own expense, the deputy director said. Kindergarten teachers, for example, can protect their students from contracting and spreading influenza by getting vaccinated themselves first. So far, pharmaceutical giant Novartis has allocated 300,000 shots for people in Taiwan who want to purchase vaccines, Shih said.To encourage high-risk groups to get shots, CDC Director Chang Feng-yi (張烽益), whose position qualifies him for the free vaccination program, was vaccinated at a press conference. Chang said that with temperatures beginning to drop and the flu season arriving soon, people should take extra precautions to prevent illnesses. He identified three strains of influenza that are expected to be present in the country this year — H1N1, H3N2 and influenza B — and said the risk of getting sick is greatly reduced if one is vaccinated against the viruses.
Merck Serono and Ono Pharmaceutical Form Collaborations to Develop Oral Multiple Sclerosis Drug and Cancer Immunotherapy
October 4, 2011 /PRNewswire/ -- Merck Serono to collaborate with Ono for the development and commercialization of ONO-4641, an oral investigational sphingosine-1-phosphate (S1P) receptor modulator, in Phase II in multiple sclerosis. - The companies will also collaborate in Japan on the development and marketing of Stimuvax, Merck Serono's investigational cancer immunotherapycurrently in Phase III clinical development. Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced the signature of two separate agreements with Ono Pharmaceutical Co., Ltd., Osaka, Japan to strengthen its multiple sclerosis and cancer franchises. The first agreement grants Merck worldwide exclusive license rights for the development and commercialization of ONO-4641 outside of Japan, Korea and Taiwan. ONO-4641 is a novel oral compound currently in Phase II of development that was originally discovered and developed by Ono for the potential treatment of multiple sclerosis. The second license agreement provides Ono with co-development and co-marketing rights of Stimuvax®in Japan.Stimuvax is an investigational therapeutic cancer immunotherapy designed to stimulate the body's immune system to target cancer cells that express the tumor antigen MUC-1 that is in development in Phase III for patients suffering from non-small cell lung cancer. "Merck Serono is committed to building on our leadership franchise in multiple sclerosis and we are excited about adding a potential oral treatment, ONO-4641, to our pipeline," said Dr. Stefan Oschmann, President of Merck Serono. "We also believe that Ono will bring a wealth of experience in developing innovative therapies and understanding regulatory requirements in Japan." "We are very glad to partner with Merck Serono for the development and marketing of ONO-4641, given Merck Serono's commitment to developing treatments for people living with multiple sclerosis," said Gyo Sagara, Ono's President and Representative Director. "Moreover, we are delighted to collaborate in Japan on Stimuvax and together with Merck Serono to offer a potential future medicine for people suffering from non-small cell lung cancer." Under the terms of the agreement for ONO-4641, Merck Serono will acquire worldwide exclusive rights, excluding Japan, Korea and Taiwan, to develop and commercialize ONO-4641. Ono will receive 1.5 billion Japanese Yen (about € 14 million) as an upfront payment and could receive additional payments based on the achievement of certain development, regulatory and commercial milestones for ONO-4641. No further financial terms are disclosed. ONO-4641 is a sphingosine-1-phosphate (S1P) receptor agonist, and the multi-national Phase II study, DreaMS (Drug Research EvaluAtion for Multiple Sclerosis) is on-going in patients with relapsing-remitting multiple sclerosis. Under the terms of the separate agreement for Stimuvax, Ono will receive a co-development and co-marketing license for Stimuvax in Japan and Merck Serono will receive an upfront payment of € 5 million. No further financial terms are disclosed. A Phase II study for Stimuvax (EMR63325-009) is being conducted by Merck Serono Co., Ltd., a Japanese subsidiary of Merck, for the treatment of non-small cell lung cancer in Japan; Phase III studies are in progress outside Japan. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA.
About multiple sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
About Stimuvax Merck Serono is investigating the use of Stimuvax® (BLP25 liposome vaccine) in the treatment of NSCLC. Merck KGaA obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA. Stimuvax is being developed in Europe by Merck Serono. In the United States and Canada, Stimuvax is being developed by EMD Serono, an affiliate of Merck. The START study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,500 patients in approximately 30 countries. The primary endpoint of the START study is overall survival (OS). The INSPIRE study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The design of the INSPIRE study is almost identical to the START study. INSPIRE will enrol approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.
About Ono Pharmaceutical Ono Pharmaceutical Co., Ltd. is a R&D-oriented pharmaceutical company specializing in creating innovative medicines in specific areas and is headquartered in Osaka, Japan.雙美藉福建莆田幫 佈建中國實體通路
雙美、御龍推有機牙套，與莆田幫合作布建大陸實體通路 2011-10-03 【時報記者何美如台北報導】 膠原蛋白針劑廠雙美生技(4728)宣布與轉投資御龍集團合作，結合雙美的膠原骨填料、再生膜等牙材相關材料，推出不含金屬的「有機牙套」。董事長王進富表示，「有機牙套」採一條龍製作流程，在時間、價格具競爭優勢，除台灣市場，將與莆田幫合作進軍中國大陸建立實體通路，提供一條龍科技的有機牙套服務。御龍集團的目標是3年內要回收本金。董事長王進富表示，御龍集團在三個月前成立，主要用途是與雙美合作，做為牙科醫師的培訓中心，推廣有機牙套概念及有機牙齒、牙套的量身定做。御龍集團資本額為7千萬元，雙美生技持有30%股權。御龍旗下有御田牙醫診所、一條龍科技，王進富表示，御田牙醫耗資3千萬元打造，要做為教學示範點；一條龍科技的資本額為1500萬元。 大陸市場部分，王進富表示，將建立實體通路，與福建莆田幫合作，引進一條龍科技的服務。莆田系統在大陸醫療系統，市佔率超過八成以上，雙方合作將加速佈建實體通路。王進富說，雖然對岸也有類一條龍的服務，但一條龍在量化科技基礎上的技術領先，技術精密度度也具優勢，初期一條龍將在台灣生產有機牙套等，運送到大陸。待雙美取得大陸的牙材、骨材認證，御龍在大陸發展到一定程度後，會在各省設立機器生產。根據全國牙醫師公會的統計，台灣裝有假牙的人口，約占總人口6成之多，傳統的假牙製作，患者必須經過非常不舒服的咬模過程，來取得牙齒的模型，過程繁複又費時。王進富指出，傳統假牙製作過程中，幾乎離不開金屬素材的應用，也會產生許多印模材、石膏模型等廢棄物，對地球環境造成傷害。有鑑於此，雙美與御龍集團合作，採用全瓷冠與氧化鋯內冠的有機牙套，研發「牙科CAD/CAM數位技術」，導入一條龍製作流程。台北醫學大學牙醫學系助理教授、醫師張維仁表示，運用先進的數位取模機，只須不到一分鐘的口腔掃描時間，就能將最精準的電腦畫面，直接傳輸到牙科醫療中心的假牙製作部門，視製作區域的範圍大小，從4~6小時至2~3天的時間，患者就能直接試戴極其環保的有機牙套。
翁啟惠….”雖然看不清前景…” !?
翁啟惠獲頒交大名譽博士2011/10/05 【聯合報】 交通大學昨天頒授「名譽博士學位」給中研院長翁啟惠，在生物有機化學及醣分子科學研究有重要貢獻的翁啟惠說，30年前，他提出醣分子研究計畫時，不管在美國或台灣都沒人支持，但他一直很好奇，希望找到答案。交大學生問翁如何保持研究熱情，他說，做任何事自己要有決心，「雖然看不清前景」，有決心又投入，總會有結果出來。 交大校長吳妍華推崇翁啟惠開創了安全且無汙染的基礎化學研究新領域，特別是生物有機化學及醣分子科學，對人類有重要貢獻，在功能基因體科學研究及新藥物開發，也有重大影響。 翁啟惠說，生物科研重要議題是：基因、蛋白質和醣分子，長久以來，大家對基因與蛋白質投入許多，唯醣分子研究不被重視，複雜的醣分子及醣蛋白合成研究，產學研界甚至認為「不可能」。 他說，30年前就好奇，麻省理工學院畢業後，進大學當助教授，向學校申請醣分子計畫，「從來沒通過」；2000年間受聘中研院特聘講座，申請研究也未通過。後來，他覺得光好奇不行，要思考對人類有什麼作用，才漸受重視，他開玩笑說，「現在年輕人做這方面研究，可以拿很多錢」。翁啟惠會後演講「從基礎研究到創新應用」說，台灣雖有百餘家大學，但同質性高，大學評鑑和國科會補助計畫標準同質性也高，應根據不同學校背景與資源，做出特色來。
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