保德信 江宜虔: 美股成長引擎 “醫療類股”

製藥大廠併購熱升溫 生醫基金頭好壯壯 2015-04-16 07:33:40 經濟日報 記者葉家瑋／台北報導過去生技股在1月財報季後進入併購及實驗數據公布淡季，股價也多半清淡，不過今年來生技相關指數屢創新高，標普500指數上周以醫療類股漲勢最強，漲幅逾2%，表現居各產業之冠，且第2季製藥大廠併購熱升溫，加上重量級醫學會議陸續登場，法人認為生醫族群持續看俏。去年全球醫療生化產業併購金額達到2,500億美元，是近15年來新高，今年初以來，製藥業併購題材熱絡，持續成為推升生技股表現的一大動力。去年MSCI醫療指數占MSCI全球指數的權重已達12.4%，僅次於金融的20.8%、科技產業的13%，居第3位，顯示醫療生化產業已成為全球最重要的產業之一。保德信全球醫療生化基金經理人江宜虔分析，美股醫療類股堪稱成長引擎，超級財報周登場後，預料生物科技、醫療器材產業的財報將優於美國企業的平均值，推估2015年美國醫療生化產業每股盈餘年成長率為8.9%，勝過標普500指數整體平均年成長率的1.7%。另一方面， 每年的美國腫瘤學會年會（American Society of Clinical Oncology Annual Meeting）堪稱全球最重要的醫學會議之一，今年的會議即將在下月登場，由於腫瘤（癌症）相關藥品目前全球銷售量最大，若會議中，出現正面的臨床實驗結果，往往有助拉抬許多醫療保健公司的股價預期。群益全球關鍵生技基金經理人沈宏達表示，根據Bloomberg統計，今明兩年MSCI全球醫療保健指數EPS仍舊穩定向上，根據S＆P500的數據顯示，醫療生技產業不但是營收成長率的亞軍，營收正成長家數占比居所有產業之冠，顯示產業具備良好基本面。

健保DRG 同病同酬 (醫藥大洗牌)!! 私人保險多準備

實支實付醫療險 二招挑選 2015-04-15 經濟日報 記者蔡靜紋／台北報導 二代健保實施診斷關聯群DRGs支付制度，壽險專家建議挑選實支實付醫療險的二大要訣，一是確認住院日額額度是否足夠，二是檢查門診手術給付是否不差於住院手術。據衛福部資料顯示，2012年國人平均每人每年醫療保健費用支出為40,086元，至2013年每人每年醫療保健費用已增加為41,242元，可見國人未來醫療照護負擔將愈來愈高。不過，健保自去年起實施第二階段的DRGs，是包裹式給付制度，將同一類疾病、採取類似治療的疾病分在同一組作為健保給付方式。不論採用何種治療方式、藥物、住院天數，在給付價格都有上限的限制（即「同病同酬」)，因此門診手術、自費部分將愈來愈多。因應DRGs新制發展，實支實付醫療險已經成為國人必備基本款保障。元大人壽表示，實支實付醫療險最大的優點，就在於能配合實際醫療支出來填補經濟損失，包括住院病房費差額、住院期間自行負擔的敷料、醫師指示用藥、掛號費及證明文件及其他外科手術費用等，都可透過實支實付的醫療雜費項目實報實銷，民眾可保有足夠彈性去選擇最適合自己的醫療方案。元大人壽協理鄭中文表示，過去認為住院手術比門診手術貴，因而保單的給付設計往往是住院手術高於門診手術。但隨著醫療科技進步、DRGs實施，未來將有更多手術不需住院就可完成，因此民眾挑選醫療險時，應該看手術類別，住院與門診給付有沒有差別。其次，應該重新檢視並調整醫療險的內容，除檢視住院日額度是否足夠。一般保單以3,000元為上限，但也有高達4,000元的保單。同時，應加強重大疾病提供的一次給付的醫療保障，才能彌補因病造成工作中斷、收入減少的困窘。鄭中文建議，預算較少的民眾可選一年期限額內實支實付型住院醫療險，保費負擔輕。

生技中心開發 植物藥紋身貼紙

創意變身 藥用紋身貼紙紋上身 2015-04-14 中央社 中央社記者黃巧雯台北14日電 藥用貼布也可以很時髦！生技中心開發出1款抗發炎植物藥紋身貼紙，除了可釋放草藥析出物提供消炎止痛及治療效果，還可客製化各種五顏六色圖案長條貼紙貼在關節上。經濟部技術處指導，工研院執行科技美學設計加值計畫，今天舉行科技美學精品展暨國際獲獎典禮，共有8大技術設計榮獲國際4大設計獎肯定，其中抗發炎植物藥紋身貼紙獲得2015Reddot。工研院表示，由生技中心開發的抗發炎植物藥紋身貼紙，如同一般的紋身貼紙，經用水沾濕後，可貼附在使用者的患部，釋放草藥析出物提供消炎止痛效果。值得注意的是，該設計能幫助罹患幼年特發性關節炎的青少年及兒童建立自信心，以愉快及個性化的藥草萃取紋身貼紙減緩不適症狀。生物技術開發中心化學製藥研究所藥物化學合成組研究員莊士賢表示，目前已申請專利，包括確認加入天然萃取物可經由皮膚吸收，並有緩步釋放的效果。莊士賢希望，未來紋身貼紙的圖案能與天然萃取物同步變化，例如圖案經紋上身1天後開始脫落，藉此提醒患者該貼紙已無效果，應進行更換。這款抗發炎植物藥紋身貼紙除了可客製化成各種圖案外，莊士賢表示，先前與設計師討論時，設計師建議還可進一步導入便利貼的概念。莊士賢指出，未來使用者可用噴墨印出行事曆樣式的紋身貼紙，提醒使用者何時該做什麼事，而時間到後貼紙的圖案還會自動消失，成為既可抗發炎，又可作為提醒便條的紋身貼紙。

深圳邁康信 醫用機器人!!

醫用實時監測康復機器人亮相 鉅亨網新聞中心　(來源：北美新浪)　2015-04-1509:06　 廣州日報訊 （記者童丹）能爬任何樓梯，還能根據病情私人定製獨有的康復機器人……深圳市人民政府與工信部主辦的2015年第三屆中國電子信息博覽會在深圳國際會展中心隆重開幕。記者在現場看到，醫用機器人引起現場關注，據悉，蘇州一家公司現場與這款機器人的生商簽訂了6000萬元的投資合同。 我國的殘疾人口每年以七十萬到八十萬的速度在增長，也就是，每天我國會增加兩千多名殘疾人，每四十秒左右會增加一名殘疾人。據統計，截至2014年，我國各類殘疾人總數8500萬人，占全國總人口的6.34%，各類殘疾人中，有肢体殘疾者2472萬人，占29.07%。在電子信息博覽會上，記者看到，醫用機器人占了展品的一席之位。深圳市邁康信醫用機器人有限公司展攤前的負責人向記者表示，這是一家下設院士專家工作站的高端研髮型企業，今年帶來的是一款醫用實時監測康復機器人，也是世界首創醫用實時監測康復機器人。由助步、頸靠、背靠、座椅、扶手、腋下支撐臂、下肢輔助、體征監測、 電腦控制等部分組成。具有多功能保健腰靠、頸椎理療及頸托機械手、助力式保健座椅、 上肢体支撐、下肢体康復、助步、床、自動爬樓、生命體征監測、北斗定位、車載電話等功能。"更主要的是可以根據客戶要求自主增減智能模組，實現私人定製。"上海交大的人體生命體征監測專家汪欣教授現場向記者表示，目前的醫療機器人已經向更智能化發展，比如可以解決行動不便者上下樓梯的難題。盡管設計很高端，但價格卻很平民化。記者在展會現場獲悉，目前的醫療機器人能針對高位截癱患者和因病或外來因素導致下肢功能障礙者特點，在脊柱變形較大的腰椎部位設計可調節位置的腰靠，這種可調節的腰靠能滿足不同患者對座椅靠背的舒適性需求。而且針對下肢的康復練習，設計了模擬蹬車，在家裏或長時間不動時可以打開腿部鍛煉裝置，機器人會帶動你做蹬車運動。此外，還設計了助步行走功能的機器人。據悉，最低價在2萬元左右即可把功能很全面的機器人領回家。

医药电商飆速(天猫/京东/1号店/八百方)!! 2014中国药品市场1.3兆(RMB) 网上药店28亿元(RMB)占0.2% !

2014医药电商大数据出炉 百度"药直达"进军医药电商 发布者：Wlb 来源：中国新闻网 发布时间：2015-04-16 09:21:30       0 《2014中国医药电商数据报告》发布 中新网4月15日电 日前，中国医药物资协会主办的第二届2015大健康产业电子商务(西湖)论坛在杭州召开。此次大会上发布了《2014中国医药电商数据报告》，百度推出"药直达" ，与中国医药物资协会达成战略合作。中国医药物资协会副会长、医药电商分会会长龙岩发布了《2014中国医药电商数据报告》。该报告显示，2014年中国药品整体市场规模约1.3万亿元，主要销售终端为城市等级医院，约6634亿元，占比53%；零售药店的2828亿元，占比23%；而网上药店销售收入约28亿元，占比只有0.2%。无论是相对还是绝对空间，医药电商尚有巨大增长空间。 医药电商B2B模式不是主流的模式，而B2C是目前医药电商的主流模式。从渠道来看，分第三方平台和官网。医药电商的第三方平台，天猫、京东、1号店、八百方是最有代表性的。天猫医药馆目前已有160多家连锁药店，近40家知名制药企业和医疗器械品牌商进驻。天猫占了近一半的整体医药电商市场。未来自建官网发展，也是医药电商的一个趋势。 数据显示，2013年-2014年电商的第一名和第二名的增长速度是100%；前十名基本上都有50%以上的增长。2014年整个医药电商销售前十名的产品中，肾宝片和阿胶成为成为最热产品。消费者的消费习惯是在不断改变，一些品牌厂家把电商渠道不单作为一个销售的渠道，也作为一个品牌展示的渠道。越来越多的医药企业品牌把品牌资源投放到电商渠道来扩大品牌营销。 对于很多中小企业，希望把电商作为一个弯道超车的工具，快速的通过医药电商挤入到行业精英。线下排名30名以上的海王星辰，双十一当天天猫医药馆的挤占排行榜前列。此外，论坛上还举行了中国医药数据研究中心成立仪式。在商务部的指导下，中国医药物资协会、中国医药商业协会、中国非处方药物协会、中国医药企业管理协会、全国卫生产业企业管理协会等五大协会联合共建，共同打造发起成立"中国医药数据研究中心"。 以促进中国医药电商行业的发展，更好服务于医药电商企业。

百度"药直达"牵手连锁药店 4月14日，大健康产业电子商务(西湖)论坛上，百度宣布与中国医药物资协会达成战略合作，并宣布推出"药直达"，5月份正式上线 。 百度战略合作部总经理孙建东表示，药直达不是做电商，而是帮助药店做电商。在PC时代一提到百度可能就认为是搜索，百度是"连接人和信息"。但是在移动互联网，百度要做的是连接人和服务。每天百度在PC端和手机上的搜索量有60亿次，另外在地图搜索量是100亿次。这么庞大的移动搜索很大一部分的搜索流量都是跟"寻医问药"有关系。百度药直达做的就是把医问药的需求变成商机。据介绍，百度"药直达"可免费为药店会员企业建立直达号站点，助其提升线上服务水平。 中国医药物资协会副会长郭亚洲表示，该协会有5万家连锁药店门店资源 ，此次与百度药直达的合作主要是该协会连锁药店的资源与百度药直达共享，在连锁药店门店建立直达号站点。手机用户在百度搜索或百度地图上有"问药"的需求时，能够迅速找到相应的连锁药店；连锁药店依托 "药直达"平台，除建立药店与消费者之间的联系外，还将为药店带来更多的自我营销机会，为提升药店服务品质及品牌，并最终带动销售起到重要作用，真正形成商业模式上的闭环。对于百度药直达来说，也为百度进军医药领域提供了大量资源。 百度药直达前期试运营阶段，首先上线的包括金象大药房、嘉事堂、复美大药房、老百姓大药房等四家国内知名连锁大药房。对于用户而言，无需单独下载手机应用，通过手机百度搜索上述四家知名连锁药店即可享受咨询、选药、购买、送药一站式服务。百度"药直达"拉近用户与商家的距离，商户与消费者的对接更加扁平化。

新北市 衛生局長林奇宏: 看診分流 &大小醫院結盟 !

新北醫院設聯盟 看病免跑大醫院 2015-04-15 03:34:04 聯合報 記者呂思逸／板橋報導為縮短大醫院候診時間，新北市衛生局昨宣布推出建置「大醫院聯盟」，目前雙和醫院與振興醫院合作，亞東醫院合作醫院則有連江醫院等，教學醫院和社區醫院資源垂直整合後，往後民眾到社區醫院即可享有大醫院醫師服務和資源，「看病不需到大醫院」。衛生局長林奇宏表示，台灣的健保方便又自由，大醫院病患其實到診所治療即可，「看診分流」宣導多年，但民眾始終比較信任大醫院，為此，衛生局將協助大醫院與社區醫院結盟，往後到社區醫院就可享大醫院資源。林奇宏說，雙和醫院是教學醫院，可與社區型醫院振興醫院合作，除了振興骨科醫師團隊多為雙和培訓，包含過去的住院醫師、骨科主任曾永輝學生，目前還有雙和骨科醫師到振興醫院看診，「增加社區醫院的信任感」。亞東醫院是教學醫院，以腦中風科別為例，經社區醫院轉診病患，社區醫院會直接聯絡大醫院急診窗口，讓醫院給予更穩妥的協助。林奇宏指出，為增加誘因，大醫院聯盟還設置「入院綠色通道」，凡在診所或社區醫院判定需轉診病患，大醫院將盡速排定病床補位、開刀順序，加速病患轉診，從社區醫院到大醫院一路暢行。「希望醫院以病人為本位」，林奇宏說，過去，大醫院只把手術做好，有的病患換完人工關節，卻疏於復健，只能以輪椅代步，未來，希望大醫院結合社區醫院給予全面性照顧，並告知相關的社會福利，或轉介給相關單位，讓福利找上所需的人。雙和醫院表示，大醫院聯盟建立後，病患可得到「團體」照護，術後治療可到社區醫院、診所，更少了路途的奔波，大醫院結盟後，病人反而更不會流失。亞東醫院的「腦中風中心」則與板橋醫院、樂生醫院、台北醫院、馬祖的連江醫院合作，亞東醫院表示，亞東腦中風團隊除每個月至合作醫院訪視病人，還會透過電訪追蹤病人情況，另還會督輔合作醫院照護品質。

 

深圳倍泰健康 七生理指标互聯網整合(心率、心电、血压、血糖、体温、体脂、体重)!

2015医疗健康展开幕 可穿戴设备和移动医疗成热点 2015-04-16 11:17:46来源： 南方网作者： 向雨航15日，2015国际医疗电子与个人健康管理产业博览会（以下简称"医疗健康展"）在深圳会展中心开幕，本次医疗健康展为期3天，围绕移动医疗、穿戴式医疗、智能养老等主题展开。据介绍，展览期间还将举办医疗健康趋势论坛和投融资论坛，业内专家和投资者将深入解读行业趋势，以及可穿戴健康产品和互联网医疗的投融资机会。15日，2015国际医疗电子与个人健康管理产业博览会（以下简称"医疗健康展"）在深圳会展中心开幕，本次医疗健康展为期3天，围绕移动医疗、穿戴式医疗、智能养老等主题展开。记者在展会现场看到，欧姆龙、倍泰、三诺生物、东软熙康、安康达、倍轻松等国内百余家医疗健康领域企业带来了最前沿的健康科技与产品，其中穿戴式健康产品、移动医疗、互联网健康管理平台成了这次展会的主角。随着传感、互联、大数据技术的发展，移动医疗、穿戴式健康产品快速席卷全球，基于各种家用、个人健康产品的数据管理与医疗服务成为未来必然趋势。记者在展会现场看到，深圳倍泰、三诺、天瑞、同方健康、德赛、奋达、大通高科、鼎芯、东方德思、智英源等企业，展出大量用于心电、心率、血压、血糖、睡眠、运动监测领域的穿戴式健康/移动医疗产品及健康管理平台，既有穿戴式健康产品提供给老百姓在家里使用，又在后台帮助使用者进行健康管理，从产品到管理平台，提供一体化的健康管理服务模式。在这次展会上，深圳倍泰健康测量分析有限公司推出了天使系列智能医护手表，可随时监测心率、心电、血压、血糖、体温、体脂、体重七项生理指标，同时还提供智能分析检测报告，并会自动生成电视、短信、微信、手机客户端、PC等多终端健康报告。除了产品本身，倍泰还提供了云端平台，通过平台即可查询使用者各种健康数据，不用再担心家中老人善意的隐瞒病情和健康状况，在老人遇到紧急情况，如摔倒、走失时，会自动判断并发出求救信号，让监护人第一时间知道状况。国内健康管理龙头企业——东软熙康则创新性地采用一体化健康监测设备，通过互联网，将区域医疗中心、基层卫生服务机构的医疗保健服务与个人、家庭的动态健康管理以及医疗监控与管理部门的数据档案系统进行无缝链接，使优质的医疗资源向基层、家庭、个人延伸，为追求生活品质的个人与家庭打造即时、便捷的健康服务模式。据介绍，展览期间还将举办医疗健康趋势论坛和投融资论坛，业内专家和投资者将深入解读行业趋势，以及可穿戴健康产品和互联网医疗的投融资机会。此外，大会还将颁发2015家用医疗健康领域最佳工业设计奖、最佳创新技术奖和最具投资潜力奖等奖项。南方日报记者 向雨航

邦特 現金減資20％ + 每股2.1元現金股利 !!!

佰研和康生領軍 生技股回神 2015年04月16日 04:10 記者杜蕙蓉／台北報導 萬點行情近鄉情怯，電子和傳產股熄火下，蟄伏逾8個月的生技股類股昨日回神當家，業績股領軍，3月業績表現亮麗佰研（3205）、葡萄王（1707）、中化生（1762）、和康生（1783）、鈺緯（4153）股價強漲；藥證申請倒數計時智擎（4162）在開放融資題材下，股價漲4.51％。

由於該類股基期低，法人認為，多頭氣勢有機會延續。另外，精華（1565）儘管今年營收成長力道放緩，但配發每股23.85元高股息，且法人預估今年仍有賺3個股本以上實力，在股價、本益比下修後，近一個月已見外資持續回補，昨日股價仍持續揚升力道。東洋（4105）昨日也公告配發每股2.5元現金股利，股價小漲；曜亞（4138）則繼配發每股3.5元現金股利，加上今年營運持續成長，新產品效益漸顯，法人預估EPS上看5元下，股價漲停慶祝。題材不斷的生醫類股，3月營收表現搶眼，葡萄王、生泰（1777）、雃博（4106）、邦特（4107）、聯合（4129）、F-麗豐（4139）、鈺緯都改寫歷史新高。鈺緯挾著外界看好今年每股盈餘挑戰7元下，股價更連二日漲停。而葡萄王則受惠去年EPS高達7.24元，在大方配股5.3元現金股利，不排除因擴建新廠，今年可能辦理16年來度的募資，而備受矚目。邦特除了業績表現優異外，由於獲利穩定且手中滿滿現金中，董事會已決議現金減資20％，退還股東每股2元現金，加計公司將配發每股2.1元現金股利，合計股東可退回4.1元下，也成為近日的強勢股。另外，營運大見轉機的佰研，繼去年營運正式虧轉盈後，今年首季營收亦持續長紅；中化生則因美國卡關問題解決，3月營收一舉改寫新高，由於該公司出售桃園廠土地利益將首季入帳，預期今年獲利將創新高下，昨日更大爆2,940成交量能。至於新藥族群，則以智擎一枝獨秀最聚焦，該股除了自昨（15）日起開放融資融券交易外，由於授權夥伴Merrimack可望在4月底向美國FDA提出胰臟癌新藥MM-398的新藥申請，為此，智擎將可有500萬美元的權利金可入帳，而且緊接著再授權夥伴Baxter也將進行歐洲、亞洲之藥證申請，法人預計智擎今年將有數千萬美元獲利進帳下， 將開始啟動高獲利，也推波近日股價有蠢蠢欲動。

環瑞醫 營收6.24億(2014) 2015營業費用降低(2014, 5.37億元) 啟動庫藏股(35-55元)

環瑞醫啟動庫藏股 預計買回1萬張 鉅亨網／鉅亨網記者張旭宏 台北-2015年04月16日 上午09:20 承業醫(4164-TW)投資的醫學影像診斷大廠環瑞醫(4198-TW)宣布實施庫藏股，預計買回1萬張，買回區間價格為35-55元，共計3個月。公司今年在baby X-ray原型機已開發完成，研發費用降低，加上瑞士技術移轉台灣，精簡費用，可望大幅降低營業費用，營運先蹲後跳。環瑞醫去年營收達6.24億元大幅成長82%，整體毛利率仍維持在18%以上，台灣成立研發中心，加上原有瑞士研發費用發生所導致，使得營業費用上升至5.37億元，拖累政體營運虧損，但baby X-ray原型機年初已開發完成，加上今年技術移轉台灣，精簡費用，營運成本可望大幅改善。環瑞醫3月營收為3687萬元，月減6.01%，年減31.62%，累計首季營收為1.13億元，年減15.99%，今年手推式Cruze設備出貨將逐步放量，另外中國客戶採購的X光機產品也在持續成長，加上埃及政府300萬美元訂單可望在第二季入帳，法人估計今年公司整體營收將有5成以上成長。

Ivabradine 治療中重度慢性心臟衰竭 健保給付早於美國上市/節省住院醫療費用1000 ~2900 萬元 !

Pharma & Healthcare 4/15/2015 The FDA on Wednesday approved ivabradine (Corlanor), Amgen's new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan. Ivabradine was approved for the reduction of hospitalization from worsening heart failure. It is indicated for use in stable heart failure patients who are in sinus rhythm, have a resting heart rate of at least 70 bpm, and who are also taking the highest tolerable dose of a beta blocker. Ivabradine slows the rate of the heart by inhibiting the so-called "funny" current within the heart's natural pacemaker, the sinoatrial node. The drug received an expedited review under the FDA's priority review program. Approval was based on results of the SHIFT trial, published in 2010, which studied 6,558 patients with heart failure who had a heart rate > 70 bpm. After a median 22 months of followup, the rate of cardiovascular death or hospital admission for worsening heart failure was 24% in the ivabradine group and 29% in the placebo group (HR 0.82, 95% CI 0.75–0.90, p<0.0001).The FDA said that that the most common side effects of the drug were bradycardia, hypertension, atrial fibrillation, and temporary vision disturbance (flashes of light). The FDA said that ivabradine can cause harm to fetuses and that women should not become pregnant while taking it.In Europe ivabradine has been approved for use for both heart failure and stable angina. In 2014results from a 19,000 patient stable angina trial,SIGNIFY, prompted the European Medicines Agency (EMA) to make several recommendations intended to lower the risk of heart problems linked to the drug. Although the overall results of SIGNIFY were neutral, troubling findings occurred in the very large subgroup (more than 12,000 patients) with symptomatic angina. The EMA review concluded that in these patients ivabradine, compared with placebo, had a small but significant increase in the risk of CV death and nonfatal MI (3.4% vs 2.9% yearly incidence rates) and a substantially higher risk of bradycardia (17.9% vs. 2.1%). The EMA said ivabradine was also associated with an increased risk for atrial fibrillation. SIGNIFY tested a higher dose of ivabradine, but the EMA concluded thatthe high dose "did not fully explain the findings."

Ivabradine 的相對療效: 實證為樞紐試驗 SHIFT (Systolic heart failure treatment with If inhibitor ivabradine Trial)，其結果在主要療效指標--降低心血管死亡率或因心臟衰竭惡化住院(複合性指標)比例的表現，ivabradine 組顯著優於安慰劑組。但 SHIFT 試驗中所 納入受試者條件與我國許可適應症並不完全相符，僅供參考。另，於廠商送審資料中所 提出之未公開發表數據，整體來說，對於使用β阻斷劑屬禁忌症的病人，ivabradine 治 療在主要療效指標與次要療效指標部分，均獲得具統計顯著之結果。

1. SHIFT 試驗：Ivabradine 比較安慰劑 為一項為期三年的隨機、雙盲、安慰劑對照、多國多中心臨床試驗，在同時服用其他治療心臟衰竭藥物的情況下，以 ivabradine 治療中重度慢性心臟衰竭以及左心室收縮功能障礙病人時的療效。主要療效指標為 ivabradine 降低心血管 死亡率或因心臟衰竭惡化住院(複合性指標)比例的表現。 共有 6505 位病人進入試驗隨機分派階段，其中 3241 位接受 ivabradine 治療。 受試者的追蹤期(中位數)為 22.9 個月，接受試驗藥物治療的時間(中位數)為 21.6 個月。 主要療效指標發生率 ivabradine 組顯著低於安慰劑組(24.5% vs. 28.7%)，對應 於 18%的相對風險降低(hazard ratio 0.82, 95% CI 0.75-0.90, P<0.0001)。

2. 在文獻搜尋過程中，查無與我國適應症完全相符之已發表文獻可供參考，廠商於送 審資料中所提出之部分數據(未公開發表)，基於保密原則，無法於此處詳實呈現。 整體來說，對於使用β阻斷劑屬禁忌症的病人，ivabradine 治療在主要療效指標與 次要療效指標部分，均獲得具統計顯著之結果。醫療倫理：查無醫療倫理相關之國內資料可供參考。成本效益：無本土決策情境之成本效果研究結果可供參考。

財務衝擊：在藥費財務影響方面，廠商預估 ivabradine 若納入健保給付，第 1~5 年之年度藥費約 460 萬元~1.28 億元。查驗中心認為建議者之分析架構及參數清楚合理，其分析結果可做為重要參考；且由於 ivabradine 屬於輔助治療(add-on therapy)，故其年度藥費也等同於年度藥費財務衝擊。若進一步考量使用 ivabradine 應可節省病人因心衰竭住院之醫療費用，廠商估計每年可節省心衰竭住院醫療費用 約 46 萬~1,300 萬元；查驗中心認為此處可能低估 ivabradine 節省之醫療費用。查 驗中心重新進行分析，預估 ivabradine 每年可節省心衰竭住院之醫療費用約 1,000 萬~2,900 萬元；合併計算 ivabradine 之年度藥費，查驗中心預估 ivabradine 每年造 成之整體財務衝擊約為 350 萬元~1.00 億元。

(Journal of Thoracic Oncology) 運動可當作治療肺癌選項!!!

Exercise is Beneficial for Lung Cancer Patients by Ajai Raj POSTED: APRIL 14, 2015 Exercise should be considered a therapeutic option for lung cancer patients and survivors, according to a review published in the Journal of Thoracic Oncology (2015 Mar 30). The review found that exercise reduces symptoms, increases exercise tolerance, improves quality of life and potentially reduces length of hospital stay and post-surgical complications for lung cancer patients. Investigators from the Medical University of South Carolina (MUSC) conducted a review of 42 studies that examined the effects of exercise on cancer outcomes, including 22 surgical studies, 11 medical studies and 9 reviews. All of the studies focused primarily on lung cancer, although one medical study focused on a variety of metastatic cancers, and another focused on lung and colon cancer. The investigators concluded that physical activity is beneficial at every stage of lung cancer, both reducing the risk of cancer development and reducing the symptom burden as the disease progresses. Moreover, the MUSC team found that exercise may have beneficial effects on quality of life, physical function, social function and fatigue, and that these benefits extend to lung cancer survivors, as well. The investigators also found that most lung cancer patients, regardless of stage, want physical activity advice directly from a physician at a cancer center before cancer treatment, and that exercise guidance may increase compliance with a dedicated program. While the ideal exercise programs for patients with different stages of lung cancer remains unclear, the authors concluded "clinicians should (at minimum) consider physical activity early, counsel against inactivity, and encourage physical activity in all stages of lung cancer patients and lung cancer survivors.""There are still large gaps in the published literature to be addressed and these could be filled with large definitive prospective trials that evaluate the benefit of exercise in lung cancer patients," they added.

醫藥互聯網三巨頭: (阿里健康+天貓)VS(百度葯直達/北京健康雲)VS(騰訊挂號網/丁香園)

整合天貓在線醫藥業務 阿里要下什麼棋 北京新浪網 (2015-04-16 04:10)⊙記者 趙曉琳 ○編輯 邱江隨著阿里巴巴集團宣布將轉讓天貓在線醫藥業務的營運權給予阿里健康，開始正式整合、打通醫療健康產業全鏈條，BAT三巨頭之間的互聯網醫療健康產業之爭愈演愈烈。

阿里大手筆整合4月15日，阿里巴巴集團宣布，和香港上市的阿里健康信息技術有限公司達成最終協議。根據協議，阿里巴巴集團將轉讓天貓在線醫藥業務的營運權給予阿里健康，以換取阿里健康新發行的股份和可轉股債券。阿里健康將以194.48億港元從Ali JK Investment及Chen Wen Xin處收購資產。阿里巴巴集團目前擁有阿里健康約38%股權，交易完成後，持股將上升到約53%（如可轉債完全兌換以後，將上升到約54.6%），阿里健康將成為阿里巴巴集團的子公司。據阿里方面介紹，目前186家擁有互聯網藥品交易服務資格的藥房在天貓平台上銷售非處方葯、醫療器械、隱形眼鏡和其他保健產品。2014年3月至2015年3月，天貓在線醫藥業務的總商品交易額達到了47.4億元人民幣。在交易完成後，消費者將能繼續在天貓上在線購買相關產品，阿里健康在後台負責運營商家，集中產品供應，以向消費者提供高質量和大範圍的選擇。整合在線醫藥業務，有利於阿里健康在醫療健康電商領域戰略聚焦，並將服務拓展至中國醫療健康行業的更多參与方。阿里巴巴集團COO張勇明確表示：「阿里集團已把健康領域的生態建設列為未來的重要戰略方向之一。」就阿里巴巴集團選擇以阿里健康為平台整合旗下醫療健康資產，有阿里內部人士表示，阿里健康已具備優勢，在未來政策允許的情況下，充分把握機會成為進軍在線處方葯市場的先行者之一。阿里巴巴集團將會繼續支持阿里健康發展為阿里巴巴在健康醫療領域的旗艦平台。天貓醫藥館與阿里健康之前是兄弟單位，各自工作有一定的重合性，但有各自的業務邏輯。處方葯一旦放開，天貓醫藥館也一定會布局。目前，天貓醫藥館主要是服務天貓上已有的線上人群，阿里健康定位的是線下的醫院人群，做的是醫院處方外流。天貓醫藥館玩的是B2C，阿里健康做的是O2O。天貓在線醫藥業務的注入，為阿里健康解決了流量來源和同業競爭問題。一旦交易如願完成，天貓醫藥館將成為阿里健康的戰略性資產，這或許是阿里健康正式打通醫療健康產業全鏈條的開始，最終使阿里健康成為「阿里巴巴集團在健康產業布局的戰略旗艦」。

BAT加速布局 進入2015年，BAT對醫療健康產業的布局全面加速：就在阿里之前，4月12日，百度正式發布葯直達，進軍藥品O2O；而騰訊投資的挂號網則完成了對金象網的控股。從三巨頭的布局側重點來看，其各有優勢。2014年9月，騰訊7000萬美元戰略投資醫療健康互聯網公司丁香園。根據規劃，丁香園將與騰訊各個平台展開一系列合作，其中包括對微信系統的探索和對接，利用通訊社交領域的優勢，建立患者和醫生的鏈接，從流量口切入市場。2014年7月，百度宣布推出「北京健康雲」。該項目為北京祥雲工程重點項目之一，在大數據分析的基礎上，為用戶提供專業健康服務。在北京健康雲之前，百度還推出了du life穿戴設備、百度健康平台等產品。負責投資移動醫療的專業人士認為，百度的優勢主要在於自身大數據的分析能力。當醫療數據積累足夠大之後，這些數據的應用場景就極具想像力，包括疫情監測、醫療診斷決策、醫療資源調度、遠程醫療等各方面，可以利用其在大數據領域的經驗和技術手段，支持從個人健康管理到大醫療、大數據研究，甚至公共衛生政策管理等不同層級的健康決策。阿里巴巴則在2014年5月推出「未來醫院」項目，通過支付寶對醫療機構開放自己的平台能力，幫助醫院提高運轉效率，優化醫療資源配置，目前已和全國主要城市的近50家三甲醫院達成合作意向。阿里的互聯網支付優勢和電商平台是支持其布局戰略的最大助力。易觀國際分析師郭陽認為，BAT的醫療布局都是在發揮其自身優勢的前提下進行的，還談不上誰更有優勢或者更有前景。

德盛傅子平: 全球併購溢價27～125％!!!

生醫基金炙手可熱 2015年04月16日 04:10 記者黃惠聆／台北報導 2014年全球生醫產業併購金額達2,500億美元 創15年新高，另外，每年的美國腫瘤學會年會 也將在5月登場，由於腫瘤（癌症）相關藥品目前全球銷售量最大，若會議中出現正面的臨床實驗結果，往往有助拉抬許多醫療保健公司的股價預期，使得生醫基金高燒不退。醫療股走勢近期再走高，截至13日為止，NBI生技指數近一周漲幅近6％，主要是製藥大廠獲利明顯增、併購情況再升溫，加上重量級醫學會議5月份快登場，讓相關生醫指數持續走高。保德信全球醫療生化基金經理人江宜虔表示，今年初以來，製藥業併購題材熱絡，超級財報周登場後，預料生物科技、醫療器材產業的財報將優於美國企業的平均值，推估2015年美國醫療生化產業每股盈餘年成長率為8.9％，遠勝過標普500指數整體平均年成長率1.7％，讓生技股上漲有基本面支撐。去年全球醫療生化產業併購金額達到2,500億美元，是近15年來新高，江宜虔指出，在低通膨之下，醫藥類物價成長動能遠高於一般消費品，也讓醫療類股獲利成長有較大上修空間，併購整合下，研發生產力將明顯提升。德盛全球生技大壩基金經理人傅子平表示，儘管生技產業時有逆風襲，但從基本面來看，生技產業整體展望仍然正向，在全球低利環境加上專利斷高崖高峰期，產業併購趨勢持續延燒，光在3月30日單日之內就出現了3件併購案，而且併購溢價還高達27～125％，顯示併購題材仍然熱絡。第二個基本面利多是美國FDA對新藥審查速度加快，傅子平說，今年以來，FDA就通過13件新藥，比過去同期還高，有利未來新藥上市與發展。

汤臣倍健: 打造 贵细药材品牌(无限能)&运动营养补充剂品牌(健乐多)!

中药品牌无限能发布 成汤臣倍健大健康格局新增长引擎 2015-04-14 17:18　来源：中华网财经　4月10日，中国保健行业龙头企业汤臣倍健正式在杭州发布旗下科学贵细药材品牌——无限能，国际功夫巨星李连杰也作为其形象代言人首次亮相。汤臣倍健董事会秘书胡超表示，作为进军健康产业下一个金矿——中草药滋补品市场的主力军，无限能将成为汤臣倍健大健康产业布局的重要一步，目标是打造汤臣倍健的又一快速增长引擎。

中药品牌无限能发布 成汤臣倍健大健康格局新增长引擎

颠覆传统中药有望重新划分中草药保健品行业格局 近期中医药产业成为社会热点。两会上,政府工作报告提出"积极发展中医药和民族医药事业"。博鳌论坛更设置中医药专场，这也是中医药首次进入中国常设的全球性国际论坛。专家认为，随着政府和公众对中医药的日益重视，中医药产业也将迎来黄金发展机遇。事实上，我国中医药保健品零售规模近年来也逐年增加。中国保健协会养生保健专业委员会名誉会长刘建文曾表示，中药类保健品正以绝对优势成为消费亮点。目前我国中药保健品年销售额超过500亿元，并以每年13%-15%的速度增长，到2020年，这个数字将接近680亿元。而目前该行业并没有领军品牌。现代化中医药保健品领域是下一个机会无限的金矿。无限能负责人介绍，目前，传统贵细药材产品存在质量标准落后、有效成分和作用机制不明确、可控性差、服用麻烦等问题。抓住这一痛点，汤臣倍健花费四年、耗资数亿元打造无限能科学贵细药材系列产品，以高效浓缩科技，对传统名贵中药材大别山灵芝、长白山人参、加拿大西洋参、云南三七、西藏红景天、山东阿胶等进行浓缩提取，具有高浓缩、高纯度、服用便利的特点，非常符合现代人的生活习惯。申银万国证券师邓敬东分析，无限能作为贵细中草药保健品极具中国特色，是市场中较有特色的产品，符合中国人传统健康理念，受国外竞品竞争小，市场潜力较大。东方证券分析师田加强则表示，无限能打造了中药滋补新理念，依托现代工艺激发了传统中医药的全新活力，未来中草药保健品行业格局有望被重新划分。

中药品牌无限能发布 成汤臣倍健大健康格局新增长引擎

创新运营模式激发无限能 据汤臣倍健2014年年报显示，无限能定位为快速成长型业务，通过创新营销模式和差异化策略切入营养品新的细分领域专业品牌业务。在管理模式上，无限能由汤臣倍健旗下子公司佰嘉独立运作，通过独立的扁平化运营团队架构和管理团队持股制度的激励，不仅激发团队二次创业的热情，更能快速应对市场变化，为迅速抢占市场机会提供保障。品牌建设上，无限能聘请了此前从未代言过保健品的国际功夫巨星李连杰作为形象代言人。其健康、责任的形象为品牌背书，有望复制姚明对汤臣倍健主品牌的代言效果。经营模式上，无限能首次尝试包括电子商务的全渠道经营模式，线上线下同时推进，既借助汤臣倍健原有线下渠道的优势，又获得大健康领域电商渠道的先机。而营销模式上，积极探索创新的大数据数字营销。利用阿里巴巴大数据管理工具，对消费者进行精准画像和精准传播，市场推广实现外科手术式的精准打击。据悉，从前期无限能产品线下试销和线上试用情况来看，消费者的品牌信任度和科学贵细药材品类接受度很高。在全国七个城市试销试点中，重庆、武汉24小时内销售即突破30万，济南7天销售金额突破100万。电商渠道的线上1万份西洋参试用活动，也取得了良好的消费者口碑。

中药品牌无限能发布 成汤臣倍健大健康格局新增长引擎

布局多品牌汤臣倍健打开大健康产业格局 上市五年来，汤臣倍健一直保持高速增长。面对健康行业的监管拐点以及移动互联网对传统营销模式的冲击，过去一年，重新规划新的战略方向，以谋求新竞争环境下的先发优势。据汤臣倍健2014年年报显示，全新制定的《2015-2017年度经营规划纲要》中明确，整体业务布局由膳食营养补充剂扩展到大健康产业，未来业务生态由三大业务板块和大健康产业布局构成，三大业务板块包括汤臣倍健药业、广东佰嘉、线上业务。胡超表示，2015年，汤臣倍健的大健康产业构想将通过多品牌布局持续发力。其中主营品牌"汤臣倍健"定位为稳健成长型业务，骨骼健康品类"健力多"保持快速增长。而"无限能"作为汤臣倍健在大健康产业推出的一个不同于目前膳食营养补充剂业务的新品类，定位于科学贵细药材，进入更加广阔的中草药滋补品市场。据透露，汤臣倍健今年还将加快产品创新，推出两全新品牌：一是定位为运动营养补充剂品牌"健乐多"，一是定位为电子商务营养补充剂品牌"每日每加"。而去年下半年已推出的移动健康管理产品"十二篮"也将归入线上业务公司，并计划择机推出其他健康管理项目。申万宏源证券分析师陈嵩昆表示，汤臣倍健制定了全新发展战略，未来业务将扩展到大健康产业，将打开新的成长空间。公司注重打造顺应行业趋势的新品类将为公司带来新活力，其中科学贵细药材品牌无限能定位注入现代元素的中药保健品，看好公司在新战略下的巨大成长潜力。

汤臣倍健 布局 互联网大健康(深圳倍泰,可穿戴设备) !

汤臣倍健：积极战略转型 打造医疗平台 2015年04月15日 08:04来源： 采编：东方财富网预计公司 2015-2016 年 EPS 为 0.90 元、1.16 元，对应目前股价 PE 分别为47X、37X。公司是我国膳食营养补充剂龙头，行业仍有增长空间，新品类值得期待，积极拥抱互联网+，布局大健康，看好公司并购潜力， 维持"推荐"评级。积极战略转型：公司董事会基于对未来发展的分析，制定了转型战略，整体业务布局由膳食营养补充剂扩展到大健康产业，未来业务生态由汤臣药业板块、广东佰嘉板块、线上业务板块与大健康产业布局构成。(1)汤臣药业板块主营"汤臣倍健"品牌，定位为稳健成长型业务，确定现有销售模式不变，以极具差异化的服务力打造与经销商、连锁店的互生、共生、再生的战略同盟关系。(2)广东佰嘉板块定位为快速成长型业务，通过创新营销模式切入营养品新的细分领域专业品牌业务，包括骨骼健康品类"健力多"品牌与科学贵细药材"无限能"品牌。(3)线上业务板块 2015 年将会成立新的线上业务公司，其主要负责运营专供电子商务的营养补充剂新品牌和一些细分领域品牌的线上业务。(4)站在未来产业升级的角度积极布局大健康产业，促进战略升级。以投资参股与合作为主，积极探索与推进移动健康/医疗平台的搭建。新品类值得期待：公司子公司广东佰嘉 2012 年推出骨骼健康品类"健力多"， 2014 年已进入爆发性增长阶段，表明公司骨骼健康品类已获得消费者的认可，已基本确认单品模式的项目探索成功。公司正在更多城市对"健力多氨糖软骨素钙片"为主的骨骼健康相关产品进行推广，逐步扩大销售区域与销售规模，预计 2015 年仍将保持快速增长。 2015 年计划推出定位于科学贵细药材的"无限能"，我国中药保健品市场快速增长，看好"无限能"的成长前景。为了提升公司的服务力，汤臣倍健2014 年在全国范围内的部分零售终端开始升级"营养家"网络，试点建立汤臣倍健"营养家会员店"与"营养家健康体验中心"，以会员为中心进一步搭建汤臣倍健营养家会员平台，提升消费者粘性。拥抱互联网，布局大健康：为了借助移动互联浪潮培育新的商业模式及利润增长点，公司站在未来产业升级的角度积极布局大健康产业，积极探索与推进移动健康/医疗平台的搭建。公司布局大健康理念明朗，参股的深圳倍泰可提供可穿戴设备， 监测收集健康数据，移动医疗公司通过平台型产品进行数据转化和衔接服务，同时预计将有线下医院和医生资源整合接入，结合线上医生和营养师的专业建议，将有效提高复购率和交叉购买率，增强用户粘性。公司已经参股深圳倍泰，投资广发信德健康产业基金，和阿里健康原 COO 张守川合资成立移动医疗公司，未来公司将继续通过并购、参股来完善平台的搭建，后续动作可期。激励+并购助力未来成长：公司已经在全资子公司广东佰嘉药业和广东佰悦网络科技有限公司和新成立的医疗公司实现管理层持股，后续其它项目也将参考此方案制定类似或创新的激励机制，项目管理团队持股比例约 20-30%，旨在形成以项目公司团队为核心的老板/事业合伙人文化。同时，汤臣倍健积极探索并购，公司投资发展中心一直在公司整体战略指导下，加大与外部专业机构的合作，公司账上现金充足，并购决心强烈，未来在产品、渠道或新业务方面均有并购可能。

JCO發表 早期介入Palliative Care(安寧照顧) " ENABLE III"改善癌病人品質與存活率!

 Early use of palliative care in cancer improves patients' lives, outcomes for caregivers A new randomized clinical trial with Dartmouth investigators Kathleen Lyons, ScD, Tor Tosteson, ScD, Zhigang Li, PhD, and collaborators has noted significant improvement in several measures among those who began palliative care early. Their findings are described in, "Early Versus Delayed Initiation of Concurrent Palliative Care Oncology: Patient Outcomes in the ENABLE III Randomized Controlled Trial," published recently in the Journal of Clinical Oncology."Survivorship and quality of life are of great interest in clinical cancer research, but can be difficult to evaluate because of high mortality and the need to measure patient-reported outcomes," explained Tosteson, a biostatistician at Dartmouth's Norris Cotton Cancer Center (NCCC). "We developed trial designs and analytic methods that allow the joint estimation and comparison of survival and quality of life data between different treatment strategies. The ENABLE trials have helped to establish the beneficial effects of palliative care on overall survival by interventions targeting patient outcomes." The team's previous ENABLE II trial established that a carefully designed intervention for patients with late stage cancers improved both quality of life and survival. The recently published ENABLE III study found that an earlier intervention strategy improved survival further. In this study, investigators researched the outcomes of palliative care which began at the first visit or three months later among 207 patients with late stage cancer. Though the early-entry participants' patient-reported outcomes were not statistically different from the late-entry participants', their one-year survival after enrollment was improved compared to those who entered later. Additionally, outcomes for caregivers were improved. "Early interventions for caregivers lowered their depression and stress burden in the last month of the patient's life," reported Lyons. Dartmouth's system of Shared Resources, including the Biostatistics Shared Resource and the Office of Clinical Research, provided key assistance in conducting this trial. The Division of Biostatistics in the Department of Biomedical Sciences at Dartmouth's Geisel School of Medicine contributed faculty expertise to develop new methods for analysis of the trial data. Team science is a priority at Dartmouth, and this study involves a highly cross-disciplinary team from the NCCC Programs of Cancer Control and Cancer Epidemiology. Looking forward, analyses are underway to identify the mediating factors leading to improved survival and quality of life in both patients and caregivers.

醫療軟體確效(Software Validation)需求增溫 !

策會_醫療器材Software Validation確效理論與實務財團法人資訊工業策進會 本新聞稿發佈於2015/04/15資策會將於2015年5月5日開辦「醫療器材Software Validation軟體確效理論與實務班」，本課程了解目前軟體驗證之要求與相關標準，使廠商在研發前期即能導入軟體確效之流程。 近年來台灣醫療電子發展相當迅速，利用軟體進行醫療設備的儀器控制與訊號處理的產品與日俱增，然而因軟體失效而造成醫療器材不良事件亦伴隨而來。軟體確效(Software Validation)成為各國醫療器材主管機關關注的重點，除要求醫療器材業者必須導入軟體開發生命週期技術外，亦需配合軟體驗證的相關活動留下紀錄以作為上市產品審查之依據。 目前美國、歐盟與我國TFDA均要求業者在上市前申請時需提交醫療器材軟體確效報告。本課程即在讓廠商了解目前軟體驗證之要求與相關標準，使廠商在研發前期即能導入軟體確效之流程。 資策會將於2015年5月5日開辦「醫療器材Software Validation軟體確效理論與實務班」，本課程了解目前軟體驗證之要求與相關標準，使廠商在研發前期即能導入軟體確效之流程。相關資訊請參閱課程網頁，或電(02)6631-6534，課程經理 黃小姐。

定量閾值測定: 早期檢驗糖尿病神經病變

國立成大醫院斗六分院：糖尿病神經病變手腳麻木，定量閾值測定可即早發現 大成報-2015年04月15日 下午23:21 【大成報記者張立明／雲林縣報導】令人印象深刻的廣告台詞，「阿嬤被孫女騎腳踏車壓過也不知道痛」、「都火災了阿伯因為腳麻而走不了」，這些都是典型的糖尿病神經病變症狀。國立成大醫院斗六分院糖尿病內分泌科陳沛吟醫師表示，超過一半的糖尿病患在罹病十年時就已經有神經的病變，經常會有刺痛、麻木或燒灼感，而有些人的症狀則是對冷熱、震動、位置的感覺消失或減弱。除此之外，很多人並不知道自己的症狀其實也是糖尿病神經病變，例如:異常出汗、頭暈低血壓、心跳增快、消化不良、頻尿或失禁等。而當糖尿病人有神經病變時，常常也伴隨有腎臟病變或視網膜病變，因此， 即早發現並積極控制血糖是治療的不二法門。成大斗六分院神經內科簡崇曜醫師表示，有別於傳統神經傳導檢查，「定量閾值測定」可更早檢驗出糖尿病神經病變。簡醫師說明，周邊神經可大致分為大神經與小神經，而糖尿病神經病變往往先影響小神經，導致輕微感覺遲鈍，一段時間後連大神經都壞死，主要感覺都會喪失，甚至出現如燒灼、觸電般的疼痛。傳統的神經電生理檢查是測試大神經的傳導速度，因此患者還在小神經病變階段時可能無法驗出異常。此外，這是經表皮用電刺激較深的神經，對於觸電敏感的患者無法忍受。「定量閾值測定」是針對小神經檢查，項目包括冷熱感覺、震動覺、壓覺及觸覺，而且會根據個人感覺閾值調整刺激大小，疼痛不適感就比較小。「定量閾值測定」更早診斷出糖尿病神經病變，患者更有機會即早積極控制治療血糖。

Biogen's novel MS drug shows promise of repairing nerve tissue

 April 15, 2015Biogen's ($BIIB) latest treatment for multiple sclerosis helped repair damaged nerve tissue in a Phase II study, an incremental victory for a novel therapy that has a long way to go. The treatment, anti-LINGO-1, met its main goal in a study on 82 patients with acute optic neuritis (AON), a disease in which inflammation erodes the layers of protein that protect nerve fibers. Biogen designed the study to measure nerve function by clocking how fast a signal moved from the retina to the brain, with a primary endpoint of improving reaction times compared with placebo. In the study, patients who got at least 5 doses of the antibody demonstrated a 34% improvement on that measure compared at week 24. At 32 weeks, that number jumped to 41%, Biogen said, and both results were statistically significant. However, anti-LINGO-1 had no effect on the actual thickness of the protein layers, called myelins, and it didn't help improve patients' visual function in the study. Looking at imaging results, Biogen notes that some of the myelins in question had significantly thinned before treatment, meaning the antibody may not have had the chance to prove itself on that measure. And the study's investigators are heralding the results as the first ever demonstration of myelin repair by any metric. This 200-page book takes an in-depth look at the biotech industry and the science that drives it. Although the industry itself is constantly changing, these fundamental concepts upon which it is built will remain important for years to come - and decision-makers who understand these fundamentals will be better able to evaluate and predict new trends. Click here to buy today! Sign up for our FREE newsletter for more news like this sent to your inbox! AON has no causal relationship with MS, but both diseases are characterized by the slow destruction of healthy nerve tissue, and Biogen figures any positive results in the former indication have a strong read-through for the latter. Despite the miss on secondary endpoints, the company is counting its Phase II effort, called RENEW, as a net positive for anti-LINGO-1."RENEW studied two distinct mechanisms of action--remyelination and neuroprotection," Biogen Chief Medical Officer Alfred Sandrock said in a statement. "We believe that the opportunity to impact neuroprotection was limited by the rapidity with which retinal ganglion cells and their nerve fibers were damaged by the disease. This insight offers valuable information on the speed of axonal loss following an AON attack, and combined with the positive primary endpoint results, will help inform future studies."Biogen is at work on a separate Phase II trial, called SYNERGY, that is studying the antibody's ability to slow the progression of MS, measuring composite change in cognitive function over 84 weeks. Data from that study are expected in 2016 and will likely make or break the treatment's potential.

大健康品牌商(营养补充): 安利直销/ 汤臣倍健零售连锁/禾健纯电商!!

大健康产业竞合加速 "最后一米" 2015-04-15 10:21:50 责任编辑： 来源：前瞻网 作者：余丰慧 老龄化社会的提前到来、慢性病的井喷，大健康产业正在成为最有潜力的朝阳产业。然而，在互联网的冲击下，整个产业正面临进化，品牌与渠道的竞合加速，进化之路之选成为业界关注焦点。 近5年来，医药电商一直保持着高速增长，年均增长率超过200%。近日，有关"网售处方药开闸"的消息更是层出不穷，一旦网售处方药开闸，即意味着医药电商市场将可能扩充至现有的4倍，预计规模会达到3000亿元。 BAT巨头更是纷纷加快布局大健康产业，而传统线下渠道则面临重重挑战。回首2014年，无锡惠润与华润医药联手出售三九医药;复星医药将金象与复美出售给国大药房;林和连锁全资被南雪药业收购;同仁堂、嘉事堂等众多知名连锁药店也都在减少自身门店数量。 面对日益恶化的生存压力，不少药店都不约而同地试水电子商务。一心堂计划投资1.2亿元进行电商业务的发展;老百姓大药房联手春雨医生，在其官网设立智能穿戴设备专区;海王星辰与支付宝合作布局O2O模式，业内普遍认为将有更多的实体连锁投身于网上药店的经营中来。

大健康产业竞合加速 "最后一米"成关键  大健康品牌商也开始转型。目前在中国膳食营养补充剂行业，存在多种渠道模式，如安利的直销模式、汤臣倍健零售终端连锁模式、禾健纯电商模式等。汤臣倍健因"二维码"事件被指责为"去连锁化"，禾健的纯电商路线表现也还需要长时间的发展，反而是生命力提出"渐进并轨"路线，追求品牌商与渠道商的共赢，表现越来越抢眼。 4月12日，生命力发布其在渐进并轨路线下的"米杀战略"，在与消费者沟通的"最后一米"的关键位置，生命力将以强势的品牌扩张、强大的内容输出为抓手，给予医药连锁空前的利润空间和激励政策，与渠道商并肩转型，以带动膳补剂行业走出一条"渐进、并轨、共赢"的进化之路。 生命力"米杀战略"无疑是直击要害，因为在未来的膳补剂行业，无论是线下的医药连锁渠道，还是移动互联网电商，品牌与消费者沟通的关键在于"最后一米"。线下经销商在与消费者面对面沟通时，需要强有力的品牌支持、内容支持、利润空间;相对于竞争对手而言，只要抓住了这"最后一米"，就可以将自身利益与消费者利益、经销商利益实现共赢，进而赢得发展机遇。 无论是走电商也好，品牌商与渠道商捆绑共赢也罢，大健康产业的转型已经开始，而未来市场致胜的关键，或许就在这"最后一米"。本文作者：余丰慧 （经济学家、著名财经评论家）

Point of care (POC) ultrasounds

Versatile Point of Care Ultrasound Technology Quickly Gaining Market Share in the United States According to a recent report by iData Research, the point of care ultrasound equipment market is the fastest growing segment of the ultrasound equipment market, valued at more than $250 million. (PRWEB) April 15, 2015(http://www.idataresearch.com), growth in the U.S. ultrasound equipment market can partially be attributed to the rapid adoption of point of care (POC) ultrasounds in new environments such as anesthesiology, critical care, and musculoskeletal applications. These areas of medical service delivery have not traditionally relied on ultrasound for their diagnostic evaluations. But, due to technological improvements and reductions in the cost of ultrasound equipment, these areas are rapidly adopting it as a tool for diagnostic and guidance procedures. "Physicians are using POC ultrasound to improve the accuracy of needle placement procedures, and to replace costly radiation-based imaging techniques with real-time, cost-effective ultrasound imaging," explains Dr. Kamran Zamanian, CEO of iData. "Apart from market segments for POC ultrasound equipment, the U.S. ultrasound equipment market is highly saturated." Other key findings from the iData Research report entitled U.S. Market for Ultrasound Imaging Equipment:

Technological Advances  Technological advances are driving the POC ultrasound market, particularly within the musculoskeletal segment. 3D and 4D capabilities are more widely used because they provide superior imaging over two dimensional systems. These technological advances also cause the price of the device to increase. Portability and higher image resolution are expected to cause rapid growth in this market.

Relatively Low Cost POC ultrasound systems are significantly less expensive to purchase compared to other modalities, including computed tomography or magnetic resonance. These systems cost well over $1,000,000 to purchase, while the average selling prices of POC ultrasound systems are a fraction of that value. Magnetic resonance scans often cost thousands of dollars, while POC ultrasound procedures are priced in the hundreds of dollars range.

Leading Competitors SonoSite is the leading competitor in the U.S. market for POC ultrasound systems in 2014, followed by GE Healthcare. Other notable competitors in the U.S. market for POC ultrasound systems include Philips Healthcare, Zonare Medical Systems, and Terason. Other leading competitors in the overall ultrasound imaging equipment market in the U.S. include Siemens Healthcare, Toshiba, Hitachi Aloka, amongst others.

康聯 李欣/黃麗蓉/鄭清棋 交保!! (涉嫌炒手)

被控炒股 F-康聯經營高層涉違反證交法交保 2015-04-1520:22 〔記者錢利忠／台北報導〕F-康聯控股公司（4144）執行長李欣、黃麗蓉夫婦被控，涉嫌在100年間炒作F-康聯股票，台北地檢署今傳喚李欣、黃麗蓉以及F-康聯副總鄭清棋，訊後依違反證券交易法，分別諭令100萬元、50萬元以及20萬元交保。 F-康聯控股公司執行長李欣、黃麗蓉，以及F-康聯副總鄭清棋，訊後均被依違反證券交易法，分別諭令100萬元、50萬元以及20萬元交保。（記者錢利忠攝） F-康聯控股公司執行長李欣、黃麗蓉，以及F-康聯副總鄭清棋，訊後均被依違反證券交易法，分別諭令100萬元、50萬元以及20萬元交保。（記者錢利忠攝） 檢調調查，李欣、黃麗蓉及鄭清棋等3人，涉嫌與市場派炒手聯手，以人頭帳戶炒作F-康聯股價，據悉，3人應訊時均否認涉案。

F-康聯高層炒股 執行長100萬交保

2015年04月15日19:32 F-康聯控股公司(股票代號：4144)執行長李欣涉嫌與市場派炒手合謀炒作自家公司股票牟利，台北地檢署今天傳喚李欣、黃麗蓉夫婦及F-康聯副總鄭清棋到案，訊後依違反《證券交易法》炒作股票罪諭令李欣夫妻各100萬元、50萬元交保，鄭男則獲20萬元交保。以中國上海國創醫藥有限公司為營運主體來台投資的控股公司F-康聯，去年被檢調查出2011年間公司副總鄭清棋涉嫌與友昱（現改名詠嘉）科技前董座鍾瑋驛、股市炒手王子元等人合謀，聯手炒作F-康聯股票牟利，當時檢調發動搜索約談後，諭令鍾瑋驛300萬元交保候傳。專案小組逐一勾稽比對查扣證物，發現F-康聯高層涉及炒股者，除了鄭清棋外，還包括公司執行長李欣及李妻黃麗蓉，3人均利用大量的人頭聯合炒作公司股價牟利。檢調今天以被告身分傳喚3人到案釐清案情，3人雖異口同聲否認非法炒作自家公司股票，但檢察官認為3人嫌疑重大，訊後分別諭令交保候傳。《蘋果》向北檢查證這起弊案，北檢低調表示案件仍在偵查中，拒絕進一步說明案情。（呂志明、賴又嘉／台北報導）

醫審會: 一般般超音波看不出異常

產檢未檢出嬰兒缺損 醫生不起訴 中央社 (2015-04-15 17:56)（中央社記者蘇龍麒新北市15日電）新北市中和區一家婦幼診所，民國102年超音波產檢未檢出女嬰有缺陷，遭控告業務過失傷害，但醫審會鑑定一般超音波看不出異常，新北檢不起訴醫生。基隆一名林姓婦人102年懷孕，到新北市中和某婦幼診所，由陳姓院長進行12次產檢及超音波檢查，都沒有發現異常。後來林女突然腹痛，待產時診斷臍帶繞頸呼吸窘迫，經緊急剖腹產下一名女嬰，但女嬰卻雙手手肘以下缺損，只存半截上臂，且沒有右腳，林姓婦人便控告陳姓院長業務過失傷害。林女認為，在診所進行了12次產檢及超音波檢查，醫師都沒有告知胎兒肢體異常，因此質疑診所陳姓院長有疏失，因此控告陳姓院長業務過失傷害罪，並提出新台幣上千萬元的民事求償。不過，醫審會鑑定認為，一般超音波檢查對於胎兒肢體殘缺的診斷率並不高，且這起案件的多張超音波照片，看不出有任何肢體缺陷的異常現象，判定陳姓院長未進行3D、4D的高階超音波檢查及羊膜穿刺檢驗，符合醫療常規。因此，檢方認定陳姓院長沒有過失，給予他不起訴處分。1040415

癌症康復 14大成功心理因素!!

個性與癌症相關？6大情緒恐提高罹癌機率 優活健康網2015-04-15 08:00(1天前) （優活健康網編輯部／綜合整理）既然個性與疾病相關，那麼，有所謂癌症個性可言嗎？現代西醫把賭注集中於遺傳基因上，試圖從中尋求癌症的解答，只有一小部分醫者注意到個性在疾病上所扮演的關鍵角色。個性在疾病上是否有舉足輕重的角色，早已被「A型人易得心臟病」的事實所證明，個性絕對與疾病有關，也確實有科學家投身研究所謂的癌症個性。1951年，克萊恩（Klein）與索賓（Sobin）觀察到有很多癌症病人有嚴重憂鬱症、自我否定、對自身疾病的過度陳述。1952年時，韋斯特（West）、布倫伯格（Bloomberg）和艾利斯（Ellis）三人的報導指出，他們利用心理測試後發現，比起腫瘤成長較慢者，癌症快速成長者有隱藏內心感受的強烈傾向，且比較沒有能力以正面行動來減低緊張。維吉尼亞大學精神科所發展的綜合個性輪廓測試法也透露，癌症病人易完全壓抑情緒和動力，伴隨此特徵的是明顯缺乏洞察力或自我察覺的力量，此外還有敵對性和依賴性這兩個特點。敵對性往往是朝自己，在意識層面以內疚和自我毀損呈現，在行為模式上則明顯有某些自殘傾向。依賴性問題則呈現在無彈性和單方向的人際關係上，常以自我犧牲來換取別人的接納與同意。個性輪廓分析並非現代的新發明。德國班琴的神祕聖尼僧─聖賀德佳（St. Hildegard）舉了35種會產生疾病吸引力反應的心理風險因子，根據她的心理治療書《生命的優點益處書》與海德堡的癌症研究機構的研究：充滿悲傷、思慮、恐懼、長期壓力和匆忙的日常生活其實非常危險，特別容易引起癌症的情緒是長期絕望或無助、懷疑感、缺乏信仰、事事擔心和悲觀性的憂傷。

有助於癌症康復的個性 陰陽共生，有負面的個性，也一定有正面的個性。癌症不是絕症，有不少病人絕處逢生，存活了多年，他們是怎麼做到的？他們的復癒可能與正面的個性有關嗎？是的，既然有易得癌的個性，有助於從癌症康復的正向個性應該也存在，甚至有治療師或醫師發明讓癌症病人能找回自己生命活力的方法與治療。首先來看看那些有記錄的「奇蹟」案例。卡萊兒‧賀西柏格（Carlyle Hirshberg）和馬克‧依恩‧波拉許（Marc Ian Barasch）合著的書《神奇的康復》就問了同樣的問題，他們收集了許多不可思議的療癒或自發性癒合的案例，並訪問這些病人，以找出哪些特質有助於讓人從癌症康復。初步研究發現，康復者將他們的成功歸功於下列的心理因素：

‧75％相信正向的成果會出現。 ‧71％有積極對抗的精神。 ‧71％有接受疾病的心態。 ‧71％視疾病為一種挑戰。 ‧68％對自己的疾病與後果承擔起責任。 ‧64％有重新再活下去的欲望或意志。 ‧64％保持正面的情緒。 ‧61％有（宗教）信仰。 ‧61％有新的生活目的感。 ‧61％改變生活習慣與行為。 ‧59％有主宰感。 ‧59％改變生活型態。 ‧57％有自我滋育感，較能肯定自我。 ‧50％有社交支持。

很明顯地，假如你想改善自己，在癌症的逆境中逢生，多採取上述的正面特質確實有助於提高生存機率。另外，在布蘭登‧歐雷根（Brendan O`Regan）和卡萊兒‧賀西柏格合編的書《自發性癒合：一本加註解的參考文獻》寫道：「從癌症獲得自發性癒合，在醫學刊物上是罕見但壯觀的現象……但對於它是如何發生的，沒有人有任何概念。」兩名作者為自發性癒合下了以下定義：「在沒有醫療治療、或被認為不足以使疾病徵狀或腫瘤消失的治療之下，癌症或疾病完全或部分消失掉。」自發性癒合一詞往往帶有神祕不可測的涵義，但是筆者要據理力爭的是，自發性癒合並不是如此的隱密和難求的。所有研究皆明顯地突顯出正面情緒有助療癒，若能利用正面情緒來克服相對的負面情緒，或許便可以更恰當地使用身心療法來幫助病人改變心性，得到自發性癒合的目標。 （本文摘自／別讓癌症醫療殺死你／柿子文化出版）

提神醒脑刮痧法

刮痧保健 刮拭头部可提神醒脑 时间：2015-04-15 08:30:03 来源：家庭医生在线刮痧是一个很好的养生方法，身体上有很多的穴位，不同的穴位会有不同的养生功效。专家介绍，头部也是汇聚了很多的穴位，如果经常刮头部、刺激这些穴位，那么将会起到提神醒脑，保健养生的功效。

刮头部，提神醒脑 头部是全身阳经汇聚的地方。清晨起床后，用刮痧梳刮拭头部，能振奋阳气使人神清气爽。方法是以头顶的百会穴为中心，向四周呈放射状刮拭，至头皮有热感。如果有疼痛点，可在此点上反复刮拭5至10次。

具体操作方法：手心向内，手指张开如抓痒一样。抓时闭眼，心神安定，身体放松。自前额上的头发抓起，由前向后，经头顶至后发际;再从后向前，循环往复。抓时主要用两小指头的螺纹面进行按摩，其他手指随着小指的按摩用指甲抓头皮，动作匀缓轻柔，以免损伤头皮。如果在抓摩头部某一穴位时，意念集中于这个穴位，并且在呼气时抓，吸气时停，使意念、气、形(抓摩)三者同时进行，效果更佳。

刮痧过程中还要注意以下几点：不建议在骨头部位进行刮痧，如脊椎，脊椎上都是骨头，如果力度掌握不好，易受伤，太阳穴周围血管分布密集，也不建议自行刮;小孩子皮肤比较嫩，不建议上小学之前的孩子刮痧;过饥、过饱、过渴、过分疲劳、醉酒等情况下也不要刮痧，可在饭后1小时刮痧;刮痧过程中要注意保温;刮痧后半个小时不洗冷水澡;刮痧后要注意水分的补充，可饮用1-2杯温水;痧没退，不能再次进行刮痧，以免伤皮肤。

还有哪些提神醒脑的方法：当你工作疲劳时，不妨静坐在椅子上，闭目养神5分钟。要全身放松，也可深呼吸。睁开眼睛后也可眨一眨眼睛。这样你会感到脑清目明的。可改善精神状态，提高工作效率。

二、握拳伸指 如果工作时，你感到昏昏欲睡。那么你可以两手握拳，然后从小指逐渐打开，打开的时候要迅速有力。然后，同样的从小指开始握进去。反复几次可以收到不错的效果。

三、提提脚尖 如果你精神萎靡不振，那么你可以提提脚尖。无论是站着或者是坐着都可以。提脚尖的时候，眼睛尽量看远方，脊柱要自然挺直。这样会让你的精神饱满一点。

肉豬養殖合資公司: 慕德生+中糧肉食(KKR/霸菱基金/厚樸/博裕)

慕德生攜陸企建現代化豬養殖公司 年產百萬頭 產值達72億 鉅亨網記者張旭宏 台北2015-01-2921:44　 慕德生技(4740-TW)宣布攜手陸中糧肉食簽訂商務合作意向書，雙方成立合資公司，發展建立現代化肉豬養殖公司，營運目標為每年生產出100萬頭肉豬，年產值約14.5億人民幣(約合台幣72.5億元)。慕德生表示，每年生產出欄100萬頭肉豬將分兩階段進行，第一階段以每年生產50萬頭肉豬啟動，由仔豬生產、飼料營養、飼養管理至肉豬出欄上市銷售，第二階段則依土地取得進度、建廠設計施工與市場環境等因素循序推動，完成每年100萬頭肉豬生產規模。 慕德生進一步表示，合資公司成立後，除豬隻養殖事業外，並建立或投資所需營養配方飼料生產、動保獸醫材料供應、健康和疾病檢測中心、農場管理作業系統，以免疫調控生技產品和豬隻飼養績效結合中糧肉食的養殖規模、加工產業鍊，提升肉豬品質、降低成本提高市場競爭力，再藉此逐步擴大經營規模和範圍及提高經濟效益。糧肉食投資成立於2009年，是中國糧油食品集團旗下的現代化農業產業化企業，集飼料加工、畜禽養殖、屠宰、深加工、冷鏈配送、分銷以及肉類產品進出口於一體。中糧肉食品牌「家佳康」，從養殖源頭開始，在全國布建66個生態養殖基地及9個加工廠，主要分布於天津、山東、江蘇、湖北及廣東等地，且目前仍在不斷興建，擴大生產基地。中糧肉食於2014年6月6日與美國KKR、霸菱亞洲基金、厚樸基金和博裕資本聯合組成的財團，宣佈結成戰略合作夥伴，並與中糧肉食的現有股東共同對公司進行投資，在大陸建設並管理大型現代化肉豬養殖場及肉食品加工廠。

紅檜精油: 桃金孃烯醇及桃金孃烯醛

興大研究證實 檜木精油助減壓放鬆 Written By: 活躍星系核|2015/04/15 |Posted In:人體解析健康養生|Tag:療效精油紅檜 在房間裡放個薰香燈，點上幾滴精油，讓香味漫布在整個房裡，不外乎是一種生活情趣阿～身心靈彷彿都輕鬆許多。然而這樣的身心舒暢到底是一種自得其樂，還是真的是精油的功勞呢？國立中興大學研究證實，檜木精油對人體的療育功能確有其事！ 國立中興大學森林學系王升陽特聘教授與其博士生陳啟榮，於《天然物通訊》（Natural Products Communication）發表了一篇有趣的研究論文（已被接受，未刊登），發現成年人吸入紅檜精油5分鐘後有助放鬆，而扁柏精油則有助於專注。王升陽指出，學術上被稱為檜木的樹種其實是指扁柏屬的針葉樹，全世界目前存在有六種。檜木類木材具有濃鬱香氣、耐久性優異，因此深受喜愛並具有極高的經濟價值。台灣就擁有了兩種檜木，即是大家所熟悉的台灣扁柏（Hinoki）和紅檜（Meniki），這兩種木材更是檜木中材質最佳並具有特殊香味的檜木品種。該研究以18 – 24歲的成年人為試驗對象，分別讓受測者吸入一定濃度紅檜與扁柏精油的精油，並以儀器量測受測者之血壓、心跳與正、副交感神經之活性，並計算自律神經總活性。結果發現，成年人在吸收兩種檜木精油5分鐘後，對兩種檜木氣味呈現了不同的反應，無論男女在吸收紅檜精油後表現出收縮壓下降、舒張壓上升以及心跳下降；交感神經活性下降、副交感神經活性上升，而在自律神經總活性方面則提升。但在吸收扁柏精油後，無論收縮壓、舒張壓與心跳均下降；但在交感神經活性上升，副交感神經活性下降；且自律神經總活性方面則提升。王升陽指出，一般而言當我們感受壓力、危險時，身體就會啟動相關必要的機能，例如：心跳及血壓上升、呼吸變快、體溫增高，讓人體保持警覺、提高專注力，達到可以積極應變的狀態，此時則是交感神經起動。而副交感神經是抑制性的，負責讓人體鬆弛休息、保存體力、促進消化、睡眠啟動等。由上述之結果顯示，經吸入紅檜精油5分鐘後，可使壓力解除。而扁柏可讓人交感神經活性上升、副交感神經活性下降，換言之可使人精神集中，提高專注力。此外，研究團隊並利用盤斯心情量表（Profile of Mood Stat, POMS）來評估成人吸收林木揮發性成分後的情緒反應，分析結果發現，當人體接受了紅檜或是扁柏的精油，於緊張、沮喪、憤怒、疲卷與困惑等構面，使用精油後緊張感顯著下降。在森林中，人們感受到的清新氣息大多來自芬多精。根據王升陽的分析，扁柏具有多樣化的成分組成，其中含量較豐的成分，包括欖香烯，杜松烷，松烯和檸檬烷；同為檜木類的紅檜之香味成分則與扁柏差異甚大，主要的香味成分則為桃金孃烯醇、桃金孃烯醛和杜松烯。事實上，若直接利用嗅覺感覺扁柏與紅檜的氣味，是可以明顯區分紅檜與扁柏的木材，我們認為紅檜中較甜的味道應該是桃金孃烯醇及桃金孃烯醛所貢獻；而扁柏的辛辣味，則應是大量的單萜類，如松烯，檸檬烷，異松油烯，松油烯所共同形成。經人體吸收後，對於人類的生理，具有正面的效益，它可以降低人體交感神經系統的活動，增強副交感神經系統的作用，達到平靜寧和的效果，若結合森林環境中的景觀與自然的聲響，效果將更為明顯。資料來源：中興大學新聞稿

 

 

Pfizer 併購策略安全牌 (投資20項Merck 開發案cancer immunotherapies)

Pfizer's hunting for safe M&A bets, not high-risk pipeline deals January 27, 2015 | By Damian Garde Pfizer ($PFE), a deal-minded drugmaker sitting on billions in cash, is more interested in acquiring near-market assets than investing in long-term projects, counting on a blockbuster oncology collaboration to keep its early-stage pipeline afloat. On a conference call with analysts, Pfizer CEO Ian Read said his company is "biased toward deals with the potential for creating value in the near term," adding that he doesn't feel the drugmaker needs to "do a large deal" to keep its engines running. Read, moving on from last year's failed effort to acquire AstraZeneca ($AZN) for about $118 billion, said Pfizer got all the pipeline ballast it needed through a roughly $2.9 billion deal with Merck KGaA signed in November. Under that agreement, Pfizer is paying $850 million up front for the PD-L1 inhibitor MSB0010718C and promising as much as $2 billion more to collaborate with Merck KGaA on up to 20 new cancer immunotherapies. The deal, Pfizer Oncology President Albert Bourla said, "positions us well to potentially compete in the first wave of immuno-oncology therapies and be a leader in the second wave of combination therapies." And, taking a broader view, the collaboration takes a load of pressure off of Pfizer as it considers its next move, Read said. "If we hadn't strengthened our research, which we did in the deal with Merck on the immuno-oncology asset, then we may have felt we needed to do more business development in acquiring assets in our research," Read said on the call. "But I feel our research pipeline, middle stage to late stage, is strong, and I would rather take our capital right now and direct it to opportunities to accelerate EPS growth." Of course, "if there was a piece of intellectual property that added huge value that we thought we could develop," Read said, "we would not be shy in acquiring that intellectual property." Just what Pfizer will do with its reported $33 billion in free cash remains anyone's guess, and Read shrugged off questions about the company's purported interest in Actavis ($ACT) and Teva ($TEVA) with the terse "rumors are rumors." But despite the CEO's assertion that Pfizer is on the right track with or without an acquisition or two, investors may not share his optimism. The company is slated to bring in about $46 billion in revenue this year, down from last year's $50 billion. Absent any major M&A splash, Pfizer is counting on a handful of new medicines to bolster its bottom line. Leading the way is palbociclib, a breast cancer treatment analysts say could peak at between $3 billion and $5 billion a year in sales. Then there's bococizumab, a member of a newfangled class of cardio therapies with blockbuster expectations, followed by ertugliflozin, a Merck ($MRK)-partnered diabetes treatment. 

Gilead 挾病毒藥成功者姿態 大舉以M&A殺進癌症治療!!

Gilead (GILD) Hungry For Oncology M&A, Bullish On Hep C Cash Flow: 2/12/2015 1:49:31 PM By Riley McDermid, BioSpace.com Breaking News Sr. Editor Biotech darling Gilead Sciences, Inc. (GILD) is continuing its charm offensive this week, on Wednesday sending Chief Operating Officer John Milligan and Vice President of Investor Relations Patrick O'Brien to lunch with analysts at Citigroup, who came away upbeat about the controversial firm's business structure and convinced it will soon be attempting more mergers and acquisitions. "We came out bullish that Sovaldi/Harvoni's volume will increase in U.S. and Europe in 2015 driven by increased rebates to public segments. Gilead's pipeline is also advancing and Simtuzumab should have interim 48 week data in late 2015 in NASH," wrote biotech head analyst Yaron Werber in a note to investors. Despite telling the BIO CEO and Investor Forum this week that Gilead "feels no urgency for mergers/acquisitions, but if we did, it would be thoughtful and reflective," Milligan's time with Citi left analysts feeling the company is hungry for new deals, particularly in oncology. "We detect that management is definitely gearing up the company to be very active on M&A in 2015 and oncology will likely be a key focus," wrote Werber. "We do not anticipate one sizable deal that will have an imminent change but instead see a few smaller deals to bolster the pipeline for the mid-term." Gilead's team also remains convinced profits will stay high, just months after Gilead Sciences, Inc. (GILD) sold $10.3 billion of its new hepatitis C drug Sovaldi in 2014. Sovaldi sells for approximately $1,000 per pill, while its sister medication, also from Gilead, Harvoni, sold about $2.1 billion in 2014. Similar competitor AbbVie (ABBV)'s HCV medication Humira recorded $12.5 billion in sales and is now gaining on the coattails of AbbVie's new hepatitis C treatment, Viekira Pak. Both Sovaldi and Harvoni have treatment rates close to 90 percent, making them essentially a cure for many patients—success several companies are attempting to duplicate soon, posited analysts. Both Sovaldi and Harvoni have treatment rates close to 90 percent, making them essentially a cure for many patients—success several companies are attempting to duplicate soon, posited analysts. "Management is also confident of the sustainability of hepatitis C cash flow for the next decade based on the rate of patients being treated, continuing innovation, and focus on eradication of disease," said Werber. "Hence management is very confident in its ability to do stock buybacks, provide a dividend, and do M&A. But the meeting also noted that there is little visibility as to how fast the public hepatitis C segment will grow, where treatment volumes will grow to, and where pricing will be as the market will get more competitive." Milligan estimated at BIO earlier this week that Gilead will have a long road ahead to effectively "cure" its initial test group of hepatitis C, which are typically in populations that already know they have the disease, such as in prisons or those covered by public health plans. "It will likely take six years to exhaust that initial group of 1.6 million patients," said Milligan. "Then we'll tap groups unaware they have HCV." He added that he thinks the duration of treatment will also come into play as payers begin to treat huge swaths of the 3.2 million estimated Americans infected with hepatitis C. "I'm not optimistic about four-week regimens for hepatitis C. I think it's more likely that six or eight weeks will work," he said. "When do you tell a hepatitis B patient they're cured? Will be open to debate, experimentation in coming years." Still, the idea that hepatitis B will be "the new hep C" has had him thinking, he said. "News of HCV cures has prompted conversations about doing the same for HBV. That's a totally different story," said, although he did hint that Gilead has not remained entirely disengaged. "We're exploring some ideas [on hepatitis B]. But we don't see new, big opportunities in virology at the moment in HBV and RSV."

Takeda 攜手 ImmunoGen 開發抗體嵌合藥物平台antibody-drug conjugate (ADC)

Takeda and ImmunoGen partner to develop anti-cancer therapeutics 24 March 2015 Japanese drug maker Takeda Pharmaceutical Company, through its wholly owned subsidiary Millennium Pharmaceuticals, has signed an agreement with US-based ImmunoGen to develop and commercialise anti-cancer therapeutics up to two undisclosed targets. As part of the deal, Takeda has secured exclusive rights to use ImmunoGen's antibody-drug conjugate (ADC) technology, including its new DNA-acting IGN payload agents to develop targeted anti-cancer therapeutics. Takeda oncology drug discovery unit head Dr Christopher Claiborne said: "ADC technology is a critically important tool in addressing unmet needs in oncology. "ADC technology is a critically important tool in addressing unmet needs in oncology." "By partnering with ImmunoGen, we are able to leverage this important technology in Takeda's R&D programme and bring novel agents through the clinic." Under the deal, ImmunoGen will receive $20m upfront payment and is also eligible to receive milestone payments up to $210m for each target, in addition to royalties on the commercial net sales of any resulting ADC products. Takeda will take responsibility for the development, manufacturing and marketing of any ADC products resulting from the deal. The deal will also allow Takeda to have a licence for a third target for an additional upfront fee. ImmunoGen president and CEO Daniel Junius said: "Takeda shares our commitment to developing novel anti-cancer therapies that meaningfully improve the lives of patients, and we look forward to collaborating with them to create important new ADC product candidates." An ADC includes a monoclonal antibody that binds to a target found on cancer cells with a cancer-cell killing agent, or payload attached. ImmunoGen's portfolio of proprietary payload agents includes its tubulin-acting maytansinoids that are used in around ten ADCs, including Roche's marketed product Kadcyla.

Novartis 重金佈署 Aduro’s STING (Stimulator of Interferon Genes)癌症免疫治療($200 million upfront)

Novartis, Aduro: Up-to-$750M Cancer Immunotherapy Collaboration Mon, 03/30/2015 - 12:52pm Stephanie Guzowski, Editor Novartis is planning to boost its cancer immunotherapy pipeline with a collaboration with California-based Aduro Biotech worth up to $750 million. The partnership is focused on the development of cancer immunotherapies based on Aduro's STING (Stimulator of Interferon Genes) technology, a next-generation method to harness the body's immune system to fight cancer. Novartis will pay $200 million upfront for rights to the program, along with an initial equity investment of $25 million. Aduro could receive up to an additional $500 million in payments tied to development milestones from Novartis, as well as a commitment for another $25 million investment from Novartis at a future date. Aduro's agreement with Novartis covers research, development and commercialization of cyclic dinucleotide (CDN)-based oncology therapies. Novartis will lead worldwide commercialization for any drug projects developed, while Aduro will focus on U.S. commercialization. "We are delighted to collaborate with Aduro," Novartis' Mark C. Fishman, M.D., president of the Novartis Institutes for BioMedical Research, said in a statement. "We believe this target is among the most exciting in oncology today, the drug candidate to be of the highest quality, and the talent of our new colleagues from Aduro to be fantastic. We anticipate many clinical opportunities will be explored with the CDN approach, both directly and in combination with other agents." Novartis has been active in the development of cancer immunotherapies, including chimeric antigen receptor T-cell (CART) drug CTL019, which is in mid-stage Phase 2 clinical trials. Said Aduro Chief Scientific Officer Thomas W. Dubensky, Jr., Ph.D. in a statement, "We look forward to collaborating with Novartis to begin a Phase 1 clinical trial with our first novel immune-oncology candidate."

荷蘭癌症中心(NKI) 目標成為歐洲T 細胞基因治療龍頭!

Kite Pharma Acquires T-Cell Factory for $21M UpFront Mar 18, 2015 Kite Pharma has acquired privately held T-Cell Factory (TCF) for €21 million ($21 million) upfront, and renamed it Kite Pharma EU, in a deal designed to establish a European presence for the buyer and strengthen its T Cell Receptor (TCR) gene therapy product platform. TCF has focused on discovery and development of tumor-specific TCRs for broad use in cancer treatment based on its TCR-GENErator? platform. TCRs allow targeting of tumor antigens found inside cancer cells, as well as surface antigens. Kite agreed to make the upfront payment, of which €3.8M (about $4 million) will be paid in Kite stock—as well as an undisclosed sum in payments tied to achieving clinical, regulatory, and sales milestones relating to TCR-based product candidates. By acquiring TCF, Kite said, it has obtained license agreements with IBA GmbH, Sanquin Blood Supply Foundation, and the Netherlands Cancer Institute (NKI) that include rights to new TCR-related intellectual property in the TCR space developed by a co-founder of TCF, professor Ton N. M. Schumacher, Ph.D., deputy director of the NKI. Dr. Schumacher will become CSO of Kite Pharma EU, while maintaining his position at NKI. "NKI's goal is to become the leader in T cell gene therapy in Europe, and we are expanding our clinical and manufacturing capacities. We are excited about partnering with Kite and potential future R&D collaborations with the company," professor Rene Medema, director of NKI, said in a statement. Dr. Schumacher co-founded TCF with professor Dirk H. Busch, M.D., director of the Institute for Medical Microbiology, Immunology and Hygiene (MIH) at Technische Universitat Munchen (TUM) School of Medicine; Lothar Germeroth, Ph.D., former TCF senior advisor, CEO of IBA GmbH and COO of Stage Cell Therapeutics; Carsten Linnemann, Ph.D., senior scientist with Kite Pharma EU; and Georg Dossinger, Ph.D., a scientist at MIH. Kite also said the acquisition provides access to European clinical manufacturing facilities, launching a base for Kite to build its global presence and initiate clinical programs in the EU. Kite has developed the engineered Autologous cell therapy (eACT?), a platform technology encompassing T cells manufactured ex vivo, that are genetically re-directed against cancerous cells. TCR is one category of eACT; the other consists of Chimeric Antigen Receptor (CAR) T cells genetically re-directed against cancerous cells through receptors comprising a target recognition domain linked to T cell activating domains. In January, Kite launched a partnership with Amgen to develop and commercialize CAR T cell immunotherapies, in a deal that could generate a combined billion-plus dollars for both companies. Kite's pipeline includes clinical-stage programs advancing multiple TCR-based product candidates: NY-ESO-1 against various tumors; HPV-16 E6 antigens against cervical and head and neck cancers, and MAGE antigens against various tumors. "The acquisition of TCF and its novel discovery and development platform provides Kite with a strong position in TCR gene therapy for cancer," Arie Belldegrun, M.D., FACS, Kite's president and CEO, said in a statement. "In addition, with our strategic plans for expanding clinical operations to ex-US sites, Kite's relationship with NKI, an internationally renowned research and clinical institution, provides an important operational platform and potential access to investigators, clinical sites and manufacturing facilities in Amsterdam." Added David Chang, M.D., Ph.D., Kite Pharma's evp, research and development and CMO: "In addition to expanding our capabilities in TCR, this acquisition is an important first step in our goal of global clinical expansion outside the US, applying our leadership and in-house clinical expertise in both CAR and TCR therapies." Kite's acquisition of TCF follows the announcement earlier this month of Kite's expanded Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop new TCR candidates, including against tumor neo-antigens, truly tumor-specific antigens generated as tumors accumulate genetic mutations.

BMS 重押 癌症疫苗 失敗再投資!! (PD-1 ab, Opdivo+ GVAX)

Bristol-Myers forges a billion-dollar cancer vaccine deal with Bavarian Nordic March 4, 2015 | By John Carroll Determined to stay ahead of the growing pack of rivals in immuno-oncology, Bristol-Myers Squibb ($BMY) has swooped in with $60 million upfront to gain an option on Bavarian Nordic's Phase III therapeutic prostate cancer vaccine Prostvac, ready to shell out an additional $915 million-plus in milestones if it takes the next step to license and ultimately commercialize the therapy. In the meantime, Bristol-Myers--which has now committed up to $2.6 billion in three new cancer R&D deals over the past two weeks--and its new partner are hatching plans for a slate of combination studies. If Bristol-Myers does take the next step, it will be on the hook for another $80 million payment, more than $230 million in development milestones if the therapy tops its Phase II efficacy results, $110 million in regulatory milestones and $495 in sales milestones. The Danish biotech will manufacture Prostvac and also stands to earn a double-digit royalty. Bristol-Myers' deal today could go a long way toward reviving expectations for cancer vaccines, which have experienced a multitude of setbacks in the clinic at Merck KGaA and elsewhere. The pioneering cancer vaccines just haven't had the efficacy punch needed to prove their value. But with checkpoint inhibitors like Bristol-Myers' leading program for Opdivo stealing the limelight in cancer R&D, leaders in the field are demonstrating a renewed interest in matching a therapy that can jump-start an immune attack on specific cancer cells with new therapies that are taking the brakes off an immune system assault. "Obviously, we've been looking for a partner for some time," Bavarian Nordic CEO Paul Chaplin tells FierceBiotech. In the early days the field's risky profile had an effect. But with the arrival of checkpoint inhibitors and the booming market for collaborations, the pendulum swung in Bavarian Nordic's favor, particularly as new data rolled in on Prostvac's efficacy. "The world has changed," adds Chaplin, pointing to the large percentage of cancer patients who don't respond to the checkpoint drugs and could well benefit substantially by adding a cancer vaccine. "I think we became quite popular in the last 18 months." Bavarian Nordic ended 2014 with its Phase III program for Prostvac fully enrolled with 1,200 patients. The final readout is expected 18 to 24 months after full enrollment with three interim analyses along the way that might possibly trigger the option deal. Bristol-Myers already has a mid-stage combination study underway with Prostvac and Yervoy to test that theory. More combo studies are being planned, according to today's announcement. And just days ago Bristol-Myers and Aduro noted that they had begun a midstage study of a combination therapy that includes Opdivo and GVAX, one of the failed cancer vaccines that has now come back into the spotlight. Last week Bristol-Myers and Bavarian Nordic rolled out some promising data from an early-stage study combining Prostvac and Yervoy. Investigators from the National Cancer Institute say that the overall survival benefit in one cohort hit 37.2 months with an average median OS of 31.3 months. That stacks up against an "expected" OS rate of 18.5 months. Researchers enrolled 30 patients in that study. The deal today marks the latest step in a multibillion-dollar deal spree in cancer R&D for Bristol-Myers. In late February the company bought Flexus in a $1.25 billion acquisition, and added a $339 million pact with Rigel. "Our agreement with Bavarian Nordic reflects our commitment to following the emerging science in immuno-oncology and supports our strategy to transform the treatment of cancer across multiple tumor types, lines of therapy and stages of disease," says Michael Giordano, who runs oncology R&D for Bristol-Myers.

 

VAX  is a granulocyte-macrophage colony-stimulating factor (GM-CSF) gene-transfected tumor cell vaccine. Original work with GM-CSF as a recombinant DNA protein (Leukine) involved proliferative stimulation of macrophages and neutrophils for the purpose of reducing hematopoietic toxicity related to dose-intensive chemotherapy. Following US Food and Drug Administration approval of Leukine several years ago, extensive preclinical results have demonstrated an immunostimulatory effect related to GM-CSF gene when transfected into tumor cells and used as a vaccine (GVAX). Tumor regression and prolonged survival was demonstrated in animal models. Toxicology with GVAX indicated no adverse effects, which enabled further testing in cancer patients. A small number of responses were demonstrated in Phase I trials in immunosensitive cancer patients (renal cell carcinoma and melanoma). However, a series of dramatic complete and durable responses in advanced non-small cell lung cancer patients, demonstrated in recent clinical trials, have generated interest in further development of this vaccine in nontraditional cancer disease types. The rationale of GVAX development and a summary of clinical results are reviewed.

 

PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) is a cancer immunotherapy candidate in clinical development by Bavarian Nordic for the treatment of metastatic castration-resistant prostate cancer (mCRPC). PROSTVAC is designed to enable the immune system to recognize and attack prostate cancer cells by triggering a specific and targeted T cell immune response to cancer cells that express the tumor-associated antigen prostate-specific antigen (PSA). PROSTVAC utilizes recombinant poxviruses to express PSA, along with 3 immune-enhancing costimulatory molecules collectively designated as TRICOM (LFA-3, ICAM-1, and B7.1). Treatment is initiated by subcutaneous administration of a priming dose of vaccinia encoding PSA-TRICOM, followed by 6 subsequent boosting doses of fowlpox encoding the same PSA-TRICOM cassette. Using this heterologous prime-boost dosing regimen, the immune system becomes focused on inducing PSA-specific T cell responses, designed to kill tumor cells expressing PSA.

 

The PD-1/PD-L1 axis and antibodies in development. T cells interact with tumor cells in peripheral tissues. Tumor cells can present antigen to the T-cell receptor, resulting in a stimulatory signal to the T cell (+). Tumor cells may also express PD-L1, which interacts with PD-1 on activated T cells, and results in inhibition (−) of the antitumor T-cell response.