OPTIMER 與 台灣浩鼎 糾結難解 ? (巨大利益測試團隊能力 !)

2012-06-22 02:04 工商時報 【記者杜蕙蓉／台北報導】台灣浩鼎（4174）研發乳癌末期標靶藥OPT-822，高達200億美元（約5,920億元台幣）商機，引爆台美股東大戰，由於本案戰火延燒，原本預計六月上興櫃掛牌的日期被迫延後，這也凸顯台灣發展新藥之路確實坎坷。 乳癌末期標靶藥OPT-822，的龐大商機，是引爆美商身兼台灣浩鼎、美國OPTIMER董事長張念慈下台的導火線，戰火從搶藥風波延燒至股權之爭，戰線從美國打到台灣。 據了解，為捍衛可能是華人研發的第一個新藥OPT-822，目前潤泰集團董事長尹衍樑已結合永豐金、富邦金、玉山金等股東以台灣股東持有約58％股權對抗OPTIMER持有台灣浩鼎的42％股權。 一名不願具名的台灣浩鼎董事表示，此起戰火，基本上就是OPTIMER覬覦OPT-822/821而使出的小手段。 OPTIMER和台灣浩鼎都是張念慈創辦，OPTIMER研發用於治療偽膜性結腸炎的新型抗生素Dificid，去年順利在美國FDA拿到上市藥證，而且也成功以2.24億美元授權日本藥廠安斯泰來（ASTELLAS），銷售歐洲市場權利。為順利行銷Dificid，張念慈引進曾經任職於輝瑞藥廠的行銷團隊到OPTIMER，並讓他們擔任董事長和CEO等要職，詎料，由於台灣浩鼎投入研發治療乳癌藥的822，完成台、美二期臨床後，雙盲測試效果頗佳，被生醫界認為成功率極高，為此，OPTIMER新團隊對822興趣濃厚，於是趁著台灣浩鼎正準備推動在台灣上市下，先搶下「優先授權」權利，但OPTIMER也同意由原本持有60％股權降至42％。 不過，OPTIMER雖有優先授權權利，但822光是乳癌藥潛在商機即高達200億美元，更何況它還有8個適應症，因此未來若有國際大藥廠來談海外授權，以OPTIMER目前規模，根本無法與國際大藥廠競爭，優先授權只能流於紙上作業。為此，OPTIMER希望直接把台灣浩鼎納入可掌控的公司，但這與張念慈和台灣股東想要在台灣建立一個由台灣成功開發新藥的理念不合，於是OPTIMER的董事在美國時間4月9日以張念慈要拿150萬技術股送給對822開發有功的「疑似利益輸送」為由，一口氣撤換張念慈在台灣浩鼎董事長的職位，同時也解任研發副總許友恭和財務長等老臣，上演一場逼宮和美國人打台灣人戲碼。 只是後來事實證明台灣浩鼎在申請公開發行和上興櫃過程中，並未執行技術股，蒙受不白之冤的張念慈，也狀告OPTIMER還其信譽，成為前董事長告自己公司的窘狀。

董事會要求Michael Chang（張念慈）辭去Optimer董事長職務!! Optimer 因compliance 與conflict of interest辭退張念慈!!

Shanghai Institutes of Preventative Medicine, Gentris sign MOU to advance personalized medicine

 Published on June 22, 2012Gentris® Corporation (www.gentris.com), a global leader in the application of genomic biomarkers to clinical studies, announced today that it has signed a Memorandum of Understanding with the Shanghai Institutes of Preventative Medicine to advance global personalized medicine. The goal of this USA-China collaboration is to create translational research and epidemiological projects, as well as training and education programs, focused on pharmacogenomics and clinical sample banking, which will drive innovation in drug development and improvements in patient care.Through this collaboration, Gentris and the Shanghai Institutes of Preventative Medicine will work together to launch cutting-edge research projects to discover, develop, and validate new genomic biomarkers. Gentris will take the lead to identify sponsors in the United States, e.g., pharmaceutical companies, for these personalized medicine projects while the Shanghai Institutes of Preventative Medicine will seek support from Chinese organizations.The tuberculosis drug-induced liver injury pilot (TB DILI Study), conducted between Gentris, the Shanghai Institutes of Preventative Medicine, and a non-profit research institute in Research Triangle Park (RTP) serves as a model for USA-China collaborations. In this study, investigators designed a common protocol and pooled their resources to investigate DILI among tuberculosis patients in three Shanghai hospitals. By utilizing metabolomics and pharmacogenomics, they are evaluating biomarkers for early detection. Dr. Tong Zhou, Senior Director of China Initiatives for Gentris, is Co-Principal Investigator for the TB DILI Study and has significant experience in developing and managing collaborations between the United States and China. Dr. Zhou has also drawn upon his extensive network in China to begin establishing a satellite laboratory for Gentris in Shanghai that complies with U.S. regulatory standards.Dr. Wu Fan, Director General of the Shanghai Institutes of Preventative Medicine and the Shanghai Municipal Center for Disease Control and Prevention (Shanghai CDC),and Dr. Howard McLeod from the University of North Carolina will provide strategic scientific oversight for personalized medicine collaborations. Director Wu is recognized internationally as a leader in public health initiatives. Dr. McLeod, Chief Scientific Advisor for Gentris, has been involved in numerous global initiatives including the Pharmacogenetics for Every Nation Initiative (PGENI), which he founded. It is anticipated that combining the resources and expertise of a research institute, academic institution, and industry—in both the United States and China—will lead to more rapid improvements in drug development and public health. 

北榮院長林芳郁…健保局應腳踏實地…!

醫療困境 林芳郁：看不到未來 2012/06/24 20:03:00（中央社記者龍瑞雲台北24日電）台北榮民總醫院院長林芳郁今天表示，整體醫療制度與環境都面臨困難，醫療人員如廉價勞工。他說，若不立即重建醫療制度，「醫療體制將在5年到10年內瓦解。」中華醫學會今天舉辦「101年度會員大會暨聯合學術研討會」，議程安排除針對內、外、牙科進行專題研討會，也增加醫學人文教育與中西醫整合治療的討論。中華醫學會理事長暨台北榮民總醫院長林芳郁在會後受訪時表示，內、外、婦、兒、急診五大皆空是已知的，還有急重症醫療、癌症治療等方面醫護人力都因整體醫療制度與環境，面臨危機，可以說是「看不到未來」。林芳郁表示，醫療占GDP（國內生產毛額）不到6%，醫護人力被當成便宜勞工或外勞運作，所以就只好跑了，因為還有其他的選擇。他說，整體制度需要重新檢討，大家一起來討論如何建立好的制度，現在重建還來得及；若沒有想辦法解決，在可預見的5年到10年間，醫療體制將會瓦解。林芳郁指出，健保局為解決五大皆空問題加碼健保給付與相關費用，但健保費用是固定的，加碼是拿別科別的來補，「這是揩別人的油，非腳踏實地的方法，這種做事方法屬便宜行事。」他說，醫療強調團隊合作，加碼是拿別的科的錢來補給另一科別，建議健保局腳踏實地，另編預算。他指出，健保不能全包，社會福利應該是由政府編列預算，例如罕見疾病可由社會福利支付、車禍是由商業保險支付，「健保是社會福利還是社會保險，這個要先釐清楚」。

Just a blood test....predict improper growth of fetus

  Published on June 22, 2012Researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) have found a protein in the blood of pregnant women that can predict if they are likely to have a fetus that doesn't grow properly, and thus has a high risk of stillbirth and long-term health complications. The research, led by Dr. Andr-e Gruslin, could lead to a widely available blood test and could help develop ways for improving the outcomes of women and their children who face this risk - estimated to be as many as one of every 20 pregnancies.Dr. Gruslin's study, published in the Journal of Clinical Endocrinology and Metabolism, focuses on a protein called Insulin Growth Factor Binding Protein 4 (IGFBP-4). While this protein has been linked to pregnancy before, this study is the first to demonstrate its important role in human pregnancy complications. A key part of the study involved examining IGFBP-4 levels in first trimester blood samples from women who participated in a large study of pregnancies and newborns called the Ottawa and Kingston (OaK) birth cohort.Dr. Gruslin found that women with high levels of IGFBP-4 were 22 times more likely to give birth to tiny babies (defined as the smallest five per cent by weight for their gestational age), than women with normal levels of IGFBP-4. This part of the study involved a total of 72 women - half with tiny babies and half with normal weight babies."Usually, we don't find out until later in a pregnancy that a fetus isn't growing properly, but this test can tell us in the first trimester if there's likely to be a problem," said Dr. Gruslin, a Scientist at OHRI, High Risk Obstetrician at The Ottawa Hospital and Professor in the Faculty of Medicine at uOttawa. "By identifying these high-risk pregnancies early on, we will be able to monitor these women more closely and hopefully help them deliver a healthier baby."

東洋開發特殊抗生素用藥Lipo-AB TFDA藥證到手 歐洲藥證努力中 !

東洋 歐洲藥證 將到手【經濟日報╱黃文奇】 2012.06.24 03:24 am 產業評析：東洋（4105）為台灣前3大學名藥廠，近年致力發展高階學名藥，也切入蛋白質藥物市場；以一般學名藥及高階學名藥為公司營運成長的雙引擎。看好理由：東洋開發特殊抗生素用藥Lipo-AB，順利取得衛生署核發藥證，並申請歐洲藥證，公司規劃明年中前可望拿下歐洲藥證。投資策略：東洋22日股價上漲1.00元，以117.50元作收，日線呈多頭排列，6月12日以後量增價揚，KD開口向上，投信近5日連續買超共1,800多張，外資連四日賣超近700張。【2012/06/24 經濟日報】