境外生科基金 坦伯頓亮眼

生技產業基本面紮實 後市表現可期 2013-12-16 01:53 旺報 【記者梁世煌／台北報導】 美歐成熟股市今年以來漲勢亮眼，其中生技產業表現尤其突出，那斯達克生技指數今年1至11月累積上漲超過6成，綜觀4檔國內已核備之境外生物科技類型基金，僅富蘭克林坦伯頓生技領航基金績效足與大盤匹敵。 該基金採取由下而上的價值選股策略，大型股中精選技術領先、營收獲利與股價穩定性較高者，中小型股則是著眼於併購題材、股價潛在爆發力，如此的布局方式，顯著提升基金表現。上周來台舉辦投資說明會的富蘭克林坦伯頓生技領航基金經理人伊凡．麥可羅持續看多生技產業後市，他認為，全球高齡化趨勢與新創新周期的成形有利生技醫療長線需求。此外，不僅新藥研發屢有突破，美國食品藥物管理局（FDA）審核環境改善也加速核准進度，為生技產業續航力加油添柴。 富蘭克林證券投顧表示，生技產業前景可期，積極型投資人不妨繼續持有，追求穩健者，則可採全球型股票基金或是布局生技相關族群的高科技基金，也可同步分享該產業的榮景。

學生兼任助理、臨時工 適用僱傭關係????

教部承諾全面檢討大學僱傭關係【聯合晚報╱記者王彩鸝╱即時報導】 2013.12.18 01:03 pm針對學生擔任兼職研究助理、臨時工和教學助理，和校方是否有僱傭關係，教育部長蔣偉寧今天表示，將於月底前邀集國科會、勞委會通案討論。但立委邱智偉要求蔣偉寧先在下周三到立法院教育文化委員會進行專案報告。立委鄭麗君強調，不能因學生身份排除其勞動權利，今年4月勞委會已作出決議，認定台大的研究助理、臨時工和教學助理和校方存有僱傭關係，台大竟表示還要上訴，提案凍結台大校務基金200萬元。台大校長楊泮池指出，有關學生勞健保問題，台大11月底就決定不上訴，但這不只是台大的問題，而是大學全面性問題，已建請教育部和勞委會協商通案考量。教育部長蔣偉寧表示，如果是全職的研究助理或教學助理，僱傭關係的存在無庸置疑，但若是兼任且跟論文有關，若解釋為有僱傭關係，對學生不見得有利，而且師生關係若簡化為僱傭關係，對校園文化恐會造成衝擊。【2013/12/18 聯合晚報】

Novartis 開發 T-cell治療ALL !!

Novartis needs special delivery for potent cell therapy By Eva von Schaper, Bloomberg News Bloomberg 9:20 p.m. CST, December 18, 2013MUNICH — Novartis AG has a promising therapy for cancer. It's just not sure how to get it to patients easily.The treatment is so potent that it cleared malignant cells in about 90 percent of patients facing almost certain death from the most common form of cancer in children. The approach involves taking T cells, part of the body's immune system, from the blood and engineering them to identify proteins on cancer cells. When returned to the patient's bloodstream, the revamped T cells seek and destroy cancer cells. It's so specific that a single mistake can mean death for a patient, and so turbo-charged that Novartis plans to set up a network of hospitals versed in treating the spiking fever, chills and flu-like symptoms that may come as side effects."The question is really if this is the right way to go at immunotherapy," a burgeoning field of medicine that empowers the immune system to fight diseases such as cancer, Michael Leuchten, an analyst at Barclays Plc in London, said in an interview. Cancer cells can use proteins on their surfaces as biological cloaks of invisibility to elude detection by the immune-system cells policing the body. Immunotherapies include checkpoint agents, drugs that strip away such disguises and expose cancer cells to attack; products such as Dendreon Corp.'s Provenge, which combines a patient's immune cells with vaccine components in an infusion; and so-called biconjugated antibodies that help immune cells anchor themselves to cancerous ones.The total market may amount to a $35 billion "watershed" for cancer drugs, according to Andrew Baum, a pharmaceutical analyst for Citigroup Inc. in London. Baum sees Roche Holding AG and Bristol-Myers Squibb Co., based in New York, as the field's leaders. Roche — like Novartis, based in Basel, Switzerland — is developing an infused immunotherapy which blocks a protein that prevents the immune system from attacking cancer cells. Bristol-Myers sells the drug Yervoy, which helps the immune system fight melanoma.Unlike those therapies, Novartis's CTL019 isn't as easy to produce and transport. For the researchers and the company, the results are worth the effort. If they find a way to deliver the treatment to the masses, CTL019, also known as CART-19, has the potential to generate $10 billion a year if approved to treat multiple forms of cancer, according to Baum."CART-19 gives us a huge move into immunotherapy, a first- mover advantage," Chief Executive Officer Joe Jimenez said during a conference this year.Nineteen out of 22 children who had exhausted all drug treatment and bone-marrow transplant options for acute lymphoblastic leukemia went into remission after receiving the therapy, also known as CART-19, according to data presented this month at the American Society of Hematology meeting in New Orleans. Five patients later relapsed, including one whose new tumor cells produced a protein that enabled them to elude the souped-up T cells.In chronic lymphocytic leukemia, a much larger market, the therapy provoked a response in 47 percent of patients, with half of those patients experiencing a complete remission."There's never been a therapy that works after a bone- marrow transplant fails," Carl June, one of the treatment's developers at the University of Pennsylvania, said in a telephone interview. Novartis licensed the technology from the university. The therapy's money-making potential may be hampered by the complexity of its administration, as well as the emergence of powerful new drugs for leukemia, according to Richard Parkes, a London-based analyst at Deutsche Bank AG."CTL019 is likely to be used as a salvage treatment and we remain skeptical on its commercial opportunity," Parkes wrote in a Dec. 10 note to investors.Novartis plans to first develop CTL019 in acute lymphoblastic leukemia patients, then in the chronic lymphocytic form of the disease, followed by patients with lymphoma, another type of blood cancer, according to Herve Hoppenot, who heads Novartis's oncology unit. Hoppenot declined to comment on the treatment's commercial prospects."What we are planning to do is to make it a very easy and practical thing to use," he said in an interview. "We are certainly going to start in centers that are specialized in sophisticated treatments. They won't find it difficult. The burden will be on us to organize and calibrate the process."The Novartis treatment first grabbed attention last year after the doctors reported that nine of 12 patients had been pulled from death's door.The company bought a plant for manufacturing immunotherapies from Dendreon for $43 million last year. The Seattle-based company sold the plant because it has struggled to persuade doctors to use Provenge, which it produced there. Like CART-19, Provenge is a treatment that uses altered cells to fight cancer.Novartis plans to conduct a larger trial next year, Jimenez said at a Morgan Stanley conference in September. If the results are positive, Novartis would then ask regulators in 2016 for permission to market the therapy."The effectiveness gets people really excited, including me," Bill Chambers, interim national vice president of extramural research at the American Cancer Society, said in a telephone interview. "It seems like things are being put in place. I'm very hopeful about this."

T-Cell Therapy Eradicates an Aggressive Leukemia in Two Children Mar. 25, 2013 — Two children with an aggressive form of childhood leukemia had a complete remission of their disease -- showing no evidence of cancer cells in their bodies -- after treatment with a novel cell therapy that reprogrammed their immune cells to rapidly multiply and destroy leukemia cells. A research team from The Children's Hospital of Philadelphia and the University of Pennsylvania published the case report of two pediatric patients Online First today in The New England Journal of Medicine. It will appear in the April 18 print issue. One of the patients, 7-year-old Emily Whitehead, was featured in news stories in December 2012 after the experimental therapy led to her dramatic recovery after she relapsed following conventional treatment. Emily remains healthy and cancer-free, 11 months after receiving bioengineered T cells that zeroed in on a target found in this type of leukemia, called acute lymphoblastic leukemia (ALL). The other patient, a 10-year-old girl, who also had a complete response to the same treatment, suffered a relapse two months later when other leukemia cells appeared that did not harbor the specific cell receptor targeted by the therapy."This study describes how these cells have a potent anticancer effect in children," said co-first author Stephan A. Grupp, M.D., Ph.D., of The Children's Hospital of Philadelphia, where both patients were treated in this clinical trial. "However, we also learned that in some patients with ALL, we will need to further modify the treatment to target other molecules on the surface of leukemia cells."Grupp is the director of Translational Research for the Center for Childhood Cancer Research at The Children's Hospital of Philadelphia, and a professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. Michael Kalos, Ph.D., an adjunct associate professor in the department of Pathology and Laboratory Medicine in the Perelman School of Medicine at Penn, is co-first author on the study. The current study builds on Grupp's ongoing collaboration with Penn Medicine scientists who originally developed the modified T cells as a treatment for B-cell leukemias. The Penn team reported on early successful results of a trial using this cell therapy in three adult chronic lymphocytic leukemia (CLL) patients in August of 2011. Two of those patients remain in remission more than 2½ years following their treatment, and as the Penn researchers reported in December 2012 at the annual meeting of the American Society of Hematology, seven out of ten adult patients treated at that point responded to the therapy. The team is led by the current study's senior author, Carl H. June, M.D., the Richard W. Vague Professor in Immunotherapy in the department of Pathology and Laboratory Medicine and the Perelman School of Medicine at the University of Pennsylvania and director of Translational Research in Penn's Abramson Cancer Center. "We're hopeful that our efforts to treat patients with these personalized cellular therapies will reduce or even replace the need for bone marrow transplants, which carry a high mortality risk and require long hospitalizations," June said. "In the long run, if the treatment is effective in these late-stage patients, we would like to explore using it up front, and perhaps arrive at a point where leukemia can be treated without chemotherapy." The research team colleagues adapted the original CLL treatment to combat another B-cell leukemia: ALL, which is the most common childhood cancer. After decades of research, oncologists can currently cure 85 percent of children with ALL. Both children in the current study had a high-risk type of ALL that stubbornly resists conventional treatments.The new study used a relatively new approach in cancer treatment: immunotherapy, which manipulates the immune system to increase its cancer-fighting capabilities. Here the researchers engineered T cells to selectively kill another type of immune cell called B cells, which had become cancerous.

T cells are the workhorses of the immune system, recognizing and attacking invading disease cells. However, cancer cells fly under the radar of immune surveillance, evading detection by T cells. The new approach custom-designs T cells to "see" and attack the cancer cells. The researchers removed some of each patient's own T cells and modified them in the laboratory to create a type of CAR (chimeric antigen receptor) cell called a CTL019 cell. These cells are designed to attack a protein called CD19 that occurs only on the surface of certain B cells. By creating an antibody that recognizes CD19 and then connecting that antibody to T cells, the researchers created in CTL019 cells a sort of guided missile that locks in on and kills B cells, thereby attacking B-cell leukemia. After being returned to the patient's body, the CTL019 cells multiply a thousand times over and circulate throughout the body. Importantly, they persist for months afterward, guarding against a recurrence of this specific type of leukemia. While the CTL019 cells eliminate leukemia, they also can generate an overactive immune response, called a cytokine release syndrome, involving dangerously high fever, low blood pressure, and other side effects. This complication was especially severe in Emily, and her hospital team needed to provide her with treatments that rapidly relieved the treatment-related symptoms by blunting the immune overresponse, while still preserving the modified T cells' anti-leukemia activity.

"The comprehensive testing plan that we have put in place to study patients' blood and bone marrow while they're undergoing this therapy is allowing us to be able to follow how the T cells are behaving in patients in real time, and guides us to be able to design more detailed and specific experiments to answer critical questions that come up from our studies," Kalos said. The CTL019 therapy eliminates all B cells that carry the CD19 cell receptor: healthy cells as well as those with leukemia. Patients can live without B cells, although they require regular replacement infusions of immunoglobulin, which can be given at home, to perform the immune function normally provided by B cells. The research team continues to refine their approach using this new technology and explore reasons why some patients may not respond to the therapy or may experience a recurrence of their disease. Grupp said the appearance of the CD19-negative leukemia cells in the second child may have resulted from her prior treatments. Unlike Emily, the second patient had received an umbilical cord cell transplant from a matched donor, so her engineered T cells were derived from her donor (transplanted) cells, with no additional side effects. Oncologists had previously treated her with blinatumomab, a monoclonal antibody, in hopes of fighting the cancer. The prior treatments may have selectively favored a population of CD19-negative T cells. "The emergence of tumor cells that no longer contain the target protein suggests that in particular patients with high-risk ALL, we may need to broaden the treatment to include additional T cells that may go after additional targets," added Grupp. "However, the initial results with this immune-based approach are encouraging, and may later even be developed into treatments for other types of cancer." Funding from the National Institutes of Health (grants 1RO1 CA165206, R01 CA102646 and R01 CA116660), the Leukemia and Lymphoma Society, and the Alliance for Cancer Gene Therapy supported this study. In August 2012, the University of Pennsylvania and Novartis announced an exclusive global research and licensing agreement to further study and commercialize these novel cellular immunotherapies using chimeric antigen receptor (CAR) technologies. As part of the transaction, Novartis acquired exclusive rights from Penn to CART-19, the therapy that was the subject of this clinical trial and which is now known as CTL019.

"Chimeric Antigen Receptor-Modified T Cells for Acute Lymphoid Leukemia," New England Journal of Medicine, Online First, March 25, 2013. To appear in print April 18, 2013.

About The Children's Hospital of Philadelphia: The Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking third in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 516-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.chop.edu.

About Penn Medicine: Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.3 billion enterprise. The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 16 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $398 million awarded in the 2012 fiscal year. The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania -- recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report; Penn Presbyterian Medical Center; and Pennsylvania Hospital -- the nation's first hospital, founded in 1751. Penn Medicine also includes additional patient care facilities and services throughout the Philadelphia region.Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2012, Penn Medicine provided $827 million to benefit our community.

 

面對中國 神隆全面衝了!! 將購常熟108畝地 投資35億元 !!

攻全球 神隆再投資常熟35億 2013/12/13 07:31:04 （中央社記者羅秀文台北2013年12月12日電）為搶攻大陸和全球藥品市場，台灣神隆(1789)已斥資新台幣逾15億元在江蘇常熟設立生產基地，第2期工程已落成，計畫再投入3、4期工程，總投資金額將上看35億元。中國大陸預估2015年超越日本，成為僅次美國的第2大藥品市場，為爭取商機，神隆2009年選定江蘇省常熟經濟開發區，擴大設立研發生產基地，2011年底完成第1期工程的建造，第2期工程今天落成，2期工程共投入逾5000萬美元(約新台幣15億元)。台灣神隆總經理兼神隆醫藥(常熟)董事長馬海怡表示，近2年神隆營運較辛苦，主要是因為產能吃緊，常熟廠去年中開始生產中間體，稍稍紓解台灣廠產能吃緊的狀況，預計2015、2016年通過美國食品藥物管理局(FDA)查廠後，產能吃緊狀況將大幅紓解。神隆常熟廠第2期今天舉行落成典禮，馬海怡同時代表神隆醫藥(常熟)有限公司，和常熟經濟開發區簽訂擴廠40畝用地的購買合約，加上之前已談定的68畝，合計將可再取得周邊約108畝的土地，作為未來擴充產線及新建製劑廠之用。預計未來計畫再投入3、4期工程，總投資金額將上看1.15億美元(約新台幣35億元)。馬海怡說，神隆在大陸發展有漸進的階段性目標。第一期由常熟廠生產關鍵中間體，有效協助台灣廠擴大原料藥產能；之後將提供「原料藥(API)加製劑(ANDA)」的雙A服務模式，與下游廠商合作完成歐美藥品查驗登記，外銷終端產品、搶攻全球市場。最終希望完成中國大陸藥證註冊程序，由常熟廠直接提供大陸原料藥內需市場。她說，短期目標已經是現在進行式，中期、長期目標也在積極布局中。今年5月和康聯藥業(4144)組成策略聯盟，從神隆已開發完成的原料藥名單中，挑選出大陸市場需求量大、競爭門檻高的抗腫瘤藥物，未來將直接推出製劑搶攻市場。8月與上海新藥代客研發公司桑迪亞簽訂合作協議，齊力爭取國際及大陸藥廠的原料藥代客研發及製造服務(CRAM Services)商機。馬海怡指出，大陸的十二五規劃中，明訂全國藥品的生產必須百分之百符合新版GMP要求，預估此一政策將淘汰許多不合格的廠商，而大陸前20大抗腫瘤用藥中，神隆已開發完成其中9項，常熟廠將可憑藉高品質的競爭優勢，及時滿足大陸市場的需求。並以台灣廠在國際藥品市場深耕多年的經驗，積極扮演歐美客戶在大陸的供應鏈樞紐，提供高附加價值的一次到位服務，強化長期合作關係。

晶宇 王獻煌: 開發香蕉、馬鈴薯病毒晶片

作物病毒檢測　台灣研發晶片 2013-11-13 15:46:24繼全球首例將生物晶片應用在蘭花病毒檢測後，朝陽科大教授張清安再發表可同時檢測多種病毒感染的香蕉、馬鈴薯病毒生物晶片系統，提升檢測效率並降低成本。 王鵬捷/整理消費者愈來愈重視食品安全，如何從作物生長過程就避免病毒干擾，成為顯學。台灣產學共同合作研發農作物病毒晶片，預計明年中上市，搶攻全球每年2億美元檢測商機。中央社13日報導，行政院國家科學委員會今天發表由朝陽科技大學應用化學系生化科技研究所教授張清安和晶宇生物科技實業股份有限公司產學合作研發成果。繼全球首例將生物晶片應用在蘭花病毒檢測並上市後，張清安再度發表可同時檢測多種病毒感染的香蕉、馬鈴薯病毒生物晶片系統，提升檢測效率及降低成本。張清安表示，香蕉、馬鈴薯都是世界上重要的糧食作物，卻容易受到濾過性病毒感染，威脅產量及品質至鉅，由於兩者都是藉由無性繁殖方式生產種苗，檢測、篩選繁殖用的母本是種苗生產流程不可缺少的程序及必要花費。他說，傳統上植物病毒檢測只能針對單一病毒分別進行，且每次電泳膠檢至少要花費5小時以上，又可能感染生物風險，耗時且不經濟。張清安所開發的生物晶片檢測系統，可同時檢測香蕉及馬鈴薯上多重病毒感染。香蕉檢測系統可檢測香蕉萎縮病毒(BBTV)、胡瓜嵌紋病毒(CMV)及香蕉苞葉嵌紋病毒(BBrMV)。馬鈴薯檢測系統可同時涵蓋最具經濟重要性的5種病毒，包括二種Potyvirus屬病毒PVY及PVA；二種Carlavirus屬PVS及PVM及Potexvirus屬PVX。他說，香蕉、馬鈴薯採傳統方式檢測，全球每年約需花費2億美元，每次檢測3種病毒費用約新台幣360元，但採用這次發表的病毒生物晶片系統費用則可降低至一半。晶宇生技總經理王獻煌說，這項成果已完成商品前的可行性評估，並符合歐盟對於植物病害檢測標準，預估明年中上市後，一年可望有新台幣2至3億元的營收，上看1成的市佔率。【中央網路報