WuXi Pharma Addresses Conviction of Former Employee for Theft of Chemical Compounds !!!!!!

 SHANGHAI, June 4, 2012 /PRNewswire-Asia/ -- WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device R&D services company with operations in China and the United States, today commented on the conviction of  a former employee for the theft of chemical compounds. In 2011, a junior employee of WuXi PharmaTech, acting by himself, stole and sold for personal gain sample amounts of two patented chemical compounds made for a customer. Working together with the customer, WuXi PharmaTech cooperated with law enforcement authorities to identify the employee, who was apprehended and subsequently convicted under applicable Chinese law on May 22, 2012. The compounds in question were recovered.WuXi PharmaTech has stringent intellectual property (IP) protection procedures and a zero-tolerance policy for any activity that damages the interests of its customers. This is the only known misappropriation of customer compounds in the company's 11 years of operations."We regret that one of our employees committed a crime on our premises," commented Dr. Ge Li, chairman and CEO of WuXi PharmaTech. "The strong and trusting customer relationships we have built over the past 11 years are based in part on our culture of commitment to IP security. As in any company, there will always be the risk of damage caused by a determined criminal. At WuXi PharmaTech, customer IP protection is our lifeline and we are committed to working closely with our customers to ensure the security of their projects."Dr. Li noted that this was an isolated case involving sample amounts of two patented compounds whose chemical structures are available in their respective patent filings. The company treats any breach of security protocols with the utmost seriousness and is undertaking an ongoing review to strengthen security measures to ensure the protection of customer IP. In addition, the company is intensifying employee training and strengthening oversight of facilities through increasing the number of both regular and unannounced laboratory and office inspections.

About WuXi PharmaTechWuXi PharmaTech is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi PharmaTech's operating subsidiaries are known as WuXi AppTec.

Source: PR Newswire

Why belly fat isn't all bad !!!!! Omentum somewhat for organ transplant ?!

Fatty membrane helps regulate immune system  June 6, 2012 in Immunology  A fatty membrane in the belly called the omentum has until recently been considered somewhat like the appendix -- it didn't seem to serve much purpose. But Loyola University Chicago Stritch School of Medicine researchers have found that the omentum appears to play an important role in regulating the immune system. The finding could lead to new drugs for organ transplant patients and patients with auto-immune diseases such as lupus and Crohn's disease. "We now have evidence that the omentum is not just fat sitting in the belly," said Makio Iwashima, PhD, corresponding author of a study published in the June 6 issue of PLoS ONE. Iwashima is an associate professor in the Department of Microbiology and Immunology. The omentum is a membrane that lines the abdominal cavity and covers most abdominal organs. It is a repository for fat tissue. A research team headed by Iwashima and Robert Love, MD, a world renowned lung transplant surgeon, examined the effect that mouse omentum cells had on T lymphocyte cells from a mouse. T cells are the immune system's first line of defense against infection. They identify, attack and destroy bacteria, viruses and other infectious agents. Normally, T cells multiply in response to an infectious agent, such as an antibody. But when researchers put omentum cells in with activated T cells that had been exposed to antibodies, the T cells did not multiply as they normally would, but instead died. The omentum cells had this effect only on T cells that had been activated. Omentum cells did not have any effect on inactive T cells. It appears that omentum cells secrete a substance that tamps down the immune system. This discovery could lead to new drugs that would suppress the immune system with fewer side effects than those caused by immune-suppressing drugs now in use. Such drugs could be used, for example, to suppress the immune system in a patient who has received a lung transplant. In addition to modulating the immune system, the omentum also appears to play a critical role in regenerating damaged tissues, Iwashima said. The omentum contains mesenchymal stem cells that migrate to the site of an injury and help regenerate tissue. Mesenchymal stem cells are cells that have the ability to develop into various types of specialized cells. In this study, researchers showed that, in tissue-culture flasks, omentum cells can differentiate into lung-type cells as well as bone cells. Iwashima believes the omentum may be the organ specified for tissue healing and regeneration.

中國對兒童用藥法規收緊中.....!!

品牌兒童藥企競技   鉅亨網新聞中心　(來源：財匯資訊，摘自：第一財經日報)　2012-06-05 南方醫藥研究所測算，2010年整個兒童用藥市場約為400億元，如果算上醫生劑量減半的部分，兒童藥市場有700億元之多，且近年都以兩位數的速度增長。 此外，3500余種藥品中僅有不足60種適用於兒童，也凸顯了兒童藥企未來的盈利空間。而接下來，便是如何為吃到這塊大蛋糕而發力了。 不過，從國內兒童用藥市場的格局來看，強生制藥、賽諾菲太陽石和北京韓美藥業等外資藥企以產品群、安全性和穩定的療效著稱，仁和藥業、康芝藥業、王老吉藥業等國內品牌藥企則以市場細分產品和強大的渠道同臺競技。

外資藥企：用安全性打敗你 安全性是兒童用藥以及藥品的第一要素。據廣州醫藥工業研究院負責人應軍介紹，在美國等很多國家，兒童藥品的開發做得比較好。 1997年前，美國藥品說明書很少標有兒童使用的信息。近年來，美國重點從法規層面推進企業在兒童藥領域的研發。比如，在《食品藥品現代化管理法》中用經濟政策給予兒科用藥6個月的市場保護期；對涉及治療兒童罕見病的藥品給予50%稅收優惠、加快審批、7年的市場保護期（即此期限內不允許其他企業仿制）等政策。 此外，歐盟、日本、韓國等國家和地區也都從法律法規的制訂上推動和促進兒童用藥的研發生產。 "在國外一些廠家將成人用藥通過成分或者配料、工藝的改變成為兒童用藥，可以申請專利進行保護，從而在藥品價格上通過高定價而得到補償，這在很大程度上提高了藥廠的積極性。但是在我國藥廠這樣做很難在藥品價格上得到體現，回報比較小。"應軍說。 在這種良好的政策環境推動下，強生制藥、賽諾菲安萬特等跨國藥企在兒童用藥和疫苗市場領域雄踞全球。 感冒發燒是兒童常見病，也是兒童用藥第一大類，據廣州標點醫藥信息有限公司的數據，2011年上半年北京、上海、廣州三地的兒童感冒化學藥前兩名分別是：上海強生制藥的偽麻美沙芬滴劑（艾暢)、仁和藥業的小兒氨酚烷胺顆粒（優卡丹），兩者市場份額平分秋色，都是16.1%。 不過，國家食品藥品監督管理局最近將"優卡丹"等含鹽酸金剛烷胺的兒童感冒藥禁用於1歲以下兒童，致使優卡丹等面臨被修改說明書、使用范圍縮小的窘境，也可能會引發市場份額逐漸萎縮。 這與去年康芝藥業的"尼美舒利"被踢出12歲以下兒童用藥市場領域多少有點類似，市場分析稱，此舉意味著兒童用藥監管將進一步收緊，而給一向以安全性著稱的外企擴大市場份額帶來更多的機會。 強生制藥的兒童藥品產品群豐富，雖然強生制藥最近幾年頻頻召回產品，但也體現了跨國藥企內部監管體系嚴格、對外信息透明的一個特征。 在兒科醫生眼中，外企的兒童藥亦有著比本土藥企產品更穩定的療效及可控的副作用，同時外企產品的價格相對較高有利於提高藥品收入，多重因素促使外企兒童藥在處方藥市場勝出。 不僅處方藥市場如此，在保健品領域，外資、合資企業也表現得非常強勢。在兒童維生素市場，90%以上的份額都被惠氏、羅氏、施貴寶幾大企業所占據。

本土藥企：渠道下沉力   2010年，賽諾菲以5.206億美元的巨資收購了本土藥企美華太陽石藥業，創下了業內最大的并購案例。太陽石藥業正是當時國內做得風生水起的兒童藥企，擁有"好娃娃"兒童藥系列和遍布國內三四線城市的銷售網絡，而這正是賽諾菲看中的核心要素。 與外企強大的產品力和在處方藥市場的學術推廣能力相比，本土兒童藥企則在OTC（非處方藥）渠道和三四線城市網絡布局上存有優勢。 仁和藥業的"優卡丹"也是兒童用藥市場上的一大成功案例。優卡丹作為兒童感冒OTC藥的品牌產品，2011年的銷售收入為3.08億元，占仁和藥業2011年全年營業總收入的13.95%。 有分析師預計，今年優卡丹的增長率仍將保持在20%以上，而仁和藥業也正通過收購江西制藥和多元化的營銷策略等手段不斷補充相關產品和銷售網絡，強化品牌形象。 先聲藥業（SCR.NYSE）的再林顆粒劑是國內首家上市的阿莫西林類兒童專用口服抗生素，在國內阿莫西林顆粒劑零售市場的占有率為61％，2010年銷售額3.2億元。 而經歷"尼美舒利門"的康芝藥業，也通過不斷收購及與康恩貝等品牌藥企合作補充產品線，進行轉型自救。 另外，嬰幼兒臟器嬌嫩，發育不完全，適合使用藥性溫和、刺激少、副作用小的藥物，而大部分中藥符合這種特點。 這種市場需求，也促使華潤三九）、江中藥業（600750.SH）、王老吉藥業等本土中藥企業在兒童用藥市場上占有一席之地。

cancer phobia, even more threatening ....!

Anxiety, Cancer, fear, health, illness, Phobias .  Anxiety: We worry. A gallery of contributors count the ways. By DAVID ROPEIK  June 2, 2012, 5:00 pm  I got a call from a friend last year. He had prostate cancer and wanted some help thinking through what to do. He had gone to his doctors for the details about his physical condition. He was calling me for help dealing with the other condition he knew he was facing — excessive fear of this dreaded disease that sometimes does more harm than good, what some have called "cancer phobia." [1] He knew that, like many cases, his prostate cancer had been detected when it was still asymptomatic, and was the slow-growing kind unlikely to ever become symptomatic or to kill him — given he was an otherwise healthy man in his 50s — before old age did. He also knew about the occasional side effects of treatment — urinary incontinence, rectal bleeding, sexual impotence —  risks that thousands of men take each year not so much to remove from their bodies something that might harm them, but to remove from their minds the fear of living with cancer.

News Analysis: Let’s (Not) Get Physicals Nonetheless, he said he was leaning toward treatment, and recognized that his emotions were making it hard to think rationally about the clinical medical evidence. I gently suggested that the perception of risk is so often based more on emotion than just the facts, and the roots of the fear of cancer are so broad and deep, that understanding these anxieties might not help much. But I offered what I could.Physical risks, I told him, have psychological characteristics that make them feel scarier or less scary, regardless of actual probability or evidence. And cancer triggers a couple of the most powerful of these emotional alarms. Research by experts in the field of decision and risk, like Paul Slovic of the University of Oregon and Baruch Fischhoff of Carnegie Mellon, has found that the more pain and suffering a risk involves, the more fear it causes. Many forms of cancer involve a great deal of pain and suffering. We are also more afraid of risks we can’t control and, despite great medical progress, most people still feel they have little control over cancer — either getting it or fighting it. Many people still assume that a diagnosis of cancer is a death sentence.

Michael DeForgeI also told my friend that cancer has been stigmatized. In the psychological sense this means that as soon as we hear the word, subconsciously all sorts of bad and frightening associations go off which frame how we think and how we feelabout anything else we then learn. This aspect of cancer phobia is rooted in the perfect storm of conditions in the 1950s and 60s when cancer first fully blossomed into public consciousness. The atomic bombings of Japan, and the Cold War, seared into our psyche the tangible existential threat of nuclear annihilation, a deep dread that was closely linked with fear of radiation from the fallout from atmospheric nuclear weapons testing. The health consequence of radioactive fallout — the reason to fear it — was cancer.Evidence first started reaching the public in the 1950s about the carcinogenicity of smoking. An issue of Reader’s Digest in 1950 featured an article titled “Cancer by the Carton.” And as the modern environmental movement got going in the ‘60s, it used the threat of cancer as a central rallying theme. Rachel Carson’s classic cri de coeur, “Silent Spring,” featured a whole chapter on cancer, warning that we were “living in a sea of carcinogens.” To drive home those fears, she regularly compared the danger of industrial chemicals to the risks of radiation.Given how this confluence of events magnified the innately frightening nature of cancer, it was no wonder that when the National Cancer Act passed in 1971 the introduction declared cancer to be “the major health concern of Americans today.” It still is.

A recent Harris poll found that cancer is the most feared disease in the United States; 41 of those polled listed it at the top, with Alzheimer’s next, at 31 percent. The benefit of all this fear, of course, has been a body of laws and regulations, and changes in individual behavior, that have significantly reduced the risk of what is indeed a group of horrible diseases. It has given rise to medical progress that has made many once-fatal forms of cancer treatable, and in some cases even preventable. But the costs of cancer phobia have also been significant.One example of the impact it has had at the policy level can be seen at the National Institutes of Health, which spends more than twice as much researching the molecular biology of cancer ($5.4 billion a year) than on figuring out the mechanisms of heart disease ($2 billion a year), which kills more people. [2] It’s a fair to suggest that more people might be alive or healthier if those investments were proportional to the risk.The health damage from cancer phobia has been significant in many ways at the individual level, too, and not just with prostate cancer. In “Overdiagnosis in Cancer” doctors at Dartmouth classified 25 percent of breast cancers detected by mammography, 50 percent of lung cancers detected by chest x-ray or sputum tests, and 60 percent of prostate cancers detected by the prostate specific antigen (PSA) test, as “overdiagnosed.” The authors describe how these overdiagnoses often lead to medically unnecessary treatments, sometimes involving radical surgery, that have major impacts on the patients’ quality of life.The authors of that study are careful not to ascribe this to fear. But a panel of experts on prostate cancer convened by the National Institutes of Health was pretty clear that our dread of cancer contributes significantly to the harm that it does. So much so that for slow growing prostate cancer they recommended: “Because of the very favorable prognosis of low-risk prostate cancer, strong consideration should be given to removing the anxiety-provoking term ‘cancer’ for this condition.”[3]I didn’t get into all those details with my friend. But I did tell him that the fear of cancer can contribute to chronic stress, which raises blood pressure and increases the risk of cardiovascular disease, and which weakens the immune system and increases the likelihood of all sorts of health problems. (A weakened immune system increases the likelihood of getting cancer in the first place, and makes it harder to fight off once you get it.) [4]) So unless he could deal with the fear of living with cancer, cancer phobia alone might make him sick. My friend was in a tough place. Cancer, in many of its forms, is a terrible disease. I’ve had it. I’ve lost relatives and friends to it. But cancer is also a frightening disease, and that fear, and the harms it can do, are no less real than the disease itself. Cancer phobia is powerfully rooted in the deep instinctive ways we perceive and respond to risk, and like many forms of cancer itself, hard to overcome.My friend thanked me, and said that just knowing all that gave him a reassuring sense of control and helped him put things in perspective as he faced his difficult choice.A year after our conversation my friend and his wife treated me to dinner at a fine restaurant. He’d decided to have radiation treatment to eliminate the cancerous cells, and was at peace with his decision, even though the treatment left him with at least one permanent side effect. He had to go to the rest room three times over two hours to urinate, something this 50-ish year-old man will have to deal with for the rest of his life — a price he was willing to pay not so much to cure a physical disease, but to cure the powerful fear he just couldn’t face.

FOOTNOTES [1] The concept of cancer phobia was first coined in 1955 by Dr. George Crile Jr. in an article in Life magazine, “A Plea Against Blind Fear.” [2] A full list of what the N.I.H. spends it’s money on. [3] The report “Role of Active Surveillance in the Management of Men With Localized Prostate Cancer” was released in 2011. [4] For more on the relationship between stress and cancer, see “Psychological Stress and Cancer: Questions and Answers.”

雲端...強調綠色資源 !!

 張善政：雲端軟體行銷待加強【2012/06/06 中央社】行政院政務委員張善政今天表示，雲端運算商業模式正在改變，台灣在雲端硬體上有很好基礎，但在軟體和行銷層面需再加強。 「2012年台北國際電腦展高峰論壇」今天上午登場，張善政以「後PC時代的驅動力─雲端運算」為題進行開場主講。 他表示，雲端商業模式正在改變，目前還沒有可見的商業模式，隨用隨付、雲端視訊下載等應用模式尚未成功，雲端分散資料庫等相關解決工具尚未成熟，對於企業採納雲端在財務面的說服力也不夠，雲端善用綠色資源的規劃也待提升。 不過，張善政指出，雲端運算發展前景仍可期，雲端應用可因應PC（個人電腦）安全性和管理問題，雲端可降低資源浪費程度，雲端應用可同時促進多種技術進步，雲端運算是目前資通訊生態體系最新發展的項目。 張善政表示，雲端運算的重點不在於技術，而是創意和協調，擴大雲端經濟規模很重要，廠商不僅要有提供服務的能力，也要具備與提供服務的對象談判的能力。 張善政指出，台灣在雲端硬體上有很好的基礎，不過在軟體部分，還無法與國際大廠競爭，在雲端軟體解決方案和市場行銷通路方面還有成長空間，軟體工程師也比較忽略行銷層面。 他建議，台灣應多增加雲端系統軟體專長，和具備創意和協調能力的人才；政府和產業界應由下而上，多向雲端終端使用者和企業宣傳雲端價值。

台灣科技要 創新+品牌 !!

【2012/06/06 中央社】副總統吳敦義今天表示，回顧台灣科技業發展「內外皆美、軟硬兼施、創新品牌、關照全球」，對台灣科技業未來有信心。 副總統在台灣科技100強頒獎典禮致詞時指出，講到科技業、台灣有很多項目全球市占率最高，不論是資通訊業的研發、製造，到服務；半導體產業的晶圓代工，到後段日月光、矽品的封裝測試，手持智慧裝置等，各項產品產值都很高。 他說，產業發展不會都是晴天、也有雨天，勉勵科技產業要力爭上游，台灣科技產業不是一朵獨亮、是百花盛開，具創新品牌的動能。 副總統強調，不論歐債風雲、還是景氣遲緩，科技產業都要發揮功能，帶領台灣往前，政府也會營造更好的經濟環境。台灣科技業要發動創新功能，如同總統馬英九提出的全球創新中心，要再創高峰，掃除任一朵烏雲。 行政院政務委員張善政也引述馬總統的看法表示，台灣過去強調效率表現，現在應強調創新表現。 他說，科技業應提高創新含量，從國內產業走到國際。

ASCO 2012: trastuzumab (Herceptin) linked to mertansine (DM1)

T-DM1治疗进展期HER2阳性乳腺癌优于卡培他滨+拉帕替尼   发布时间：2012/6/6 8:43:00 来源：爱唯医学    在美国临床肿瘤学会(ASCO)2012年会上报告的EMILIA III期随机试验表明，抗体-药物共轭新药T-DM1用于进展期HER2阳性乳腺癌比标准治疗更有效，毒性也更小。  在这项试验中，研究者总共招募了991例局部进展或转移性HER2阳性乳腺癌患者，并且所有患者之前都曾接受紫杉烷和曲妥珠单抗治疗。这些患者被平均分组，接受静脉输注T-DM1 (又名曲妥珠单抗emtansine)，每3周1次，或者口服标准剂量的卡培他滨和拉帕替尼，后者是目前唯一在美国获得批准的用于曲妥珠单抗耐药性HER2阳性转移性乳腺癌的联合用药方案。不准备在疾病进展时进行治疗交叉。  主要研究者、美国杜克大学杜克癌症研究所的Kimberly L. Blackwell博士报告称，该试验的主要疗效终点之一中位无进展生存期在T-DM1组中为9.6个月，而在卡培他滨+拉帕替尼组中仅为6.4个月[危险比(HR)：0.65；P<0.0001]。基于这一结果，研究者就总生存期开展了中期分析，这是该试验的另一个主要疗效终点。虽然T-DM1也有效延长了患者的中位总生存期(没有达到vs. 23.3个月；HR：0.62；P<0.0005)，但组间差异还是略低于事先定义的终止试验的统计学阈值。  就药物的安全性而言，T-DM1组3级或3级以上血小板减少(12.9% vs. 0.2%)以及天冬氨酸转氨酶(4.3% vs. 0.8%)和丙氨酸转氨酶(2.9% vs. 1.4%)升高的发生率更高；另一方面，卡培他滨+拉帕替尼组腹泻(20.7% vs. 1.6%)、手足综合征(16.4% vs. 0%)和呕吐(4.5% vs. 0.8%)的发生率更高。T-DM1组3级或3级以上不良事件的总发生率大约比联合治疗组低1/3 (41% vs. 57%)。  Blackwell博士补充道，卡培他滨+拉帕替尼组因药物毒性而停止治疗的患者比例也显著高于T-DM1组。她希望这些数据能够支持该药获准用于HER2阳性乳腺癌患者。Blackwell博士还在新闻发布会上表示："T-DM1是一种全新的HER2阳性乳腺癌治疗方式。我认为这是诸多抗体-药物共轭物中首个能将强效抗癌药物与抗体的靶向给药体系相结合的产品。我相信它将会给HER2阳性转移性乳腺癌患者提供一种非常重要的治疗选择。"  美国纪念斯隆 - 凯特琳癌症中心的Andrew D. Seidman博士在接受采访时评论道："这是今年最令人振奋的乳腺癌研究进展之一。"他高度称赞该药的作用机制："可以说这是改变陈旧思维的一种方式。我们手中已经握有一颗灵巧炸弹：我们已经能让曲妥珠单抗靶向作用于癌细胞而发挥一定的毒性作用。这是精准医学，优于现行的标准治疗，即两种口服药物联合使用。"  Seidman博士补充道，T-DM1"可以预防乳腺癌进展，至少在早期分析中能够延长HER2阳性转移性乳腺癌患者的生存期。在纪念斯隆 - 凯特琳癌症中心开展的临床试验中，我们自己也有使用该药的实践经验，它确实有效，也很温和，因此广受欢迎"。  生产商目前正在准备向美国食品药品管理局(FDA)提交T-DM1的上市申请，所申请的适应证很可能与该试验纳入的患者人群类似，即作为晚期HER2阳性乳腺癌患者的一线、二线和三线治疗。  Blackwell博士声明无相关经济利益冲突。该试验由T-DM1的生产商基因泰克公司资助。Seidman博士声明担任了Enzon和惠氏公司的顾问，接受了Celgene、基因泰克和Genomic Health公司提供的酬金。

贝伐珠单抗 (Avastin) 可延长转移性CRC生存 !!

发布时间：2012/6/6 8:46:00 来源：爱唯医学 美国临床肿瘤学会(ASCO)年会上报告的一项研究显示，对于进展期结直肠癌(CRC)患者，在二线化疗基础上追加贝伐珠单抗可延长无进展生存期和总生存期。  德国Eppendorf大学医院Hubertus Wald肿瘤中心主任Dirk Arnold博士报告，在这项III期随机试验中，820例无法切除的转移性CRC患者在接受伊立替康或奥沙利铂为基础的一线化疗后，根据医生的判断，追加贝伐珠单抗治疗。在疾病进展时，患者随机分组接受之前未用过的二线方案治疗，加用或不加用贝伐珠单抗。主要终点为中位总生存期。  结果显示，接受贝伐珠单抗治疗和单纯化疗者的中位总生存期分别为11.2和9.8个月[危险比(HR)为0.81，P=0.0062]。接受和未接受贝伐珠单抗治疗者的中位无进展生存期分别为5.7和4.1个月(HR，0.68，P<0.0001)。接受贝伐珠单抗治疗使无法切除结直肠癌患者的总生存期和无进展生存期分别延长了1.4和1.6个月。贝伐珠单抗组和单纯化疗组的总应答率分别为5.4%和3.9%，差异无统计学意义。二线治疗中继续使用贝伐珠单抗的不良事件与贝伐珠单抗作为一线或二线治疗的历史对照相似。  这项研究为既往接受过贝伐珠单抗联合方案预治疗的疾病进展患者提供了一种新的二线治疗选择。  这项名为ML 18147的研究是由罗氏公司资助的。Arnold医生披露担任了安进、默克雪兰诺和罗氏诊断公司的顾问并接受这些公司提供的酬金，此外，Arnold医生还接受了罗氏诊断公司提供的研究资助。

細胞液晶? 取代動物及細胞毒性安全檢測 !??

「取代動物及細胞毒性安全檢測套組細胞晶體」技術說明會  June 6th, 2012經濟部生技醫藥產業發展推動小組為推動我國生技醫藥產業發展，特舉辦「取代動物及細胞毒性安全檢測套組細胞晶體」技術說明會。國內外法規規定，舉凡健康食品、新原料、含藥化粧品、醫療器材及醫藥品，基於人體之安全性，須依據產品原料差異進行不同的毒理學評估，包含急性毒性實驗、細胞實驗、刺激實驗，而這些實驗不僅要支付大筆金錢，亦耗費大量時間。細胞液晶是一個模擬生物規則結構的分子，當要測試有刺激毒性物質時，也就是會破壞細胞的液晶結構造成顏色的改變，由透明變為混濁，而可被肉眼或吸光光度計在波長405nm偵測出來，因此可以用來取代動物及細胞對毒性的反應，具有正確、省錢、省時的特點。動物刺激實驗耗時6週要價5萬元；細胞液晶只需5小時，成本也只需動物刺激實驗的百分之一，並能減少不必要的動物犧牲。嘉南藥理科技大學教授郭俊成教授擬於2012年6月21日下午02：00假南港軟體園區經濟部生技醫藥產業發展推動小組，說明取代動物及細胞毒性安全檢測套組細胞液晶的產品、技術優勢及可能的合作計畫，誠摯邀請您共同參與和指教。

會議時間：民國101年6月21日(四)PM 2:00 ~ 4:00

會議地點：經濟部生技醫藥產業發展推動小組會議室 (台北市南港區園區街3號F棟17樓，南港軟體園區F棟17樓)

參加費用：免費

指導單位：經濟部工業局

主辦單位：經濟部生技醫藥產業發展推動小組

報名時間：即日起至6月20日17:00止

Therapy for depression can work over the phone

Tuesday, June 5, 2012 By Kerry GrensNEW YORK (Reuters Health) - Patients with depression are more likely to stick with a type of talk therapy when it's given over the phone, compared to traditional, face-to-face settings, according to a new study."This is very encouraging and suggests that the telephone can be an effective medium to communicate with clients during (cognitive behavioral therapy)," said Stefan Hofmann, a psychology professor at Boston University, who was not involved in this study.However, the results also show that while people might be less likely to drop out of telephone-based therapy, this approach may be slightly less helpful than office-based treatments."Apparently, there is an advantage of doing therapy face-to-face, but the reason is not clear," Hofmann added in an email to Reuters Health.Cognitive behavioral therapy is an approach to psychotherapy that tries to change the thoughts and attitudes leading to a person's condition.David Mohr, the lead author of the study and a professor at Northwestern University Feinberg School of Medicine, said that many people want therapy as part of their depression treatment, but "one of the things we've found over the years is that it's very difficult for people with depression to access psychotherapy."In addition to the expense, if health insurance doesn't cover it completely, therapy requires a time commitment -- sometimes an hour or more a week for months -- that is a challenge for people to meet.

U.S. cancer survivors face new test in long-term care

 Tuesday, June 5, 2012 By Debra ShermanCHICAGO (Reuters) - Mario Alberico got his education in oncology the hard way. He has lived with cancer and the long-term effects of his treatment for most of his life.At 51, Alberico has finally assembled a team of doctors near his home in suburban Chicago to manage his care. Before that, he saw one doctor after another who failed to recognize serious health problems that stemmed from radiation and chemotherapy drugs used to treat his bone cancer decades earlier.During his senior year of high school, Alberico, the seventh of nine children supported by his widowed mother, got radiation and rotated through 4 different chemotherapy drugs at high doses that eradicated the cancer. Each one of those drugs can have grave long-term effects.As Alberico and many other cancer patients have learned, most doctors outside the oncology community never learned about the impact cancer treatment may have on the longer lifespan they fought to achieve.That has deep implications for the ranks of U.S. cancer survivors, which have quadrupled to nearly 12 million people since the 1970s, according to the National Cancer Institute.Alberico has already had several close calls. The most alarming episode happened about 10 years ago, after he attended a seminar for survivors through the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.There he learned that adriamycin, one of the chemotherapy drugs he was treated with 24 years earlier, can affect heart function. Alberico consulted a cardiologist who found that he was on the verge of heart failure."I never had any symptoms," said Alberico. "I would have been dead two or three times over incidents like that.""Once you're finished with the oncologist and you're sent back to a family doctor, it's a time bomb," said Alberico, an artist and active advocate for cancer survivors.A survey of 1,072 primary care doctors (PCP), which include internists and family practitioners, showed that 94 percent of them were unaware of the long-term side effects of four of the most commonly used chemotherapy drugs used to treat breast and prostate cancer.The findings were presented at the American Society of Clinical Oncology meeting in Chicago this past weekend.Heart problems, such as those Alberico experienced, are common long-term side effects of chemotherapy drugs. Others include osteoporosis, nerve damage, early menopause, infertility, leukemia, and the recurrence of cancer."We are creating more and more survivors and we owe it to them to make sure they have good subsequent care," Dr Michael Link, a pediatric oncologist and former ASCO president. "It is an emerging problem, but it's a good problem in some ways because people are surviving."

ORGANIZED COMMUNICATIONBetter treatments and an aging population are expected to fuel this trend in the coming years. At the same time, many health insurance plans will only cover oncology visits for a limited period of time, eventually pushing patients back to family doctors or internists."Passing off patients in this way is fine if there has been communication between the oncologist and the PCP," said Dr Otis Brawley, Chief Medical Officer of the American Cancer Society.That means having the oncologist tell the PCP what the patient was treated with, what the potential long-term side effects might be and what to look out for. But it often does not happen. "An oncologist cannot bill for that," Brawley added."The thing I'm most worried about is the transitioning of the pediatric survivor of cancer into adult cancer life," he said.The survey results also showed that about a third of the oncologists surveyed were unable to identify long-term side effects that occur after chemotherapy."Oncologists didn't know as much as one would think either. That was surprising," said Dr Larissa Nekhlyudov, a general internist who is the director of Cancer Research in the Department of Population Medicine at Harvard Medical School and lead author of the study."When people attack primary care physicians, I remind them that it wasn't long ago when oncologists didn't think about survivorship either," Nekhlyudov said.She said her aim was to highlight a growing problem, and the need to shift from a traditional approach of care that solely focused on acute treatment and getting the patient into remission to helping doctors recognize the long-term side effects and help patients cope. Sharing information is becoming all the more crucial as dozens of new cancer drugs reach the market, each with their own risk profile."There's no way a PCP can know all the late effects of these drugs. There's too much and they keep changing," Nekhlyudov said. "This will become more important as a discipline of study. This needs to be taught in medical schools. There's some movement, but very little."Dr Carol Rosenberg, director of Living in the Future (LIFE) Cancer Survivorship Program at NorthShore University HealthSystem in suburban Chicago, said she recently obtained a grant for a pilot program teaching residents and interns about the long-term effects of cancer treatment."If a 50-year-old woman came to the hospital with shortness of breath and had a history of breast cancer, there are a lot of (doctors) who would not know that the drugs could have caused cardiac issues," she said."If it wasn't taught to them in medical school, how would they know?" Rosenberg asked.(Reporting by Debra Sherman; Editing by Michele Gershberg and Cynthia Osterman) Reuters Health

Enzon Presents Final Analysis of Phase II PEG-SN38 (EZN-2208) Study in Patients With Metastatic Breast Cancer at 2012 ASCO Meeting

 5 Jun 2012 WDM Group PR Network  PISCATAWAY, NJ--(Marketwire - June 4, 2012) - Enzon Pharmaceuticals, Inc. (NASDAQ: ENZN) today presented data from the final analysis of a Phase II study in which PEG-SN38 demonstrated notable activity in patients with previously treated metastatic breast cancer. The data were presented in a poster session (Poster #1017) at the American Society of Clinical Oncology Meeting in Chicago, IL."Despite existing therapies, new and effective treatment options for patients with previously treated metastatic breast cancer are needed," said Joyce A. O'Shaughnessy, MD, a breast cancer specialist at Texas Oncology, Baylor Sammons Cancer Center, and US Oncology, and the principal investigator of the study. "In this study, PEG-SN38 resulted in a significant overall response rate in previously treated patients, as well as in triple negative breast cancer and platinum-resistant patients. These findings provide further clinical evidence indicating the potential of PEG-SN38 to deliver meaningful therapeutic benefit in patients with breast cancer."The study was designed to evaluate the efficacy of single-agent PEG-SN38 in 164 female patients who had previously been treated for metastatic breast cancer with either anthracycline and taxane (AT, up to 2 prior lines of therapy) (n=81), or anthracycline, taxane and capecitabine (ATX, up to 4 prior lines of therapy) (n=83). The primary objective of the study was to determine overall response; secondary objectives included duration of response, progression-free survival (PFS), overall survival (OS) and safety.Overall response was found to be meaningful in both the AT group (25%) and the ATX group (11%). For the AT and ATX cohorts, the response rate and clinical benefit rate among estrogen response positive patients were 15% and 39% (n= 92), respectively. In patients who progressed during or within 30 days of prior platinum-containing regimens, the clinical benefit rate was 18% (n=40). Among triple negative breast cancer patients, the response rate and clinical benefit rate were 23% (n=47) and 32% (n=47), respectively. For triple negative breast cancer patients with prior platinum-containing regimens, the clinical benefit rate was 18% (n=22). PEG-SN38 was generally well tolerated in these heavily pretreated patients, with neutropenia, diarrhea and leukopenia being the most common adverse events. Investigators concluded that PEG-SN38 warrants further clinical study in metastatic breast cancer. Enzon does not intend to pursue development of PEG-SN38 in this indication or in other malignancies on its own, absent a partner. Zhejiang Hisun Pharmaceuticals Co. Ltd recently acquired exclusive development and commercialization rights to PEG-SN38 in China. Enzon is seeking strategic partners for PEG-SN38 in other territories.

About PEG-SN38 (EZN-2208)Through the use of our PEGylation technology, Enzon designed PEG-SN38 (EZN-2208), a PEGylated conjugate of SN38, to offer therapeutic advantages over unmodified SN38 and existing therapies. The PEGylated version allows parenteral delivery, increased solubility, higher exposure, more profound deoxyribonucleic acid (DNA) damage, inhibition of angiogenesis, and longer apparent half-life of SN38 as compared to irinotecan.

About Enzon Enzon Pharmaceuticals, Inc. is a biotechnology company dedicated to the research and development of innovative therapeutics for patients with high unmet medical need. Enzon's drug-development programs utilize two platforms: Customized PEGylation Linker Technology (Customized Linker Technology®) and third-generation mRNA-targeting agents utilizing the Locked Nucleic Acid (LNA) technology. Enzon currently has four compounds in human clinical development and multiple novel mRNA antagonists in preclinical research. Enzon receives royalty revenues from licensing arrangements with other companies related to sales of products developed using its proprietary Customized Linker Technology. Further information about Enzon and this press release can be found on the Company's website at www.enzon.com.

牛道明...法布瑞氏症是發生率最高的罕見疾病 !

捐罕病檢測器 北榮感謝扶輪社2012-06-06 【中央社】扶輪社今天捐贈台北榮民總醫院檢測分析罕見疾病基因的儀器，醫師表示感謝，將免費提供罕病家族基因檢測，同時也感慨健保制度應檢討。1名50多歲婦人，罹患罕見脂肪代謝障礙遺傳疾病「法布瑞氏症」，40年沒有被檢查出來，雖然從小學就有四肢疼痛問題，走路就像走針板一樣灼熱刺痛，多年來被誤診為維生素B群營養不足，還打多年營養針，最近接受基因遺傳檢驗，才找出原因，並發現1家3代共6人罹病。台北榮民總醫院罕見疾病治療中心主任牛道明表示，國內男性每1600人就有1人帶有法布瑞氏症基因、每800名女性中就有1人帶有基因，法布瑞氏症是國人發生率最高的罕見疾病。牛道明表示，罕見疾病多為家族遺傳性疾病，一人發病則全家族都需進行基因檢測並追蹤，即可早期發現早期治療，延緩疾病進程，然而，檢測費用?貴且健保未給付，精密檢驗設備不足，並無法立即確診。牛道明表示，由於醫療費用及健保制度困難，投入罕見疾病有限，透過募款、產官學與研究計畫支撐；現在將健保床配置提高到75%，醫院財務面臨問題，也不敢責難院方，咬牙與院方一同度過難關，若政府不正視面對，將出大問題。扶輪社捐贈台北榮總一台「罕見疾病基因檢測分析儀器－高通量即時螢光定量PRC系統」，牛道明表示，所有疾病與基因異常方面有關的疾病都可以用這台儀器檢驗，將免費提供罕病家族確實快速檢測基因突變，希望能杜?世代遺傳，有效提升人口素質。1010606

Afatinib* as first line efficacy in EGFR mutations lung CA !!

 Afatinib* delivers unprecedented first line efficacy in patients with EGFR mutation positive lung cancer in registration trial   June 4, 2012, 12:01 a.m. EDT LUX-Lung 3 results highlighted at the official ASCO Press Conference: Afatinib* delays cancer progression significantly more than the best standard chemotherapyINGELHEIM, Germany, Jun 04, 2012 (BUSINESS WIRE) -- For NON-US media only The LUX-Lung 3 Phase III results showed that lung cancer patients taking the novel compound afatinib*, an irreversible ErbB Family Blocker, as a first-line treatment, lived for almost one year before their tumour started to grow again (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on standard chemotherapy (pemetrexed / cisplatin).(1) Importantly, patients taking afatinib* with the most common EGFR mutations (del19 and L858R, accounting for 90% of all EGFR mutations) lived for well over a year without progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.(1) Boehringer Ingelheim's registration trial LUX-Lung 3 is investigating the company's front runner molecule afatinib*, and is the largest and most robust trial to date in EGFR (ErbB1) mutation positive advanced lung cancer patients. The primary endpoint was progression-free survival (PFS). "Not only did LUX-Lung 3 meet its primary endpoint, but it also showed that afatinib*, especially in patients with the most common EGFR mutations, almost doubled the progression free survival time compared to chemotherapy." commented Prof. James Chih-Hsin Yang, Director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan and principal investigator of the LUX-Lung 3 trial. "Based on this proven efficacy in the largest and most robust registration trial, coupled with its novel mode of action, afatinib* may become one of the most valuable treatment options for this distinct patient population." The delay in disease progression for afatinib*-treated patients was associated with better control of life-restricting disease-related symptoms.(1) More patients taking afatinib* experienced improvement of symptoms such as dyspnea (shortness of breath), cough and chest pain. Afatinib* also delayed the onset of these symptoms.(1) A standard lung cancer questionnaire to assess the quality of life of cancer patients revealed that afatinib* treatment translates into significantly improved quality of life (e.g. at work and during household activities).(1) "We are pleased to see that the first compound from our large oncology portfolio has clearly demonstrated its clinical benefit and the potential to effectively help those lung cancer patients harboring EGFR mutations." said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The results of the LUX-Lung 3 clinical trial are very encouraging and we strive to bring this personalised treatment to patients in need as soon as possible." The most common adverse events associated with afatinib* treatment were diarrhea and skin-related side effects. These adverse events were as expected with EGFR inhibition, consistent with previous studies, and were predictable, manageable and reversible.(1) These rarely led to discontinuation of the treatment.(1) To further explore the potential of afatinib* as a lung cancer treatment, Boehringer Ingelheim has initiated two new trials aimed at comparing afatinib* head-to-head with targeted treatment agents. Both trials are currently recruiting patients. LUX-Lung 7 is a Phase IIb trial evaluating afatinib* versus gefitinib as a first-line treatment in EGFR mutation positive NSCLC patients. LUX-Lung 8 is a Phase III trial evaluating afatinib head-to-head versus erlotinib in second-line treatment of squamous cell carcinoma of the lung. Afatinib* is different to currently available targeted therapies in that it irreversibly blocks the ErbB Family of receptors, meaning afatinib* blocks EGFR (ErbB1) as well as the other relevant members of the ErbB Family, all of which can be involved in pathways that help tumour cells grow, migrate and metabolise. Investigation of the clinical relevance of afatinib*'s unique mode of action which could potentially lead to a greater effect on the tumour, has provided the basis for initiation of the LUX-Lung trial programme. Full data from the trial will be presented today in a late-breaking oral presentation at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

About LUX-Lung 3 Trial LUX-Lung 3 is a large, randomized, open-label, Phase III registration study comparing afatinib* to two chemotherapy agents, pemetrexed and cisplatin, as first-line treatment for patients with stage IIIb or IV NSCLC harboring an EGFR mutation. The study included 345 patients with EGFR mutation positive NSCLC globally. LUX-Lung 3 is the largest trial to date in patients with EGFR mutation positive NSCLC and the first study in this population to use pemetrexed / cisplatin as a comparator.(1) The most common drug-related adverse events observed in the afatinib* treatment arm were diarrhea (95%), rash (62%), and paronychia (57%). The most common drug-related adverse events observed in the chemotherapy arm (pemetrexed /cisplatin) were nausea (66%), decreased appetite (53%), and vomiting (42%). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy). One percent of patients in the afatinib* arm discontinued due to diarrhea.

About Lung Cancer Lung cancer is the most common and most deadly form of cancer in the world: it accounts for 1.6 million new cancer cases annually. Because of its poor prognosis, 1.38 million deaths each year are attributable to lung cancer.(3) Overall, lung cancer is the cause of 18% of all cancer deaths.(3) Thirteen percent of all new cases of cancer are lung cancers(4)and smoking is attributed as the main cause.(5) Early testing for EGFR mutation status of lung cancer patients is critical in improving patient outcomes. Between 10-15% of Caucasian and 40% of Asian NSCLC patients have EGFR mutations, with 90% of these a result of two mutations (del19 or L858R).(2)

About Afatinib* Afatinib* is an irreversible ErbB Family Blocker which inhibits signal transduction of all kinase receptors from the ErbB Family(2), which is known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast, and head & neck cancers). Afatinib* is currently also in Phase III clinical development in breast cancer and head and neck cancer.

About Boehringer Ingelheim in Oncology Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world's leading cancer centres, Boehringer Ingelheim's commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers. The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. Nintedanib* (BIBF 1120), an angiogenesis inhibitor is currently in Phase III clinical development in NSCLC and ovarian cancer. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing an inhibitor of polo-like kinase 1 (Plk1), volasertib*, a protein that is involved in the processes of cell division. The compound is in Phase II development for acute myeloid leukaemia. Boehringer Ingelheim's oncology pipeline is evolving and demonstrates the company's continued commitment to advance the disease area.

Boehringer Ingelheim The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine. As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavours. In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales. *Afatinib, nintedanib (BIBF 1120) and volasertib are investigational compounds. Their safety and efficacy have not yet been fully established.

References (1) Abstract no: LBA7500, LUX-Lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations. Oral Presentation at 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2012. (2)Jang, T.W. et al. 2009. EGFR and KRAS Mutations in Patients With Adenocarcinoma of the Lung. The Korean Journal of Internal Medicine, March; 24(1), pp.48--54. (3)Ferlay J et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127 2893-2917. (4)Cancer Research UK. UK lung cancer incidence. CancerStats -- Key Facts 2009. [Online] Available at: http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/ [Last Accessed April 2009]. (5)Allen J et al. J Natl Compr Canc Netw 2008;6(3): 285-293.

SOURCE: Boehringer Ingelheim

 

龍燈..農業生技數據保護策略!

F-龍燈董座：每年營收維持逾2成成長 3年內衝破150億元  2012/6/4  鉅亨網國內首檔農業生技股F-龍燈(4141)，董事長羅昌庚樂觀指出，未來每年營收將維持2成以上穩定成長，3年後營收將上看150億元，並將透過種子基金布局，並同時啟動公司黃金10年。 F-龍燈主要產品為作物保護劑及植物營養劑，羅昌庚強調，同樣東西在歐洲賣55元，但在中國卻賣11元，靠的是利用全球的資源，及「環球農業」的佈局開花結果，加上集團內JRB氟化瓶的包材優勢，解決作物保護劑遠地配成本，因此毛利比同業高，成為全球少數可以源頭材料集中生產並共同享數據研發成果的「環球」農業生技廠。 羅昌庚指出，目前F-龍燈在全球60國取得超過700張藥證，且每年維持100-130張新增藥證的速度，擴大產品線。他解釋，相較於人用藥品，作物保護劑的藥證數據需依適用作物及蟲類，分門別類，因此因應藥證取得，該公司已完成超過9900個實驗，未來除每年維持新增藥證外，也將增加既有藥證新適用作物或蟲類，擴大單張藥證的含金量。 羅昌庚進一步解釋，不同西藥的專利保護，植物保護劑強調是「數據保護」，因作物保護劑的內容屬於不純物，原廠不會公布化學配方，有意切入的學名藥廠進行化學等同性分析時，必須有足夠的試驗數據證明與原廠配方吻合或是更好，否則就很難取得註冊登記，特別是作物保護劑的受體不像西藥統一，更添研究數據的難度，因此業界常說，農化註冊登記的法規障礙相當高，僅次於民用航空業。 羅昌庚自豪表示，植物保護劑學名廠怕的不是專利，而是數據，一般而言，原廠原始數據保護是十年起跳，因此即便原廠專利到期，還是可以透過不斷試驗的新數據延後對手新品上市的時間，這也讓植物保護劑學名廠切入的難度更高於西藥。如果沒有能力進行獨立數據產生及分析的廠商，一則只能選擇非歐美及巴西的二級市場，一則與原廠購買數據，並限用原廠保護劑的主要成分，僅添加其他非主要成分，賺取微薄的利潤，因此為何龍燈可以維持高獲利的原因在此。

學名藥短缺 美忙立法改善

(AFP) （法新社芝加哥4日電） 醫師今天表示，美國學名藥，特別是癌症用藥嚴重短缺，可望經參眾兩院立法改善。 美國臨床腫瘤學會（ASCO）年會的專家小組表示，參眾兩院已分別通過兩個類似版本，可望趕在歐巴馬總統本月或下月簽署生效前，協調成一致版本。 這項法律首次要求學名藥廠必須支付使用費給美國食品暨藥物管理局（FDA），加速藥物審核過程。 這項法律也要求廠商，必須在任何藥物可能短缺前6個月，先通知FDA。ASCO政府關係委員會主席、芝加哥大學（University of Chicago）腫瘤學家席爾斯基（RichardSchilsky）說：「我們從來就無法確定學名藥何時會突然供應短缺，這不僅會讓病患陷入很大的不確定性和焦慮，也可能打亂臨床醫師的處方規劃。」 席爾斯基並表示，首次加收學名藥使用費，未來幾年可望讓FDA進帳15億美元。 他說：「如此一來，應能縮短新藥申請至學名藥上市的審核時間，從原本約30個月降至10個月以內，這是吸引新廠商加入製造學名藥以及藥物銷售的一大步。」（譯者：中央社陳怡君）

α-fetoprotein vaccine?!! 康恩贝设合资公司研发肝癌疫苗项目

发布时间：2012/6/6 11:18:00 来源：药品资讯网信息中心 日前，康恩贝与美国AFP Sino Development Corp.，LLC正式签订《AFP项目合作协议书》。协议决定，双方作为发起人，筹资在杭州成立合资公司，合作开发肝癌治疗性疫苗（AFP）项目。合资公司注册资本为800万元人民币，其中公司以现金入股，占合资公司股本70%；AFP开发公司以技术入股，占合资公司股本30%。 美国AFP开发公司于2011年12月6日注册设立。根据美国凯德药业公司董事会的有关授权和相关约定，凯德公司将原拥有的AFP项目在中国的商业开发权转让授予AFP开发公司，凯德药业公司研发的&alPHa;胎蛋白用于肝癌的治疗性疫苗药物经过美国食品药品管理局相关审评，批准进入临床研究，目前正在美国进行Ⅰ期临床试验。 康恩贝称，我国AFP研究尚属空白，在该项目现有基础上，公司通过与AFP开发公司合作成立合资公司，在国内同步开展研究开发和新药注册工作具备相对优势。同时，通过合作对于引进国外先进技术加快国内开发癌症治疗性疫苗工作也将起到积极作用。

信邦制药重磅新药将迎药监局“大考”

发布时间：2012/6/6 来源：药品资讯网信息中心 高考临近之际，信邦制药备受关注的皂苷_Rd注射剂也将迎来药监局药品审评中心的"大考"，该研发产品终于进入了关键的技术审评阶段。如若皂苷_Rd注射剂审评通过，其未来市场价值颇为可观。 信邦制药今日公告，接到公司全资子公司贵州信邦远东药业有限公司的通知，国家药监局药品审评中心将于6月13日至15日召开人参皂苷_Rd注射剂药品审评咨询会议，会议将召集专家对该品种技术审评，对药学、临床、药理毒理等技术问题进行咨询。药审中心将依据技术审评意见、样品生产现场检查报告和样品检验结果，形成综合意见，连同有关资料报送国家药监局。药监局依据综合意见，作出审批决定。符合规定的，发给新药证书，申请人已持有《药品生产许可证》并具备生产条件的，同时发给药品批准文号；不符合规定的，发给《审批意见通知件》，并说明理由。 上述情况意味着，皂苷_Rd注射剂在被贵州省药监局初审后，即将迎来第二关技术审评，该审评将最终决定该新药能否早日获"准生证"并投产推广。 据了解，人参皂苷_Rd为国家中药一类新药，是从中药材三七中经多步分离提取的一种单体化合物。更重要的，该药是目前为止唯一报道的具有特异性阻断受体依赖性钙离子通道的化合物。近期的基础研究显示，该药还具有抑制谷氨酸释放、调节NO、抗氧化以及保护线粒体的多重作用，其主要用于急性缺血性脑卒中风的治疗，对脑缺血有明显保护和治疗作用，能明显降低脑卒中自发性高血压的中风率和死亡率。 信邦制药上市后，一类新药人参皂苷-Rd及人参皂苷-Rd注射剂的申报就成为公司头等大事。2010年9月21日该药的申报资料被贵州省药监局受理，当时被视为该项目的一个进展。2012年3月30日，信邦制药披露接到承担公司国家一类新药人参皂苷_Rd临床研究组长单位第四军医大学西京医院通知，由该医院牵头完成的"人参皂苷_Rd注射液治疗急性脑梗死的随机、双盲、安慰剂对照的多中心Ⅲ期临床试验"的研究论文已在线发表于国际专业杂志《European Journal of Neurology》（《欧洲神经病学》）。 根据《药品注册管理办法》规定，在省级药监局初审后的第二个阶段，即技术审评及生产现场检查阶段由国家药监局审评中心主导，审核时限为120天。符合审批规定后，药品进入审批阶段，该阶段也由国家药监局主导，时限20天，符合规定的，发给新药证书。最后进入生产线通过GMP认证阶段，该阶段由国家药监局主导，时限100个工作日。 业内人士分析，如若皂苷_Rd注射剂审评通过，其未来市场价值颇为可观。我国是脑血管病患者高发的国家，其发病率和死亡率位居前列，相关药物市场容量巨大。在这一领域，化学药并不占优势，反而是中药特别是中药注射剂占据了重要位置。公司人参皂苷-Rd投产后，凭借植物单体药物身份和公司在心脑血管领域的营销优势，市场前景将颇为乐观。

日本用小分子RNA治疗脊髓延髓肌萎缩症获进展

发布时间：2012/6/6  来源：药品资讯网信息中心 日本名古屋大学和自治医科大学的研究小组在新一期《自然·医学》期刊网络版上报告说，他们在老鼠实验中发现一种用小分子RNA(核糖核酸)遏制脊髓延髓肌萎缩症的新疗法。 脊髓延髓肌萎缩症是引发全身肌无力的神经变性疾病，很难治疗，患者年龄常在30岁至60岁之间。神经变性疾病由神经细胞内积聚的异常蛋白质所致，异常雄性激素受体蛋白质被认为是导致该病的原因。 研究小组分析老鼠基因时发现，参与合成异常雄性激素受体蛋白质的异常信使RNA与名为"CELF2"的蛋白质结合后，前者就会保持稳定，最终造成老鼠运动机能减退。但是一种名为"196a"负责调节基因表达的小分子RNA能遏制"CELF2"蛋白质的表达，从而导致异常信使RNA的稳定性下降并分解，异常雄性激素受体蛋白质的总量也随之减少。 研究小组给患有脊髓延髓肌萎缩症的老鼠注射名为"196a"的小分子RNA后，其神经细胞内的异常雄性激素受体蛋白质减少了约60%，老鼠的运动机能得以维持。 研究小组负责人、名古屋大学教授祖父江元说："这是从根本上遏制(脊髓延髓肌萎缩症)病情的治疗方法。"研究小组认为，此类疗法还有望用于阿尔茨海默氏症、帕金森氏症、肌萎缩侧索硬化症等神经变性疾病的治疗。

骨髓移植 奇美醫院年底成軍投入

自由時報-2012年06月06日 〔自由時報記者孟慶慈／台南報導〕骨髓移植是血液性惡性疾病治療的最後希望，雲嘉南地區現僅成大醫院從事自體、異體骨髓移植治療，很多患者需到北部求醫，奇美醫院年底將成立完整的骨髓移植團隊，投入相關治療行列，目前正積極訓練團隊成員。奇美醫院血液腫瘤科醫師吳鴻昌表示，骨髓移植是治癒嚴重再生不良性貧血、血癌、淋巴癌、先天性免疫缺損等疾病的最後希望；奇美醫院今年光是血液腫瘤科就有四名需移植的病患。吳鴻昌表示，雖然骨髓移植後感染、排斥的風險都很高，但骨髓移植是治療血液性惡性疾病唯一的希望，不到最後關頭不會提出，因此更需要完整的醫療團隊來照顧患者，所幸目前醫學精進，患者的存活率已大為提高。吳鴻昌指出，骨髓的捐贈者或來自親屬，或是一般的捐贈者，早期取捐贈者的骨髓必須進開刀房，全身麻醉，在髖骨位置穿數十針抽取骨髓。如今醫學進步，捐髓者只需事先服用白血球生長激素，讓幹細胞進入靜脈，只要挨一針就能收集到一袋血液幹細胞，對捐髓者來說輕鬆許多。吳鴻昌表示，奇美醫院八年前曾經為數名病患做過骨髓移植，但因故中止，現今重新整軍啟動，相關醫師已到外院接受訓練，他自己已在台大受訓一年，接下來是護理師、藥師等訓練，預定年底骨髓移植團隊正式成立。

NeoStem: An Investment In Both Stem Cell And Immunotherapy

June 5, 2012Chemistfrog  |  about: NBS Modern medicine is a result of centuries of observations, theories, hypotheses and experimentation. Many of the dramatic changes in our medical history have been sudden and often accidental while others are a product of years of surmising and the subsequent trial and error. Mankind is in the process of making its most abrupt revolution in medicine yet by focusing on a most amazing approach. This approach goes well beyond the last few decades of small molecule and chemically-synthesized compounds that are often designed to merely fight symptoms or to fight the immediate disease itself and not the cause of the disease/ailment or even aid longer-term recovery or prevention of recurrence. The new era has two major approaches with each deserving its own spotlight. The new, novel and creative source of these two approaches with one focusing primarily on injury treatment and tissue regeneration while the other focuses on protecting the body from its own self destruction due to cancer has been under our noses the whole time. We marvel at our chemical synthesis processes, our logic and deduction to fight injury and disease and our medical devices we tout as being the result of our creative genius and modern technology. Meanwhile, the solution to both the fight against cancer and the fight against injury and other cellular damage has been with us the entire time in the form of our own human body.ImmunotherapyThe immunotherapy approach to fighting cancer has been evolving rapidly with Dendreon's Provenge leading the charge with the first cancer vaccine approved by the FDA. This approach and the subsequent therapies and trials following all utilize our immunity system by teaching it that cancer cancers are foreign and should be attacked, just as viruses and bacteria should be. This is a growing area and is beginning to prove itself to be both legitimate and significant in its applications and is ushering in an entirely new era in the fight against cancer instead of the traditional chemotherapy, radiotherapy and surgery, each with their own successes but each with its own drawbacks

.Stem Cell Therapy  As this approach gains more traction, modern medicine is also beginning to take more note of another novel tool at their disposal in our own human body, regenerative medicine and more specifically cell therapy. Like the immunotherapy approach to helping the body by teaching it what it should fight and destroy from within, cell therapy helps the body by moving the powerful stem cells located in some areas (largely bone marrow) and moving them to areas of need. The source of these cells may be from within (autologous) or from an outside source (allogeneic). These cells may be either directly transplanted from one area to another or may be altered in an intermediate step to coax the cells into differentiating into the proper type of cell needed at the point of insertion for regeneration and repair

.Investor Opportunity is Phenomenal  Both the immunotherapy companies and stem cell companies are beginning to garner much attention by investors and large pharmaceuticals. However, the stem cell companies appear to be the more undervalued of the two and a great value investment as the increasing attention due to trial successes will likely begin driving the stock prices in the sector higher despite the degrading overall markets. The demand for goods and services in many sectors of the economy may wane as consumers cut costs. Meanwhile, the demand for health care is a fixed cost and one that only continues to grow as the population increases and ages.There are many stem cell companies with potential to have successful trials and growth through their own clinicals and subsequent marketing or licensing of their approved therapies. As with much of the biotech sector, the risks are typically obvious with a great deal of loss for ill-conceived investments and much upside for the correct decisions. One relatively unknown company whose growth potential appears to be unrealized is actually one of the biggest players in the field, NeoStem (NBS), an adult stem cell company. NeoStem's Progenitor Cell Therapy (PCT) division was actually involved in the manufacturing of the now-famous Dendreon's (DNDN) Provenge (immunotherapy approach) during its clinicals. The company has a host of other deals with customers such as Johnson & Johnson (JNJ), Baxter (BAX) and many others. As a supplier for each of these customers, not only has the company benefited from the obvious revenue from each of these, but it has also grown its knowledge base by manufacturing over 30,000 cell products.The experience, knowledge and revenue generated by being a valued source of cellular products for these companies is giving NeoStem exposure to potential pharmaceutical partners/suitors as well as knowledge as it grows its own pipeline, most notably their Amorcyte division's ARM-001. NeoStem initiated enrollment in their PreSERVE phase II stem cell therapy of AMR-001 for myocardial infarction on January 25th of this year. An autologous bone marrow derived cell therapy enriched for CD+34 cells, AMR-001 is administered 5-11 days after stent placement. The purpose of the treatment is to aid the body's natural repair mechanism by supplying the CD+34 stem cells that will aid in generating new blood vessels that will supply much needed oxygen and nutrients to facilitate repair and survival of cardiomyocytes (cells that comprise cardiac muscle), thus preserving heart function. With over 800K myocardial infarction events in the U.S. annually, and 20% of those having so much damage to their heart muscle tissue that the remaining muscle cannot compensate for the lost functionality, the area of need and associated market is huge for AMR-001. The phase II trial is just getting underway, and anything is possible with the upcoming data. If the data is as impressive as the phase I appeared to be, the upside for this small biotech can be great. A poor response, although a definite negative for the company and its current lead product, doesn't offer as much downside as the value in the company is currently more in its manufacturing sector (PCT) than their own pipeline.NeoStem's undervalued price is rapidly garnering attention as the stock price has soared over 33% since an April 10th dip due to a recent stock offering. This offering and the grossly oversold state it still resides at offers investors a likely phenomenal entry point into one of the most exciting and dynamic companies in not only the stem cell sector, but also the entire biotech field. The company has many notable catalysts coming up in 2012 and 2013 with deals coming in the forms of manufacturing contracts in their PCT division, updates on enrollment and interim data in their Amorcyte division's AMR-001 and a likely sale of their 51% stake in their Chinese subsidiary, Suzhou Erye Pharmaceutical. Time will only tell if, when and how much the sale of Suzhou will provide in terms of added cash to the company's cash base. The potential sale of Suzhou, the $6 million offering in March and the company's growing manufacturing contracts are each contributing to the bottom line and will likely soon create an even more solid stem cell company still currently in development phase but yet generating revenue to benefit share holders with increased earnings and additional money for financing their own clinicals.The risk obviously, in so many biotechs is largely offset here as their own pipeline is actually not the biggest source of optimism and revenue. However, the company does need to streamline somewhat to start generating a solid profit. A Suzhou sale announcement would be a welcome event as the company needs to streamline more and focus more on its core cell therapy divisions as well as the obvious cash infusion (amount yet to be determined or even hinted at in PR's). Investors are expecting the company to sell its stake in the Chinese pharmacy and for the proceeds to create a significant cash position for the company to develop its cell therapies. If for some reason this sale did not occur it would be a blow to the company, as it needs to abandon that aspect of the business and focus on the PCT and clinical development of its products.The value for this biotech is not solely based on hope and "potential sales" of an approved product in the future like many or even most biotechs, but rather it is based also on current manufacturing contracts as well as an upcoming divestiture. In fact, the only sizeable risks that I can identify are the questions surrounding the sale of its stake in the generic pharmacy to provide cash and in terms of its manufacturing business the company must show that clients are willing to sign long-term contracts that provide continuous revenue even after approval. The risks with all biotechs are generally the same in the developmental phase. Since AMR-001 is a new class of treatments investors must always question how accepting regulators will be to new therapies. Yet with approvals in cell therapy already being seen and more biotechnology companies choosing to focus on cell therapies it appears NeoStem is perfectly positioned to capitalize on the growing interest in the space, assuming that the space continues to grow.The headlines for NeoStem, Inc. should be exciting and potentially profitable for investors in the upcoming weeks, months and even years with steady and sustained growth likely due to a growing sector growing more dependent on it. Any positive outcomes on their clinicals are simply "icing on the cake". Investors making a proper entry into this sector's "cake" may fare very well in the short, mid and long-term; with or without icing.Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

胰岛素注射剂市场萎靡 寻找口服胰岛素

发布时间：2012/6/6 15:34:00 来源：药品资讯网信息中心 6年前，诺和诺德首席执行官索文森(Lars Soerensen)启动了"寻找胰岛素药丸"的工作。 现年66岁的法国人杰基·沙林(JackieChaline)每天都需要注射胰岛素维持生命。16年前被诊断出患有糖尿病后，在过去7年中，沙林使用了大约9000支胰岛素注射剂。"如果服药方式从注射变为口服，我就能彻底解放了。"沙林说。

预计销售峰值 就患者的适应性而言，口服给药与注射给药存在巨大差异。全球最大的胰岛素生产商诺和诺德正试图让沙林，以及数百万像她一样的糖尿病患者的愿望成真。近年来，诺和诺德与其他制药公司竞相开发"重磅炸弹"级口服胰岛素。为此，该公司至少花费了20亿美元，旨在令药物能避开人体自身的防御机制，并补充血液中的胰岛素。 诺和诺德首席科学官麦德斯·汤西嘉·汤姆森(Mads Krogsgaard Thomsen)表示，5年前，研发口服胰岛素成功的赔率为100万∶1，"而现在，我们越来越近50∶50了。" 分析师表示，如果诺和诺德的口服胰岛素研发成功，预计销售峰值将达50亿～100亿美元，并将长期成为全球畅销药物。 诺和诺德表示，口服胰岛素药物的临床研究进展顺利。本月初，该公司开展了一项新的临床研究。目前，糖尿病患者必须注射胰岛素，以防止血糖在血液中堆积。一个成功的口服胰岛素必须足够"强大"，在消化道中抵挡得住胃酸的袭击，并顺利经过肠壁进入肝脏。 汤姆森认为，口服胰岛素要做到上述这些关键点相当困难，"诺和诺德要么努力完成，要么放弃。"

革命性改变 糖尿病是因为人体缺乏将血糖转化成为能量的胰岛素引起的。国际糖尿病联合会估计，全球大约有3.66亿人患有糖尿病，每7秒就有一人因糖尿病死亡。 汤姆森认为，口服胰岛素不能完全取代注射用胰岛素，因为口服胰岛素只能适用于人体仍可以产生一些胰岛素的患者。相反，注射用胰岛素能让糖尿病患者及早得到治疗，因为医生不会等到口服胰岛素上市后，再来开处方。 内分泌专家认为，如果口服胰岛素能研发成功，影响将是革命性的，会有更多糖尿病患者转用这种新剂型。 沙林患有最常见的2型糖尿病。当初她对使用胰岛素具有强烈的抵触情绪，因为她害怕注射。7年过去了，她有时仍感到注射胰岛素是一件痛苦的事情。当她外出就餐时，她会迅速躲进卫生间，以免让其他人看到她在扎针。她还不得不在她的手臂、腹部和大腿之间翻转，以寻找完好的皮肤部位扎针。沙林说，吃药会改变所有这一切。 到目前为止，诺和诺德的长效口服胰岛素已在大鼠、比格犬和超过100个受试者身上进行测试。2月2日，该公司发布2011年财务报告时表示，被称为NN1953的口服胰岛素已完成了首轮临床试验，其中参加临床试验的受试者只需服药一次。 临床试验在德国杜塞尔多夫附近的Profil新陈代谢研究所进行。早些时候，另一种药物NN1952由于在早期试验中遭遇失败而被抛弃。

"违背自然的力量" 早在6年前，诺和诺德首席执行官拉尔斯·索文森(Lars Soerensen)就启动"寻找口服胰岛素"的工作。 诺和诺德急需补充新产品以应对赛诺菲和礼来的竞Ｄ壳埃霉菊群騀DA对其长效胰岛素注射剂Degludec的上市审批。Degludec的竞争对手为赛诺菲的最畅销药物来得时(Lantus)。诺和诺德希望Degludec上市后，从来得时手中夺取更多的市场份额。由于糖尿病治疗药利拉鲁肽(Victoza)和血友病治疗药诺其(Novoseven)的销售额不及预期，致使诺和诺德2012年第一季度的盈利普遍低于分析师预期。 "当我们吞下胰岛素口服药后，药物首先经过胃和肠道，在那里，药物将受到酸和酶的攻击，然后转变为被称为氨基酸的更小颗粒后，穿过肠壁，最后到达血液，进入肝脏。"汤姆森在描述口服胰岛素药物的吸收、代谢过程时表示，肠壁的功能是确保有毒的物质不进入人体，而诺和诺德研发的药物则要"违背自然的力量(Mother Nature)"。 为应对挑战，诺和诺德召集公司的科学家和外部研究人员，研究胰岛素药物制备工艺。 诺和诺德新聘用的科学家包括纳沙尼·布帕力(Nazaneen Pourkavoos)。布帕力曾成功帮助默沙东研发西格列汀(Janumet XR)缓释片，该药联合了西他列汀(Januvia)和二甲双胍(Metformin)。今年2月，FDA批准西格列汀用于治疗2型糖尿病。 布帕力的工作就是寻找到一个配方，让口服胰岛素通过肠壁。他拿起一片药片笑着说："这是实实在在的东西，也是迷人的东西，你想一下注射剂的针头，再看看这片药片，这就可以解释为什么我们不辞劳苦也要开发口服胰岛素。"

提高生物利用度 使口服胰岛素顺利通过肠壁，仅是其中一项挑战。研究人员必须延长该药在血液中的药效，并提高被人体吸收的程度，即生物利用度；诺和诺德已成功寻找到提高药效的方法，并致力于提高药物的生物利用度。 最后，科学家们必须避免药物在复杂的胃肠道中被吸收，例如患有腹泻的患者，可能由于经过胃肠道的时间过短，使人体不能适当地吸收胰岛素。每日一次服用口服胰岛素就能给予患者足够的胰岛素，以防止危险的低血糖发生。 一些规模较小的糖尿病药物制造商，如宾夕法尼亚州的Diasome制药公司、耶路撒冷的Oramed制药和海峡群岛的Diabetology公司，都试图解决这个问题，但是有些公司放弃了。4月，印度的百康制药公司表示，正寻找合作伙伴以进一步研发口服胰岛素药物。 分析师表示，诺和诺德口服胰岛素上市后，将侵占现有的胰岛素注射剂市场份额，致使其他公司被迫研发口服胰岛素。诺和诺德将在明年底准备进行口服胰岛素的中期临床试验。