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Tuesday, April 28, 2015

Sorrento Therapeutics登NASDAQ 總裁Henry H. Ji (季紅俊): 三年河東三年河西!!!

華人企業家:在美創業貴在堅持美中生物醫學與製藥協會橙縣/洛杉磯分會(SABPA OC/LA)前任會長楊彥博博士、會務後勤部主席王濤博士、現任會長倪勁松博士、創會會長趙瑩女士、贊助商聯絡人劉玉發博士和副會長王吉成博士。楊彥博表示,協會所有工作人員都是義工式志願服務。(張岳/大紀元)0更新: 2015-04-27 18:59:52 PM【大紀元20150428訊】(大紀元記者張岳爾灣報導)來美的華人多懷有一個美國夢,憑藉自己的本事成功創業是夢想之一。425納斯達克上市公司索倫托(Sorrento Therapeut)總裁季紅俊博士(Henry Ji)在美中生物醫學與製藥協會(SABPA OC/LA)第10屆論壇上做主題演講,分享了自己的創業故事,並表示成功的關鍵在於堅持不懈。
創業機會多 但成功需要時間 人生無常,而至今現代醫學界尚未能攻克癌症這一頑疾。季紅俊直言:現在沒有通用的可治癒癌症的藥物或醫學方法。不過,從另一角度看,這也意味著機會,大量的資金等待著投給更好的治療方案。以目前的抗癌前沿技術——嵌合抗原受體重組T細胞CAR-T舉例,KiteJuno等公司分別藉此獲得數十億美元的投資,Sorrento公司目前也在研發該項技術。 不少創業夢想者,至少自認為,懷揣著好的方案、技術,但在尋求資本時往往碰壁,對方可能對其精心編寫、信心滿滿的企劃書不屑一顧。美國私募基金經理人Diane Mulcahy曾表示,只有極小部分(少於1%的美國初創企業獲得風險投資。不過,季紅俊表示,即使創業者聽到100個拒絕,仍要堅持,因為只要有一個風險投資家認可了你的項目,就是實際創業的開始。 萬事開頭難。季紅俊笑稱,當過了一個門檻,比如市值升到10美元以上,投資者會蜂擁而至,所謂三年河東,三年河西,這時候「股票變得比投資者手中的現金更值錢了」。不過,現實中不一定是三年,很可能是三十年。例如抗癌藥物公司Celgene的市值在22年內增長了666倍,但在前面的大部分時間都是低位徘徊,無論是創業者或投資人,若耐不住寂寞,就不可能收穫如此多的回報。 夢想創業的人士除了研發和找資金,是否會忙的靜不下來?季紅俊講,他的車庫裡有數百本書。他說自己平時喜歡讀書,讀成功人士的傳記和創業成功的案例,也讀企業失敗的案例。例如,《十億元的分子(The Billion-Dollar Molecule)》一書中就講述了Vertex 公司在藥物開發和創業中的各種曲折,同樣過了20多年才贏得投資市場的熱捧。
創業似長跑 綜合素質要求高 無論是創業或投資,表面上看都是與金錢(money)相關,但季紅俊借用金錢英文單詞中的字母表示,創業這一漫漫旅程更關乎創業者本人(me)的綜合素質,同時又關乎投資人(you)能否慧眼識才,選對項目,並能堅持到創業成功。 衣帶漸寬終不悔,為伊消得人憔悴。季紅俊認為這句話恰好可以描述他自己和眾多初創企業家的經歷。 協會前任會長、企業家楊彥博博士認為,在堅持之外,創業者還需要對自己的項目做客觀的評估,同時建立良好的人脈關係,而參加專業的協會活動可以相互啟發和激勵。
最新醫療技術和進展 此外,Ocean納米技術公司總裁Andrew Wang博士介紹了利用量子點對乳腺癌進行早期診斷與治療的最新研究成果。威唐科技公司首席技術官丁博士介紹了3D打印技術在牙科的應用,例如使牙齒矯形器的製作從過去的12個星期縮短到了1天。FDA官員對國外醫用產品進口法規做了講解並回答提問,爾灣市長Steven Choi博士亦到場致辭祝賀。數百位聽眾中包括企業家、技術研發人員、大學教授和學生等。南加大生物科技專業的幾位博士生皆表示,雖然演講內容與自己的課題不直接相關,但擴展了視角,對今後的研究與職業發展皆有幫助。
Dr. Henry H. Ji, Ph.D. has been the Chief Executive Officer and President at Sorrento Therapeutics, Inc. since September 2012. Dr. Ji Co-founded Sorrento Therapeutics, Inc. (STI) in January 2006 and served as its Interim Chief Executive Officer from April 2011 to September 2012, Chief Scientific Officer from November 2008 to September 2012 and Secretary from September 21, 2009 to June 2011. He has more than 18 years of biotechnology and biopharmaceutical experience. In 2002, Dr. Ji founded BioVintage, Inc. and served as its President since 2002. From 2001 to 2002, Dr. Ji served as Vice President of CombiMatrix Corporation, a publicly traded biotechnology company that develops proprietary technologies, including products and services in the areas of drug development, genetic analysis, molecular diagnostics and nanotechnology. From 1999 to 2001, Dr. Ji served as Director of Business Development, and in 2001 as Vice President of Stratagene Corporation (later acquired by Agilent Technologies, Inc.) where he was responsible for novel technology and product licensing and development. In 1997, Dr. Ji co-founded Stratagene Genomics, Inc., a wholly owned subsidiary of Stratagene Corporation, and served as its President and Chief Executive Officer from its founding until 1999. He has been a Director of Conkwest, Inc since December 2014. He has been a Director of Sorrento Therapeutics, Inc. since January 2006. He served as a Director at Quikbyte Software, Inc. since September 21, 2009. He is the holder of several issued and pending patents in the life science research field and is the sole inventor of STI’s intellectual property. Dr. Ji has a Ph.D. in Animal Physiology from the University of Minnesota and a B.S. in Biochemistry from the Fudan University.
Education* PhD: University of Minnesota /BS: Fudan University
Other Affiliations:  University of Minnesota /Quikbyte Software, Inc. /Fudan University /Conkwest, Inc.

KRAS等多基因特徵 決定轉移性大腸癌 metastatic colorectal cancer標靶治療效果不同(cetuximab vs bevacizumab)

腸癌標靶治療訣竅 多點基因檢測延存活2015-04-27 16:50:15醫師歐偉仁強調,過去研究顯示大腸直腸癌患者當中有家族病史的不超過兩成,主要成因還是年齡與飲食生活習慣所致,早期發現、早期治療,乃是良策。近來傳出多位名人罹患直腸癌的消息,大腸癌的高發生率,必須受到更多的重視。新店耕莘醫院血液腫瘤科主任歐偉仁表示,大腸癌症狀多元,除常見的消化不良、腹瀉、便祕之外,也常有大便帶血、大便解不乾淨、貧血、體重減輕等症狀。早期大腸癌以手術切除為主,再依病情決定術後是否需要輔助性治療,早期大腸癌五年存活率約60~80%;而轉移性大腸癌通常無法單純以手術根除,必須配合全身性化學治療為主,五年存活率下降到10%左右,因此必須及早發現以避免惡化。 歐偉仁說,一旦大腸癌的癌細胞轉移至其他器官時,治療大多會搭配標靶藥物,而選擇會影響到病患的存活時間。標靶治療屬於個人化醫療的一環,主要針對癌細胞的生長接受器,阻斷訊號傳遞,抑制癌細胞生長轉移;化學治療則是針對細胞分裂過程中的基因複製進行阻斷干擾,使正常細胞與癌細胞死亡,這是兩者最主要的不同。目前國內轉移性大腸癌的標靶藥物已有健保給付,歐偉仁醫師表示,以患者的基因檢測結果來選擇標靶藥物,是較佳的治療方式。 20148月國際著名期刊刺胳針(Lancet Oncology)所發表的研究指出,轉移性大腸癌病患若基因檢測確定為野生型,則第一線治療使用特定標靶藥物,其中位存活期可達近 29 個月若改採「多點基因檢測」,將檢測位置增加到六個常見位置,而都沒有發生突變的話,則病患在使用特定標靶治療的中位存活期可達到 33 個月左右,4個月的差距在臨床上還是有統計意義的。因此根據基因檢測結果來用藥的個人化醫療是大腸癌的治療趨勢。 歐偉仁強調,過去研究顯示大腸直腸癌患者當中有家族病史的不超過兩成,主要成因還是年齡與飲食生活習慣所致,早期發現、早期治療,乃是良策。大腸癌的危險因子包括年齡、動物性脂肪攝取過量、肥胖、缺乏運動、抽菸以及大腸直腸癌家族史等。政府近年來大力推動糞便篩檢,遇有異常之檢驗報告,切不可諱疾忌醫,白白耽誤診治良機。(陳奕均編,文章來源:健康醫療網)【中央網路報】
Cetuximab delivers better overall survival than bevacizumab in metastatic colorectal cancer  18 Aug 2014  by ecancer reporter Janet Fricker  Patients with KRAS exon 2 wild type metastatic colorectal cancer achieve longer overall survival with FOLFIRI plus cetuximab than FOLFIRI plus bevacizumab, concluded the FIRE-3 trial published in Lancet Oncology. While cetuximab and bevacizumab have both been shown to improve outcomes in patients with metastatic colorectal cancer when added to chemotherapy regimens, their comparative effectiveness when partnered with first-line fluorouracil, folinic acid, and irinotecan (FOLFIRI) is unknown. In the open-label, randomised, phase 3 FIRE- 3 trial Professor Volker Heinemann, from the University of Munich, and colleagues set out to explore whether cetuximab or bevacizumab was a more effective partner for FOLFIRI in first-line treatment of metastatic colorectal cancer. Patients were initially recruited without regard to KRAS tumour mutation status. However, following reports that cetuximab was not active in patients with tumour KRAS exon 2 mutations (codon 12 or 13) enrolment was restricted to patients without KRAS exon 2 mutations (wild type). Between January 2007 and September 2012 752 patients from 116 centres in Germany and Austria were randomly assigned to a treatment group. For the 593 patients with KRAS exon 2 wild-type tumours 297 were assigned to FOLFIRI plus cetuximab and 295 to FOLFIRI plus bevacizumab. Results showed that 184 patients in the cetuximab group (62%) achieved an objective response compared with 171 in the bevacizumab group (58%) (OR 1·18, 95% CI 0·85–1·64; p=0·18). Furthermore median progression free survival was 10 months in the cetuximab group versus10·3 months in the bevacizumab group (HR 1·06, 95% CI 0·88–1·26; p=0·55); however, median overall survival was 28·7 months in the cetuximab group compared with 25·0 months in the bevacizumab group (HR 0·77, 95% CI 0·62–0·96; p=0·017). The most common grade 3 or worse adverse events in both treatment groups were haematotoxicity (affecting 25% of cetuximab patients versus 21% of bevacizumab patients), skin reactions (affecting 26% of cetuximab patients versus 2% of bevacizumab patients) and diarrhoea (affecting 11% of cetuximab patients versus 14% of bevacizumab patients).“Our data suggest that FOLFIRI plus cetuximab should be the chosen first-line treatment regimen for patients with RAS wild-type metastatic colorectal cancer,” wrote the authors.
Reference V Heinemann, L Fischer von Weikersthal, T Decker, et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncology. Published online August 1, 2014.

 Biomarkers for Screening and Follow-up for Cancer: Positives and Pitfalls The National Institute of Health (NIH) defines a biological marker (biomarker) as a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. In addition to screening for disease, a biomarker may be used to evaluate how well the body responds to a treatment and can also be called a molecular marker or signature molecule. A biomarker can exist as related to DNA, RNA, micro-RNA, epigenetic changes, protein and even antibody expression. Biomarker discovery is increasing with the modern throughput of medical research in genomic and proteonomics. New biomarkers are building upon growing information at the same time that research tools are becoming cheaper and more efficient. Currently, biomarkers are routinely used to help guide treatment decisions in lung cancer, breast cancer, and colon cancer30 with simple testing of existing tumor samples. Though many biomarkers are interesting in their cell function as related to malignancy, biomarkers such as telomerase, transforming growth factors (TGFα and TGFβ) , epidermal growth factors (erbB2 and erbB3) and mucin (MUC1 and MUC2) have not shown clinical utility. Prostate specific antigen (PSA), carcinoembrionic antigen (CEA) and cancer antibody maker 125 (CA-125) have proven observational associations with malignancy but lack specificity. Moreover, a reduction in mortality has not been shown using these biomarkers. Fecal occult blood test (FOBT) is the only known protein biomarker shown to decrease cause-specific mortality in cancer screening Biomarkers have the potential to change treatment and diagnostic algorithms across a broad spectrum of patients. Risk stratification for screening might be augmented by finding biochemical signatures that recognize either a predisposition to disease alone or as a complement to existing tests. For example, particular HLA alleles in conjunction with certain human papillomaviruses can increase the risk of cervical cancer and could change the screening algorithm. Tissue biomarkers are at the forefront of discovery and investigations are ongoing regarding their prognostic value and the ability to accurately guide therapy.

Prognostic Colorectal Cancer Biomarkers Extensive CRC research over the last decade has suggested promising biomarkers. Although many biomarkers have been described, only a select few have provided prognostic data. This list includes markers such as epidermal growth factor receptor (EGFR), BRAF, tumor MSI-H expression (defects in DNA mismatch repair, MSI phenotype), 18q AI expression, p53 expression and KRAS mutation. Decisions regarding the modality and combination of treatments for CRC patients are made based on a variety of clinical factors in an effort to deliver patient-specific care proven to be efficacious without untoward adverse effects. This set of clinical factors has been revised and expanded as radiographic and laboratory techniques have improved. The physician today must decide eligibility for specific treatment based on an evolving set of diagnostic tests based on molecular profile of the patient's tumor. This profile is based on a number of mutations common to many patients which, when correlated with survival data, provide meaningful criteria for treatment decision making. Therapy targeting the epidermal growth factor receptor (EGFR) has been studied extensively for patients with metastatic CRC. In the largest experience, the addition of cetuximab to standard cytotoxic chemotherapy conferred a progression-free survival benefit but no benefit in overall survival. On further analysis, this benefit was only found in the Kirsten-RAS (KRAS) wild-type patients. This is because a mutation in the KRAS gene leads to constitutive activation of the EGFR signaling pathway, thereby abrogating any effects of upstream EGFR blockade. This finding has led to the selection of patients for EGFR blockade therapy based on KRAS status, with cetuximab only offered to those patients with no KRAS mutation in the primary tumor. In a similar fashion, a small percentage of primary CRC contains a mutation in the BRAF gene. The BRAF(V600E) mutation in CRC confers poor survival with standard chemotherapy regimens. Vemurafenib, a small molecule inhibitor of the mutant protein, was recently approved for use in patients with metastatic melanoma harboring the BRAF(V600E) mutation. Interestingly, CRC patients do not enjoy response rates similar to patients with BRAF(V600E) melanoma when given vemurafenib. The reason for this therapeutic failure was recently shown to be caused by compensatory increased signaling upstream at the level of the EGFR. By adding cetuximab for EGFR inhibition to a standard regimen of vemurafenib, a significant antitumor response was shown in vitro and in vivo40. While there are no reported results of this combination therapy in adult patients, the laboratory results are promising and may offer another option for late stage CRC patients with wild-type KRAS and the BRAF(V600E) mutation. While CRC may develop through a sequence of acquired mutations, another theory of carcinogenesis implies that microsatellite instability (MSI) may play a role. When mutations occur in mismatch repair (MMR) genes such as MSH2, MSH6 and MLH1 the tumor is referred to as mismatch repair deficient (dMMR). With the ability to repair single nucleotide polymorphisms lost, instability develops in microsatellites—sites in the genome normally comprised of dinucleotide repeats. Individual tumors can be assayed for the level of MSI and are described as MSI-High, MSI-Low, and microsatellite stable (MSS). MSI-H phenotype has been associated with improved clinical outcome (disease-free and overall survival). In addition, some published data supports the recommendation not to administer chemotherapy to Stage II patients with a MSI-H primary colon cancer. The overall predictive value of MSI-H phenotype is currently being tested in the Eastern Cooperative Oncology Group Trial 5202 (E5202) adjuvant CRC trial. This trial is specifically intended to identify patients with AJCC Stage II CRC most likely to respond to adjuvant systemic therapy. Other mutations can yield prognostic information. Tumor expression of 18q AI has been associated with decreased survival and is currently being studied in the E5202 trial35. A mutation in the tumor suppressor gene p53 has been associated with poor prognosis, including decreased disease free survival (DFS), recurrence free survival (RFS) and overall survival (OS). These validated criteria are changing the way patients are treated and also how the response to treatment is judged. Using modern molecular biology methods, findings from the laboratory are being translated to the clinic in an effort to focus therapy on patients who are most likely to benefit. As therapies become more sophisticated, the methods of patient selection must follow. In order to derive the most efficacious results from therapies with not insignificant side effects, these methods must be employed and others must be developed.

Putative Colorectal Cancer Stem Cell-Associated Biomarkers The methods of patient stratification based on tumor mutation status have resulted in significant advances for patients with CRC; however, in order to expand upon these advances new criteria must be developed to further stratify patients. The precise cell of origin of CRC remains unknown. Recently, compelling evidence has emerged in support of the cancer stem cell (CSC) hypothesis in several solid organ epithelial malignancies including CRC. The theory of the cancer stem cell was originally proposed by Cohnheim in 1875.This theory encompassed four principles: 1. A number of external or internal insults, such as radiation, injury, or carcinogens, may result in genetic damages in the stem cells; 2. Each damaged stem cell gives rise to a morphologically distinct type of tumor; 3. All the cells within a given tumor share the same profile at different stages of progression; 4. Different tumors from different stem cells have different genetic and biochemical profiles. Following this, the theory of clonal evolution was introduced by Nowell in 1976 stating, 1. A number of external or internal stem cell insults, such as radiation, injury,or carcinogens, may result in genetic damages in stem cells; 2. A genetically damaged stem cell gives rise to a morphological distinct type of tumor; 3. New cell clones constantly emerge from the same tumor; 4. Only the more aggressive ones with growth advantages progress, and from which, new clones emerge. Currently, both of which have been supported by several lines of evidence. The CSC hypothesis posits that CSC's are responsible for tumor initiation, metastases and resistance to treatment leading to disease relapse following surgery and/or chemoradiotherapy. The traditional, stochastic model of tumorigenesis suggests that all cells within a tumor are capable of tumor initiation and propagation. The CSC hypothesis proposes a hierarchical model, in which only a small fraction of cells (CSC) are capable of tumor propagation56. The CSC hypothesis therefore raises questions regarding current diagnostic and therapeutic modalities, suggesting that the CSC is a rational target for the development of more efficacious screening, early detection, prevention, treatment and surveillance modalities and interventions. Based on the tenets of the CSC hypothesis, identification, proper selection, characterization, testing, biological implications and validation of CRC derived CSC (CRCSC) are imperative for improving early detection, screening, risk stratification prognostication and individualized prediction of treatment response. Properties that define potential CSC's are: [1] self-renewal; [2] the capacity for differentiation (allowing for recapitulation of all cell types of the original tumor); [3] tumor initiating capacity; and, [4] asymmetric cell division via non-random chromosomal co-segregation. Investigators have used these properties and various membrane and cytoplasmic markers to isolate putative CRCSC: CD133, CD24, CD29, CD44, CD166 (ALCAM), EpCAM, Lgr5, ALDH1A1 and ALDH1B1. These markers represent all reported CRCSC. Despite the potential of CRCSC's to be utilized as clinically relevant biomarkers, little is known about the prognostic value of non-CD133 CRCSC markers. Notwithstanding, the CSC hypothesis may herald a paradigm shift in screening and early detection in CRC once the precise role of CRCSC markers is further established. Therefore, we hypothesize that CRCSC markers can be used as biomarkers to predict disease progression, and identify patients at risk for recurrence. Two fundamental issues regarding colorectal carcinogenesis remain unanswered. First, the level of differentiation in the initiating neoplastic cell has not been well described i.e. colonic stem cell vs. differentiated mature colonic mucosal epithelial cell. Second, since tumors are well known to be composed of a heterogeneous group of cells, the specific identity of tumor cells that lead to lymph-node involvement, and metastatic disease is not well characterized. Recently, attempts to address both of these issues pragmatically, which are critical to our understanding of tumor biology, have resulted in the description of cancer stem cells. While the stochastic model of tumorigenesis holds that every cell within the tumor population is capable of tumor initiation and propagation, the cancer stem cell model proposes that only a small fraction of cells possess the ability to initiate cancer growth and promote metastatic dissemination. We posit that only stem cells possess the potential for unlimited proliferation, multi-lineage differentiation, and colonization at new sites, and thus, represent the most likely precursor for invasive and metastatic CRC. Therefore, these cells require much further attention and introspection.
 Reference: J Cancer 2013; 4(3):241-250

Affymetrix認證實驗室: 創源

創源染色體晶片檢測技術獲肯定 20150428 04:10 台北訊 看好「精準醫學」時代來臨,基因檢測在全球生技醫療產業更顯重要,基因晶片領導廠商Affymetrix、美基因檢測服務龍頭企業Quest Diagnostics不約而同看中台灣,與訊聯生技集團(1784-TW)旗下基因應用與科學資訊公司創源生技(4160-TW)策略合作,引進最新技術與服務項目,將已趨成熟孕產前基因檢測,推向新生兒及癌症篩檢,希望未來可作為亞太市場基因檢測示範點。Affymetrix總裁兼亞太區商務運營總監Matt Levy此次特別來台,親自頒給創源由Affymetrix認證的檢測服務實驗室(Affymetrix Authorized Service Provider)證書。創源生技不但斥資建置高規格實驗室,還積極引進國際最新染色體晶片(SNP array)檢測技術,Matt表示,透過雙方合作,此最新的染色體晶片檢測技術在台灣將會在最短的時間快速普及與應用。美國最大臨床診斷服務公司Quest Diagnostics除美國外,在英國、墨西哥、愛爾蘭與印度設有分公司,因看好基因檢測在亞洲市場的發展潛力,希望以台灣為亞太市場打下更好的基礎。選擇與創源生技合作,不僅因為在台灣擁有孕產前基因檢測的高滲透率,還提供日本、大陸等醫療院所檢測服務,在亞洲具有知名度,同時創源去年還取得CAP認證,其檢測流程及品質有一定的國際水準

高水準的Mylan 不賣給低水準的Teva !!!

Mylan's stock falls after company rejects Teva's hostile buyout bid Published: Apr 27, 2015 9:42 a.m. ETMylan N.V.'s stock MYL, -5.71% slumped 3% in morning trade Monday, after the drug maker said its board of directors unanimously rejected Teva Pharmaceutical's TEVA, -4.32% unsolicited buyout bid. Mylan said it not only believes the bid Teva made early last week, which would value Mylan at about $40 billion, did not meet any of the key criteria that would cause the company to depart from its current course. "After thorough consideration, Mylan's Board unanimously determined that Teva's proposal grossly undervalues Mylan, and would require Mylan's shareholders to accept what we believe are low-quality Teva shares in exchange for their high-quality Mylan shares in a transaction that lacks industrial logic and carries significant global antitrust risk," said Mylan Chief Executive Robert Coury. Teva's stock shed 1.1% in early trade. On Friday, Mylan's stock had closed at a record high after the company raised its bid for Perrigo Co. PRGO, -2.39% to about $33 billion to help fend off Teva's hostile buyout attempt.
企业并购:MylanTeva出价太低;置疑Teva股票及成长前景Mylan执行董事长Robert Coury在致Teva的一份长长的带有批评语气的信件中说,对Mylan提出的每股82美元报价过低。Coury称,除非“报价起点大大超过每股100美元”,董事会才会考虑(合并)协商。这份信件于周一公布。华尔街分析师说过,Mylan可能希望把报价提高至每股90-95美元,并增加报价中的现金比重。Coury在信件中说,过去三年Teva的股价跑输包括Mylan在内的同业,是“不可接受的”。“Mylan董事会无意考虑这样一份意向书...要求Mylan股东接受以Teva股票为形式的低质高风险出价,”信件称。此外,信件还称,Mylan的客户和合作伙伴也不支持这起潜在的合并交易。()(编译 刘秀红/许娜/杜明霞;审校 王丽鑫/郑茵)

Twi(安成藥) Takeda(武田)和解 共享Dexilant (胃食道逆流藥) 10億美元市場

安成藥 將獲武田和解金 2015-04-28 04:44:24 經濟日報 記者黃文奇/台北報導安成國際藥業(4180)昨(27)日宣布,旗下所開發Dexilant學名藥與原廠武田(Takeda達成和解協議,內部透露,此次和解金額度將超越「抗過動症藥」的600萬美元(約新台幣1.85億元),有機會改寫安成藥史上新高紀錄,將是一筆不小的貢獻,並於本季認列,今年轉盈在望。執行長暨總經理陳貞如表示,此項和解,除了讓安成的Dexilant學名藥能在武田的相關專利到期之前許多年,就得以在美國上市,帶來盈利。更重要的是,安成藥在一段時間之內將是Takeda的授權學名藥廠商並供應美國市場Dexilant兩種劑量學名藥,有利未來Dexilant學名藥的上市銷售。安成藥表示,此次與武田和解同步獲得獲得「授權學名藥廠商」(Authorized Generic, AG)資格,未來可共享逾10億美元美國市場,該產品並有機會提前上市。安成藥昨日股價收179元,上漲2.5元。法人估,安成藥本季將可認列與武田的和解協議及授權與供應契約,近期經美國公平交易委員會及司法部審核通過後,因和解金額的貢獻,將使本季單季轉盈無虞,和解金額有機會上看千萬美元。展望全年,若下半年順利認列Megace ES學名藥的原廠Par擔保金1,600萬美元,將有機會提前轉盈。安成藥表示,依據公司與武田的和解協議,武田將撤銷所有對安成Dexilant學名藥相關的專利訴訟;外,安成開發的Dexilant學名藥緩釋口服劑型分別有30mg60mg兩種劑量,目前已經完成藥證申請,正在美國食品藥物管理局(FDA)進行審核中。市場方面,據悉,Dexilant為治療胃食道逆流用藥,根據IMS Health資料顯示,該藥品去年在美國全國市場的銷售金額約10.4億美元(約新台幣320億美元)。安成藥表示,在和解協議中,雙方同時簽訂授權與供應契約,使安成藥及其所屬企業有權以武田授權學名藥廠商資格,進行產品銷售。此外,該和解協議亦允許安成藥自行生產之Dexilant學名藥,在第一家以第四類學名藥法規(paragraph IV, P4)申請上市的藥廠,在該產品銷售180天後,得以上市銷售其Dexilant學名藥。Dexilant為治療胃食道逆流用藥,據IMS Health資料顯示,該藥品去(2014)年在全美市場的銷售金額約10億美元。
TWi signs Settlement Agreement with Takeda on patent litigation related to generic Dexilant  Published on April 27, 2015 at 7:24 AM  TWi Pharmaceuticals, Inc. ("TWi") today announced that it has entered into a Settlement Agreement with Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals America, Inc. (individually and collectively, "Takeda") to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. An Abbreviated New Drug Application for TWi's generic product is currently under review at the U.S. Food and Drug Administration. If approved, TWi's product would be a generic version of Takeda's Dexilant®. The Settlement Agreement allows TWi to launch its generic Dexilant® one-hundred eighty (180) days after the first applicant to file its ANDA (commonly known as "first-to-file" or "FTF") launches its generic Dexilant® product, or on an earlier date under certain circumstances. As part of the settlement, the parties also entered into a License and Supply Agreement allowing TWi and its affiliates to sell Dexilant® in both dosage strengths as the Authorized Generic. "We are pleased to resolve the patent litigation with Takeda related to our pending ANDA for dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. This settlement allows TWi to bring a generic Dexilant® to the U.S. market many years prior to the last patent expiration date of Takeda's patent(s) while eliminating the uncertainties and inherent risk of patent litigation and avoiding the substantial cost of continued litigation. Furthermore, the license and supply of the Authorized Generic from Takeda allows TWi to be the supplier of both strengths of a generic Dexilant® in the U.S. market for a period of time, which provides significant sales and marketing advantage as well as furthering TWi's goal bringing affordable healthcare to patients," said Tina Guilder, President & CEO of TWi. The agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. Dexilant® is indicated for healing of all grades of erosive esophagitis, maintaining healing of erosive esophagitis and relief of heartburn, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease. For the 12 months ended December 31, 2014, the product had total U.S. sales of approximately $1.0 Billion, according to IMS health data.

台微體BioSeizer包覆類固醇緩釋 關節炎新藥 3874.1萬研發費用持續增加

台微體關節炎新藥,獲准人體臨床試驗 20150428 09:57 【時報記者郭鴻慧台北報導】 台微體(4152)TLC599(關節炎新劑型藥物)取得台灣衛生福利部食品藥物管理署(TFDA)核准進行人體臨床試驗。台微體表示,TLC599以新的傳輸技術包裹既有藥物。傳輸技術係運用公司發展的BioSeizer藥物長效緩釋技術平台,將既有藥物類固醇前體包覆於磷脂質藥物載體內,注射於患處,應用疾病領域為關節炎。(尚未證明有療效)台微體指出,目前已投入的累積研發費用為3874.1萬元,預計第一/二期臨床試驗收40人,於收案完成後申請進入第二/三期臨床試驗。

健保署拚經濟! 個人健保用藥&電子病歷 B2B 直接加值利用 (亞博健康數位)

健康自主管理蔚成風氣,健康存摺守護您 發布日期:1040428日 在提升生活品質及自我風險意識觀念不斷受到重視之際,國人對健康自主管理的觀念已蔚成風氣,健保署順勢推出健康存摺,將成為國人健康自主管理之利器。健保署表示,目前國人可持自然人憑證,至健保署各分區業務組聯合服務中心、聯絡辦公室臨櫃申請個人健康存摺資料,或是在家利用網路進入健保署全球資訊網健康存摺專區,利用自然人憑證下載個人最近12年的健保就醫資料。考量讓目前仍未持有自然人憑證的民眾也能夠享受便利服務,增進自主健康管理之可近性,健保署將提升健保卡的功能,預計今年4月底該署即可開發完成利用健保卡下載自己的健康存摺。據健保署表示,民眾進入該署全球資訊網健康存摺專區,即可以下載其本人最近12年的健保就醫相關紀錄(包含門診、住院之醫療院所名稱、就醫日期、疾病分類名稱、醫療處置名稱、處方藥品、特材、健保支付點數、自付之部分負擔、牙科健康存摺、過敏資料、投保及保險費繳納等資料)到自己的行動儲存裝置(如隨身碟、手機或雲端硬碟等),成為可攜式個人健康資訊,作為自主健康管理的運用。健保署推廣健康存摺的目的,不僅可作為國人自主健康的管理工具,並可使國人充分瞭解個人健康狀況、健保醫療使用情形,以及可提醒個人及醫療院所避免重複用藥、重複檢驗等醫療浪費,使健保更透明。同時健保署亦表示目前將更進一步規劃將預防接種紀錄、器官捐贈意願註記納入健康存摺的資料內容,使健康存摺具有個人電子病歷的功能,讓民眾充分掌握自己的就醫資料,落實個人健康自主管理的需求。人力資源是企業重要的資產,為了能發揮民眾手中健康存摺的功效,讓國人更方便取得自己的就醫資料,健保署正密集地與企業洽談個人健康存摺應用創新模式,使企業在取得民眾同意授權下,由員工將其健康存摺資料交由服務單位作健康促進,甚而進一步可交由健康管理業者做健康管理的前提,以B2B方式下載,創造企業與員工雙贏的局面。同時,健保署為推廣健康存摺理念,於28日舉辦「健康存摺創新應用及推廣交流工作坊」,並邀請中華電信研究院智慧聯網研究所、國泰健康管理顧問股份有限公司及亞博健康數位股份有限公司與會,B2B資料拋轉模式與應用、健康管理等議題進行演講,及邀請資策會王可言副執行長就健康存摺的應用及資訊安全等面向,擔任本次工作坊意見交流主持人。此外,亦邀請壽險業、健檢中心、軟硬體廠商、物聯網等健康管理相關產業,共同探討拓展健康存摺創新應用之可能性。健保署亦冀藉由工作坊交流意見所得到的共識意見,作為未來改善與提升健康存摺推廣運用的參考依據,讓健康存摺運用能夠更加多元,進而與國人共同攜手達到自我照顧、健康一生的目標。

太厲害! 智擎 進補7.5億! Merrimack FDA送件 & Baxte歐亞申請藥證 !!

授權金進補 智擎今年獲利爆發 20150428 04:10 記者杜蕙蓉/台北報導 智擎(4162)昨(27)日宣佈,授權夥伴Merrimack已向美國FDA完成胰臟癌新藥MM-398申請送件。根據協議,Merrimack也將在4月底前支付500萬美元(約1.5億台幣),對EPS挹注約1.5除此之外,由於智擎再授權的歐洲夥伴Baxte也將向歐亞地區申請藥證,法人圈預估將可望在第3季完成,並且為智擎帶進約2,000萬美元(約6億台幣)的授權里程金,EPS貢獻度為6元,而帶動智擎今年有機會大賺一個股本以上,目前法人也給予買進評等,目標價340。去年稅後淨利1.23億元,EPS 1.23元的智擎,是國內少數步入收成的新藥股,該公司已決議配發每股1元現金股利。智擎表示,Merrimack已向FDA提出MM-398新藥申請送件(New Drug Application, NDA),該適應症為胰臟癌病人於第一線標準藥物gemcitabine失敗後的治療。MerrimackNDA送件申請是以機動審查(rolling submission)的方式,依照類別將所完成的法規文件,分批次送交美國FDA進行新藥藥證核發的申請。此外,Merrimack在此次送件同時,也向美國FDA提出新藥優先審查資格(priority review)的申請。智擎總經理暨執行長葉常菁表示:新藥開發就像接力賽一樣,一棒接過一棒。智擎完成MM-398前臨床到第二期臨床試驗後,就將它交棒給美國Merrimack公司,使Merrimack公司得以成功的完成第三期臨床試驗。葉常菁表示,智擎將以MM-398在美國FDA的新藥申請文件,進行在台灣FDA藥證核發的申請,期待能儘快取得藥證後上市,造福有需要的病患。
智擎新藥向美FDA送件 500萬美元將入袋 經濟日報記者黃文奇/27日電】智擎生技製藥(4162今日宣佈,授權夥伴美國Merrimack製藥公司(NASDAQMACK)已向美國食品藥物管理局(FDA)完成MM-398新藥申請送件(New Drug Application, NDA),根據該公司與Merrimack簽定之授權暨合作契約修改協定,Merrimack公司將在20154月底前支付500萬美元予智擎MM-398適應症為胰臟癌病人於第一線標準藥物gemcitabine失敗後的治療。美國Merrimack公司的NDA送件申請是以機動審查(rolling submission)的方式,依照類別將所完成的法規文件,分批次送交美國FDA進行新藥藥證核發的申請。此外,Merrimack公司在此次送件同時,向美國FDA提出新藥優先審查資格priority review)的申請。智擎表示,本次新藥申請是以MM-398之第三期臨床試驗(NAPOLI-1所得到的試驗數據結果為基礎來進行送件。NAPOLI-1試驗的主要受試者為曾接受含標準化療藥物gemcitabine治療失敗的轉移性胰臟癌患者,試驗結果顯示成功達到該試驗的主要目標(primary endpoint)及次要目標,受試者之整體存活期(overall survival)、無疾病進展存活期(progression-free survival)與整體腫瘤反應率(overall response rate) 等皆得到顯著的改善。此外,對於接受含標準化療藥物gemcitabine治療失敗後的轉移性胰臟癌,NAPOLI-1也是全球第一個成功證明仍然有效的第三期臨床試驗。NAPOLI-1的臨床試驗資料已分別於20146月與20151發表於歐洲與美國臨床腫瘤協會舉辦之國際醫學會議。智擎公司總經理暨執行長葉常菁表示,新藥開發就像接力賽一樣,一棒接過一棒,非常高興能和Merrimack公司合作進行NAPOLI-1臨床試驗以及MM-398在美國FDA的新藥申請送件程序;不久,智擎將以MM-398在美國FDA的新藥申請文件,進行在台灣TFDA藥證核發的申請,期待能儘快取得藥證後上市,以造福有需要的病患。美國Merrimack總經理暨執行長Robert Mulroy表示,此次向美國FDA提出新藥申請送件,不僅是Merrimack公司非常難得的第一次經驗,也是Merrimack公司在新藥開發上重要的里程碑之一,並且也實現了為癌症患者提供一個新的治療選擇的承諾。 2015/04/27 21:38

併購非Big Pharma專屬! Valeant 買對手的藥 (Michael Pearson, former McKinsey consultant)!

藥廠瘋併購 搶賣現成新藥 2015-04-28 00:06:43 經濟日報 編譯/劉品佳、黃智勤 大藥廠希望藉收購小型生技業者,取得具成長機會的新藥。 美聯社 拚研發…不如靠戰利品獲利 一年來收購總額達4,600億美元 超過奧地GDP去年初以來,全球製藥業者達成協議的併購金額已達4,620億美元,比奧地利經濟規模還大,凸顯大藥廠希望藉收購小型生技業者,取得具成長機會的新藥,規模較小的業者則希望擴大規模,以與傳統大藥廠相抗衡,而這股併購風潮近期還看不到終點。金融時報報導,製藥業最近的併購活動,是以色列學名藥大廠Teva製藥上周對美國同業邁蘭藥廠發動430億美元的敵意併購。若雙方合併,年營收將達300億美元,超越英國阿斯特捷利康,躋身全球前十大藥廠之列。Teva前任執行長李文指出,帶動這股併購潮的主因為財務考量,而非策略。由於資金成本降低,來自收購資產的投資報酬率也比過去還高。對於Teva和邁蘭等學名藥廠來說,成本較低的印度同業興起也帶來壓力,紛紛藉由併購轉往高價值品牌的產品、或節省成本並趕上對手。蓬勃發展的併購活動,也讓先前的二線製藥商得以與全球大藥廠相抗衡。這也加重大藥廠的壓力,開始併購小型生技公司,取得前景可期的新藥、追求成長。輝瑞、羅氏等藥廠近年雖砸重金研發,成果卻不如預期。李文指出,生技業科學日益成熟,是促成這股併購潮的另一個重要因素,因為大藥廠近年在龐大的專利到期後,都急著補充產品組合。他說:「併購案帶給出資者報酬,並提供創新提供動力,讓這個循環邁向進一步創新。」各大藥廠在追求新成長機會的同時,也已在削減非核心業務、精簡規模。Polar資本公司經理人馬哈尼指出,隨人口老化而來的需求將日漸攀升,製藥業須提高效率,這也是驅動不同規模併購案的共同動機。
到手後…漲價海撈一筆 對藥廠而言,買下對手的藥品並調漲售價,比花費數年時間進行高成本、高風險的研究來研發新藥,更能輕易提振營收。華爾街日報報導,加拿大Valeant藥廠2月買下心臟病藥物NitropressIsuprel後,這兩種藥品的售價同日就分別上漲525%212%這些藥物並未經過高成本投資或人體試驗而加以改良,也沒換到昂貴的新廠製造,差別只在於所有權轉變。愈來愈多藥廠買下他們認為價格被低估的藥物,再調漲售價。此舉已成為製藥業的策略之一,藥廠也會定期調漲較舊產品的售價、並推出新療程,推升藥品成本。藥品給付管理業者快捷藥方(Express Scripts)的研究顯示,專利藥價格自2008年來已上漲127%,漲幅遠大於消費者物價指數的11%

戰略角度 看 Robert Wessman (艾威群集團總裁暨執行長) 進入美時董事會!!!

艾威群執行長入美時董事會,強化公司治理/結盟效益 MoneyDJ新聞 2015-04-24 08:30:29 記者 新聞中心 報導 特殊學名藥廠美時(1795)於昨(23)日召開2015年第2次股東臨時會,由董事長林東和親自主持,會中除通過修訂部分公司內部制度以配合審計委員會之設置,並順利增選一席獨立董事及一席非獨立董事,其中,非獨立董事的部分係由艾威群集團總裁暨執行長Robert WessmanAlvogen Asia Pacific Holdings Limited法人董事代表身分高票當選。美時指出,Robert Wessman親自參與美時董事會,不僅代表美時與艾威群在業務合作及集團策略之整合進展順利、亦展現了艾威群集團對與美時團隊長期夥伴關係及深根亞太市場之承諾與決心。 美時表示,自去年8月引進策略性投資人艾威群集團的現增私募案順利完成、由艾威群成為美時之最大股東、並與艾威群旗下韓國、印度及台灣等子公司進行合併至今尚未滿一年,但不論在業務拓展、集團營運及資源整合上皆已有具體之成果進展。其中,美時擬送往美國市場查登之產品亦依原本規劃時程進行中,同時預計今年第三季在美國市場推出抗癲癇藥Levetiracetam 此外,美時已將部分核心產品如TemozolomideThalidomide,送往韓國查驗登記;在艾威群集團的協助評估下,美時亦於去年底完成了合併韓國減肥藥市佔率第一的Dream Pharma,而兩家韓國子公司KunwhaDream Pharma的整合亦隨之積極地進行中,除了業務及人員的整併外、兩家公司董事會亦已決議通過在法律個體上合併為一,預計將於今年6月左右完成合併作業程序,進一步強化合併效益。時新增選之獨立董事係由董事會所推薦之Hjorleifur Palsson當選。Hjorleifur Palsson曾任哥本哈根NASDAQ OMX上市之Ossur hf公司財務長近十二年,負責財務會計、策略規劃、投資人關係、人力資源及全球發展等重要業務,並曾擔任冰島德勤會計師事務所合夥人;而於目前擔任雷克雅維克大學基金董事會主席、Vodafone Iceland及多家投資公司之董事一職,擁有豐富的跨國管理經驗。 而美時也將於股東臨時會後正式成立審計委員會,由三名獨立董事組成,提前適用審計委員會相關之制度規範,未來將以更嚴謹的標準及態度協助董事會執行監督管理階層之職責。此外,公司表示,董事會將借助Hjorleifur Palsson之財會長才,領導公司新設立之審計委員會,致力執行公司治理以最大化股東權益。 美時指出,新增選的兩席董事,不僅強化了美時之董事陣容及公司治理,更將深化與艾威群集團的策略聯盟、奠定美時在艾威群亞太市場布局之戰略樞紐地位相信在艾威群總裁暨執行長Robert Wessman親自參與監督公司運作下,更能有效落實雙方間的資源整合,不論在產品研發、生產及市場拓展上更具國際視野及競爭力,並致力朝向成為亞洲領導學名藥廠的目標邁進。

海洋性貧血之骨鬆

血液疾病-海洋性貧血未就醫 18歲少女停經骨鬆 20150428 04:10 廖珮妤/台北報導 長期貧血、鐵中毒,妙齡女竟停經。28歲中度海洋性貧血患者Grace,長期輕忽未追蹤,強忍暈眩不適,結果18歲停經,還有嚴重骨質疏鬆症。她說,曾坐雲霄飛車造成頸椎塌陷,和小朋友玩耍時,甚至被撞斷肋骨,骨齡比阿嬤還老。開始穩定服藥、輸血後,終於回復正常生活。58是國際海洋性貧血日,台灣海洋性貧血協會理事長林凱信表示,該病是國人常見的遺傳疾病,患者因染色體基因變異,色紅素缺乏、功能不全,國內有610%民眾、約150萬帶因者,依貧血嚴重程度,可分為輕度、中度及重度。我國自1995年起針對孕婦做免費篩檢,找出潛在帶因者,重度患者大幅減少,不過一些中度或輕度的病患,卻常忽略身體狀況,長期下來,可能導致肝脾腫大、骨質疏鬆、骨骼變形,一旦血鐵質沉積,還可能造成肝腫瘤、心臟衰竭等致命併發症。28歲的Grace是中度海洋性貧血患者,但她過去不願面對這個疾病,害怕輸血,血色素最低只剩3mg/dl,遠低於正常女性的12。她說,18歲就開始停經,長期貧血、身體缺氧,還有嚴重骨質疏鬆,3度骨折,骨頭輕輕撞一下就斷掉。在台灣海洋性貧血協會協助下,Grace不再畏懼輸血、也開始口服藥物治療,身體、生活都逐漸回復正常。台大醫院小兒部主治醫師盧孟佑指出,中度海洋性貧血患者紅血球壽命比一般人短,除骨髓加強造血,腸胃道也為了造血加強吸收鐵質,當破裂的紅血球內鐵質釋放到人體後,長期下來就會造成鐵質沉積在心臟、肝臟、胰臟等器官。盧孟佑說,一旦確診為中度海洋性貧血,建議依個人狀況,每36個月追蹤一次。由醫師針對病患的血色素值、日常生活品質、生長發育情況,判斷是否需要輸血治療,減少併發症風險。

南科動物中心啟用中型動物實驗平台

 Written By: 劉珈均|2015/04/27國家實驗研究院位於台南科學園區的動物中心21日啟用中型動物試驗平台,主要供骨科、牙科、心血管、影像及微創手術等高階醫材的臨床前動物手術驗證。中心提供人醫級手術設備與照護空間,研究人員公開宣誓注重動物福祉,期盼帶動國內從業人員同等重視動物福利與科學研究兩者,並促進相關議題討論。

人醫等級動物專用手術房 在動物房區域,兔子、豬和狗各有寬大活動空間。手術房區域則將研究人員、動物與手術器械的動線分為三區,手術設備有超音波、升降手術台、恆溫水毯、手術電刀、電腦斷層掃描、氣體麻醉機、生理監視儀等,手術房可同時執行四台手術,牆上有影像設備可轉播手術實況作為教學之用。動物也有術後恢復區,備有烤燈、生理監控設備等器材,確認動物恢復至一定程度再回動物房。動物中心副研究員秦咸靜博士說,許多單位的動物手術房都相當簡單,可能就一個房間放一台手術台,因陋就簡。動物中心的空間則是為動物專用而打造,設備也為動物改良設計。至於獸醫編制,台北分部有五位,南科分部有三位,獸醫師主要負責實驗動物的健康照護,以及支援麻醉步驟,手術開刀會另跟富經驗的獸醫師合作。麻醉是許多動物實驗失敗的關卡,「傳統作法是一個麻醉師在旁邊看,看這個人或動物麻醉的深度如何,全都靠這個人。」動物中心動物試驗組組長蘇裕家說。不同物種和手術需要不一樣的麻醉,氣體麻醉機是利用吸入麻醉氣體麻醉動物,此機型可針對不同物種或手術設定麻醉方式,經測試後可設定為12種模組的麻醉最佳化設定。有別於傳統機型,它也能偵測動物呼吸甚至幫助控制呼吸,設定好氣體容量、氣體壓力、頻率,將氣體送到動物身上。若氧氣筒的氧氣不夠,機器也能抽室內空氣與麻醉劑混合。實驗動物依重量分級,重量小於2公斤的老鼠為小型實驗動物,各研究機關實驗室都可以作;230公斤的如兔、犬、迷你豬為中型實驗動物,大型醫院多有附設中型動物實驗平台,動物中心也屬於此層級,以蘭嶼豬與兔子為主軸;大於30公斤的豬、羊、牛為大型實驗動物平台,台灣尚無能力建構,需要大型實驗動物的單位多從國外進口,唯苗栗一家民間公司「豬博士大型動物試驗場」提供大型實驗豬隻蓄養與實驗場域。蘇裕家預估動物中心一年接20幾件案子,中心的蘭嶼豬來自農委會畜產試驗所台東分所;實驗兔則由中心自力培育無特定病原(specific pathogen free, SPF)等級的兔子,自農委會家畜衛生試驗所於去年12月停止供應SPF兔後,未來動物中心會是台灣唯一提供SPF兔子的機構,一年供量約300隻,主要作為藥品檢定之用。

動物實驗爭議 動物實驗的議題一直爭論不休,本月17日國民黨立委王育敏召開記者會,提出《化粧品衛生管理條例》修正案,禁止化妝品業進行動物實驗;紐西蘭今年三月底剛通過法令禁行化妝品動物試驗;2014年一月8隻歷經8年藥物動力學實驗的米格魯故事也引發討論(見泛科學討論串精華);台灣過半數的動物實驗機構無獸醫編制;20137月台灣爆發狂犬病疫情,農委會提出「鼬獾狂犬病毒動物試驗計畫」,計畫以190隻小鼠、36隻鼬獾、14隻米格魯進行攻毒試驗以了解傳播途徑、驗證疫苗效力,此計畫引發爭議,延緩至隔年,20145月台灣動物社會研究會對此提出調查報告質疑其防疫效益與科學必要性(報告原文),農委會重新規畫。日前泛科學記者向農委會確認,小鼠實驗已完成,待下半年鼬獾實驗完成、分析數據後再決定是否進行米格魯試驗。倫敦大學動物福利協會(1928年更名為動物福利大學聯會 Universities Federation of Animal Welfare, UFAW)於1950年代提出的「3R原則」是目前判斷動物實驗必要性的主要依據:替代(Replacement)、減量(Reduction)及精緻化(Refinement)。意即盡量尋求替代方式、減少使用活體動物作實驗,並完善實驗計畫與實驗動物照護環境。秦咸靜簡報時提到,全球實驗動物有75%是大小鼠,15%實驗魚,5%實驗兔,5%豬、犬、牛、羊、雞、兩棲爬蟲類、非人類靈長類。秦咸靜說,台灣一年的實驗兔(不分種類)總使用量約兩萬隻(其中SPF等級的兔子用量約一年一千隻),實驗豬的用量每年約2500隻(含肉豬與迷你豬)。

為什麼我們需要動物實驗? 秦咸靜解釋,兔子常用於生物相容性試驗與抗體疫苗產製,有些動物疫苗如豬瘟疫苗也會用到兔子;許多人都聽過業者用兔子試驗化妝品的刺激性與敏感性,但除了化妝品,化學品、隱形眼鏡、OK蹦等會長時間和人體接觸的用品皆需要此試驗,更別提要進入人體的醫療器材。「若不做(動物)試驗,就只能人來作。」會選兔子是因為牠免疫系統特別敏感,「體型也比小鼠大鼠適合,不用將東西縮小太多。」蘇裕家補充。豬的器官尺寸及生理結構與人體相像,皮膚移植、創傷修復、再生醫學、幹細胞治療都會用到豬。以前台灣多使用大豬作心臟與器官移植研究,現在為了飼養與照護方便,多用迷你豬(除了心臟瓣膜這類研究仍有體型限制,仍需要用大豬)。秦咸靜也提到,因為人對狗有較多情感,對於使用實驗狗觀感不佳,有些法規規定用狗作標準實驗動物,實驗者卻會改用豬作實驗。「狗目前無法被取代的是毒性試驗。」秦咸靜和蘇裕家解釋,醫學上用狗作實驗的歷史將近百年,資料完整,其中米格魯是最常用的實驗犬,「因為米格魯標準成犬都10公斤,怎麼長就是10公斤,劑量什麼的很好算。」加上品系純正,成為標準實驗動物。秦咸靜解釋:「在狗身上測試後的數據較能預測在人身上的狀況。不能說換就換,那需要很長一段時間的驗證和數據累積,不是說換成豬,在豬身上有效就有效,沒毒就沒毒。」目前有研究探討轉換實驗物種與減量,但不是短期內可以完成。根據「藥品非臨床試驗安全性規範」(去年7月公告的第五版為最新內容),新藥在臨床試驗前必須分別經過嚙齒類與非嚙齒類動物試驗,「這全世界法規都一樣,因為大小鼠跟人差太遠了,中間要再挑一個,而中間品系選項沒幾個,就兔子、狗、豬、靈長類。」秦咸靜說。各種實驗動物中,猴子和狗的術後安養照護的需求較大,其他動物大多會為實驗犧牲。秦咸靜解釋,原則上只會讓動物經歷一次手術,不會讓同一隻動物這輩子一直重複挨刀,所以採樣後就讓牠犧牲(安樂死),「以實驗室角度,會希望牠感受到痛苦之前就讓一切都結束,而不是讓牠受苦後半生。」

誓言的意義 動物中心的宣誓內容延伸自世界醫學會發表的「赫爾辛基宣言(Declaration of Helsinki)」精神,該宣言探討人體試驗倫理,亦提及須注重實驗動物福祉。「這些動物跟我們朝夕相處,最了解牠的就是照顧牠的人,如果連照顧他的人都不願多盡一點心力的話,那外面的人再怎麼喊都沒有助益。」秦咸靜說,宣誓的意義有兩個層面,一是以國家機關的身分作為起頭,影響國內其他機構與飼育人員,呼籲完成科學目標不是唯一任務,維護動物福祉應是同樣重要、甚至是更重要的使命。另一方面,相關人員常覺得動物實驗殘忍而不願意提,愈不講,就愈無法敦促、建立正確觀念,「我們公開討論這件事是希望讓大家知道,若這件事無法避免,那我們有責任把他作好。」秦咸靜提到,曾有實驗者說,這宣誓讓心中有了寄託,「終於可以去承諾什麼事情,而不是一個見不得人的祕密永遠無法講。」她說,歐盟地區動物權呼聲高的時候,科學進展相對緩慢,甚至學生會怯於選擇醫學、生科相關領域,「不討論的話,只會看到天平一端的資訊,這不是太公平,因為我們現在還無法避免動物實驗,我也很希望有一天能完全不要作。」蘇裕家述說研究最常遇到的掙扎,例如在動物身上種腫瘤或注射藥物,審理動物實驗時會事先制定好,腫瘤多大時就要犧牲該動物,避免動物隨腫瘤長大而受苦。然而,當藥物效果不明顯時,研究者就會希望再多養一段時日,讓對照組動物的腫瘤再大一點,期待實驗數字更顯著,「今天作這宣誓就是提醒自己,沒有一個實驗會比這些宣誓中道德的事情重要,要把動物福祉放第一位。」動物中心助理研究員吳侑峻博士以前從事醫材開發,常到醫院或其他設備沒那麼好的地方作動物實驗測試,但一來獸醫師專業度沒那麼精良,二是作醫材植入這類侵入性較大的手術時,常造成動物麻醉中死亡,「其實動物實驗作得越精確,越不需要重覆去作。」若手術過程完整、有良好動物照護,數據會讓人更信服,對之後人體臨床的可預測性就更高,不只可以減少動物犧牲(達到3R中的「減量」),也能提高資源投入效益。台灣動物社會研究會執行長朱增宏表示,國家單位公開表態值得肯定,但實驗動物管理更核心的問題在於「不好的應該淘汰。」雖然相關單位和NGO投入許多人力稽查、檢驗,但現行制度下,法源依據不夠、沒有退場與懲處機制、檢查密度不足,造成動物實驗單位素質參差。「全國大概有200多個動物實驗單位,近七八年來開始每年抽查40幾個單位,有些機構45年才會去一次,有些單位隔幾年去看甚至還退步。」朱增宏表示,這些表現不良的「後段班」約占3成,大學、藥廠、醫院居多,主管機關分散也造成管理困難,例如大學研究歸屬教育部或科技部,醫院與藥廠歸屬衛福部。而《動物保護法》對實驗動物只有兩三條原則性的規定,比起管寵物的少很多,農委會查核時對表現不好的單位只能「給予建議」,缺少足夠法源真正規範表現不佳的單位,是目前急待解決的問題。