晟德轉投資效益佳 挹注獲利 2015年05月06日 04:10 記者林燦澤／台北報導 國票新金部指出，儘管大盤震盪偏弱，但櫃買市場的生技指數仍然有撐，指數收172.69點漲幅0.79％，可注意生技題材股晟德（4123）之熱門權證。晟德是國內內服液劑的專業製造藥廠，主要營收來自以兒童用藥水佔比最高（約6成），中樞神經用藥水佔比重小於5％，轉投資收益約佔3成。今年3月間旗下持股6成的金樺生醫已登錄興櫃買賣，持股約4成的順天生技也預計在今年掛牌興櫃。晟德近年來的重大投資案是投資在香港掛牌的澳優乳業，從原先預計投資新台幣15億元到目前已實際投資金額達21.23億元，預計投資39.73億元，總持股比率達到近三成的29.6％。澳優手上已有代理幾家國際乳業大廠的產品，晟德著眼澳優乳業的長線經營，未來轉投資獲利挹注可期。國票新金部表示，建議看好晟德的投資人，可挑選價外10％左右的權證布局，看好短期股價有升值的潛力可挑選天期較短，槓桿較大的權證如：國票PP（716952）、國票RD（718034）；若是投資人中長線看好，可挑選天期較長，目前位於價外的權證如：國票SC（718484），該3檔權證依天期的不同，目前實質槓桿分佈約2.94～4.16倍。
Wednesday, May 6, 2015
林榮錦: 不要害怕公司整併…非誰被誰併吞的遊戲!!!!!!
生技業拚全球化 先找對夥伴 2015-03-23 00:50:25 經濟日報 晟德生技董事長／林榮錦口述、記者／黃文奇整理台灣生技產業正經歷風波後的整理，「下一步」大家都在看也都在問。前幾天，晟德生技主導的台灣首家細胞株開發公司金樺登興櫃，我在興櫃前法說與媒體朋友碰面，有些朋友就問我「台灣生技下一步該怎麼走？」我簡單地說，就是抓緊時間邁入「全球化、國際化」。全球化、國際化是大原則，做法是深入了解各市場法規、強化智財（專利），而在此之前「找到對的品項、做好市場開發（business development）」及與對的人合作，才是關鍵。若問這三者的順序何者為先，我認為是「因人而異」。舉例來說，如果你是生技的外行，但你有大筆的資金與人脈想要投入這個領域，那麼「對的人」（與誰合作）就是首要，因為對的人能幫你找到「未被滿足的醫療需求」（unmet medical needs）的利基產品。復次，如果你是研發型的學者，自詡擁有利基產品，那麼做好市場開發、強化智財就是第一要務。又如果你是生技專家，對市場開發嫻熟，那麼找一個能加值、有熱情的夥伴，應該是最好的選擇。以台灣現況來看，以上述前兩者最多，也造成台灣生技體質虛胖，這對於投資而言，最危險，也是台灣生技業當前的挑戰。因此，台灣市場要邁入全球化，找到對的夥伴、強化市場能力，是當務之急。我們一起來想像一個故事。有個學研單位的生技專家開發出很好的抗病細胞株，從實驗室的數據來看，毒殺癌細胞或消滅病毒的效果很好，也在國際期刊發表文章，繼而引來許多熱情的投資者注資，而科學家也興奮的埋頭實驗室，期待產品問世。這個產品看來很有競爭力，開發產品的科學家也是國際知名專家，產品也送進美國食品藥物管理局（FDA）申請臨床試驗，一切似乎萬事俱備。進入臨床後，大夥很興奮，但最後結果是，由於副作用太大，還沒進入二期就失敗了。另一個結果是，很順利的把臨床做完了，也申請到了藥證，結果市場反應不佳，賣了幾年還回不了本。讓時間拉回當下，台灣生技的發展還在幼年階段，除了去年的基亞事件，這些故事都還沒有發生。生技投資不免有風險，但如何避免這些事件發生，值得業界思考。以型態來看，台灣有科學家型也有投資者型的生技公司，前者應該及時檢驗、強化產品的市場性，做好智財、專利，讓產品做到最優化，尋求與市場領域專家合作。否則，產品做到一半發現「回不去了」，投資的心血與金錢全部白費。另一種投資者型的生技公司，老闆大多是各業界的翹楚，找的研發團隊、市場專家都對了，但是卻跨不出台灣。為什麼？我看過很多類似的例子，這些公司大多想要「獨當一面、獨占全拿」，而不願與國際夥伴合作，甚至認為國際公司來談合作，是想占便宜。最後的結果是，繞了一大圈，時間機會不再，產品也被時代淘汰。迄今，我所投資的公司，我都不斷地檢視這些問題，找到擁有核心技術的夥伴、找到對的人、適時的進入市場，當然，分享是必要的。所以，我能與張有德、黃文英、葉常菁、陳佩君這些頂尖專家合作，除了運氣好，還要懂得什麼是合作互利。如果你也正在經營生技新創公司，擁有好的產品，卻仍覺得難以為繼，不妨放下身段，找這些領域的專家合作，請他們給予建議。甚至，不要害怕與其他公司整併，整併是為了要更有能力跨出下一步，完成全球化。這是優勢互補的概念，而非誰被誰併吞的遊戲。我認為華人、亞洲、全球生技公司的整併，即將要到來。對台灣而言，這也是不可避免的趨勢。對我來說，雖然晟德當前投資狀況不錯，但我持開放的態度，只要有對的人、對的時機來到，我並不在意誰主導公司。生技是贏者全拿的零合遊戲，全新的技術將會破壞市場。如果你沒有信心在對的時間進入市場，現在幡然醒悟還不會太晚，一切才剛開始。在生技產業的領域中，時間最重要，過去了，成功就不會再來。
化療漾年產100萬瓶/ 中天 十億元擴廠
中天集團衝刺新藥 營運添動能 2015年05月06日 04:10 記者杜蕙蓉／台北報導 中天集團（4128）新藥布局兵分三路展契機！董事長路孔明表示，已取得藥證的化療漾與賀必容將強化行銷，5、6月將開始密集打電視廣告；而泉盛（4159）開發的3個新藥，將啟動大陸授權，合一生技（4743）的慢性糖尿病足潰瘍藥ON101，也將以臨床數據向美FDA申請快速審核資格。旗下已有9個新藥陸續步入收成的中天集團，除了化療漾與賀必容已上市外，進入三期臨床的有大腸用藥的瘜必寧、慢性糖尿病足潰瘍藥ON101，另外，泉盛開發二個過敏藥和一個類風濕性關節炎，即使都還在人體臨床前階段，卻備受大陸藥廠青睞，有機會採授權模式合作。路孔明表示，今年將以打開化療漾與賀必容的市場為目標，預計5月底或6月初將開始在電視打廣告，預計將有助於賀必容在藥局與藥妝通路的銷售；而化療漾則已打進26家醫療院所，全年以打入80家醫院通路、取得90％滲透率為目標。海外市場部分，以化療漾打前鋒搶攻大陸340億人民幣癌症化療後新藥市場，該新藥已送出中國進口藥品的查驗登記申請，正在藥證審批中，未來將透過代理商銷售，下半年也規劃進入不需申請藥證東南亞及歐洲市場（以植物萃取物）。另外，合一開發的新藥中，進度最快的ON101，國內三期臨床有效收案百例以上，預估明年上半年完成三期臨床收案，下半年送件藥證申請，直攻集團第三張生技新藥藥證。由於該項適應症目前在全球屬無藥可醫，治癒率僅25％，合一也將以臨床數據向美國FDA申請認定為突破性療法的可能。至於泉盛，由於現有新藥都還在人體臨床前階段，在考慮資源配置與後續發展下，內部也轉向對外授權的可能。路孔明表示，為了強化中天與合一新藥商化準備，中天已規畫投資十餘億元在龍潭興建新廠，該廠年產能為100萬瓶，是現有產能12萬瓶的8倍，預估2016年第3季投產。合一則決議斥資5億元在屏東興建南州廠，該新廠將做為未來培養牛樟芝菌絲體和生產WH-1軟膏，初估軟膏廠初期年產規模約2千萬條，預計2015年底完工。
醫/ 工超合作! 長庚劉浩澧: 超音波腦部藥物釋放
長庚大學分子醫學研究 卓越 2015年05月06日 04:10 李水蓮 在教育部頂尖大學計畫支持下，長庚大學團隊以分子醫學研究及產業應用為特色，帶動工、管學院與長庚醫院臨床研究，並與學校六大產學應用聚焦技術中心，採跨領域整合方式協助產業技術合作，日前參加教育部高教司主辦的「從邁頂殿堂奔向新創事業」系列成果展，共同為開創臺灣產業新氣象邁進。長庚大學校長包家駒表示，為奠立長庚大學新創事業之基礎，以癌症治療尖端科技暨六大聚焦團隊為主軸，在癌症治療方面，該校粒子束流核心實驗室與長庚醫院合作，以目前最先進的質子放射系統治療腫瘤，成立亞洲最大且最先進的放射治療中心，為全台及大中華地區唯一的質子治癌系統。該校分子醫學研發團隊亦為國內唯一以「癌症生物標記」為研究主軸，進行轉譯醫學研究之學術單位。近期已將口腔癌、膀胱癌、胰臟癌、鼻咽癌等10多種癌症生物標記技術整合至相關生物晶片，將帶來領先世界之加值應用。此次展出亮點之一，長庚大學電機系劉浩澧教授之「超音波腦部藥物釋放技術」為醫、工跨領域合作，臨床應用之一項重大技術突破典範，對未來非侵入式的腦部手術及治療方法，帶來新希望，其相關專利成果高達19件，已有多項專利技術移轉並成立新創公司，將成為行銷世界的經典案例。包家駒強調，長庚大學在頂尖分子醫學研究中心的帶動下，近期在諾貝爾獎得主Leland H Hartwell教授領導下，已建立口腔癌、大腸結腸癌等多種癌症及慢性疾病之早期篩檢與預後預測生物標記整合技術。在可預見的未來，將改變人們對這些疾病的診療方式，大幅提升台灣在生醫領域的國際領導地位，創造下一波台灣經濟亮點。
AbbVie 重金(21 billion) 買半砲(Imbruvica, ibrutinib)) 也值得! 強化血腫治療(CLL) 霸主地位!
AbbVie to buy Pharmacyclics for pipeline boost 10 March 2015 Andrew Turley AbbVie has agreed to buy US biotech Pharmacyclics for $21 billion (£14 billion) in a bid to re-stock its pipeline. The move grants AbbVie a share of future sales of anticancer drug Imbruvica (ibrutinib), which launched in December 2013 and generated $548 million in sales in 2014. Peak sales of the drug are expected to reach $6 billion per year. Whether this will be enough to justify the price of the deal, however, remains to be seen. Pharmacyclics already has a 50:50 marketing deal for Imbruvica with Janssen (part of Johnson & Johnson), so AbbVie will only be entitled to half of the income. Pharmacyclics has three other candidates in its pipeline, but none has yet progressed beyond Phase II trials. Nonetheless, Imbruvica will provide a much needed boost to AbbVie's portfolio. The kinase inhibitor is already approved for three blood and lymphatic system cancers, and Pharmacyclics is investigating its effectiveness in seven other conditions. AbbVie owns anti-inflammatory antibody Humira (adalimumab), which is currently the best selling drug in the world, with $10.7 billion in sales in 2013. But its patent protection will expire in late 2016, opening the door to generic competition from biosimilar versions. This has pushed the company to top up its pipeline with deals. In July 2014, the firm entered a $55 billion merger with Shire, which would have allowed AbbVie to cut its US tax bill, by registering the new company in the UK. But AbbVie abandoned the deal in October 2014, after the US government changed the rules covering so-called 'tax inversions'. The current deal highlights a remarkable turnaround in fortunes for Pharmacyclics. The company was founded in 1991, but it was not until 2006 that acquired the basis for ibrutinib from US genetic sequencing firm Celera. In 2007, the US Food and Drug Administration (FDA) rejected anticancer candidate Xcytrin (motexafin gadolinium). It was then hit hard by the economic crash of 2007–2008. In 2009, the shares changed hands for about $1 each. Now, AbbVie has agreed to pay $261 per Pharmacyclics share. This means that someone who had invested £4000 in 2009 would have made £1 million in six years.'There is a noteworthy synergy with AbbVie's oncology pipeline, which is itself expected to deliver peak annual revenues of $3 billion,' says Joshua Owide, director of healthcare industry dynamics at market research firm GlobalData. AbbVie will have the eighth most valuable oncology portfolio in the sector. 'While the Pharmacyclics deal is very costly, there is an opportunity for AbbVie to derive value from the deal in the long term, as well as use Imbruvica as a springboard for its strategic move into oncology.' Owide expects ibrutinib to generate sales of more than $40 billion over 15 years.
FDA expands approved use of Imbruvica for rare form of non-Hodgkin lymphoma First drug approved to treat Waldenström's macroglobulinemia FDA January 29, 2015 Release The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for patients with Waldenström's macroglobulinemia (WM), a rare form of cancer that begins in the body's immune system. The drug received a breakthrough therapy designation for this use. A type of non-Hodgkin lymphoma, WM usually gets worse slowly over time and causes abnormal blood cells, known as B lymphocytes (B-cells), to grow within the bone marrow, lymph nodes, liver, and spleen. In WM, abnormal B-cells also overproduce a protein known as immunoglobulin M or IgM (macroglobulin) that may lead to excess bleeding, problems with vision and with the nervous system. According to the National Cancer Institute, approximately 70,800 Americans were diagnosed and 18,990 died from non-Hodgkin lymphomas in 2014. Imbruvica works by blocking the enzyme that allows the abnormal B-cells in WM to grow and divide. "Today's approval highlights the importance of development of drugs for supplemental indications," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Continued research has discovered new uses of Imbruvica." The FDA initially granted Imbruvica accelerated approval in November 2013 for use in patients with mantle cell lymphoma who received one prior therapy. In February 2014, the FDA granted accelerated approval to Imbruvica for use in patients with previously treated chronic lymphocytic leukemia (CLL), and then in July 2014, expanded its use to include treatment of CLL patients who carry a deletion in chromosome 17. The FDA based its approval of Imbruvica for WM on a clinical study of 63 previously treated participants. All study participants received a daily 420 milligram orally administered dose of the medication until disease progression or side effects became intolerable. Results showed 62 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 2.8 months to approximately 18.8 months. The most common side effects associated with the drug are low blood platelet counts (thrombocytopenia), a decrease in infection-fighting white blood cells (neutropenia), diarrhea, low red blood cell counts (anemia), lack of energy (fatigue), musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash. Healthcare professionals should inform patients of the risk for bleeding (hemorrhage), infections, abnormal heartbeat (atrial fibrillation), development of new cancers (second primary malignancies), metabolic disturbances following treatment (tumor lysis syndrome), and toxic effects on an embryo (embryo-fetal toxicity) associated with the use of Imbruvica. The FDA granted Imbruvica for WM breakthrough therapy designation, priority review, and orphan product designation because the company demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; has potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively. The product's new use is being approved more than two months ahead of its prescription drug user fee goal date of April 17, 2015, the date the FDA was scheduled to complete review of the drug application. Imbruvica is co-marketed by Pharmacyclics, based in Sunnyvale, California, and Janssen Biotech, based in Horsham, Pennsylvania. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Ibrutinib has been reported to reduce CLL cell chemotaxis towards the chemokines CXCL12 and CXCL13, and inhibit cellular adhesion following stimulation at the B cell receptor. Together, these data are consistent with a mechanistic model whereby ibrutinib blocks BCR signaling, which drives cells into apoptosis and/or disrupts cell migration and adherence to protective tumour microenvironments. In preclinical studies on chronic lymphocytic leukemia (CLL) cells, ibrutinib has been reported to promote apoptosis, inhibit proliferation, and also prevent CLL cells from responding to survival stimuli provided by the microenvironment. Treatment of activated CLL cells with ibrutinib resulted in inhibition of Btk tyrosine phosphorylation and also effectively abrogated downstream survival pathways activated by this kinase including ERK1/2, PI3K, and NF-κB. Additionally, ibrutinib inhibited proliferation of CLL cells in vitro, effectively blocking survival signals provided externally to CLL cells from the microenvironment including soluble factors (CD40L, BAFF, IL-6, IL-4, and TNF-α), fibronectin engagement and stromal cell contact. In early clinical studies, the activity of ibrutinib has been described to include a rapid reduction in lymphadenopathy accompanied by a transient lymphocytosis, suggesting that the drug might have direct effects on cell homing or migration to factors in tissue microenvironments.
AbbVie (Genentech and Roche) 共同開發Venetoclax 強化血腫治療(relapsed/refractory CLL) 霸主地位
AbbVie's venetoclax granted FDA Breakthrough Therapy Designation for CLL patients with 17p deletion
Published on May 6, 2015 at 8:30 AM · AbbVie (NYSE: ABBV) today announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. CLL is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell. CLL accounts for approximately one quarter of the new cases of leukemia diagnosed in the United States. Approximately 3-10 percent of CLL patients have 17p deletion at diagnosis, and it occurs in 30-50 percent of patients with relapsed/refractory CLL. The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent. The median life expectancy for CLL patients with 17p deletion is less than 2-3 years. "The Breakthrough Therapy Designation of venetoclax supports the continued development of this investigational medicine in CLL patients with 17p deletion," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "The continuing advancement of the venetoclax development program is one example of AbbVie's focus on delivering innovative medicines that address unmet clinical needs." According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation includes preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy Designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.
Venetoclax (ABT-199) also known as ABT-199 or GDC0199, is an orally bioavailable, selective small molecule inhibitor of the anti-apoptotic protein Bcl-2, with potential antineoplastic activity. Venetoclax mimics BH3-only proteins, the native ligands of Bcl-2 and apoptosis activators, by binding to the hydrophobic groove of Bcl-2 proteins thereby repressing Bcl-2 activity and restoring apoptotic processes in tumor cells. Bcl-2 protein is overexpressed in some cancers and plays an important role in the regulation of apoptosis; its expression is associated with increased drug resistance and tumor cell survival. Compared to the Bcl-2 inhibitor navitoclax, this agent does not inhibit bcl-XL and does not cause bcl-XL-mediated thrombocytopenia. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus) (last updated: 4/30/2015). Current developer: Abbott and Genentech.
癌症藥!! 強者全拿趨勢漸顯!
全球癌症用藥支出 去年達千億美元 2015年05月06日 04:10 記者吳慧珍／綜合外電報導 《金融時報》報導，癌症藥物漲價加上癌症發生率攀高，去年全球癌症用藥的支出年增10％，首度觸及1,000億美元大關創新高紀錄。而製藥業又準備推出新一代癌症療法，勢必再推升癌症治療成本。以上數據係由美國權威研究機構艾美仕醫療資訊研究所（IMS Institute for Healthcare Informatics）提供。默克（Merck & Co）、必治妥施貴寶（Bristol-Myers Squibb）、羅氏（Roche）及阿斯特捷利康（AstraZeneca）等國際大藥廠，皆投入開發所謂的癌症免疫療法（cancer immunotherapy），亦即利用身體的免疫系統來對抗腫瘤。此新興療法最早在美國發表，還是近幾個月的事，1年花費約15萬美元（約合台幣460萬），因成長乏力悶了10年的製藥業，為此重燃樂觀情緒。但所費不貲的抗癌新藥如雨後春筍般湧出也引發質疑，那就是全球人口老化下，各國醫療體系面對照護成本高漲已窮於應付，還負擔得起昂貴的抗癌藥物嗎？艾美仕報告指出：「確診時間提早，治療時間拉長，藥物療效提高，在在推升癌症醫療的支出。」過去5年，癌症藥物花費的年複合成長率揚升至6.5％，而隨著癌症新療法陸續問世，艾美仕預測從現在起到2018年，成長率會進一步拉高到6％～8％。製藥業之所以刮起併購風，多少和垂涎高利潤的癌症藥物資產有關。例如美國大藥廠AbbVie今年3月斥資210億美元，收購成長看俏的抗血癌口服藥Imbruvica製造商Pharmacyclics。不過艾美仕報告也提到，無論是大型製藥集團或小型生技公司，都搶著在潛力看好的新興癌症免疫療法市場卡位，白熱化競爭料將緩和癌症藥上漲趨勢。
合一WH-1 Ointment與敷料(Aquacel(R) Hydrofiber(R))比較有機會獲FDA breakthrough therapy資格 ?! (待協商)
合一糖尿病藥 臨床三期將達陣 2015-05-06 05:04:33 經濟日報 記者黃文奇／台北報導中天生技集團董事長路孔明昨（5）日表示，目前華人疾病大宗為肝病（癌）、糖尿病併發症等，集團旗下合一（4743）的抗糖尿病足新藥ON101，有機會獲得美國食品藥物管理局（FDA）突破性療法資格，抗C肝、肝癌藥也將積極聚焦大陸市場。中天集團旗下新藥公司還包括泉盛，路孔明指出，合一糖尿病足部傷口潰爛的ON101，國內三期臨床有效收案百例以上，個案治癒比重遠超過現有藥物，突破50%。ON101臨床三期試驗年底可望完成，明年第4季有機會送件申請藥證，若以該產品在治療糖尿病足的表現，未來尋求FDA認定為突破性療法，有極大機會獲得此資格。泉盛目前的新藥還在人體臨床前階段，路孔明透露，在考慮資源配置與後續發展下，不排除對外授權。中天近十年來研發費用達13.8億元，共開發九個新藥產品，今年開發陸續有成果，路孔明指出，「最外的階段已經過去」，公司近五年合併營收複合成長率達39%，相較同業毫不遜色。
Evaluate the Efficacy and Safety of WH-1 Ointment for the Treatment of Chronic Diabetic Foot Ulcers
Primary Outcome Measures: The incidence of complete ulcer closure [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment. For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.
Secondary Outcome Measures: The time of healing rate [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] Time to complete ulcer healing, The time of the original healing will be taken as the time to healing. change in ulcer area [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] Percentage change in ulcer surface area from baseline 50% reduction in ulcer area [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] Percentage of subjects with a 50% reduction of ulcer surface area Incidence of infection of the target ulcer [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Incidence of infection of the target ulcer
Estimated Enrollment: 212
Study Start Date: September 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Experimental:
WH-1 ointment WH-1 ointment(1.25%),15g ointment per tube. Twice daily for up to 16 weeks.
Aquacel® Hydrofiber® dressing Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.
Detailed Description: This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects' treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit. One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.
AQUACEL® Ag dressing incorporating unique Hydrofiber® Technology with 1.2% (w/w) silver combines the favorable gelling characteristics of Hydrofiber®Technology with the broad-spectrum antimicrobial properties of ionic silver (Ag+). It is a versatile primary dressing indicated for moderate to highly exuding chronic and acute wounds where there is an infection* or an increased risk of infection. * when used in a comprehensive protocol of care. Also available in ribbon form, with stich bonding for added strength.
FDA breakthrough therapy: A drug that is intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies
台灣 取得藥證反成票房毒藥??!!
雲端生技 櫃買主打星 2015-05-06 00:00:26 經濟日報 記者周克威／台北報導分享櫃買指數近期雖受法人買盤略為縮手，等待上櫃公司法說會內容之際，在5日、10日與月線糾結區以盤待變，不過，市場專家指出，包括雲端、生技等族群未來成長趨勢仍看好，可留意法人近期進出狀況，做為參考依據。 元大寶來精準中小基金經理人劉家宏表示，目前選股須較為警慎，選擇要點不應僅以股價高低做衡量，而需同時考量評價與成長性，目前櫃買指數相對大盤指數仍未突破金融海嘯前238點，甚至是2014年155高點，但以其未來性來看，許多產業仍在上升曲線，例如網路雲端、生技、汽車電子等概念股。日盛日盛基金經理人林佳興表示，近期店頭指數與傳產股表現相對抗跌，看出市場資金持續換股操作，第一季財報已陸續揭曉，指數位於高檔震盪，後續只要類股持續健康輪動，有助盤面保持走穩，此時可以第1季財報及第2季公司展望為依據，汰弱擇強，調整持股，產業方面，電子族群鎖定在蘋果供應鏈，可留意供貨比重較高族群。就上櫃生技股而言，劉家宏指出，市場著重點將在財報的檢驗，可先從具有財報獲利支撐的醫材保健類做為首選，挑選當中營收獲利續創新高的個股。新藥股是生技族群中今年以來表現最差者，但今年以來反而看到有公司申請或取得藥證、臨床進入新一階段，甚至多家重量級興櫃新藥股也將陸續掛牌。
線粒體治療 是科學或商業目標??
新奇助孕技術：線粒體注入助卵細胞恢復活力 北京新浪網 (2015-05-05 09:03)新浪科技訊 北京時間5月5日消息，據國外媒體報導，1978年，世界首個試管嬰兒誕生，試管受精技術的出現為許多受孕困難、有生育障礙的人帶來了福音。僅僅在試管受精技術領域，醫學家們幾十年來提出了無數新奇的理論和想法，研究出許多助孕技術。這些技術有的取得了臨床成功，有的目前仍處於理論研究和試驗階段，甚至某些理論提法奇特得有些令人不可思議。在過去幾十年間，關於幫助人們提高受孕機率的技術層出不窮，尤其是在試管受精領域。試管受精技術的最新研究進展包括，可以有針對性地挑選精子、卵子或晶胚，這樣就可以大大提高受孕的成功機率。近年來，各醫學研究機構和醫學家們又在不斷在開展臨床試驗，試圖通過改變晶胚的生物學特性以提高晶胚的存活機率。近期，美國馬薩諸塞州的「卵巢科學」公司宣稱，該公司已研究出一種全新生殖技術，可以為衰老的卵細胞注入活力，助其恢復青春。臨床醫生從婦女體內尚未成熟的卵細胞中提取「年輕的」線粒體，然後再將其注入成熟的卵細胞中。從理論上講，這一過程可以替換掉衰老的線粒體，讓卵細胞恢復青春，從而提高受孕機率。而且該公司認為，這一技術與備受爭議的「線粒體治療」技術並不相同。「線粒體治療」技術在英國剛剛獲得批准，該技術通過將婦女核染色體注入到攜帶健康線粒體的供體人體卵細胞中，從而使該婦女懷上的孩子不會患有因母親線粒體問題而出現的遺傳病。「卵巢科學」公司于上周提供的數據顯示，接受利用該公司新技術的助孕手術的婦女中，有25%到53%的人成功懷孕。當然，這僅僅只是「卵巢科學」公司的一面之詞。該公司已在許多國家實施臨床試驗和手術，如阿聯酋、土耳其和加拿大等，但至今尚未有嬰兒順利出生的報導。此外，該公司在美國也沒有人接受過這種手術，因為2013年美國食品與藥物管理局曾經禁止「卵巢科學」公司在美國開展臨床試驗。不過，「卵巢科學」公司對自己的技術充滿信心，該公司首席執行官米歇爾-迪普表示，「我們相信，這項技術肯定能夠證明是可行的。醫生對他們早期看到的成果，感覺很受鼓舞。」不過，一項關係到能否生下健康寶寶的醫學技術，「相信」和「感覺」兩個詞意義是完全不同的。自1978年世界首個試管嬰兒誕生以來，科學家們已經搞清楚晶胚到底需要什麼營養，知道如何成功向卵細胞中注入單個精子，知道如何冷凍卵子和晶胚，以及如何檢測晶胚的基因狀態。儘管如此，大多數的試管受精手術還是以失敗而告終，甚至常常連醫生都不明白問題究竟出在哪裡。35歲以下的婦女中，美國全國平均成功率僅為40%左右，而且年齡越大，成功率越低。此外，不同的醫院，成功率差異也極大，因為他們的技術方法和具體操作也有不少差異。美國埃默里大學生育學專家詹尼弗-卡瓦斯介紹說，「完成這項手術的最佳操作步驟和方式到底是什麼，確實存在較大爭議。」因此，這就留給研究者們更多的研究空間，他們也提出了許多越來越新奇怪異的助孕方式，有的人開始專註研究試管受精技術的每一個步驟。將來，醫生可能會採用一種被稱為「冷凍一切生理周期」的技術。一些用於試管受精技術的處方葯可以刺激婦女分泌荷爾蒙達到超高水平，從而促進卵細胞的成熟。不過，這種額外的荷爾蒙也有可能造成子宮內膜不利於晶胚生存，實際上導致成功率降低。因此，研究人員希望通過冷凍晶胚來檢測他們的理論，排掉婦女的荷爾懞直到下一個生理周期子宮內膜又恢復正常時。美國斯坦福大學試管受精實驗室主任巴里-貝爾表示，「主要思想就是將你的晶胚放在一個更加自然的環境中，這個環境是通過正常的生理周期形成的，而不是靠激素療法過度排卵形成的。」此外，還有一些助孕技術和方式聽起來更為怪異，如刮掉子宮內膜以提高懷孕的機率。有的研究人員認為，這種做法可以讓試管嬰兒晶胚更容易植入子宮中。不過，沒有人知道究竟該怎麼做，更多的人甚至高度質疑這種理論是否可行。還有一種被稱為「試管激活」的實驗技術，醫生通過手術摘取卵巢的部分組織，並用某種酶對其進行處理，幫助停止排卵的女性生成新的卵細胞。還有的就是「卵巢科學」公司所提出的思想。如果不考慮該思想的局限性，其實線粒體移植技術也有可能是可行的。卡瓦斯表示，「我對此持謹慎樂觀態度，它也許是有用的。但目前還沒有得到驗證。」當然，試管受精技術還有更廣闊的前景，這是一個年輕的領域，但也是一個值得深入研究的難題，因為老鼠和靈長類動物並不能完全替代人類。只有經過多年的研究和臨床，不同技術之間的優劣差異和成功率差異才可顯現。科學在緩慢發展，因此這一領域還有更多的機會。
肥胖增加整型受術後風險!
Obesity Tied to Risk of Complications After Plastic Surgery Study findings suggest these patients might need more thorough care before and after procedure By Mary Elizabeth Dallas Monday, May 4, 2015 MONDAY, May 4, 2015 (HealthDay News) -- Obese people who choose to have plastic surgery are 35 percent more likely than normal-weight people to have to visit the emergency room or be admitted to the hospital within 30 days after their operation, new research suggests. The findings highlight the importance of telling obese patients about the risks involved with such surgical procedures, the study authors said."It is important to educate overweight and obese patients regarding their risk of complications" before they undergo the procedure, the researchers wrote. And doctors should more carefully manage existing health conditions these patients may have, the study authors cautioned. "Because most insurance companies will not cover complications associated with elective cosmetic procedures, these additional costs [of treating complications] may fall on the patient," they added. The researchers, led by Dr. Michelle Sieffert, of Wright State University in Dayton, Ohio, examined data on about 48,000 adults who had undergone outpatient plastic surgery. The patients had widely performed procedures, such as liposuction, "tummy tucks," breast reduction or eyelid surgery. About 4 percent of the patients were deemed obese. These patients had higher rates of other health issues, such as diabetes, high blood pressure, heart disease and mental health problems, the researchers said.The study, published in the May issue of Plastic and Reconstructive Surgery, found that just over 7 percent of the obese patients had to visit the emergency department or were admitted to the hospital within 30 days after surgery, compared to just under 4 percent of the patients who were a normal weight.Obese people with three or more health issues who had a "tummy tuck" had the highest rate of hospital visits, the authors said in a journal news release.Meanwhile, 3.2 percent of the obese patients developed complications within 30 days after their cosmetic procedure, compared with 0.9 percent of those who were not obese, according to the report.More hospitalizations and complications led to increased health care costs for these patients, the study authors said. The researchers calculated that expenses were $3,900 higher following liposuction, $7,100 higher after a "tummy tuck" and $7,400 higher for breast-reduction surgery.SOURCE: Plastic and Reconstructive Surgery, news release, April 30, 2015