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.
Subscribe to:
Posts (Atom)
.jpg)
Posts
