(歐盟) 國鼎 口服 Antroquinonol 治療胰臟癌 孤兒藥申請

國鼎生技:歐盟執委會(European Commission)接受國鼎生技研發中小分子新藥Antroquinonol用於治療胰臟癌的孤兒藥認證申請 鉅亨網新聞中心※來源：台灣證券交易所2017/01/18第三十四條第43款1.事實發生日:106/01/172.公司名稱:國鼎生物科技股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司，請填不適用):不適用5.發生緣由:歐盟執委會(European Commission)接受國鼎生技研發中小分子新藥Antroquinonol用於治療胰臟癌的孤兒藥認證。6.因應措施:無7.其他應敘明事項:(1)研發新藥名稱或代號：Antroquinonol(Hocena)(2)用途：治療胰臟癌的小分子新藥(3)預計進行之所有研發階段：口服劑型：二、三期臨床試驗(需與美國FDA與歐洲EMA協商確認)。(4)目前進行中之研發階段：A.提出申請/通過核准/不通過核准：提出向美國FDA申請多國多中心的胰臟癌人體臨床試驗(pre-IND no.:133158)。B.未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：不適用C.已通過目的事業主管機關許可者，未來經營方向：本公司將依原計畫，持續展開胰臟癌之人體臨床試驗。D.已投入之研發費用：已完成臨床前之相關試驗與人體一期安全性的評估。(5)將再進行之下一階段研發：A.預計完成時間：口服劑型臨床試驗規劃及範圍，需依據與美國FDA與歐洲EMA討論結果而定，若一切順利完成，預計試驗完成時間約在108年。B.預計應負擔之義務：該小分子新藥係國鼎生技獨立研發,擁有100%專利權, 僅須完成並通過相關臨床試驗即可申請上市許可。(6)新藥開發時程長、投入經費高且未保證一定能成功，此等可能使投資面臨風險，投資人應審慎判斷謹慎投資。

基因: 徐洵平 辭 ! 星寶電子入主 第3次易主

胖達人母公司基因易主 徐洵平辭總座 2017年01月19日 【江俞庭╱台北報導】胖達人母公司基因母公司基因國際（6130）日前宣布將售出51%股權給星寶電子及陳思羽，日前已完成收購，並敲定於2月23日召開股臨會，全面改選董監，昨更公告總經理徐洵平將自31日起辭任，基因國際也進入第3次經營權易主。 基因國際於去年12月22日宣布，星寶電子及陳思羽將公開收購51%股權後，股價自24.8元一度飆漲至38.8元，收購期間於1月11日屆滿，預計於1月26日召開董事會、2月23日開股臨會，改選董監。

星寶背景令人好奇 星寶電子入主後，為第3次經營權易主，最早是藝人小Ｓ老公許雅鈞家族入主達鈺後更名為基因生技，轉型為醫學美容商，外界也對成立不到2個月的星寶電子背景相當好奇。4年前鬧得沸沸揚揚的胖達人事件，遭檢調深入調查，意外衍生出基因前董座徐洵平的內線交易風波，去年二審判徐洵平、姜麗芬夫妻各2年、1年8個月徒刑，均可緩刑。徐洵平及所屬的韓星公司，合計已減持基因1萬3510張，持股比剩約15%；姜麗芬在洽特定人方式轉讓持股5330張後，僅剩2062張。

葡萄王: 膠囊日產量 35-45萬粒

曾盛麟：葡萄王產品未被要求下架2017/01/19 | 生技產業 | 杜蕙蓉／台北報導　葡萄王(1707)昨(18)日開放平鎮新廠的首度媒體參訪及進行產品退貨銷毀說明，董事長曾盛麟(附圖)表示，自己接任以來，產品安全沒有問題，日前食藥署及衛生局已到工廠查核，並沒有要求產品下架。2016年9月完成遷廠的平鎮新廠，已於10月試車投產，該新廠以膠囊及粉包為主。目前生產的膠囊，日產量約35~45萬粒，但仍將引進新的機台及產能優化，將膠囊的日產能再提高20~30萬粒。針對竄改食品效期引發爭議，曾盛麟表示，對近期因一連串恩怨情仇與內部動盪，造成消費者的不安，感到抱歉，而開放新廠參觀，就是希望大家明白生產製程的安全無虞。他坦誠，目前雖然有少量的退貨，但數量有限，金額還無法對外透露；而食藥署及衛生局也未要求其產品下架。不過，為杜絕消費者疑慮，即日起到2月底，消費者可憑發票到原購買通路進行退貨。退貨的產品也將於年後全數報廢銷毀，銷毀過程將全程記錄，供外界檢驗。葡萄王的平鎮新廠原本是要等觀光工廠開放後，一併開放參觀，但在食品爭議下，葡萄王昨日也提前帶媒體參訪，希望公開生產製程，讓外界明白安全無虞。曾盛麟表示，自他接任以來，就非常重視國家法規、品質安全管理及消費者權益，他可以打包票，產品安全沒有問題，他自己十幾年來也一直食用自家產品，希望消費者能夠繼續支持。葡萄王研發處主管表示，該公司擁有國際標準的檢驗實驗室，從原料、半成品到成品的檢驗項目最高可達674項。2014年飲料生產線通過國際食品安全管理系統驗證(ISO22000)及食品安全管制系統驗證(HACCP)；2015年膠囊劑及顆粒劑生產線也通過上述兩項驗證，品管實驗室則通過ISO17025國際認證，自主性委託SGS評鑑獲得優級殊榮，2016年平鎮廠導入ISO22000及HASSP等。

葡萄王​救商譽　接受退貨另推買一送一促銷2017年01月19日07:12 搶救商譽大作戰，葡萄王​去年底被爆產品改標再出售，為力挽消費者信心，接受退貨還有優惠。《蘋果》即時報導，葡萄王去年底遭爆料暢銷多年的保健品靈芝王，涉嫌改標，原本2012年產品就到期，卻竄改到2015年，董事長曾盛麟強調是家族鬥爭，自他接班以來，食品絕對符合法規。葡萄王為了挽回消費者信心，昨開放媒體參觀桃園平鎮廠新產線。今日出版的《自由時報》報導，曾盛麟昨宣布，消費者若對葡萄王相關產品有疑慮，都可退貨，沒有購買單據者，可至葡萄王官網下載相關文件辦理。葡萄王也宣布購買商品送好禮等優惠，1月25日起到2月15日到指定門市購買葡萄王全系列保健產品，可獲贈價值750元的保健品，2月16日到3月30日另有買一送一優惠。（即時新聞中心／綜合報導）

(愛派司 羅翔煒) 建立亞洲骨骼 曲率資料庫!

愛派司骨板 最適亞洲人 2017年01月19日 04:10 魏益權 致力於研發並生產優良的醫療器材的愛派司「A-Plus」，初期是由總經理羅翔煒有感於市場上醫師客戶的反應，使用的國外的產品（美國、歐洲）骨板大小、角度、曲率並不適合亞洲人使用。所以，在醫界及學界鼓勵之下整合了臨床學術行銷，創立愛派司生技，專為在地的台灣人及亞洲人設計、研發出屬於國人體型需要之互鎖式骨板系統。「每一創新都來自臨床的需求，每一設計都擁有實證的基礎，每一製造都符合認證的要求，每一產出都具備未來的內涵，每一商品都將著眼世界市場。」羅翔煒說，愛派司產品整合「台灣醫療器材創新發展協會」之創新能量，與中原醫工、陽明醫工、大同大學、秀傳醫院、台中榮總、台大、成大、高醫、亞東、高榮、長庚等醫學中心合作，以臨床研究數據資料庫為基礎，進行亞洲曲率解剖型骨板之設計與開發。愛派司日前建立亞洲骨骼解剖曲率資料庫，大數據可說是相當完整與即時，以獨門適合東方人骨骼的「亞洲曲率」套用在脛骨高位截骨系統，提供四款脛骨高位截骨骨板曲率做選擇，減少骨板折彎塑形的時間，降低骨板曲率不貼合所導致的異物感疼痛。愛派司以新創研發能力及營運模式，掌握產業趨勢，2015年愛派司獲得「台灣生醫暨新農業產業選秀大賽」、「金根獎」、「中小企業創新研究獎」以及「臺北國際發明技術獎」，足以證明該公司產品獨具特色與競爭力。(工商時報)

Merrimack 處理 (10.25億美元)微脂體抗癌藥 (irinotecan & Doxil by Teva ) Ipsen接手/ 專攻3項抗癌抗體新藥

法藥廠買胰臟藥 智擎打強心針 2017年01月18日 04:10 杜蕙蓉／台北報導 智擎（4162）在胰臟癌新藥安能得（Onivyde）今年可望有來自於取得亞洲藥證的里程金、歐洲銷售額的分潤外，由於授權夥伴Merrimack（MACK.US）日前將該安能得等資產以10.25億美元，出售予法國藥廠Ipsen。法人預期Ipsen未來將加速Onivyde新適應症研發，而有助於智擎的營運加值，提升獲利。就Merrimack公告，該公司是將Onivyde與Teva旗下阿特維斯（Actavis）藥廠合作研發的卵巢癌學名藥Doxil，以合約價值約10.25億美元，出售給法國藥廠Ipsen。法人指出，雖然根據授權合約，智擎並無法分潤安能得在美國市場的銷售，此次Merrimack出售新藥資產，對智擎業績並無影響，不過，由於先前Merrimack的財務問題，一直被法人放大檢視，如此安能得出售給財務實力更佳的Ipsen，無疑也幫安能得未來的臨床開發打了一針強心劑。據統計，Mack已積極擴大ONIVYDE市場價值，規畫以ONIVYDE+5FU/LV+Oxaliplatin合併療法挑戰美國年銷售額高達10億美元的一線藥Gemzar+Abraxane，現已在二期臨床試驗（2a）中，先確定組合物劑量，預計2017年完成收案。另外，該公司也規劃投入乳癌、大腸癌、兒童骨癌的治療，若臨床試驗成功，將再擴大銷售額，讓智擎有更多的分潤。安能得已取得台灣、美國和歐洲藥證，其中歐洲藥證是在去年10月取得，也讓智擎獲得2500萬美元的里程碑金，帶動去年EPS約有7元。另外，由於亞洲藥證可望在2017年上半年取得，將再獲得2500萬美元，推波智擎獲利吃下大補丸。由於智擎可以分潤歐洲和亞洲的銷售額，預期安能得在歐洲已上市下，初估今年首季開始，智擎即可望依照銷售淨額認列約9-15％的權利金。(工商時報)

Merrimack Sells Onivyde and Generic Doxil to Ipsen for up to $1.025B/ January 9, 2017/ Ipsen is paying Merrimack Pharmaceuticals $575 million in cash to acquire Merrimack's marketed anticancer drug Onivyde® (irinotecan liposome injection) and global oncology assets, including a generic doxorubicin HCl liposome injection, and commercial and manufacturing infrastructure. Merrimack could receive up to another $450 million in regulatory milestones if Onivyde is approved for additional indications in the U.S. The transaction is expected to close during the first quarter of 2017, subject to customary conditions and Merrimack stockholder approval. Onivyde was approved in the U.S. in October 2015, and in the EU during October 2016, for the treatment of metastatic adenocarcinoma of the pancreas after disease progression with gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin. Under terms of the proposed deal with Merrimack, Ipsen will market Onivyde in the U.S. and retains exclusive U.S. commercialization rights to potential future indications for the drug. The French firm will also take over the existing licensing agreement with Shire, through which the latter has ex-U.S. commercialization rights to Onivyde and with PharmaEngine for commercialization rights in Taiwan. Merrimack could receive net milestone payments of up to $33 million from the Shire deal. The potential $450 million in additional regulatory milestones from Ipsen for further development of Onivyde are composed of $225 million if the drug achieves FDA approval in first-line pancreatic cancer, $150 million for FDA approval in small cell lung cancer, and $75 million for FDA approval in any third indication. Ipsen says the transaction offers the potential to achieve significant synergies through integration of the Onivyde franchise with its existing commercial infrastructure in the U.S. for the cancer drug Somatuline®, which achieved global sales of €255 million ($268 million) in the first half of 2016. "The acquisition of Onivyde represents a compelling strategic opportunity to further strengthen Ipsen's oncology portfolio, while leveraging our U.S. infrastructure and creating meaningful potential incremental growth and profitability," commented David Meek, Ipsen's CEO. The firm will take over the clinical development program for Onivyde, which includes a Phase II trial in first-line previously untreated metastatic pancreatic cancer, a Phase II/III trial in relapsed small-cell lung cancer, and a Phase I pilot trial in breast cancer. Teva retains worldwide commercial rights to the generic doxorubicin HCl liposome injection product, which is currently under FDA review for the potential treatment of ovarian cancer, multiple myeloma, and Kaposi's sarcoma. Ipsen will be eligible to receive milestones and shared profits on potential future sales. Merrimack reported $14.5 million product revenues from the commercial sale of Onivyde during the third quarter of 2016, up $1.6 million compared with Q2 2016. License and collaboration revenues were $12.4 million during Q3 2016. The firm says the deal with Ipsen will provide the financial resources needed to focus on three priority clinical-stage antibody candidates: MM-121 (seribantumab), MM-141 (istirabumab), and MM-310, which it has identified through a strategic review process. It plans to plow $125 million into the pared-down pipeline, which will allow it to remain self-funding through to second half of 2019. MM-121 is a fully human HER3 receptor monoclonal antibody (mAb) that is undergoing a Phase II evaluation as combination therapy with docetaxel or pemetrexed, in non-small-cell lung cancer. MM-141 is a bispecific tetravalent antibody that targets the phosphatidylinositol 3-kinase/AKT/mechanistic target of rapamycin (P13K/AKT/mTOR) pathway. The drug is in Phase II development in combination with nab-paclitaxel and gemcitabine as first-line therapy in metastatic pancreatic cancer patients who exhibit Merrimack's insulin-like growth factor-1 (IGF-1) biomarker profile. MM-310 is an antibody-directed nanotherapeutic (ADN), which contains a prodrug of docetaxel and targets the EphA2 receptor. A Phase I study with MM-310 is expected to start during Q1 2017. Merrimack confirmed that it will now discontinue the Phase I study with its three-mAb combination therapy MM-151 and will instead look to partner the program or seek external financing. Continued investment in MM-131, MM-302, and other preclinical programs will also be shelved until partners or other funding opportunities can be identified. A Phase II study with MM-302 in HER2-positive metastatic breast cancer was halted in December 2016. Merrimack in addition plans to use funds from the Ipsen deal to extinguish $175 million in outstanding Senior Secured Notes and return $200 million to its shareholders through a special cash dividend. Since October 2016, the firm's headcount will have been cut by 80%, to 80 employees.  At the start of October Merrimack announced cutting 22% of its workforce, and the resignation of its then CEO, Robert Mulroy. Commenting on the deal with Ipsen, Merrimack board chairman and interim president and CEO Gary L. Crocker, stated, "with this transansformative step, Merrimack is moving forward as a more focused R&D company targeting three clinical stage assets with outstanding value potential. This strategic transaction also enhances stockholder value by providing sufficient, nondilutive capital to fund our new, strongly focused clinical objectives for MM-121, MM-141, and MM-310." Dr. Yasir Al-Wakeel, CFO and head of corporate development of Merrimack, added, "through the transaction announced today, we are streamlining our operating structure to significantly reduce operating expense, while bolstering our capital structure through an infusion of cash and the extinguishment of the Senior Secured Note Going forward, we will have a more focused capital allocation program dedicated to advancing MM-121, MM-141, and MM-310. With the multiyear cash runway provided by this transaction, Merrimack will have ample resources to fund its development programs into the second half of 2019, by which time we expect to have additional data regarding the viability of MM-121, MM-141, and MM-310."