兆良系列10家公司吸金20億元(禾晶/耀德/捷安..)

台版「華爾街之狼」捷安司林宥呈100萬交保 2015-08-0616:30 〔記者張文川／台北報導〕檢調偵辦台版「華爾街之狼」兆良科技疑似「印股票、換鈔票」，違法販售未上市股票吸金案，台北地檢署今年6月30日聲押「捷安司生物科技」前負責人林宥呈並禁見，獲台北地院法官裁准；林宥呈聲請具保停押，法官今提訊林宥呈調查後，認定雖有羈押條件，但無羈押必要，裁定100萬元交保，但予「三限」管制，限制住居、限制出境、出海。檢調6月搜索兆良系列10家空殼公司中，以禾晶公司涉吸金4.7億元最多，耀德2.3億元居次、捷安司1億餘元排第3，檢調初估10家公司涉嫌吸金至少20億元。 此案由台北、士林2地檢署主辦，耀德、捷安司等6家公司，由台北市調查處負責；台版「華爾街之狼」兆良科技，由調查局中部機動站負責。耀德案移送士檢，捷安司案移送北檢。 北檢6月30日約談捷安司前負責人林宥呈到案，林被控以與台北醫學大學洽談過卻沒有實績的「髖關節技術」計畫書，誆騙民眾購買股票，訊後以有串證、重罪、共犯在逃理由聲押林，北院同日裁定羈押禁見至今，林聲請交保，今天獲准。

易威 李世仁 瞄準長效咳嗽藥/神經刺激疼痛舒緩/ Rx-to-OTC市場 (96億美元)!!

原料藥夯 易威業績爆衝 2015年08月08日 04:10 記者杜蕙蓉／台北報導 易威生醫（1799）受惠原料藥買賣和體溫量測產品銷售業績爆衝，今年前7月營收達3.27億元、年增高達648.14％。法人認為，易威今年不僅不僅轉機題材十足，年度營收也將優於原預估的5億元，有機會力拚損平。已正式由紅電醫更名的易威，目前正積極進行轉型。原本的體溫測量不僅擴大至中低階市場，並從檢測跨足治療外；而新布局的藥物事業，則從原料藥向下延伸至劑型開發，並瞄準Rx-to-OTC（處方藥轉成不須處方）利基市場。易威董事長李世仁表示，下半年預計將推出經皮電神經刺激（TENS）原理的疼痛舒緩產品，而開發的長效咳嗽藥，也規畫送美國FDA申請藥證。易威自結7月營收3,089萬元，年增285.55％；累計前7月營收3.27億元。由於業績支撐，易威昨（7）日股價逆勢上漲1.02％，收29.7元。李世仁表示，目前醫材產線產能滿載，為擴大市占率，積極尋求委外代工合作，並新增額溫槍等產品線，下半年將推出具藍牙功能的婦女基礎體溫計等產品，瞄準日本Citizen退出的中階市場空缺。藥品方面，則會從原料藥向下延伸至藥物劑型開發，鎖定Rx-to-OTC利基市場，目標每3～4年拿到一張藥證，將銜接歐、美通路，結合診斷及治療產品來配套銷售。李世仁指出，Rx-to-OTC市場在2013年就高達96億美元，目前應有百億美元的商機。該市場主要是指藥物專利到期後，不需要處方就可自行購藥的自費市場；他指出，因美國總統歐巴馬政策獎勵，近2年Rx-to-OTC藥品持續成長。該公司目前藥品開發的領域是美國市場大於1億美元、通路保障期已過，且競爭者較少（劑型難度較高）的學名藥，目前3項產品在開發中，進度最快的長效咳嗽藥，美國市場1.8億美元，預計2017年上市。(工商時報)

行政院食安聯稽小組 稽查: 6~7月(水工廠,加水站) / 8~9月 (蔬果製造廠)

食品聯合稽查 下一波瞄準蔬果輕食 2015年08月06日 22:56 呂雪彗 行政院今天表示，國人養生概念當道，蔬果輕食類商品銷量攀升，行政院食品安全聯合稽查專案小組將預計8至9月將對「芽菜及生鮮截切蔬果製造廠」進行稽查，保障國人食安需求。行政院今天召開食品安全聯合稽查專案小組會議，由於夏季炎熱，養生概念當道，蔬果輕食商品銷量攀升，為因應民眾對食品「便利性」及「營養性」的需求，將進行「芽菜及生鮮截切蔬果製造廠」的聯合稽查。此外，行政院表示，為避免不肖業者以未明水源混充飲用水，在6至7月間，小組以系統性跨部會方式，針對包、盛裝飲用水工廠及加水站的水質衛生安全與水源合法性進行全盤稽查，檢驗工作正進行中，後續將由衛福部公布共同稽查成果。而行政院表示，食安聯稽專案小組將持續針對重大民生物資稽查，如查獲不法情事，主管機關將依法重罰，並公布不合格產品資訊，依法進行後續處理，以強化食品安全管理，保障國人健康(工商即時)

佳醫 解除競業: 盧怡雁/周臣孝 (國藥控股煜嘉投資,北京御佳誠悅投資,上海菱泰醫療器械)

佳醫：公告本公司董事會解除經理人競業禁止之限制 鉅亨網／鉅亨網新聞中心-2015年08月07日 下午12:30 第二條　第21款1.董事會決議日:104/08/062.許可從事競業行為之經理人姓名及職稱:(1)盧怡雁，副總經理。(2)周臣孝，財務長。3.許可從事競業行為之項目:擔任與本公司營業性質相同或類似公司之業務。4.許可從事競業行為之期間:任職本公司經理人期間。5.決議情形（請依公司法第32條說明表決結果）:經主席徵詢全體出席董事無異議照案通過。6.所許可之競業行為如屬大陸地區事業之營業者，經理人姓名及職稱（非屬大陸地區事業之營業者，以下請輸〝不適用〞）:盧怡雁:副總經理周臣孝:財務長7.所擔任該大陸地區事業之公司名稱及職務:盧怡雁:(1)國藥控股煜嘉投資有限公司董事(2)北京御佳誠悅投資管理有限公司監事  周臣孝:(1)北京御佳誠悅投資管理有限公司董事(2)國藥控股煜嘉投資有限公司監事(3)上海菱泰醫療器械有限公司監事8.所擔任該大陸地區事業地址:(1)北京御佳誠悅投資管理有限公司：北京市東城區永定門內東街中里9-17號2679房間。(2)國藥控股煜嘉投資有限公司：上海市康寧路1089號1幢301-2室。(3)上海菱泰醫療器械有限公司：上海市徐匯區龍吳路1500號A樓615室。9.所擔任該大陸地區事業營業項目:(1)北京御佳誠悅投資管理有限公司:投資管理；資產管理；經濟信息諮詢；設計、製作、代理、發布廣告；會議服務；承辦展覽展示活；技術開發、技術推廣、技術轉讓、技術諮詢、技術服務；醫學研究；租賃醫療儀器；銷售醫療器械(限I類)。(2)國藥控股煜嘉投資有限公司:(一）在國家允許外商投資的領域依法進行投資；(二）受其所投資企業的書面委託（經董事會一致通過），向其所投資企業提供下列服務：1.協助或代理其所投資的企業從國內外採購該企業自用的機器設備、辦公設備和生產所需的原材料、元器件、零部件和在國內外銷售其所投資企業生產的產品，並提供售後服務；2.在外匯管理部門的同意和監督下，在其所投資企業之間平衡外匯；3.為其所投資企業提供產品生產、銷售和市場開發過程中的技術支持、員工培訓、企業內部人事管理等服務；4.協助其所投資企業尋求貸款及提供擔保；(三）在中國境內設立科研開發中心或部門，從事新產品及高新技術的研究開發，轉讓其研究開發成果，並提供相應的技術服務；(四）為其投資者提供諮詢服務，為其關聯公司提供與其投資有關的市場信息、投資政策等諮詢服務；(五）承接其母公司和關聯公司的服務外包業務；(六）醫院管理系統軟體和配套硬體的開發、設計、製作、系統集成、銷售；醫療器械的批發（內容詳見許可證）、進出口及佣金代理（拍賣除外），並提供相關的配套服務和技術諮詢服務，醫療信息諮詢（不含醫療診斷、治療、心理治療諮詢）。(涉及行政許可的憑許可證經營）。(3)上海菱泰醫療器械有限公司:三類醫療器械（詳見許可證）、機電產品、儀器儀表、化工產品（除危險化學品、監控化學品、煙花爆竹、民用爆炸物品、易制毒化學品）的批發，從事貨物及技術的進出口業務，貿易經濟與代理（除拍賣），從事醫療器械領域內的技術服務，醫療器械維修，醫療器械的租賃。10.對本公司財務業務之影響程度:無。11.經理人如有對該大陸地區事業從事投資者，其投資金額及持股比例:無。12.其他應敘明事項:無。

Tocagen 腦癌治療 獲孤兒藥資格: 基因載體 (cytosine deaminase )+化療(flucytosine-à 5-FU)_存活率7個月提升至13.8個月 !

FDA grants Tocagen's glioblastoma treatment orphan drug status  San-Diego based biopharmaceutical company Tocagen has secured orphan drug status for its investigational gene therapy treatment for glioblastoma. It follows hard on the heels of the combination treatment Toca 511 & Toca FC winning fast track designation just last month assisting the company in its quest to further advance the drug's development. Glioblastoma is the most common type of brain cancer, and most aggressive, with more than 10,000 new cases every year in the United States. However once diagnosed, patients have a five-year survival rate of less than 5%. Harry Gruber, CEO of Tocagen, said: "There's an extraordinary need for new treatment options for patients with this devastating disease."We believe the FDA's granting of both orphan drug and fast track designations to Toca 511 & Toca FC will enable us to more efficiently advance our programme, which we hope will ultimately offer physicians and patients a new option in the fight against brain cancer." Both components of the combination treatment are designed to programme cancer cells to convert prodrug 5-FC into the FDA-approved anticancer drug, 5-flurorouracil (5-FU), which kills tumour cells and additionally significantly boosts immune responses. Toca 511 is a retroviral replicator vector that delivers a gene, responsible for the enzyme cytosine deaminase, to the tumour. This is followed with oral doses of Toca FC which is converted within infected cancer cells into 5-FU, killing cancer cells while preserving healthy host cells. The treatment will enter phase II and III trials later this year and so far interim results have shown median survival rates of 13.8 months compared with historical benchmarks of around 7 months. This programme will be supported by companion diagnostic tests that Tocagen is working on in partnership with Siemens Healthcare Diagnostics under an agreement signed last year.

Feb 7, 2012  Tocagen is enrolling patients in its clinical trials of Toca 511 (vocimagene amiretrorepvec), for injection & Toca FC (flucytosine), extended-release tablets. These multicenter, open-label studies(3) are in patients with recurrent high-grade glioma, such as those with glioblastoma multiforme (GBM, Grade 4), who have had prior surgery and chemoradiation. Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a cytosine deaminase (CD) gene selectively to cancer cells. After allowing time for the administered Toca 511 to spread through the tumor, those cancer cells expressing the CD gene may convert the antibiotic flucytosine into the anti-cancer drug 5-fluorouracil (5-FU). In these studies, patients receive multiple cycles of oral Toca FC. Tocagen plans to work with Siemens Healthcare Diagnostics on the assays used during these clinical studies. Subject to FDA approval, Siemens may commercialize diagnostic tests capable of monitoring patient levels of Toca 511 and Toca FC."We believe that developing the necessary diagnostic tests with the right diagnostic partner is an important component for the successful commercialization of Toca 511 & Toca FC," said Harry E. Gruber, CEO, Tocagen Inc. "Siemens' capabilities in developing commercial viral assays in addition to their market presence in the diagnostics space make them an excellent complement to Tocagen's focus on the development and commercialization of viral gene transfer products to treat advanced cancer."

 

Toca 511 & Toca FC  (www.tocagen.com/) Toca 511, the key novel component of Tocagen's first Product Candidate (Toca 511 & Toca FC), was developed using the breakthrough RRV technology that allows selective targeting of cancer cells and a selective, local and systemic antitumor immune response without off-target toxicity. Toca 511 is used in combination with Toca FC, a novel extended-release tablet containing 5-FC (flucytosine).

Our Preclinical Studies  Preclinical data indicate that Toca 511 can hide in the cancer environment and spread from cancer cell to cancer cell, thereby allowing targeted delivery of a potent anticancer drug selectively to the cancer tissue while leaving healthy tissue unharmed. In addition to the direct killing of cancer cells, we believe that the immune system is selectively activated by the local tumor killing, with resultant systemic anti-tumor immunity. Toca 511 is specifically designed to deliver the genetic instructions to produce Cytosine Deaminase (CD) protein inside cancer cells. The CD enzyme then catalyzes the conversion of the antifungal drug 5-FC (flucytosine) to the anticancer agent 5-FU (5-fluorouracil) inside the cancer cells. Thus the CD protein enables local production of a powerful, FDA approved anticancer drug (5-FU) that selectively destroys the cancer cells. This targeted gene delivery strategy may result in higher local concentrations of the cytotoxic drug 5-FU and its phosphorylated metabolites in the cancer cells than would be otherwise attainable under currently accepted treatment regimens. This is because 5-FU has a narrow therapeutic index and when administered systemically, it exhibits dose-limiting toxicity to the rapidly dividing cells of the GI tract and bone marrow. Yet 5-FU has a very short half-life and is rapidly cleared. Additionally, 5-FU does not readily cross the blood brain barrier thereby further limiting the concentration of drug that can be delivered to cancer cells in the brain. In multiple preclinical models of brain cancer, the animals treated with Toca 511 and 5-FC demonstrated statistically significant prolonged survival compared to control (non-treated and Toca 511 alone treated) animals. The control groups showed a median survival of approximately 1 month, compared to prolonged survival in the Toca 511 and 5-FC treated animals. In experiments extended out to one year, almost all mice treated with Toca 511 and 5-FC remained alive. No significant toxicity was observed in the animals treated with Toca 511 and 5-FC. In similar experiments as shown above conducted in immune deficient and immune competent mice, tumors recur after stopping 5-FC treatment in immune-deficient, but not in immune-competent animals. This suggests that the immune system is able to control any residual tumor following treatment with 5-FC in syngeneic mice with an intact immune system, resulting in long-term survival. Furthermore, as shown below, animals that had long-term survival from their brain cancer treatment with Toca 511 and 5-FC and subsequently re-challenged with the same tumor administered to their flank region were able to resist tumor growth. In contrast, animals not previously challenged and treated, allowed extensive brain tumor growth in their flank region. Finally, if PBMC are taken from syngeneic mice successfully treated for their tumor and the T cells exposed to tumor in vitro then stained for reactivation (an ELISpot assay for IFN gamma production) many more positives are observed in the cured mice compared to naïve mice. Thus memory T lymphocytes (T cells) remain active against gliomas previously treated with Toca 511 & 5-FC in mice that are in 1 year remission. The preclinical studies conducted to date have supported our ongoing clinical trials evaluating Toca 511 in combination with Toca FC in patients with recurrent high grade glioma (HGG), including recurrent Glioblastoma Multiforme (GBM) and recurrent anaplastic astrocytoma. We believe these clinical trials may allow for early conceptual validation of our RRV platform. In the future, Tocagen is considering additional studies of Toca 511 & Toca FC in patients with high grade glioma in the first line (primary) setting, and in patients with cancers that have metastasized to the brain, liver and lung from other advanced cancers including breast, lung, colorectal, prostate and melanoma.