全球2014醫藥併購 $460bn (破紀錄) 看好壞 各有戰略!!!!

GlaxoSmithKline chief questions rivals' chasing M&A deals  May 11, 2015 6:14 pm Andrew Ward, Pharmaceuticals Correspondent  GlaxoSmithKline's chief executive has warned that cheap money has increased the risk of companies making "poor choices" in mergers and acquisitions and questioned the "stretched" valuations of recent pharmaceuticals deals. Sir Andrew Witty said ultra-low interest rates inevitably reduced M&A discipline and he cautioned investors that not all the medicines being snapped up in multibillion-dollar deals would pay off. GSK has remained on the sidelines of the pharma M&A boom in recent months as other drugmakers have paid big premiums for growth assets."Some of these valuations look stretched," he told the Financial Times in an interview. "We're not going to get drawn into the idea that just because money is cheap we can do anything." More than $460bn of deals have been struck across the pharma and biotech sectors since the start of last year — the busiest period of M&A on record. An $8.4bn takeover of Synageva Biopharma by Alexion, a rival US rare disease drugmaker, last week, involved a premium of 124 per cent on the target's share price a week earlier. This was the fourth highest premium on record for deals over $5bn, according to Dealogic. Without singling out specific deals, Sir Andrew said: "When interest rates are essentially zero it is inevitable that you are going to see a discipline reduction in M&A . . . and therefore the probability of people making poor choices must have gone up." He said the mood reminded him of the last biotech boom around the turn of the millennium when investors were enthused by a wave of scientific breakthroughs — only to see many of them fall flat. "It is a little bit reminiscent of the early 2000s where every bit of new scientific news was good and would be permanent and would lead to great value-creation." Other industry leaders have argued the latest boom is sustainable because it is underpinned by more mature science. But Sir Andrew said not all new drugs would obtain the high prices needed to justify current valuations."Either only a few will make it and you get really good rewards, or lots will make it, in which case competition is going to bring the price down. In either scenario the model that says everybody succeeds and everyone gets maximum returns doesn't work." Andrew Witty, chief executive officer of GlaxoSmithKline Plc, speaks at the 13th Nikkei Global Management Forum in Tokyo, Japan, on Tuesday, Oct. 25, 2011. The 2 day forum is organized by Nikkei Inc., IMD and Japan Center for Economic Research. The one big deal GSK has done in the past year involved a $20bn asset swap with Novartis in which the UK group traded its cancer drugs for vaccines and consumer products. This has reduced GSK's dependence on pharmaceuticals in line with Sir Andrew's belief that developed world drug pricing is set to come under sustained pressure."Believing that the pharmaceuticals industry can carry on relying on pricing power and believing, no matter how high the price, no matter how small the patient base, that it is going to be paid for; it is quite hard to see how that carries forward." Sir Andrew is known for his cautious approach to M&A and some critics believe this explains why GSK has been left so badly exposed to the decline in its best-selling Advair asthma drug in the past year. "He should have bought something in the US to fill that gap," says a senior healthcare banker. But Sir Andrew said the "artificial high" from M&A was often not worth the cost and disruption. "We've made enormous progress replacing sales lost to generics. It means the top line hasn't moved much but we've done it without a big deal. Everybody else has . . . done a big deal. The approach we've taken is more cautious but I think it's the right one."

投資攻略：併購推動 生科醫療股看好[2015-05-22] 藥物專利到期，為大藥廠積極併購中小型藥廠提供機遇，藉此拓展產品版圖。去年下半年以來，全球生科醫療產業出現十大併購案，交易金額超過2,500億美元（約1.93萬億港元），保德信投信分析，生科醫療業界彼此之間競爭減少，有助提升盈利，而透過溢價併購，也能刺激股價上漲動力，有利相關基金表現。保德信全球醫療生化基金經理人江宜虔分析，根據美國個人消費支出（PCE）報告，消費者花費在醫藥產品上的支出增長率，持續領先整體消費支出，在低通脹環境下，多數產業只能「凍漲」，反觀製藥業界，掌握了較強的訂價能力。 傳統五六月 醫療股贏標普 回顧過去美國標準普爾500指數（S&P 500）股價，從過去各月的股價表現來追蹤短期表現，醫療生化產業表現可能超過S&P500指數幾率較高的月份為5、6月，其次為11月。江宜虔說，美股財報季踏入尾聲， S&P 500指數最新公布的474家企業中，有67%盈利優於市場預期，細究各產業，醫療保健業居冠，有83%優於市場預期；若看預測盈利年增率，醫療保健產業達18.3%，同樣是各產業中最出色的。逾十場國際醫學年會利氛圍 除了併購題材，江宜虔指出，展望本季，逾十場國際醫學年會輪番登場，值得關注的是下周舉行的美國腫瘤學會年會，由於去年全球癌症藥品銷售額已達1,000億美元，預測今年到2018年癌症藥品支出年增長率將為6%到8%，若會議中，出現正面的臨床實驗結果，往往有助拉抬許多醫療保健公司的股價預期。 江宜虔提醒，生物科技業具爆發力，但股價波動度高；投資人應該擴大目光，兼顧收益穩定、不受景氣循環影響的製藥業；受惠人口老化，長線看好醫療器材業以及具有高盈利率、現金充足的醫療服務業，透過平衡配置，才有機會在多頭時參與生物科技增長，空頭時運用製藥業防禦。

 

 

MERCK (grazoprevir + elbasvir) 全新無干擾素 口服C肝治療將主導未來趨勢! (肝纖維化 病人) VS 太景 TG-2349 phase II study

 

Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial, The Lancet, Volume 385, No. 9973, p1075–1086, 21 March 2015

Background  There is a high medical need for an interferon-free, all-oral, short-duration therapy for hepatitis C virus (HCV) that is highly effective across diverse patient populations, including patients with cirrhosis or previous null response to pegylated interferon (peginterferon) plus ribavirin (PR-null responders). We aimed to assess the efficacy, safety, and effective treatment duration of grazoprevir (an HCV NS3/4A protease inhibitor) combined with elbasvir (an HCV NS5A inhibitor) with or without ribavirin in patients with HCV genotype 1 infection with baseline characteristics of poor response.

Methods  The C-WORTHY trial is a randomised, open-label phase 2 trial of grazoprevir plus elbasvir with or without ribavirin; here we report findings for two cohorts of previously untreated patients with cirrhosis (cohort 1) and those with previous PR-null response with or without cirrhosis (cohort 2) enrolled in part B of the study. Eligible patients were adults aged 18 years or older with chronic HCV genotype 1 infection and HCV RNA concentrations of 10 000 IU/mL or higher in peripheral blood. We randomly assigned patients to receive grazoprevir (100 mg daily) and elbasvir (50 mg daily) with or without ribavirin for 12 or 18 weeks. Randomisation was done centrally with an interactive voice response system; patients and study investigators were masked to treatment duration up to week 12 but not to treatment allocation. The primary endpoint was the proportion of patients achieving HCV RNA less than 25 IU/mL at 12 weeks after end of treatment (SVR12), assessed by COBAS TaqMan version 2.0. This study is registered with ClinicalTrials.gov, number NCT01717326.

Findings  We describe findings for 253 patients enrolled in cohort 1 (n=123) or cohort 2 (n=130). In cohort 1, we randomly assigned 60 patients to the 12-week regimen (31 with ribavirin and 29 with no ribavirin) and 63 to the 18-week regimen (32 with ribavirin and 31 with no ribavirin); in cohort 2, we randomly assigned 65 patients to the 12-week regimen (32 with ribavirin and 33 with no ribavirin) and 65 to the 18-week regimen (33 with ribavirin and 32 with no ribavirin. High SVR12 rates were achieved irrespective of the use of ribavirin or extension of the treatment duration from 12 to 18 weeks; SVR12 rates ranged from 90% (95% CI 74–98; 28/31; cohort 1, 12 weeks, ribavirin-containing) to 100% (95% CI 89–100; 33/33; cohort 2, 18 weeks, ribavirin-containing). Among patients treated for 12 weeks with grazoprevir plus elbasvir without ribavirin, 97% (95% CI 82–100, 28/29) of patients in cohort 1 and 91% (76–98, 30/33) of patients in cohort 2 achieved SVR12. Adverse events reported in more than 10% of patients were fatigue (66 patients, 26% [95% CI 21–32]), headache (58 patients, 23% [95% CI 18–29]), and asthenia (35 patients, 14% [95% CI 10–19]).

Interpretation  Treatment with grazoprevir plus elbasvir, both with and without ribavirin and for both 12 and 18 weeks' treatment duration, showed high rates of efficacy in previously untreated patients with cirrhosis and previous PR-null responders with and without cirrhosis. These results support the phase 3 development of grazoprevir plus elbasvir.

The direct-acting antiviral agents (DAAs), particularly NS3 protease inhibitors, telaprevir and boceprevir, which were approved in combination with current SOC (peg-IFN and ribavirin) for the treatment of HCV infection that significantly increased SVR, have opened a new window in HCV therapy. However, the side effects associated with this new therapy are a questionable maker. Anemia is the most frequent adverse effects with either telaprevir or boceprevir. They also exhibit strong inhibitory effect against an important drug metabolism enzyme, cytochrome P4503A4 (CYP3A4) resulting in the development of drug-drug interactions. In addition to drug resistance, the efficacies of these inhibitors differ significantly between HCV genotypes. It is well known that IFN itself has significant side effects. Another important issue arises with their short half-life and frequent dosing. With the advent of different small classes of DAAs, the future aim is to introduce an IFN-free regimen, oral cocktails of DAAs. The proof-of-concept studies presented some promising data confirming that the achievements of SVR without introducing IFN may be feasible. Thus, the combination of host and viral targeted inhibitors could be an attractive strategy in maximizing antiviral efficacy.

Reference: BioMed Research International, Volume 2013 (2013), Article ID 467869

telaprevir (Vertex)  A significant proportion of patients with HCV who present particular challenges to treatment are not represented in the current clinical trials, including patients co-infected with HIV and patients with recurrent HCV following liver transplantation. These patients have a poorer response to pegIFN and ribavirin therapy and generally faster progression of liver disease. An interim analysis of a small phase II trial of telaprevir for treatment-naïve patients co-infected with genotype 1 HCV and HIV found considerably higher rates of RVR in patients receiving telaprevir (70% compared with 5% in those receiving pegIFN and ribavirin alone) [Sulkowski et al. 2011a]. The full results of this study are eagerly awaited to see if this translates to improved SVR rates for these patients. A trial of telaprevir for treatment-experienced genotype 1 HCV patients co-infected with HIV is also currently underway. A major challenge for telaprevir use in patients with HIV co-infection is the potential for drug– drug interactions. Telaprevir is a substrate and inhibitor of CYP3A, leading to significant interactions with protease inhibitors and nonnucleotide reverse transcriptase inhibitors used in the treatment of HIV. At present, this limits use of telaprevir to patients either not requiring antiretroviral therapy, or stably maintained on a limited number of treatment regimens with tested interactions with telaprevir (such as efavirenz, tenofovir and emtricitabine, or ritonavir-boosted atazanavir, tenofovir and emtricitabine or lamivudine) [Sulkowski et al. 2011a]. Drug interactions with immunosuppressant medications will also complicate the use of telaprevir in patients posttransplant. In healthy volunteers, co-administration of telaprevir substantially increased blood concentrations of both tacrolimus and ciclosporin [Garg et al. 2011]. No studies have yet been performed in organ transplant recipients, or with other commonly used immunosuppressants, so whether dose adjustment is required to allow safe co-administration with telaprevir is currently unknown. Although telaprevir clearly enhances response to treatment in genotype 1 HCV infection, its role in treatment of other viral genotypes is not clear. Interestingly, telaprevir appears to have equivalent antiviral efficacy in treatment-naïve patients with genotype 2 infection as genotype 1, but very limited efficacy in patients with genotype 3 infection [Foster et al. 2011a]. Whether telaprevir will play a role in shortening treatment duration for patients with genotype 2 infection, in retreatment of genotype 2 patients who have failed previous pegIFN and ribavirin therapy, or in treatment of genotype 4 infection remains to be established.

Conclusions The recent approval of telaprevir for treatment of chronic HCV infection is an exciting development. Although resistant viral variants emerge rapidly when telaprevir is used alone, in combination with pegIFN and ribavirin substantial increases in SVR are seen in both treatment-naïve and treatment-experienced patients. This benefit extends to those patients usually thought of as difficult to treat. The addition of telaprevir may allow shortening of treatment duration in treatment-naïve patients who show an early and sustained virological response. Knowledge of previous treatment response is important when considering telaprevir for treatment-experienced patients, as those with prior relapse have a greater chance of achieving SVR than prior null responders. A short lead-in phase of pegIFN and ribavirin could be considered for previous null responders, to estimate the likelihood of achieving SVR before commencing telaprevir-containing therapy. The efficacy and safety of telaprevir has yet to be established in some subgroups of patients who would greatly benefit from viral eradication but who respond poorly to pegIFN and ribavirin therapy, such as those co-infected with HIV or patients with recurrence of HCV infection following liver transplantation. Telaprevir is generally well tolerated, but significant side effects include rash, pruritis, anaemia and gastrointestinal disturbance. A strategy of sequential discontinuation of therapy, starting with telaprevir, may permit management of a severe adverse event whilst maximizing SVR rates. As experience of using telaprevir grows, local multidisciplinary strategies for the management of adverse events will need to be developed. In the majority of patients who do not achieve SVR following telaprevir-containing treatment, viral variants conferring telaprevir resistance can be detected. Although these variants are gradually replaced by wild-type virus over months following treatment, the implications of these variants on future treatment with telaprevir or other protease inhibitors is currently unknown. Successful treatment of these patients may await the development of further novel antiviral agents.

Reference: Ther Adv Gastroenterol. 2012;5(2):139-151

智擎: 林榮錦 & 陳俊宏(元富) 2008增資苦思對策/ 張鴻仁: 五人公司開發新藥…不可思議!!!

研發抗胰臟癌藥物 智擎總座：創造第三個轉折2015年 05月 22日智擎生技（4162）今日舉行新辦公室揭牌暨旗下抗癌藥送申請歐美藥證慶祝酒會，走過辛苦，智擎執行長葉常菁表示，公司產品將會陸續推向前，抗胰臟癌產品最快下月就會送申請亞洲藥證，下一步要創造公司的第三個轉折（高峰）。葉常菁今天以一襲紅白小禮服現身，長久以來神隱在幕後的葉常菁的夫婿奚百里，今天也化身為酒會的「攝影師」穿梭其中，為妻子在生技領域的成功故事，捕捉閃耀的剪影。智擎酒會今天由董事長何俊輝、執行長葉常菁主持，揭牌前請人扮文武財神、撒金元寶添個采頭，而幾位核心經營團隊主管也手拿菜頭（采頭）、鳳梨（旺來）討個吉利。現場生技界的大老群聚，一屋子祝賀聲不斷。智擎成立於2003年，由現任執行長葉常菁、前董事長林榮錦共同創辦，目前公司進度最快的產品抗胰臟癌藥PEP02已於2011年授權美國新藥公司Merrimack，目前已經完成美國、歐洲臨床並成功申請藥證，下一步將申請亞洲藥證，並陸續認列里程碑金。錦上添花人人有，但智擎真正辛苦的時候，雪中送炭的人卻寥落無幾。葉常菁今日在酒會間分享公司創辦過程，他回憶，2003年被晟德董事長林榮錦「說服」回台創辦智擎，從開始找錢到公司營運，到2008年的五年間可謂艱苦卓絕，2008年甚至發不出薪水，還要自掏腰包1,000多萬元，才能「過關」。林榮錦今天也出席酒會，他補充，2008年時，智擎募資的錢差不多燒光了，必須要再增資，他坦言，一度想要放棄，如果不是葉博士的堅持，讓他備受感動，他也不會「再加碼」。葉常菁表示，她被說動回台是智擎到2008年是第一個轉折，2011年產品授權美國公司Merrimack後，終於取得第一個勝利，股價開始以十倍的規模成長，這是第二個轉折，至於第三個轉折，她期待不久就會來到。元富證券董事長陳俊宏今天致詞時也提到，2008年時，智擎真的彈盡援絕，當時林榮錦找他一起商議增資智擎的計畫，兩個人約在台北市忠孝東路四段聯合報舊大樓的星巴克咖啡館談，結果，那天星巴克休息，他們兩個大男人就蹲在階梯上苦思對策。最後，陳俊宏的一席話，讓林榮錦勇敢再加碼增資，協助智擎繼續走下去。林榮錦說，人對了、產品對了、生意模式對了，剩下的就不用懷疑了。林榮錦說，智擎是因為葉常菁而存在，她是關鍵人物、靈魂人物；生技新藥發展協會理事長張鴻仁私底下表示，雖然當初沒有投資智擎，但是今日看來，這個當初只有五個人的公司，竟然能夠開發出新藥產品，真是「不可思議」。酒會今天早上十點半陸續進場，智擎新辦公室位在民生東路三段的繁華地帶，葉常菁說，本來有意「買下」，但是希望暫時把現金保留一些，等未來產品開始銷售、權利金入帳後，有充足的銀彈再考慮為公司添新厝。2015/05/21 17:16

台灣生技多頭指標: 智擎

胰臟癌新藥收割 智擎衝高獲利 2015年05月22日 04:10 記者杜蕙蓉／台北報導 智擎（4162）胰臟癌新藥MM-398繼向美國FDA和歐盟EMA申請藥證後，預計5月底前也將跟進申請台灣TFDA藥證，法人預期因里程金和明年起在歐、亞銷售的權利金拆解，智擎自今年起獲利由一個股本起跳的氣勢已具雛型，將開啟國內新藥公司邁入高獲利新紀元。已成生技多頭指標的智擎，昨（21）日舉行胰臟癌新藥MM-398完成歐美送件申請上市與喬遷新居慶祝酒會，總經理葉常菁表示，智擎旗下三個發品項都已陸續報佳音，進度最快的MM-398，除了胰臟癌適應症分別向美國、歐盟申請藥證外，台灣和亞洲也將很快跟進；而且Merrimack也已計畫啟動MM-398的其他適應症，包括如胰臟癌一線用藥、胃癌等，另腦癌數據也將於6月1日的美國癌症學會發表。另外，放射輔助治療PEP503，法國夥伴主導軟組織肉瘤樞紐試驗，預計明年完成。而智擎負責的亞太區臨床部分，日前已經向菲律賓、香港以及澳洲送出臨床申請，由於是比照歐盟方式採創新醫材臨床，因此，臨床時程將會縮短；而台灣地區智擎則是另開直腸癌的臨床，日前已經獲TFDA核准進入人體臨床，第3季前啟動收案。至於與廣州必貝特合作的新化合物抗癌藥PEP06，今年會選定1～2個適應症，開始細部的臨床前試驗。預期今年獲利將有機會挑戰一個股本的智擎，今年可望來自於里程金的挹注，主要是Merrimack和再授權夥伴Baxter協議，除了因向美國FDA提出藥證申請，500萬美元里程金已經於4月底認列之外，歐亞送出藥證申請，將可以再各領至少1千萬美元的階段里程碑金下，也讓智擎今年獲利少會超過2,500萬美元（台幣7.5億元以上），EPS貢獻至少7.5元。另外，若歐亞藥證順利取得，還將再獲總計5千萬美元、約合15億台幣的里程碑金，而以進度來看，今年可望有歐洲藥證的挹注，因此，EPS上看10元機會濃厚，而明年除了亞洲藥證外，亦將開始有歐洲和亞洲的銷售權利金分潤，獲利將更可觀。

太景 C肝新藥TG-2349 (Furaprevir) 如何抗拒 MERCK 攻勢 (grazoprevir, MK-5172,+ elbasvir, MK-8742) ! 藥價合理??

太景抗感染新藥 年底兩岸開賣 布局海外市場 授權中、俄、土耳其等 2015年05月22日F*太景董事長許明珠表示，抗細菌感染新藥將於兩岸率先全球開賣。【黃馨儀╱台北報導】F*太景(4157)昨舉行業績發表會，董事長暨執行長許明珠表示，新藥研發專注於抗感染及抗腫瘤領域，均名列全球前10大疾病用藥類別。其中，抗細菌感染新藥太捷信R率先報佳音，最快年底於兩岸率先開賣。 而幹細胞驅動劑布利沙福正陸續與國內外重要醫學機構合作開發適應症；C型肝炎蛋白抑制劑TG-2349，則以開發出療效顯著、藥價合理，且副作用低的雞尾酒療法為目標，嘉惠全球C肝病患。抗感染抗腫瘤需求大 F*太景旗下產品包括獲得台灣首例全新小分子新藥上市許可證的新一代抗生素太捷信R、幹細胞驅動劑布利沙福及抗C肝病毒藥物TG-2349。 許明珠表示，抗感染與抗腫瘤相關醫藥領域的藥品需求都炙手可熱，根據IMS統計，抗感染藥品2014年全球市場規模403億美元(約1.24兆元台幣)，抗腫瘤藥品市場更達744億美元(約2.28兆台幣)。 許明珠指出，由於太捷信R是大中華區唯一獲美國FDA(Food and Drug Administration，食品藥物管理局)資格的抗感染藥物，將在年底兩岸開賣。太捷信R口服劑型已獲台灣藥品許可證，現正申請健保核價程序，取得核價後即可銷售。 至於太捷信R在國外市場部分，已授權給中國浙江醫藥外，俄羅斯、土耳其及獨立國協等市場，也已授權俄羅斯藥廠R-Pharm，公司也積極洽談其他地區授權。而另外一新藥布利沙福，則可望取代既有自體與異體造血幹細胞動員藥物，並開發針對血液腫瘤與轉移性固體腫瘤，包含乳癌、攝護腺癌等的化療增敏適應症。 至於抗C肝病毒藥物TG-2349，則設計搭配與干擾素與雷巴威林的療法，針對好發於華人的病毒基因Ib型病人，將療程縮短到8周以下，已向中國申請1.1類新藥IND，擴大到第一基因型以外的病患。【F*太景(4157)小檔案】 董事長：許明珠 資本額：2024萬元 ●主要產品： ◎癌症相關藥物，如太捷信R、幹細胞驅動劑布利沙福 ◎抗C肝病毒藥物TG-2349 ●首季財報： ◎營收1879萬元 ◎稅後虧損8464萬元 ◎每股虧損0.12元 ●近期布局： ◎太捷信R最快年底兩岸開賣，並與俄藥廠洽談授權 ◎布利沙福擬針對血液腫瘤與轉移性固體腫瘤，包含乳癌、攝護腺癌進行應用開發 資料來源：公開資訊觀測站、業者、記者整理

A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve East Asian Subjects with Chronic Hepatitis C Virus Genotype 1b Infection.

Primary Outcome Measures: Antiviral efficacy of TG-2349 in combination with Peg-interferon (IFN) and Ribavirin (RBV) in treatment naïve East Asian subjects with HCV GT1b infection [ Time Frame: 12 weeks after the end of treatment (SVR12), after 12 to 24 weeks treatments ] [ Designated as safety issue: No ]Antiviral efficacy is measured by the proportion of subjects with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at 12 weeks after the end of treatment (SVR12) in the Full Analysis Set (FAS) population, which include subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.

Estimated Enrollment: 48 /Study Start Date: January 2015 /Estimated Study Completion Date: June 2017 /Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)  

The study is divided into two parts:  Part A:  Part A is a multicenter, randomized, open-label study to evaluate the safety, tolerability, and antiviral efficacy of two different doses of TG-2349 combined with Peg-interferon (IFN) and Ribavirin (RBV) in HCV-GT1b treatment naïve East Asian subjects. The treatment duration of TG-2349+IFN+RBV is 12 weeks, with or without an additional 12-week treatment of IFN+RBV, depending on HCV RNA level at On-Treatment Week 4. Approximately 24 subjects will be randomized (1:1) to one of the following 2 treatment groups:  

Group I (n=12): 200 mg TG-2349 (2 capsules) + IFN + RBV

Group II (n=12): 400 mg TG-2349 (4 capsules) + IFN + RBV Randomization will be stratified by IL28B genotype "CC" or "non-CC". Subjects with HCV RNA < LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at Week 4 will receive 12 weeks of TG-2349+IFN+RBV treatment. Subjects with HCV RNA ≥ LLOQ but < 100 IU/mL at Week 4 will receive 12 weeks of TG-2349+IFN+RBV treatment followed by an additional 12 weeks of IFN+RBV treatment. However, subjects with HCV RNA ≥ 100 IU/mL at Week 4 will discontinue the study treatment and complete the Early-Termination (ET) visit. The study will be terminated if 3 or more of the first 12 subjects enrolled across both Groups I and II, or ≥ 25% of subjects thereafter, fail to respond to treatment (i.e., confirmed on-treatment virologic failure or post-treatment relapse). Patients, except those who have achieved SVR12, will be offered the standard of care with Peg-interferon and Ribavirin for duration of 24, 48, or 72 weeks based on Taiwan's regulatory guideline and principal investigator's judgment.

Part B:  Based on the preliminary safety data and SVR 4 efficacy data obtained from Part A, one or two optimal dose(s) of TG-2349 will be selected for Part B in order to evaluate the antiviral efficacy of 8-week treatment of TG-2349 +IFN+RBV, with or without an additional 12-week treatment of IFN+RBV, depending on the HCV RNA level at On-Treatment Week 4. Approximately 12 subjects per dose group will be enrolled.  Subjects with HCV RNA < LLOQ, TND at Week 4 will receive 8 weeks of TG-239+IFN+RBV treatment. Subjects with HCV RNA ≥ LLOQ, TND but < 100 IU/mL at Week 4 will receive 8 weeks of TG-2349+IFN+RBV treatment followed by an additional 12 weeks of IFN+RBV treatment. However, subjects with HCV RNA ≥ 100 IU/mL at Week 4 will discontinue the study treatment and complete the Early-Termination (ET) visit. Part B study will be terminated if ≥ 25% of subjects fail to respond to treatment (i.e., confirmed on-treatment virologic failure or post-treatment relapse). Patients, except those who have achieved SVR12, will be offered the standard of care with Peg-interferon and Ribavirin for duration of 24, 48, or 72 weeks based on Taiwan's regulatory guideline and principal investigator's judgment.   

Inclusion Criteria:  Willing and able to provide written informed consent. East Asian subjects, male or female, and age between 18 (or legal adult age) and 70 years, inclusive, at Baseline/Day 1. Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 (inclusive) and body weight ≥ 40 kg. Presence of chronic hepatitis C (CHC) as documented below: (1) A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit or (2) A liver biopsy or FibroTest performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection, such as the presence of fibrosis and/or inflammation.  5. Positive for anti-HCV antibody at Screening. 6. Presence of an HCV RNA level ≥ 1 x 10000 IU/mL at Screening as determined by the Central Laboratory.  7. Presence of genotype 1b HCV-infection at Screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation.  8. HCV treatment naïve defined as no prior therapy with any interferon (IFN), ribavirin (RBV), or other approved or investigational HCV-specific agent.  9. Absence of cirrhosis  

Cirrhosis as defined as any one of the following:  

Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score ≥ 5).

FibroScan showing cirrhosis or results > 12.5 kPa.

FibroTest fibrosis score of > 0.58 and APRI (AST: platelet ratio index) of > 2 during Screening. If no definitive diagnosis of cirrhosis by the above criteria, a liver biopsy is required; liver biopsy results will supersede non-invasive testing results and be considered definitive. 10. Screening ECG without clinically significant abnormalities. 11. Subjects must have the following laboratory parameters at Screening:  ALT ≤ 10 × the upper limit of normal (ULN) AST ≤ 10 × ULN Total bilirubin ≤ 1.5 × ULN except history of Gilbert's syndrome. If Gilbert's syndrome is the proposed etiology, the total bilirubin must ≤ 2 × ULN. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 Platelet count ≥ 90,000 cells/mm3 HbA1c ≤ 8.5% Thyroid stimulating hormone (TSH) and T4 ≤ ULN Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation Serum creatinine ≤ 1.5 × ULN Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects Albumin ≥ 3.5 g/dL INR (International Normalized Ratio for Prothrombin Time) ≤ 1.5 x ULN unless subject is stable on an anticoagulant regimen affecting INR Anti-nuclear antibodies (ANA) ≤ 1:320. 12. Subject must be of generally good health, with the exception of chronic HCV infection, as determined by Investigator. 13. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments, including all required Post-Treatment visits. 14. A female subject is eligible to enter the study if it is confirmed that she is: (1) Not pregnant or nursing. (2) Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal - women > 50 years of age with cessation (for ≥12 months) of previously occurring menses), or (3) Of childbearing potential (i.e., women who have not had a hysterectomy, have not had both ovaries removed, and have not had medically documented ovarian failure).  Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from Screening until 6 months after the last dose of study drug(s):  - Complete abstinence from intercourse. Periodic abstinence from intercourse (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.  Or - Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from Screening until 6 months after the last dose of study drug(s):  intrauterine device (IUD) with a failure rate of < 1% per year female barrier method: cervical cap or diaphragm with spermicidal agent tubal sterilization vasectomy in male partner hormone-containing contraceptive: i. implants of levonorgestrel ii. injectable progesterone iii. oral contraceptives (either combined or progesterone only) iv. contraceptive vaginal ring v. transdermal contraceptive patch. 15. Male subjects must agree to consistently and correctly use a condom, while their female partner agrees to use 1 of the methods of birth control listed above, from Screening until 6 months after the last dose of study drug(s).  16. Male subjects must agree to refrain from sperm donation from Screening until at least 6 months after the last dose of study drug(s).  

Exclusion Criteria:  Presence of cirrhosis. Positive serological test for IgM anti-HAV (hepatitis A virus) antibody or HBsAg at Screening. Positive ELISA test for HIV-1 or HIV-2 at Screening. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson disease, alfa-1 antitrypsin deficiency, cholangitis). Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1. Clinically-relevant drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by Investigator. Alcohol misuse as defined by an AUDIT score of ≥ 8. Contraindications to RBV or IFN therapy, including hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia), autoimmune thyroiditis or other autoimmune disorders including autoimmune hepatitis. Pregnant or nursing female or male with pregnant female partner. Use of any prohibited medications within 30 days of the Baseline/Day 1 visit: (1) Hematologic stimulating agents (e.g., erythropoiesis-stimulating agents [ESAs], granulocyte colony stimulating factor [G-CSF], and thrombopoietin [TPO] mimetics) (2) Chronic use of systemic immunosuppressants including, but not limited to, corticosteroids (prednisone equivalent of > 10 mg/day for > 2 weeks), azathioprine, or monoclonal antibodies (eg, infliximab) (3) Investigational agents or devices for any indication (4) Drugs disallowed per prescribing information of RBV or IFN (5) Any prohibited medications listed in Table 6-2. 11. Known hypersensitivity to RBV, IFN, TG-2349, sulfa drugs, or formulation excipients. 12. Current or prior history of any of the following:  Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.  Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drugs. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage). Central nervous system (CNS) trauma, seizure disorder, stroke or transient ischemic attack. Solid organ transplantation. Significant cardiac disease (including but not limited to the myocardial infarction based on ECG and/or clinical history). Significant pulmonary disease or porphyria.

Clinically significant retinal disease. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 12 months prior to Baseline/Day 1 or has not required medication in the last 12 months may be included.

Malignancy within 5 years prior to Screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible. Significant drug allergy (such as anaphylaxis or hepatotoxicity).  

Drug: TG-2349 TG-2349 (Furaprevir) is available as a Swedish orange capsule (size 0) for oral administration. Each capsule contains an equivalent of 100 mg of TG-2349 spray dried solid (SDD) and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, and colloidal silicon oxide.

Drug: Ribavirin RBV (Ribavirin or COPEGUS®) is available as a light pink to pink colored, flat, oval-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin and the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, cornstarch, and magnesium stearate. The coating of the tablet contains Chromatone-P® or Opadry® Pink (made by using hydroxypropyl methyl cellulose, talc, titanium dioxide, synthetic yellow iron oxide, and synthetic red iron oxide), ethyl cellulose (ECD-30), and triacetin.

Drug: Interferon Alfa-2a IFN (Interferon, Peg-interferon alpha-2a or PEGASYS®) is available as a sterile, preservative-free, colorless to light yellow injectable solution administered subcutaneously.  

Each prefilled syringe of 180 μg/0.5 mL IFN (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.0231 mg), benzyl alcohol (5 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4 mg) at pH 6 ± 0.5.  

TG-2349，正在美國進行I/II期臨床試驗。與既有的藥物相比，TG-2349的競爭優勢包括：(1)可對抗6種基因型之C肝病毒，(2)安全性高，(3)每日僅需口服一次，(4)無須與干擾素並用，可避免干擾素帶給病患的強烈不適根據在美國與台灣進行的Phase I/IIa臨床試驗顯示，病患口服三天TG-2349，每日一次，血中病毒濃度即大幅降至原來的萬分之一。台灣病患接續以健保給付的干擾素與雷巴威林進行治療，四周後即偵測不到病毒。太景的目標在將現有治療C肝標準之24週療程，縮短到8週，甚至更短，如此將可大幅減輕病患的副作用，並讓病人與保險機構負擔得起。太景也已向中國申請TG-2349的1.1類新藥IND，將擴大到第一基因型以外的病患。

 

 

See also...太景口服C肝藥TG-2349 Phase I/IIa成關鍵

54億元銀彈護駕! 美時 買回庫藏股 (1000張/ 68-105元)

庫藏股發威 美時直奔漲停 2015年05月23日 04:10 記者杜蕙蓉／台北報導  美時（1795）為捍衛股價，昨（22）日起將買回1千張自家股票，買回區間價格68-105元間，由於公司護盤心切，加上合併效益陸續顯現，激勵該股昨日股價直奔漲停，以79.9元坐收。營運已逐步展現轉機的美時，今年前四月合併營收17.4億元，年成長869.6％；而首季毛利率57.55％，較去年同期9.74個百分點，呈現大幅成長；營業利益7,038萬元、稅前淨利2178萬元，已正式由虧轉盈，不過合併後的稅後淨損是2114萬元，每股淨損0.13元。美時表示，2015年第一季是新美時集團正式整軍完成後的第一個完整季度，除了因合併增加子公司營收貢獻外，該公司本身業務亦較去年同期成長，強化了集團整體成長動能。而且受惠集團旗下子公司持續進行資源整合，韓國子公司Kunwha及Dream Pharma整併進度順利，在兩家公司團隊已於今年四月一日起開始共同辦公，加上美時4月份也認列了第一筆與中國大陸客戶策略合作之產品權利金收入下，4月份合併營收4.48億元，再創單月歷史新高。美時表示，該公司目前在台銷售的26項產品，將透過集團通路銷售韓國及東南亞，其中1項抗癌藥今年可望在韓國上市。日本市場部分，抗癌用藥TS1產品已開始小量出貨，而另1款腦癌的 產品也在台灣上市；目前美時與合作的日本客戶，已挑選出8個可行性高的產品，其中5個產品已著 手進行開發，未來希望每年有3～5個產品推進日本市場。因此，整體來看，今年營運頗為樂觀。業績持續報佳音的美時，是在2013年12月16日宣布，艾威群集團（Alvogen Group）將以每股39.5元台幣，合計2億美元（約新台幣60億元）取得美時近67％股權，預期雙聯手進軍國際特殊學名藥市場，將帶動美時躋身高獲利下，也掀起該股股價的飆漲風，並創下187元歷史新天價。不過，基亞事件後，生技類股氣氛不佳，美時股價也一路下殺，日前更創下70.5元的低點。為此，該公司21日董事會通過，自22日起至7/21止，買回自家股票1,000張，預定買回股份占公司已發行股份總數之0.42％。

美時製藥：公告本公司董事會決議買回庫藏股事宜 鉅亨網新聞中心2015-05-21 20:56:00 第二條第35款1.董事會決議日期:104/05/212.買回股份目的:維護公司信用及股東權益3.買回股份種類:普通股4.買回股份總金額上限(元):5,452,255,987  5.預定買回之期間:104/05/22~104/07/216.預定買回之數量(股):1,000,000 7.買回區間價格(元):68.00~105.008.買回方式:自集中交易市場買回9.預定買回股份占公司已發行股份總數之比率(%):0.4210.申報時已持有本公司股份之累積股數(股):011.申報前三年內買回公司股份之情形:101年買回40,000股並轉讓員工。102年買回172,000股並轉讓員工。12.已申報買回但未執行完畢之情形:為顧及市場機制及考量整體資金之有效運用，故未予以全部執行完畢13.董事會決議買回股份之會議紀錄:提案(1)：案由：買回本公司股份案，提請決議。說明：1.為維護公司信用及股東權益，本公司擬依據「證券交易法」第28-2條及「上市上櫃公司買回本公司股份辦法」之規定、自櫃檯買賣市場買回本公司股份。2.本次買回本公司股份相關事項如下：I.買回股份之目的：維護公司信用及股東權益，買回並辦理註銷股份。II.買回股份之種類：普通股。III.買回股份總金額上限：新台幣5,452,256仟元。IV.預定買回之期間：民國104年5月22日至民國104年7月21日止。V.預定買回之數量：1,000,000股。VI.預定買回之區間價格：每股新台幣68元至新台幣105元，若股價低於此區間價格之下限，公司將繼續執行買回股份。VII.買回之方式：自櫃檯買賣市場買回。VIII.本次預計買回本公司股份佔本公司已發行普通股之0.42%，且如以本次預計買回股份之價格上限計算所需資金約新台幣105,000仟元、佔本公司民國104年3月31日止流動資產之2.15%，不影響本公司財務狀況及資本之維持。IX.本次買回庫藏股之證券承銷商對買回股份價格之合理性評估意見，請參閱附件一。X.依據「上市上櫃公司買回本公司股份辦法」規定，公司申報買回股份應檢附「董事會已考慮公司財務狀況，不影響公司資本維持之聲明書」，請參閱附件二。3.謹提請 討論。14.「上市上櫃公司買回本公司股份辦法」第十條規定之轉讓辦法:不適用。15.「上市上櫃公司買回本公司股份辦法」第十一條規定之轉換或認股辦法:不適用。16.董事會已考慮公司財務狀況，不影響公司資本維持之聲明:美時化學製藥股份有限公司董事會聲明書一、本公司經民國104年5月21日第十八屆第十一次董事會三分之二以上董事之出席及出席董事超過二分之一之同意通過，自申報日起二個月內於集中交易市場﹙證券商營業處所﹚買回本公司股份1,000,000股。二、上述買回股份總數，僅占本公司已發行股份之0.42%，且買回股份所需金額上限僅占本公司流動資產之2.15%，茲聲明本公司董事會已考慮公司財務狀況，上述股份之買回並不影響本公司資本之維持。三、本聲明書業經本公司上述同次董事會議通過，出席董事9人均同意本聲明書之內容，併此聲明。美時化學製藥股份有限公司17.會計師或證券承銷商對買回股份價格之合理性評估意見:美時製藥預計買回公司股份，所擬定之買回區間價格新台幣68元至105元間，係落在金融監督管理委員會證券期貨局發佈之「庫藏股疑義問答彙整版」，所認為合宜之買回區間價格新台幣52.29元至137.65元範圍內。18.其他證期局所規定之事項:無

義美 高志尚…肉燥清香醬沒有肉 全化學原料!!!!!

談食安 義美董座：買食品先看成分 發稿時間：2015/05/21 18:35 最新更新：2015/05/21 22:17 食安問題層出不，義美食品公司董事長高志尚（右）21 日出席國立高雄第一科技大學「HIWIN傑出總裁講座」 暢談食安問題，並呼籲消費者，買食品要先看成分． 中央社記者程啟峰高雄攝104年5月21日 食安問題層出不，義美食品公司董事長高志尚（右）21 日出席國立高雄第一科技大學「HIWIN傑出總裁講座」 暢談食安問題，並呼籲消費者，買食品要先看成分． 中央社記者程啟峰高雄攝104年5月21日 (中央社記者程啟峰高雄21日電)食安問題層出不窮，義美食品公司董事長高志尚今天呼籲消費者，買食品先看成分。高志尚下午受邀出席國立高雄第一科技大學「HIWIN傑出總裁講座」談食安問題，300名師生及樂齡大學的阿公阿嬤慕名前來聆聽。「過去的人是吃不起，現在變成大家都不敢吃。」高志尚表示，義美食品曾遭名嘴質疑，只有鮮奶、雞蛋、砂糖、香料等4種材料如何做出雞蛋布丁，當時義美隨即在網站上發表布丁原料並公開製作過程，證明確實只用4種材料做出雞蛋布丁，且能保存21天。高志尚表示，布丁是一項傳統食品，過去製作均沒添加化學原料，但在這個年代，大家卻反倒認為原料不夠多就做不出布丁。高志尚提到，根據日本統計數據，上班族一天三餐外食，包括飲料、便當，每人一天平均至少會吃進60-70種不同化學添加物，後來又針對至超級市場購買料理包等食品的日本家庭主婦調查，發現從沒上過餐館的家庭主婦所吃下肚的添加物居然高達70-80種。曾購買台灣某大廠出產的肉燥清香醬，看了成分嚇一跳，高志尚表示，成分原料近60種，不但沒有肉，且全都是化學原料。高志尚也奉勸消費者，挑選食品時應先注意成分，一項食品除了小麥、蛋等天然原料，若有超過10種、20種成分是不認識的化學原料時，就應避免購買，因為消費者並不會研究吃下肚的成分是否會對身體造成負擔。1040521

互聯網+感測晶片原相 拼 豪威, OmniVision (北京清芯/ 華創投資/ 中信資本/ 金石)

要做唯一 原相布局智慧醫療 2015年05月22日 04:10 記者楊曉芳／台北報導 原相昨(21)日獲經濟部頒發中堅企業獎，行政院院長毛治國(左)鼓勵獲獎企業找到獲利新藍海，以「不做第一、要做唯一」，原相董事長黃森煌(右)也回應，迎戰OV獲中資銀彈挹注，原相將積極做到唯一，布局智慧醫療。文／楊曉芳 昨（21）日獲經濟部頒發卓越中堅企業獎，董事長黃森煌開心受獎，並呼應行政院長毛治國給受獎廠商「不做第一，要做唯一」的鼓勵，指出原相發展物聯網、機器人市場，不追求與標準型感測元件拚量，而是提供特殊型感測元件，目前已往車聯網、智慧醫療布局。原相在去年的台北國際電腦展上被聯發科董事長蔡明介公開點名，指出CMOS感測元件的技術在物聯網時代將扮演最重要的「感知」角色，讓原相在IC設計中成為最夯的物聯網概念股。然而，挑戰也伴隨著機會而來，今年5月大陸北京清芯集團宣布，聯合了華創投資、中信資本、金石投資三家公司，預計將以19億美元收購美國CMOS感測元件廠豪威（OmniVision，OV），預計將在明年財務年度第3或第4季度完成，該收購案將成為大陸發展半導體產業在CMOS感測元件領域最有力武器，未來中資豪威也將是在物聯網、機器人等市場與原相短兵相接的競爭對手，更被業界視為原相未來的一大對手。在豪威確定被收購後，黃森煌昨日首度公開回應看法，他指出，對產業的影響仍待觀察，不過，競爭對手有充足的銀彈，對產業內任何競爭者都一樣，是增加了不小的壓力。他指出，原相思考出自己的利基點，相較於競爭激烈的標準型的感測元件，原相正朝向差異化設計發展，積極「做到唯一」，已在智慧醫療市場有了初步成果。原相完成與Avago專利授權協議，取得了完整的Optical Navigation Device完整專利權，研發團隊快速挺入懸浮觸控、手勢等感測技術，並已具備多種手勢功能的微小化手勢辨識IC，而且已推出心律感測晶片、血氧感測晶片，為其進軍機器人、智慧醫療市場的立下基石。

 

永信 李天德醫藥獎 院長/院士 加持 !

永信李天德醫藥科技獎 2015年05月22日 04:10 李盛雯／台北報導 深耕10年，財團法人永信李天德醫藥基金會「第10屆永信李天德醫藥科技獎」日前頒獎，副總統吳敦義連續6年到場，身兼生策會創辦人的立法院長王金平也致詞，國家衛生研究院長龔行健、科技部生命科學研究發展司長蔡少正、中央研究院院士吳成文、伍焜玉、陳垣崇、彭汪嘉康、劉扶東等人都出席。永信李天德醫藥科技獎是國內知名醫藥科技大獎，今年獲獎者包括卓越醫藥科技獎陳儀莊教授；青年醫藥科技獎黃東明、楊尚訓、劉浩澧與劉景平教授；傑出論文獎尤泰元、王壯維、李雅玲、袁維謙、莊琇珺、陳俞任、陳筱凡、陳啟寬、傅馨慧、楊舒婷。今年增設東南亞傑出論文獎，由兩位馬來西亞籍人士獲獎，分別是Ms. Thenapakiam Sathasivam與楊筱溧博士，兩人都從馬來西亞親自來領獎。卓越醫藥科技獎得主陳儀莊致力於A2A腺酸受體對神經退化疾病的調節機轉與治療策略發展探討，已有超過25篇著作發表，被引用次數很高。她證實在漢丁頓舞蹈症中，A2A是關鍵的腺酸受體。她與合作團隊發展出一種具潛力藥物可刺激A2A，研究獲美國、台灣與大陸專利，不侷限於基礎科學範圍，更延伸到醫藥開發應用，並發展為臨床前研究，將對國內藥物科技發展做出貢獻。走過10年，得獎者的研究領域範圍更加深入且擴大，今年論文涵蓋神經退化疾病如亨丁頓舞蹈症、阿滋海默症、漸凍人、血液、抗癌標靶新藥等，若能順利做成新藥上市，將造福許多病人。基金會董事長李芳裕表示，疾病與藥品無國界，自第9屆增加Y.S.P. SAH傑出論文獎後，獎勵範圍更擴大，廣納世界各地人才，提升台灣醫藥科技水準、逐步國際化。繼創辦人李天德的無界花園之後，當初創立時就想要籌建的永信醫藥文物館也將在今年開館，希望藉由史料與文物展示推廣藥品訊息，提供社會大眾醫藥參考平台，記錄台灣醫藥發展。

合世生醫 檢調調查 (重訊說明104/05/14 & 104/05/18)

1.事實發生日:104/05/18 2.公司名稱:合世生醫科技股份有限公司。3.與公司關係[請輸入本公司或子公司]:本公司4.相互持股比例:不適用。5.傳播媒體名稱:不適用。6.報導內容:不適用。7.發生緣由:104年5月14日檢調單位至本公司調查一事做進一步的說明。8.因應措施:關於民國104年5月14日檢調至本公司調查一事，係因有李姓高階主管被指稱於二年前涉有內線交易嫌疑。此係其個人之行為與本公司無關，不影響本公司之財務、業務。9.其他應敘明事項:無。

1.事實發生日:104/05/14 2.公司名稱:合世生醫科技股份有限公司。3.與公司關係[請輸入本公司或子公司]:本公司4.相互持股比例:不適用。5.傳播媒體名稱:不適用。6.報導內容:不適用。7.發生緣由:檢調單位於104年5月14日至本公司進行調查,本公司全力配合司法調查。8.因應措施:無。9.其他應敘明事項:對財務,業務無重大影響。

 

合世 投入智慧運動表 彌補 霧化器FDA回收衝擊

合世跨足穿戴 推運動表 2015-03-30 00:38:40 經濟日報 記者高行／台北報導 醫材大廠合世（1781）旗下篩孔式霧化器儘管遭美下令回收衝擊，但公司近期積極跨入穿戴式裝置，推出結合雲端功能的運動表搶市，成為國內首家進軍穿戴式醫材的業者，同時，其霧化器產品在美回收期進入尾聲，有望重啟獲利動能。合世2012年營收衝破13億，締造七年來歷史新高，主要是旗下篩孔式霧化器通過美國食藥局（FDA）核准在美上市，搭配當地大型藥廠呼吸用藥全美鋪貨，銷售高峰一度月出10萬台，但後因發生噴孔鬆脫鬆脫事件遭FDA要求進行自主回收，業績因此遭受衝擊，前年營收仍維持13億元以上水準，而去年則幾近腰斬。不過，合世在霧化器產品暫時失利後，除靠原本在市場占據一席之地的血壓計支撐外，公司團隊積極進軍目前最夯的穿戴式領域，近期推出內建運動程式的功能表款，已在國內醫療院所小量鋪貨，後續將推出系列產品搶攻國內外健康照護市場。合世表示，該款運動表和市面一般僅具計步、測量心跳的裝置不同，最大亮點為其內建程式由專業醫師建構，運用不同的程式組合，指導使用者在最短時間內達到最佳的卡路里消耗和心肺運動效果，主要為減肥和運動族群量身訂製，可說是目前市面上的獨門產品，在先前舉行CES展中受高度矚目。法人指出，合世藉由新推運動程式表成功卡位穿戴裝置領域，並結合無線傳輸等物聯及雲端技術，以該公司強大的研發能力觀察，後續將結合本身在血壓和血糖測量等優勢，進行進一步產品升級，有機會成為業績爆發的祕密武器。再者，該公司高毛利的霧化器產品在美回收期已進入尾聲，最快有望在年中前截止，由於和既有藥廠有合作基礎，屆時將重新展現出貨力道。合世表示，除等待FDA回音，現階段正積極和對岸醫療院所尋求合作機會，將霧化器產品推進對岸市場，拓展在美國以外的市場空間。據了解，合世研發的篩孔式霧化器可調整藥物濃度劑量，預期後續愈來愈多藥品採吸入式給藥方式。

帝寶生醫(合世) 品牌練兵 (免費血糖機 帶 藥物霧化器)

建立自有品牌合世成立帝寶生醫自由時報自由時報–2013年11月25日上午6:11記者陳永吉／台北報導合世生醫（1781）積極切入自有品牌領域，去年底成立的帝寶生醫，以銷售血糖計、血壓計及霧化器為主；帝寶總經理方欽瑩表示，目前每個月營收約為2百萬元，現在主要以台灣為根據地。方欽瑩表示，帝寶生醫產品線包括有血糖機、血糖試片、耳溫槍、血壓計及霧化器，其中以血糖機及血糖試片的銷售比重最高，公司產品則由母公司合世代工，未來也不排除到東南亞找代理商，銷售帝寶產品。方欽瑩指出，合世研發的霧化器具有專利，全世界僅歐姆龍有生產類似產品，帝寶現在已取得中國的銷售證照，且已開始銷售，至於台灣的銷售證照，也於日前取得，計畫年底前上市銷售。方欽瑩說，帝寶生醫的目標，就是希望把最先進的醫療器材、健康服務推廣至各級醫療院所及每個家庭，結合預防醫學並增進人類健康，以回饋、關懷、服務、感恩為核心價值。帝寶為合世百分百持有的公司，由於今年合世主力產品霧化器因為銷美產品有少數零件脫落，客戶停止下單，業績大受影響，並提列回收產品的損失，切入自有品牌不失為另一個開創業績的途徑。

帝寶生醫靠獨門祕器勇闖品牌路2013-12-1012:30【財經事】帝寶生醫靠獨門祕器勇闖品牌路/林哲良先打知名度，下一步再衝業績經營品牌對台灣廠商而言，一直是相當辛苦的路。帝寶生醫在掌握關鍵技術下，透過全球僅三、四家廠商具備生產能力的藥物霧化器，楊國和期待能藉此立足品牌市場。上櫃醫療器材廠商合世生醫，去年靠著搶攻藥物霧化器代工訂單，繳出不錯的獲利成績。儘管手握金雞母，但董事長楊國和為了讓公司營運體質更健康，切入自有品牌領域耕耘，找來曾任高中老師的方欽瑩擔任合世轉投資公司帝寶生醫總經理，希望以台灣為根據地，逐步落實合世的品牌夢。合世旗下的產品包括血壓計、耳溫槍、血糖機與測試片等，方欽瑩選擇以血糖與測試片做為第一波主打產品，讓資本額僅五百萬元、月營收二百多萬元的帝寶生醫，直接與羅氏、嬌生、拜耳及亞培等四家國際大廠硬碰硬。全球血糖機與測試片產值約一百億美元，其中將近九成的市場由羅氏等四大品牌廠商所壟斷。除了仿效大廠耕耘一般的醫療器材及醫院通路，方欽瑩計畫與便利商店合作，藉由提供免費的血糖機，希望快速打響帝寶生醫（Tipocare）的知名度，力求在大廠夾擊下殺出一條血路。血糖機市場相當封閉，不同廠牌的血糖機試片並不能互相應用。換句話說，消費者若使用帝寶生醫的血糖機，就必須採用帝寶生醫的測試片。因此，雖然大方地送出機器，但若消費者願意試用，即可從測試片上逐步回收機器成本，對一個品牌後進、弱勢者，不失為搶市巧思。其實，血糖機與測試片只是帝寶生醫在品牌市場「練兵」工具之一，對楊國和而言，藥物霧化器或許才是帝寶生醫進軍醫療器材品牌市場更有利的武器。合世所生產的藥物霧化器有專利，全球僅有三、四家廠商具備生產能力，若能避免品牌業務干擾代工訂單，拓展相關產品的阻力相對較小。帝寶生醫的藥物霧化器已取得中國的銷售證照，並開始銷售；台灣部分也已取得主管機關的銷售許可，據瞭解，今年底、明年初就可以在台灣銷售。對於帝寶生醫而言，藥物霧化器成功與否，將是其在品牌市場能否立足的關鍵。

 

海峽生技医薬品の風雲: 帝寶生醫董事長: 李紹弘楊國和

王雪紅 挖角 合世研發主管: 游山逸

300億美元吸入劑商機 大家搶 2015年01月26日 04:10 記者杜蕙蓉／台北報導 搶進吸入劑藥器廠商 在氣喘等慢性阻塞性肺病已成全球前三大致死疾病下，高達300億美元吸入劑呼吸用藥也成新主流，吸引科技、製藥、通路商大搶灘。除了益得已取得2張藥證並獲健保價外，微邦也給合康聯、保瑞開發新藥，並規劃2015年向台灣、大陸、美國等市場申請IND人體臨床。此外，去年宏達電董事長王雪紅挖角合世研發主管游山逸，目前是以開發穿戴裝置，結合智慧型手機為主，未來是否跨進吸入劑醫材也備受關注。被譽為是繼隱形眼鏡後，第二波醫材廠和科技業最想跨進的吸入劑相當熱門！包括合世、雃博、泰博、微邦、訊映等都紛紛佈局；其中霧化器，更因應用面廣泛，除了最普遍應用於呼吸科用藥和美容保濕外，篩孔式霧化器更因可調整治療的藥物濃度與劑量最為聚焦。微邦董事長孟憲鎧表示，公司已建立微米級霧化產品應用平台，可適用於非氣管藥物，例如抗生素或可混合多種藥物治療，因此，目前也有癌症用藥廠洽談研發中。康聯執行長李欣表示，根據專業市場研究機構Transparency Market Research分析，藥械合一已成醫療市場的主流趨勢之一，預估2019年藥械合一市場產值將有超過1,150億美元的規模，而霧化器結合新藥的治療模式更受矚目。例如輝瑞推出的胰島素藥品就是結合醫材，而去年拿到美國FDA藥證的Mannkind，開發藥械合一的吸入式胰島素，更以10億美元授權大廠賽諾菲，目前市值超過25億美元。根據統計，國內目前至少有8家廠商投身吸入劑藥品市場，進度最快的是健喬轉投資的益得生技，該公司是唯一同步掌握MDI（定量噴霧吸入劑）與DPI（乾粉吸入劑）關鍵技術的劑型開發廠商，已有2張呼吸科用藥藥證和健保價，另外，也有2項新藥符合向FDA申請新藥；其中1項將搶首仿學名藥（First Generic）；另1項則為全球新藥。而合世、微邦共同開發的霧化器，算是國內最早商品化的產品，該霧化器3年前成功取得美國FDA認證後，並獲美國藥廠採購，搭配呼吸用藥行銷，不過，後來因噴孔片鬆脫事件進行回收，才導致合世營運不如預期。

台原藥 今起每60分鐘撮合

 2015年05月22日 04:10 記者高碩圻／台北報導 櫃買中心昨（21）日說，台原藥（4415）最近30個營業日內曾發布處置，又因連續3個營業日達櫃買中心公布或通知注意交易資訊暨處置作業要點第四條第一項第一款，經櫃買中心公布注意交易資訊，自今（22）日起10個營業日改以人工管制之撮合終端機執行撮合作業，約每60分鐘撮合一次。另外，依櫃買中心業務規則第12條規定，各證券商於投資人每日委託買賣該有價證券，應就其當日已委託的買賣，向該投資人收取全部的買進價金或賣出證券，且採分盤交易方式。但違約專戶委託買賣該有價證券時，不在此限。