Thursday, November 29, 2012

醣聯 單株抗體庫 !!!


台灣醣聯12/18上櫃 手握3核心平台 年年賺錢 鉅亨網記者張旭宏 台北2012-11-29 19:51:17 抗體新藥廠台灣醣聯(4168-TW)敲定1218掛牌上櫃,掛牌價暫訂105元。公司第四季技術顧問及人體臨床授權金入帳下,維持第2年賺錢,未來將持續掌握前期新藥開發平台、抗體篩選及抗體量產平台等三大核心平台,持續獲利。台灣醣聯成立於2001年,董事長張東玄專精於醣質領域研究已超過40年,善用國際資源,積極引進具前瞻性學識及技術,使得公司成立短短數年間即建立完整的抗體藥物平台及多樣化的單株抗體庫,由於擁有前期新藥開發平台,成為全球大藥廠積極尋求合作的對象;此外更以優異的抗體篩選與量產平台,提供國際大藥廠抗體新藥技術服務,協助其加速抗體藥物開發的時程。此外,台灣醣聯輸出完整的抗體量產平台,除技術移轉金的收入外,上下游量產的整合效應將相當可觀,因此三大核心平台推動醣聯走出台灣、授權國際製藥大廠,與世界生技接軌。台灣醣聯以具有原創性的標靶藥物站上世界製藥舞台,2009年以1.96億美金的階段授權金和新藥上市後12%的銷售回饋金,把用於治療大腸癌的醣質單抗GNX8在進入臨床試驗之前便授權日本大塚製藥廠,預估2016年市場規模可達116億美金。其他已有GNX101~104單抗新藥陸續開發。此外,台灣醣聯移轉建廠技術給日本的三菱瓦斯化學,輔導其建立抗體生產技術平台,除了挹注了562.5萬美金的技術移轉收入外,同時也形成了強大的國際策略聯盟,建立從上到下一貫性的單株抗體及蛋白質藥物開發鏈,可提供更高效率且低成本的量產技術。目前台灣醣聯擁有龐大的抗體資料庫,持續推進的研發技術在癌細胞機轉問題上取得了重要的突破,繼2009年授權治療大腸癌的醣質新藥抗體GNX8給日本國際大藥廠外,目前還有二株醣抗原抗體新藥GNX101/GNX102 開始洽談新藥授權的事宜,2013年可至少完成一項抗體新藥的授權,未來並維持每2-3年就有開發新藥與授權的進度。

 

全球高質量 學名藥代工 將持續升溫 !!


中美醫改加持,4生技股續夯 2012-11-30 【時報-台北電】中美新政府團隊上任,醫改政策加速推動,法人認為生醫產業仍是2013年的投資新亮點,原料藥、具外銷發展及新藥代工族群最具漲相,旭富(4119)、南光(1752) 、神隆(1789)、東洋(4105)業績和股價都有期待空間。富邦投顧認為,歐巴馬連任後,持續推行全民醫保,有利於台灣原料藥、學名藥及醫材代工廠商。而大陸政權交替後,也將延續十二五規劃的概念,預計加強科技研發、醫療制度及保險改革後,未來兩岸研發及市場開發合作將更密切。就基本面來,製藥產業積極尋求轉型,加上又有加入PIC/S會員國的加持,將推波藥廠明年起可積極爭取外銷訂單,而全球暢銷藥專利到期,在針劑類學名藥供不應求下,國內廠商紛紛投入布局,目前包括南光、東洋、健亞和杏輝都陸續傳出接單佳音。東洋除了紫杉醇成功外銷歐洲外,微脂體可望取得代工訂單,而轉投資智擎新藥PEPO2已成功對外授權,未來將成為獲利金雞母。南光年底癌症新廠即將落成,後續癌症、高規格針劑等新產品將啟動外銷成長動能,公司可望轉型為外銷導向針劑廠,明年外銷訂單展現頗佳。至於原料藥長期以來就是國內最具競爭力的族群,神隆、旭富、台耀目前都積極搶攻減肥藥市場,而中化生的除了MMF今年出貨量激增外,與母公司中化、美國上市藥廠Endo合作研發的免疫抑制劑Tacrolimus,預計明年出貨量應有不錯的成長空間,另外,生泰、永日的代工訂單也是穩定成長。富邦認為,原料藥為製藥產業的上游,受惠於全球專利藥到期趨勢,原料藥產業近年表現相對突出,神隆已有4項產品上市,5項產品在臨床三期試驗階段,旭富中間體客戶亦有減肥新藥成功上市,都讓明年營運相當看好。(新聞來源:工商時報─記者杜蕙蓉/台北報導)

 

 

美吾華: Good Distribution Practice, GDP


美吾華榮獲GDP績優廠商【聯合晚報╱記者徐睦鈞/即時報導】 2012.11.30 09:20 am 美吾華 (1731)2004年取得衛生署「優良藥品製造規範」GMP資格後,定期接受衛生署查核;昨再榮獲衛生署食品藥物管理局主辦之「藥品優良運銷規範」 (GDP)輔導性訪查績優廠商資格。美吾華為提升國人用藥安全,桃園工廠積極參與衛生署「藥品優良運銷規範」管理制度並接受輔導。衛生署近年來著手擬訂GDP管理機制,規劃相關推動方案,舉辦多次說明會與業者協商,美吾華公司深知提昇藥品運銷品質之責任重大,均積極參與,獲認證為績優廠商。「藥品優良運銷規範 (Good Distribution Practice, GDP)」為藥品品質管理重要的一環,為確保藥品儲存、運輸與配送過程中,品質及包裝完整性得以維持,使藥品品質管理制度完整涵蓋整個藥品生命週期,確保民眾用藥安全,不少國家已立法實施GDP。【2012/11/30 聯合晚報】

 

 

Wednesday, November 28, 2012

Big Pharma ups its game in providing drugs to people in poor countries

Wednesday 28 November 2012 07.00 GMT Pharmaceutical companies are doing more to help people in developing countries obtain the drugs they need, according to the latest Access to Medicines Index.Big Pharma appears to have concluded, after years of bad publicity and allegations that it was greedy and uncaring in pursuit of profit, that it needs to change its practices in the developing world – or at least public perceptions.While British drugmaker GlaxoSmithKline (GSK), whose chief executive Sir Andrew Witty has announced moves to increase access to medicines in the developing world, continues to top the league table, its lead on the rest has shrunk. Two other major pharmaceutical companies, Johnson & Johnson and the vaccine manufacturer Sanofi, are now close behind.The index ranks 20 leading pharmaceutical companies and is published every two years by the Netherlands-based non-profit Access to Medicines Foundation. It has become an authoritative guide, with input from the World Health Organisation, governments, universities, NGOs and institutional investors.Drug companies are scored on a range of measures, from their willingness to discount prices in poor countries, to research on neglected diseases of poor people to lobbying, transparency and conduct in clinical trials.This is the third index and it finds a much greater focus on drug access within drug companies – where it is now often an issue for the board."This year's index shows that companies are becoming more organised internally in their approach to access to medicine and that those who do this best tend to perform well across the other aspects we measure. The leaders are really raising the bar," said Wim Leereveld, founder of the index. "It's also clear that companies that do not continue to step up their efforts tend to be overtaken by their peers."Although there has been improvement and a greater willingness among companies to change their business practices, it is not yet enough. More companies are using tiered pricing – offering a discount for poorer countries – for a broader range of products, "but it is unclear whether the price reductions are enough to meaningfully increase affordability", says the report.Only five companies varied their pricing in 2010 but 12 did it this year. Yet they do not always disclose the full extent of the reduction nor take account of mark-ups by sales agents within a country. The best performer on tiered pricing is Gilead Sciences, which makes some of the leading Aids drugs. GSK has fallen to second place for a number of reasons, including reducing prices in fewer countries than Gilead.More companies are researching and developing medicines for diseases of poor countries. Some now have as much as 20% of their pipeline – drugs they are in the process of researching which one day will get to market – devoted to them.But there are concerns that Big Pharma is not demonstrating real influence over the private contractors it now increasingly uses to carry out drug trials in the developing world. No company is publicly transparent about all the Contract Research Organisations (CROs) it employs, says the report. The foundation says companies must ensure they hold these CROs to account for ensuring the wellbeing of volunteers in trials and conducting the trial scrupulously. Only four companies – Merck and Co, Sanofi, GSK and Eisai – provided evidence to show that they could and would use disciplinary measures to ensure CROs carried out trials in a safe and ethical manner."Access to medicine is a multi-faceted challenge and therefore responsibility for improving it lies with a number of different actors, but the pharmaceutical industry has a critical role to play. While the index shows it has made strides in many areas, companies that have sector-leading practices also show us there is more the industry can contribute," Leereveld said.

馬英九總統促產學合作


科技創新 總統促產學合作 (中央社記者李淑華台北28日電)總統馬英九今天說,台灣每一年要花58億美元購買外國的專利,可見在科技研發上還有努力空間;希望提升科技發展與產業結合。中國國民黨下午召開中央常務委員會,邀請行政院國家科學委員會主任委員朱敬一就「科技創新:台灣成長與希望的軌道」提出專題報告。兼任黨主席的馬總統聽取報告後表示,台灣每一年要花58億美元去買外國的專利,約合新台幣2000億元,「可見我們在科技研發上還有一些空間需要努力」。他說,經濟部已特別挑選十種基礎工業技術,分別結合工研院與各大學一起開發,希望將來把原來自己沒有的技術透過研發發展出來後,能夠取代進口的技術或專利。總統說,台灣相關產業的效率非常高,但創新略有不足,所以特別在就職典禮表示,希望能從效率導向轉移到效率導向加上創新導向。他說,世界銀行在2個月前所做的「知識經濟指數」全球評比,台彎排名全球第13名、亞洲的第1名;此外,高中生、科技大學學生到國外參加奧林匹亞等比賽,名列前茅,「這代表了我們自己本身創意、知識經濟並不差」。不過,馬總統說,就如同朱敬一所指出的,「我們的產學合作還有很大的努力空間,我們的發明、專利產業化,可以說還相差非常遠」,希望未來能進一步提升科技發展跟產業的結合。他說,12月將舉行「全國科技會議」,就每一個力有未逮的領域進行檢討。朱敬一的報告非常坦率,徹底將問題提出來,「這樣一個非常誠懇、而且務實的態度,值得肯定」。

 

alveice Team. Powered by Blogger.