TFDA: Avastin合併paclitaxel治療metastatic breast cancer效益大於風險!

食品藥物管理局說明維持「Avastin（bevacizumab）」用於治療轉移性乳癌之適應症 (TFDA發布日期2011-07-01) 針對美國食品藥物管理局建議移除Avastin（bevacizumab）用於治療乳癌之適應症乙事，台灣食品藥物管局已請廠商提供對於治療乳癌之相關臨床試驗資料，進行療效再評估作業，並於今（100）年6月1日召開藥品諮議小組及藥品安全評估委員聯席會議討論。依據上市後臨床試驗的資料顯示，雖在轉移性乳癌病人的整體存活期(overall survival，OS)並無統計上有意義的延長，但對於無疾病進展存活期(progression-free survival，PFS)達統計意義，顯示仍有臨床上的效益。故聯席會結論維持該藥品原來的適應症，但廠商需提供風險管理計畫書(risk management plan，RMP)，內容應包括：充分病人用藥資訊(包含藥品之療效及風險資料)，以加強對於此藥治療患者的風險監控。歐盟於去（99）年12月16日亦發表新聞稿，表示avastin合併paclitaxel治療metastatic breast cancer (mBC)之效益大於風險，並於今（100）年2月28日作出決議，維持原核准Avastin 併用paclitaxel作為轉移性乳癌第一線治療用藥之適應症。「癌思停Avastin（bevacizumab）」是一種抗血管內皮生長因子(VEGF)的單株抗體，台灣食品藥物管局(TFDA)所核定之適應症為「轉移性大腸直腸癌(mCRC)：Avastin與含有irinotecan/5-fluorouracil/leucovorin或5-fluorouracil/leucovorin 的化學療法合併使用，可以作為轉移性大腸或直腸癌患者的第一線治療。Avastin與含有5-fluorouracil/leucovorin/oxaliplatin的化學療法合併使用，可以作為先前接受過以fluoropyrimidine為基礎的化學療法無效且未曾接受過Avastin治療的轉移性大腸或直腸癌患者的治療。轉移性乳癌(mBC)：Avastin與paclitaxel合併使用，可以做為HER2 (-) 轉移性乳癌患者的第一線治療。說明：1. Avastin與paclitaxel併用在治療轉移性乳癌患者之療效，僅在無疾病進展存活期方面可達統計上顯著優於paclitaxel單獨使用，目前並無以整體存活期為主要療效指標之臨床試驗證實Avastin與paclitaxel併用延長整體存活期之效果。2. Avastin不適用於經anthracycline及taxane治療轉移性乳癌又出現疾病進展的病患。惡性神經膠質瘤(WHO第4級) - 神經膠母細胞瘤：Avastin 單獨使用可用於治療曾接受標準放射線治療且含Temozolomide 在內之化學藥物治療失敗之多型性神經膠母細胞瘤(Glioblastoma multiforme)復發之成人患者。晚期、轉移性或復發性非鱗狀非小細胞肺癌 (NSCLC)：Avastin 與carbolatin及paclitaxel合併使用，可以作為無法切除的晚期、轉移性或復發性非鱗狀非小細胞肺癌患者的第一線治療。」

(Taiwan) Forum discusses Taiwan's role as springboard to China and other Asia-Pacific biomedical markets

(BiotechEast)1 July, 2011 Held a day before the annual Biotechnology Industry Organization (BIO) convention, concluding this week in Washington DC, a forum took place June 26 in Rockville, Maryland, examining Taiwan's strengths in biosciences and its unique position as a stepping stone into China and emerging Asia-Pacific markets for US and European firms. Attended by over 200, the forum entitled 'The Biotech Business Potential of Taiwan as a Springboard to Asia-Pacific' featured presentations by Taiwan industry and government representatives as well as US company executives with first-hand experience with Taiwan. The forum's keynote speech, entitled 'Taiwan Biotech Strategies', was given by Dr. Cyrus C.Y. Chu, Minister without Portfolio, The Executive Yuan, Taiwan. Chu first explained that Taiwan's niche is in developing upstream R&D. "But we need to bridge the gap between academia and industry, as many of these inventions do not get to the downstream process value adding chain," he added. "So, after consulting with invited industry experts, we decided to focus on the so called 'second runner' stage, from patent development through to clinical Phase II. Because Phase III is so costly, we'll leave that to Big Pharma." This and other industry development strategies, including a new large scale venture capital fund and startup-assistance services, all part of the government's new 'Diamond Action Plan for Biotech Takeoff' were further explained by Chu and others during the forum as a way of leveraging Taiwan's strengths, with benefits for both Taiwan companies and overseas collaborators. Dr. Jeff Wang, President of the Taiwan's Development Center for Biotechnology (DCB), talked about recent biomedical collaborations between Taiwan and global companies as well as Taiwan-China collaborations, and the attraction of China to Western pharma companies. "Pharmaceutical market growth rate is around 14-16 percent for developing countries, but for more mature markets only 1-3 percent. For China, the growth rate is over 20 percent. That's why Western companies come East; market expansion, cost-effective drug manufacturing, and a large clinical patient population. And East needs West's help, as it needs new innovation technology to develop new drugs," he explained. And with the landmark Economic Cooperation Framework Agreement (ECFA) bilateral trade accord between Taiwan and China, signed in 2010, comes the prospect of regulation harmonization and what it will bring to the table. "We work with lots of US companies," said Dr. Benjamin Chien, CEO of services firm QPS Holdings, USA. "We say that Taiwan has good qualities, but these companies all have their eyes on China. It's hard to convince them to look at Taiwan. But clinical trials in Taiwan are so superior, and with ECFA [regulatory harmonization] in place, once a company knows that study data conducted in Taiwan will be accepted in China, they will look to Taiwan because the risk will be much lower." Industry consultant and one of the forum's featured speakers, Dr. Whaijen Soo, elaborated. "Where and who you can trust but still have the access to China, to East Asia? I can tell you that it's Taiwan. It's not the only alternative, but it's the strongest alternative to develop and launch products in China." What about long-standing political differences between the Republic of China (Taiwan), and the People's Republic of China? Will these differences ever be reconciled enough to enable such smooth business cooperation? Dr. Joe Harford, in charge of international affairs at the National Cancer Institute, USA, talked on this issue from his unique perspective, being responsible of putting together 'health diplomacy' cancer research initiatives. These included projects involving Cyprus, Turkey, Jordan and Israel; and a long-standing project involving Ireland and Northern Ireland. "There's an Arab quote: 'The enemy of my enemy is my friend.' If we can recognize that cancer is our common enemy, then there's a lot that we can do together, even in areas where political tension may exist," he explained. This could be the model for Taiwan-China collaborations, he posited. And with the National Cancer Institute hosting both post-doc researchers from China and Taiwan, there's added possibilities. "The NCI has about 1,000 visiting research fellows a year. China is now the number one provider of researchers from outside US with 181. There are also 13 from Taiwan. To date, there has not been a systematic attempt to bring these two groups together. One of the things that I would suggest is working with these future scientists together that are already working in NCI labs," he said. And with cancer a research specialty among Taiwanese, it seems a good fit, he added. The Taiwan government has been working on its own initiatives as well. DCB Chairman Dr. Johnsee Lee mentioned that recent reduced corporate tax rates have made Taiwan's business environment more attractive for foreign investors. "Corporate income tax has been reduced from 25 to 17 percent. Also a reduction in asset and gift tax, from 50 to 10 percent, both major tax reductions that will encourage investment in Taiwan." Lee also praised the consistently strong and positive support the government has given to the biotech industry in recent years. Christopher Linthwaite, President, Bioproduction Business Platform, of services provider Life Technologies, USA, and one of the featured speakers at the event, also praised Taiwan's comparative advantages. "Taiwan's strengths are in its education levels, employee talent and easy access to the service support ecosystem," said Linthwaite. While he also applauded recent tax reductions and gave high marks to the government for its industry support, Linthwaite added that comparative advantage can be eroded over time, and Taiwan still had to find its niche within the biosciences. "Look for opportunities that are not apparent. For example, information management, the convergence of biology, chemistry, nanotechnology. We don't know how these will develop. But these will create new industries that don't exist today, new value propositions that don't exist today. Look to the future and find a new space that will carve out Taiwan's role as part of the global network that is required to make the biotech industry successful." Highly relevant to the theme of this forum, Dr. Ming-Chu Hsu, CEO of TaiGen Biotechnology, explained how TaiGen runs a model that ties in Taiwan and China with global pharmaceutical companies. Headquartered in Taipei, Taiwan and with a subsidiary in China, as well as developing its own NCEs TaiGen also in-licenses early stage drug candidates from overseas, taking them up to Phase III trials before out-licensing them to Big Pharma for further development and marketing in the West, with TaiGen keeping China market rights. "TaiGen's key value is we have a very innovative pipeline with full IP protection, highly productive discovery scientists, and a clinical team that can conduct multinational trials. In China we can conduct trials and get into the local market faster and with much less cost [than other companies can]," Hsu said. "Our vision is driven by the global market," she concluded. The forum was also the venue for the signing of Memorandums of Understanding (MOU) between the Development Center for Biotechnology and three US companies. The first with Life Technologies, was for a joint initiative to set up for a biomanufacturing training center in Taiwan, with Life Technologies providing planning and consulting services for the project. MOUs with Contract Research Organizations (CRO) Ricerca Biosciences and QPS Holdings were also signed, both for the promotion of CRO services within Taiwan.

微整形減痛玻尿酸!

減痛配方凝膠式玻尿酸上市 2011/07/02 【經濟日報】玻尿酸注射是目前最夯的微整形項目，但是哪一針下去，八成以上痛到立刻飆淚，尤其是嘴唇，更是痛到最高點。目前最新的玻尿酸內含微量麻藥，這種「減痛配方凝膠式玻尿酸」，讓玻尿酸注射正式進入「新減痛時代」。而另外一家市占率更高的玻尿酸品牌，也有這種減痛配方的玻尿酸，目前還未取得許可證，未來加入戰局後，市場競爭會更加白熱化。

乾眼症影響近視雷射與白內障手術的效果!!

國內首屆AOC眼科醫學年會建立眼科醫學交流平台 2011/07/02 經濟日報由中華民國眼科醫學會與愛爾康大藥廠共同合辦的AOC（Alcon Ophthalmological Congress）眼科醫學年會，日前在台北舉行。由於此次是由國內眼科醫界與藥廠首度攜手舉辦的眼科專業研討會，加上由重量級眼科醫師發表白內障手術、技術，以及乾眼症治療趨勢等議題，吸引超過200 名菁英眼科醫師參加，成為國內眼科界一大盛事。中華民國眼科醫學會理事長林浤裕表示，此次研討會是眼科醫學會首度與藥廠合辦，藉由會議創造一個眼科專業溝通互動的平台，主要是藉由資深眼科醫師，將各項眼科技術與經驗，分享給年輕一輩的眼科醫師，讓與會的醫師能夠交流最新的眼科醫療資訊以及彼此的醫專業經驗，激盪出更多眼科醫療新概念與更進步的醫療方法。他也認為眼科醫學會能夠與愛爾康這種世界頂級的眼科藥廠合作，是一次相當難得的經驗，希望未來還有合作的機會，甚至邀請國外眼科專家參與研討會，提供國內眼科醫師更多與國外專家交流的機會。愛爾康藥廠總經理許鴻麒表示，愛爾康是全球眼科的領導品牌，擁有眼科專業領域的豐富經驗、雄厚的研發基礎，以及充沛的資源，不斷發展最先進的眼科醫療產品。藉由舉辦此次專業研討會議，讓愛爾康與眼科專家共同為台灣眼科醫療發展而努力。他強調，過去愛爾康藥廠連續幾年舉辦大型的「全民護眼」系列活動，讓民眾能夠更重視眼睛的健康議題。在既有的基礎下，愛爾康藥廠未來將加強與專業眼科醫師的對話， 今年首屆AOC眼科醫學年會會議內容涵蓋青光眼、乾眼症、白內障、人工水晶體等12項研討主題。其中，奧斯卡眼科診所院長張正忠以評估白內障患者手術後植入訴求「降低艷陽中紫外線、高能量藍光」黃色人工水晶體的術後效果，發表專題報告，內容包括保護視網膜以及對於視覺的影響性。張正忠指出，人類天然水晶體具有過濾高能量波長藍光的能力，一旦經由白內障手術移除後，讓眼睛更容易受到光害影響。因此，白內障術後的防曬保護，成為眼科醫界聚焦重點，有「植入式太陽眼鏡」之稱的黃色人工水晶體，就是近年來許多白內障患者的首選。他表示，最新研究報告顯示，黃色人工水晶體不但有降低光害、保護視網膜的功能，在白內障手術後常見的眩光增加後遺症的問題上，黃色人工水晶體也優於不具光保護功能人工水晶體，在視覺品質與視覺表現上都很好。台北馬偕醫院眼科主治醫師鄭惠川針對「乾眼症對於眼科手術效果的影響性」進行報告。他說，以往醫界對於乾眼症的認知，多半認為是造成病患生理上的不適，主要包括眼睛乾澀、異物感、疲勞、紅癢、流淚不止、嚴重者眼睛發炎等症狀。最新醫學研究證實，乾眼症不只造成生理上的不舒服，還會影響病患的視覺品質。研究還發現，乾眼症同樣也會影響到眼科常見的手術-近視雷射與白內障手術的效果，乾眼症的病患如在手術前先進行乾眼症治療，病患對於術後視覺品質與手術結果都有較高的滿意度。

台灣防疫工作: 衛生福利部疾病管制署!

防治愛滋 疾管局推友善同志標章  2011/7/1疾管局 1日舉辦12週局慶，並宣示降低愛滋感染率，將推動男同性戀三溫暖友善環境計畫，與業者合作提供保險套，降低危險性行為。台灣愛滋病人口逐年增加而且有年輕化趨勢，根據疾病管制局的統計，台灣目前約有2萬名愛滋感染者，其中男男性行為的危險性最高。因此，疾管局計畫在公共營業場所推動友善同志標章，提供免費保險套，強調使用保險套一次不能少，期望能降低40%的危險性行為。根據疾病管制局的統計，台灣目前通報愛滋病感染者有20,057名，且每年約新增2000名，但只有不到1萬人接受治療，疾管局預估，如果再加上隱匿人數，全台愛滋感染者將高達3萬人，一旦全數接受治療，初估1年將花上新台幣100億的經費預算。因此，疾管局除了呼籲接受治療外，也預計從8月開始在5都的三溫暖試辦「男同性戀三溫暖友善、健康、安全商店標章計畫」。疾管局表示，根據世界衛生組織(WHO)的研究，男男同性間發生的性行為比一般人約有20倍的愛滋病風險，因此計劃在公共營業場所提供方便易取得的保險套，強調保險套的使用一次不能少，也期望藉此計劃能降低40%的危險性行為。疾管局組長楊世仰表示：『(原音)我們會營造一個同志友善的場所，提供足量的保險套，也做必要的篩檢諮商的協助，那警察方面我們也有去拜會，那警政署他們現在答應說，只要是同志出沒的比較多的，本來就不是他們查緝的一個重點，他查緝的主要還是一般的，所以對同志其實我們國家算是滿friendly。』疾管局1日舉行了12週年的局慶，首任疾管局局長張鴻仁也特別到場祝賀，張鴻仁表示，台灣的防疫工作近年來有長足進步，在國際上也享有知名度，但是防疫工作首重謙卑，必須日日如臨深淵。明年疾管局將升格為「衛生福利部疾病管制署」，也期盼台灣的防疫工作再升級。