Sunday, November 20, 2011
國際醫療添佳話 台大成功救治大陸罕病小女孩
超貴罕見疾病用藥eculizumab (Soliris) 考驗健保局智慧!!
美國撤銷Avastin治療轉移性乳癌 台灣仍評估中!!
食品藥物管理局說明含bevacizumab成分藥品用於與太平洋紫杉醇合併治療轉移性乳癌之情形 (TFDA發布日期2011-11-21) 美國 FDA 今日決定刪除 Avastin 用於治療轉移性乳癌的適應症。美國 FDA 表示,根據最新上市後研究結果,認為 Avastin 用於治療乳癌病人在效果上弊大於利。但 Avastin 藥品仍然可以使用,但限用於治療其他癌症 ( 包括 : 大腸直腸癌、 非小細胞肺癌、腎癌及惡性神經膠母細胞瘤等適應症 ) 。 針對美國 FDA 對該藥品的處理,食品藥物管理局曾於今( 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。依據當時所得國內外資料評估後認為,上市後臨床試驗的資料顯示,該藥品對於轉移性乳癌病人的整體存活期 (overall survival , OS) 的延長,雖無統計上的意義,但對於無疾病進展存活期 (progression-free survival , PFS) 卻達統計意義,顯示仍有臨床上的效益,因此維持該藥品用在與 paclitaxel 合併治療轉移性乳癌的適應症,同時要求藥商需執行風險管理計畫 (risk management plan , RMP) ,內容應包括:病人用藥資訊充 分告知病人接受該藥品治療的風險,以加強對於此藥治療患者的風險監控。食品藥物管理局已要求藥商須於下週二 (11 月22 日) 以前檢送目前最新於各國所進行之臨床試驗結果及全球核准情形予食品藥物管理局,食品藥物管理局將盡速彙整進一步資料,再評估該藥品在轉移性乳癌之臨床效益與風險效。食品藥物管理局已建立藥物安全資訊主動監控機制,除有藥物不良反應通報系統之外,對於安全有關訊息,隨時進行瞭解,以保障民眾之用藥安全,提醒醫療人員或病患懷疑因為使用(服用)藥品導致不良反應發生時,請立即通報給衛生署所建置之全國藥物不良反應通報中心,藥物不良反應通報專線 02-2396-0100 ,網站: http://adr.doh.gov.tw 。
中國4兆醫美商機 雙美與五洲集團合作
雙美生技通過上櫃審議 最快年底前掛牌 前3季獲利倍數成長 鉅亨網2011-11-18 膠原蛋白廠雙美生技(4728-TW),通櫃買中心上櫃審議會,最快年底前掛牌交易。公司前3季營收1.02億元,年增23%,毛利率提高年增4.39個百分點至78.14%,稅後淨利成長超過2倍達4652萬元,EPS0.94元。雙美生技目前實收資本額4.97億元,產品線可分為醫美用品及醫材,目前營收比重約6:4,前者主要為膠原蛋白植入劑,後者則為牙材及骨填料等耗材。雙美去年正式切入的醫療耗材方面,挹注今年相當大動能,年底前醫美產品及醫療耗材的營收佔比有機會達到各半。至於大陸市場,膠原蛋白植入劑早於2009年1月即取得中國大陸藥監局(SFDA)第三類醫材銷售許可,第二代產品強調有效期可從原半年延長至12-18個月,並可降低敏感度,已送大陸SFDA申請銷售許可,預計12月中獲准通過,明年開始貢獻營收。 日前雙美宣布與大陸五洲集團策略合作,雙方計畫合資,鎖定醫美、植牙及牙腔美容領域,搶食大陸達4兆醫美商機。由於五洲集團有通路,雙美則有醫材、技術,加上又拿到中國衛生部銷售許可證,是中國唯一可銷售膠原蛋白針劑的公司,合作之後會合資成立醫美據點,初期會先以植牙及牙腔美容等領域為主,未來再延伸至眼科、骨科等事業。
Taiwanese hospital helps Chinese patient with rare disease
砍藥價 但支持學名藥??!!
邱文達支持 學名藥繼續成長【2011/11/19 聯合晚報】國內進口藥商大動作抨擊中央健保局調整藥價之際,衛生署長邱文達今天出席「第一屆亞洲學名藥研討會」強調,近年來世界人口老化,各國醫療保健支出逐年攀升,推展學名藥已是全球趨勢,全民健保繼續採用學名藥已成為我們減少醫療支出的重要選擇。他這番宣示,無疑為下月調整全保藥價定調,我國藥價下修已成既定政策。
學名藥比率提高的影響 【2011/11/19 聯合晚報】衛生署長邱文達今早在「第一屆亞洲學名藥研討會」中宣示,未來我國健保採用的學名藥比率,應有合理成長的空間,此話一出在藥界引起陣陣波瀾,有人認為將擠壓到外國藥廠的生存空間,但也有人認為這是未來趨勢,不用太緊張。
Developments in pharmaceutical industry having ripple effects – PM
by Annaliza Borg 18 November 2011 Developments in the new, but growing, local pharmaceutical industry, are having ripple effects in the economy and the need to keep the highest quality standards is being reflected in enhanced transportation systems. The Ħal Far industrial estate, like a number of others, is currently being embellished as roadworks and landscaping are under way in a €17 million investment project by the Malta Industrial Parks. Prime Minister Lawrence Gonzi, together with Finance, the Economy and Investment Minister Tonio Fenech, yesterday visited Siegfried Generics, which opened shop in Malta four years ago, employing 20 people. It has invested constantly and by 2009, the number of employees went up to 39. This doubled to 80 this year and the plan is to have another 20 people employed by 2013, when an extension at the back of the factory, will be completed. The company made some €6.5 million in revenue by the end of last year and has invested €23 million. The next expansion project will see an investment of another €7 million. The building will be in the form of a tower double the height of the existing factory and will include a new warehouse, offices and labs. Siegfried Generics employs 700 worldwide and started in 1873. Its headquarters are in Switzerland but has branches in the USA and in Malta. It also has joint ventures in China and Taiwan. It concentrates on the development and manufacturing of active pharmaceutical ingredients (API) and intermediates, as well as drug products. The Malta facility this year has achieved FDA approval for High-Potent process, validation of equipment and process for capsule filling. Dr Gonzi said the company employs people ranging from lab technicians to operators who have qualifications starting from O-level and A-Level standard, and then they are further trained by the company. Therefore, a variety of talents is sought. It is obvious the company is being successful because it is expanding to be able to stock more. The visit at this company has taken place three days after the budget, Dr Gonzi noted. Results it achieved are a product of measures undertaken in the past three budgets that will be consolidated next year. One of the company's challenges is to find human resources academically prepared for the field of specialisation. Dr Gonzi said the problem here, contrary to what is happening in other countries, is that we need more people, and employees to specialise in new industries like the pharmaceutical and financial services sectors. Since developments are also planned for the biomedical industry, with the building of the new biotechnology centre starting soon, students will need to specialise in this field as well. Sir Christopher Evans, owner of 40 companies, will be an ambassador for the centre and will help attract investment to Malta. A €200 million fund has been established for this reason.
Polaris Group to Build Factory in Taiwan to Produce Anti-Cancer Drug
2011/11/17 Taipei, Nov. 17, 2011 (CENS)--Polaris Group of the United States, a privately held multinational biopharmaceutical company specializing in research and development of protein drugs to treat cancer and other debilitating diseases in humans, plans to set up a new protein-injection factory in Taiwan for total investment of about US$50 million. The factory will mass produce Polaris Group-developed ADI-PEG 20 products, with targeted annual production value of about US$2 billion. ADI-PEG 20 is a biologic being developed by Polaris to treat cancers carrying a major metabolic defect that renders them, unlike normal cells, unable to make arginine internally. A reinvested company of Taiwan-based Hsin Tung Yang Corp., Polaris recently signed an investment memorandum of understanding (MOU) with the Hsinchu County Government. According to Polaris, its ADI-PEG 20 has been identified by the U.S. Food and Drug Administration (FDA) as an orphan drug, a pharmaceutical agent that has been developed specifically to treat a rare medical condition; and the new drug has completed Phase 2 clinical trial in Taiwan, proving its lower side-effects than counterparts. ADI-PEG 20 is advancing into a pivotal Phase 3 trial, while Polaris is also investigating ADI-PEG 20 as a treatment for other cancers, such as metastatic melanoma, prostate cancer, leukemia, lymphoma, sarcoma and pancreatic cancer. Polaris estimate the new drug can pass the Phase 3 trial and win the FDA certification in the second quarter of 2014. Hsin Tung Yang, the largest shareholder in Polaris with a 37% stake, has over 90% of its shares held by local investors as domestic banks, enterprises, venture capital firms, and government units. Polaris plans to kick off factory construction in the second quarter of 2012 and complete it by the second quarter of 2014, with help from its Taiwan affiliate TDW Pharmaceuticals Inc. To facilitate the factory construction, TDW Pharmaceuticals is scheduled to raise initially by the yearend about US$20 million.
癌症篩檢與美髮業結合!!
Taiwan's Q3 pharmaceutical exports up 6.2 percent
Central News Agency 2011-11-19 Taipei, Nov. 19 (CNA) Exports from Taiwan's pharmaceutical sector for the third quarter of this year rose 6.2 percent from a year earlier to total NT$3.42 billion (US$113 million) on the back of rising demand for western medicines, a government report said Saturday. According to the report released by the Industry and Technology Intelligence Service (ITIS), exports of Taiwan-made western medicines in the three month period rose 11.0 percent from a year earlier to NT$1.72 billion. The ITIS is a research institute of the Department of Industrial Technology under the Ministry of Economic Affairs. The report said exports of active pharmaceutical ingredients (APIs) from Taiwan rose 1.3 percent from a year earlier to reach NT$1.58 billion, while the island's exports of Chinese medicines rose 9.1 percent year-on-year to NT$120 million. Meanwhile, Taiwan's pharmaceutical imports during the July-September period rose 7.5 percent from a year earlier to NT$17.97 billion, the ITIS said. Imports of western medicines during the same period rose 7.2 percent from a year earlier to NT$16.53 billion and imports of APIs rose 10.9 percent to NT$1.43 billion, while imports of Chinese medicines fell 2.9 percent to NT$10 million, the report said. The ITIS said pharmaceutical exports will continue to grow no less than 10 percent for the whole of this year, while overseas sales of western medicines will enjoy the highest growth. For the entire year, the report estimated Taiwan's pharmaceutical exports would reach NT$13.19 billion, up 12.5 percent from a year earlier, while exports of western medicines and APIs are expected to rise 24.9 percent and 1.5 percent year-on-year to NT$6.63 billion and NT$6.61 billion, respectively. In terms of imports, the ITIS forecast the value for 2011 is expected to rise 4.3 percent from a year earlier to NT$68.51 billion. Imports of western medicines for 2011 are expected to grow 3.5 percent from a year earlier to NT$62.96 billion and API imports are likely to rise 6.6 percent to NT$5.51 billion, while imports of Chinese medicines may fall 42.2 percent to NT$40 million, the ITIS said.
生醫股搶掛牌 比價可期
諾華於南台灣醫學中心….
台灣藥廠的日本佈局!!
台耀營運調整 提升醫療原料藥!!
台耀本季營收 衝新高 【2011/11/21 經濟日報】台耀18日股價以76.7元作收,下跌2.4元;該公司今年前三季稅後純益約1.77億元,每股稅後純益為2.69元。法人表示,台耀因第三季認列匯兌收益,挹注營運近3,000萬元,登上了原料藥族群獲利王寶座,一洗第二季因出貨延遲的陰霾。 台耀目前的兩大領域產品為防曬系列活性成分及原料藥,其中防曬系列活性成分仍占公司營收比重逾六成,主要供貨給荷蘭最大防曬原料供應藥廠DSM。此外,由於該公司今年開始調整庫存水位,明年下單間距將縮短,出貨成長率轉趨保守。 法人表示,荷蘭DSM是全球主要防曬原料供應商,主要客戶包括前幾大化妝品牌如資生堂、香奈兒等;該公司對台耀下單狀況,明年應可保有5%的成長空間。台耀積極拓展的原料藥部分,目前營收占比35%,目標第四季營收占比可拉高到四成,年底前也將維持不墜,該公司第四季季營收可望有上攀到7.5億元,將有連二季創單季新高紀錄。 法人表示,近期台耀積極調整公司產品占營運比例,將把醫療用原料藥,包括維他命D衍生物等調高比重達五成左右,明年起防曬系列活性成分營收占比也將逐漸調降,有助於該公司整體營運。 台耀表示,過去公司每年營收貢獻都有15%左右成長,明年由於景氣影響,可能轉趨保守,不過至少也會有10%水準。而新產能方面,台耀新廠第一階段產能預計在明年第三季投產,第二階段落在2013年,其中第一階段投產的產能中,約七到八成生產降膽固醇及磷酸鹽吸收劑等產品,預計相關產品產量將較目前至少增加20倍。