Wednesday, February 9, 2011

台灣顯微手術龍頭: 林口長庚顯微重建中心(Kingdom of Reconstructive Microsurgery)

國家生技醫療品質獎得主 11日獲總統接見表揚 

2011/02/09 【台北訊】2010國家生技醫療品質獎得主,將於11日受邀面見馬英九總統,包括台大醫院陳明豐院長、新光醫院侯勝茂院長、以及林口長庚醫院王正儀院長等26名獲獎代表,將親自接受表揚。而這也是馬總統上任以來,連續三年召見國家生技醫療品質獎的得主,顯見對生策會所辦理的SNQ國家品質標章審查機制以及國內生醫發展狀況至為重視。推行已經屆滿12年的國家生技醫療品質獎,所評選出的醫療服務品質、皆具世界水準。中國附醫總執行長許重義肯定:「生策會推動的SNQ國家品質標章和國家生技醫療品質獎是揚善的機制,把最好的生醫服務、技術與產品挑選出來,推薦給民眾,保障消費者的健康。」事實上,SNQ不只是一套專業、嚴格的把關機制,更是台灣生技業成長的縮影。參與評選的團隊,品質、技術年年都在提升,不斷精益求精。尤其經過SNQ標章認證,再獲得金、銀、銅獎的單位,更是難得。其中,銅獎需接近國際水準,而銀獎需達到國際水準,金獎更是以超越國際水準做為評選標準,過去經常出現從缺的情況,特別是「醫療院所類」項目中,僅在2004 (林口長庚紀念醫院臨床病理科)2005 (長庚紀念醫院高雄分院-肝臟移植中心)2009 (桃園長庚顱顏中心)曾頒出金獎,今年林口長庚醫院,則以技冠全球的顯微手術,榮獲2010金獎肯定。 林口長庚顯微重建中心,每年施行約1,000例顯微手術,總病人數超越兩萬兩千名,為世界之冠;成功率則和美國MD Anderson Cancer Center相當(97%-98%);所發表顯微手術相關研究論文數也是世界第一。顯微重建中心每位醫師皆各有專長,形成堅強的醫療團隊,被譽為Kingdom of Reconstructive Microsurgery,並被美國顯微重建手術學會推薦為訓練中心;累積近三十年顯微重建發展的努力,在創新、學術論文發表皆有優異成績。在應用上,有腳趾移植至手部重建,穿通枝皮瓣手術的創新,乳房顯微重建術的改良與創新,並首創世界唯一的顯微加護病房,表現相當傑出。另一項技冠群倫者,則是台大醫院外科加護病房葉克膜團隊,所應用的「體外膜氧合維生系統」已經累積1,400多例的臨床經驗,院內從接到電話到ECMO運轉只需要15分鐘,病人存活率達40%。僅次於密西根醫院轉送中心,成為世界第二大ECMO中心、更是遠東第一個有葉克膜中心的醫院,醫術卓越勇奪2010國家生技醫療品質銀獎。

如何利用台灣電子業優勢創造醫療器材產業商機!!

醫療電子法規競爭力提升計畫』說明會(2011/3/18)

2011/2/9生技產業被政府選定為新兆元產業之一,也是「愛台十二建設」發展重點之一。行政院優先推動高階醫材之研發,研議修正「生技新藥產業發展條例」,將納入所有第三等級醫療器材享有租稅優惠,經濟部希望藉此鼓勵電子材料業者投入醫療器材產業,掌握各國高齡化社會的醫療保健需求、美國與大陸的醫療改革市場成長契機,推動台灣的醫療器材產業挑戰2000億元產值。經濟部工業局為加速推動醫療電子產業發展,鼓勵電子資訊產業運用電子元件設計製造技術優勢,投資研發醫療電子器材,97年起委託工研院執行「智慧型醫療電子產業技術推廣與輔導計畫」,協助產業建立醫療電子關鍵技術,發展高附加價值醫療電子產品與系統,以使醫療電子產品產值快速提升,並提高競爭力。本計畫項下「醫療電子法規競爭力提升計畫」分項計畫,參考美國FDASRI InternationalUniversity of Arizona推動之醫療產品法規關鍵路徑方案(Critical Path Initiative)協助國內電子資訊業者順利跨越醫療器材法規鴻溝,縮短取得國際法規驗證時程,建立具國際競爭力之優質醫療器材品質管理及產品研發能量。為協助國內電子資訊業者了解本計畫今年度提供之服務,特訂於100318日假台北科技大樓605會議室舉辦計畫說明會,歡迎有志於投入醫療電子產業之廠商踴躍參加。會議時間:100318日(星期五)09:00 ~ 12:00地點:台北科技大樓(台北市和平東路二段106) 605會議室  報名方式:請向劉純秀小姐報名 傳真:03-5734092 Email: cs1108@itri.org.tw報名截止日期:100317 活動費用:免費 (本說明會由經濟部工業局全額補助)

 

報告人/主持人

09:00~09:15

 

09:15~09:30

09:30~10:15

97-99年度「醫療電子法規競爭力提升計畫」計畫執行成果

工研院量測中心 陳錦豐

10:15~10:30

 

10:30~11:15

「醫療電子法規競爭力提升計畫」產出指引與產品技術文件範本簡介

工研院量測中心 吳俊彥

11:15~11:45

100年度「醫療電子法規競爭力提升計畫」 計畫執行方法/ 如何報名/ 廠商參與計畫之優先順序排定原則

工研院量測中心 陳錦豐

11:45~12:00

綜合討論

 

台灣神隆代工研發生產臨床第三期實驗所需藥物(Vilazodone Hydrochloride)

台灣神隆代工研發生產之抗憂鬱新藥 通過美國FDA審查批准上市

(中央社訊息服務20110209 11:48:39)專精於原料藥的台灣神隆,輔助美國生技新藥公司Clinical Data生產技術完成之新型中樞神經藥物維拉佐酮 (Vilazodone Hydrochloride,產品名稱為Viibryd),日前通過美國食品藥物管理局FDA審查批准,正式取得在美銷售資格。Viibryd用於日漸增加的憂鬱症患者,根據市場分析師的預測,該新藥全美單一市場製劑的最高銷售額每年將超過10億美元,可望為台灣神隆開拓代工研發及製造的市場再下一城,帶來另一波新的營收獲利成長動能。維拉佐酮為Clinical Data公司申請的專利新型抗憂鬱藥物,係由該公司轄下的PGxHealth公司交付台灣神隆優化生產技術,提供臨床第三期實驗所需藥物,並將由台灣神隆持續獨家生產上市後所需用之原料藥。不同於以往的抗憂鬱症藥物,該藥物沒有引起體重增加、性功能障礙等副作用,擁有良好的安全性和耐受性,為憂鬱症患者帶來多一項的治療選擇。台灣神隆總經理馬海怡博士表示,憑藉著豐富的原料藥開發經驗及服務口碑,台灣神隆廣獲國內外新藥公司及國際大藥廠青睞,接受委託進行新藥的原料藥製程研究開發及製造,提供一步到位的專業服務。迄今,台灣神隆代客研製新藥的產品計劃已超過六十項,目前已有三項代客研製的新藥已上市,另有四項產品進入臨床試驗第三期。任一項代客研製新藥一旦通過臨床試驗、取得上市之資格,都將正面刺激公司的業務成長。依據世界衛生組織預估,憂鬱症的盛行率是全球總人口數的3%,大約近2億人深受其苦,而全球抗憂鬱藥物市場約為120億美元。隨著環境及生活壓力增加,現代人心理層面的精神健康問題包括:憂鬱、焦慮及失眠等疾病罹患率增加,對於藥物的需求也越來越高,該項新藥的推出預計將在這塊市場大餅上搶奪先機。主要供應國際原料藥市場的台灣神隆,技術能力含括小分子有機合成、胜肽化合物以及生技製藥等,研發能量相當完整。由於公司產品製程係自行開發,且不抵觸其他現行專利,深厚之研發及技術能力使台灣神隆在競爭激烈的國際市場中,依然能夠吸引到知名大廠訂單,成功橫跨新藥及學名藥市場。此外,該公司也計劃加強在中國大陸產能擴充,在新一波跨國藥廠外包代工風潮中爭取原料藥代工市場的商機,擴大神隆國際市場競爭的利基。新建位於江蘇常熟的工廠將於今年第三季開始生產關鍵中間體,透過該公司在常熟的營運,能夠提供國際藥廠所需之專業配套之外包服務及技術支援,提供顧客快速回應、彈性可靠且具有價格競爭力的服務。

關於台灣神隆  台灣神隆開發生產的原料藥產品目前供應國際間超過二百六十家藥廠,其中多家排名全球前十大的專利藥廠及十大主要學名藥廠均包括在內。除供應各大藥廠原料藥、提供代工生產服務外,台灣神隆並提供新藥開發服務,從臨床用之原料藥製程開發到生產。已開發生產的原料藥產品包括抗癌、賀爾蒙、抗發炎等種類,並在世界各主要市場完成產品藥物主檔(DMF)之登記註冊,目前全球各地藥物主檔案之註冊超過520件,包括美國37件、日本5DMF之註冊。進一步資訊請至台灣神隆網站 www.scinopharm.com查詢。

關於Clinical Data公司  Clinical Data公司的使命是發展治療領域中最領先且最佳的療法。公司的主要產品Viibryd已被美國食品藥物管理局FDA核准用於治療成人的憂鬱症,另一個已進入第三期的候選藥物Stedivaze開發上也有斬獲,這是在核醫心肌灌注造影時用的心肌壓力性試驗藥物。Clinical Data公司擁有許多前景看好的候選藥物進入主要臨床治療領域,包括哮喘、眼科和糖尿病。進一步資訊請至公司網站www.clda.com查詢。訊息來源:台灣神隆公共事務處

接種流感疫苗與猝睡症(narcolepsy)的關聯性?

世衛表示新流感疫苗與及猝睡症的關聯性尚待進一步調查釐清

資料來源: CDC公關室 Public Relations Office日期: 2011/2/9有關電子媒體今(9)日報導「世衛證實流感疫苗與猝睡症有關」乙文,疾病管制局表示,根據世界衛生組織(WHO)(8)日的發表聲明,該組織已接獲12個國家通報兒童及青少年接種H1N1新流感疫苗後出現猝睡症現象,其中瑞典、芬蘭和冰島通報的發生率有增加,過去未有接獲接種流感疫苗引起這類現象,有關接種流感疫苗與猝睡症(narcolepsy)的關聯性需要更進一步調查。芬蘭於今(100)21發表一項接種新流感疫苗與出現猝睡症的研究結果,發現4-19歲兒童及青少年在接種葛蘭素史克廠牌的H1N1新流感疫苗Pandemrix後,出現猝睡症的機率是未接種者的9倍,但芬蘭強調,目前對於猝睡症增加的可能解釋為疫苗與其他未知因素之共同作用所引起,且芬蘭也指出,在冰島,猝睡症在未接種疫苗的兒童與青少年,也同時有增加的現象,因此,該國將對此進行更大規模的調查與研究,最終的研究報告預計在本年8月底公布。對此,WHO表示全球共有47個國家使用葛蘭素史克廠牌的H1N1新流感疫苗,但並未觀察到猝睡症有全球性發生的現象,因此,WHO認為有必要深入調查猝睡症與流感疫苗之關連性。疾管局表示,我國所採購的新流感疫苗為國光生物科技股份公司及Novartis Vaccines & Diagnostics, s.r.l(諾華公司)所產製,並未採購葛蘭素史克H1N1新流感疫苗,除此之外,依據預防接種受害救濟小組(VICP)所提供的資料,國內並無民眾因接種H1N1新流感疫苗或季節性流感疫苗引起猝睡症而申請預防接種受害救濟案例。

兩岸觀光醫療 製藥廠濟生加入戰局!

濟生Beauty兩岸觀光生醫美學健康館 搶觀光財

 2011/02/10 【新竹訊】濟生化學製藥董事長蘇東茂表示,濟生對兩岸醫學產業的佈局極為用心,最近中國陸進行醫療保險制度改革,將血液透析相關醫療費用納入,濟生已投資1,200萬美元(新台幣3.65億元)在上海成立公司,衝刺大陸洗腎及保健品市場商機。該公司經營穩健踏實,戰略具有前瞻性,戰術則能掌握關鍵成功因素,發展潛力十足。「濟生Beauty兩岸觀光生醫美學健康館」申請並取得觀光工廠執照,投入上千萬元進行廠區整建規劃,成為國民旅遊卡特約廠商,各道路相關指標告示牌都合法設立,更納入經濟部「觀光工廠自在遊」網站宣傳。濟生看好兩岸觀光前景,將與國內各大旅行社結合,在發展製造本業外,以觀光工廠佈局兩岸觀光生醫的產業聯盟,營造優質的觀光產業休閒空間,增進企業形象、創造無限商機,放眼世界邁向國際。濟生Beauty兩岸觀光生醫美學健康館 耗資千萬打造,為台灣首家通過(PIC/SGMP、觀光工廠雙認證,為兩岸頂級的觀光生醫美學健康館,開幕期間舉辦一元排隊商品Smart Buy活動。廠區規劃保健保養品、廠區導覽與實際體驗三大主題,開放營運後,全程公開保健食品製作流程,由專人導覽廠區各館、美容保養體驗區、膚質檢測區等。舒適寬敞的環境及媲美高級美容中心的設備,讓消費者深度體驗美學、醫療、科技三合一的魅力,促使兩岸觀光及生醫產業邁向全新的里程碑。

Optimer製藥公司fidaxomicin第三期臨床試驗

5. February 2010 01:36  Optimer製藥公司(納斯達克:OPTR)今天宣布,正頂線結果從第二期兩個關鍵的第三期臨床安全性和有效性評價的fidaxomicin(選購- 80)的患者難辨梭狀芽孢桿菌感染(CDI)的。這項研究是在大約100個臨床試驗點遍布北美和歐洲 。該公司計劃利用這項研究數據支持提交的新藥申請(NDA)美國食品和藥物管理局(FDA)在2010年下半年。 該試驗達到主要終點的非劣效性與 91.7%的患者治療 fidaxomicin(每協議人口計算)達到 90.6%,臨床治愈率為 Vancocin對比,唯一美國 FDA批准的治療課程發展處。重要的是,fidaxomicin也有顯著降低復發率和高治愈率全球(定義為治療,無復發在四個星期內完成治療)相比,Vancocin。只有12.8%的患者治療 fidaxomicin經歷了復發主場迎戰 25.3%的患者治療 Vancocinp= 0.002)。此外,79.6%的患者治療 fidaxomicin達到 65.5%,與全球治愈的患者治療 Vancocin性(P"0.001)。由於在第一階段 3期試驗,fidaxomicin受到良好的耐受性研究。 "強勁的結果從我們的第二個第三期臨床試驗結果的fidaxomicin確認我們的第一個第三期試驗顯示,fidaxomicin有可能是第一個同類產品中的藥物治療難辨梭狀芽孢桿菌感染。目前有限的治療選擇對於這種疾病,我們認為有需要創新的替代品," 邁克爾說北昌博士,Optimer的行政總裁。 "一個體現了較高的全球治愈潛力 fidaxomicin改善患者的治療效果,減少重複訪問到醫院,減少人對人傳人,這可能導致在一個較低的成本負擔的醫療保健制度。" 說:"課程發展處的發生率越來越高在醫院,長期護理設施,在社會上,我們相信這是由於部分由的使用廣譜抗生素和人口老齡化,需要建立一個新的課程發展處療法"說舍伍德屬Gorbach醫師,Optimer的首席醫療官。 "這些結果表明,單一的,有效的抗生素可以提供很高的治愈率,同時,低復發率。我們相信fidaxomicin演示了臨床顯著差異,課程發展處提供了實實在在的好處患者和醫學界。" 來源 Optimer製藥公司

Fidaxomicin demonstrates 45% reduction in recurrences vs. existing treatment for C. difficile infection

3. February 2011 04:31 Source: Jewish General Hospital  Significantly reduces recurrence of infection, improves cure rates Clostridium difficile infection (CDI) is a significant and growing problem in hospitals and other health care facilities, but no new drugs to treat the condition have been developed in several decades. However, a large-scale, phase 3 trial conducted by Canadian and U.S. researchers shows that the new antibiotic Fidaxomicin is superior to existing treatments, demonstrating a 45 percent reduction in recurrences vs. the existing licensed treatment. Their results were published in February, 2011 in The New England Journal of Medicine."There wasn't much interest in C. difficile for many years, because it wasn't considered a serious disease," said study co-author Dr. Mark A. Miller, head of the Division of Infectious Diseases and Chief of Microbiology at the Jewish General Hospital in Montreal, and a clinical investigator at the Lady Davis Institute for Medical Research. "However, over the past decade the bacterium has mutated into something much more serious that has caused epidemics worldwide. It is particularly notorious for recurrences. About 20 to 30 percent of patients suffer relapses. Recurrent C. difficile is very difficult to treat, and this has spurred interest in newer and better treatments."Fidaxomicin, developed by Optimer Pharmaceuticals of San Diego, is the first in a new class of narrow-spectrum macrocyclic antibiotics. It is only minimally absorbed from the gut into the bloodstream and is specifically targeted at C. difficile in the intestine. Thus the drug acts by killing C. difficile bacteria without affecting the beneficial flora in the human gut which help stave off recurrences.A total of 629 patients were enrolled in the multicentre, double-blind, randomized, parallel-group trial conducted between May 9, 2006, and August 21, 2008. They received Fidaxomicin (200 mg twice daily) or the antibiotic vancomycin (125 mg four times daily) orally for 10 days. Vancomycin was first developed in the 1950s, and to date is the only FDA- and Health Canada-approved treatment for CDI. "These results showed that recurrence of CDI is significantly less likely to occur following treatment with Fidaxomicin versus vancomycin," said lead author, Thomas J. Louie, M.D., Medical Director, Infection Prevention and Control for the Calgary Health Region and professor in the Departments of Medicine and Microbiology-Infectious Diseases, University of Calgary. "Anybody who knows C. difficile recognizes that recurrences are the major problem with this disease," agreed Dr. Miller, also assistant professor in Medicine, Microbiology and Immunology at McGill University. "Anything that can reduce the recurrence rate, especially as dramatically as Fidaxomicin, is a very important milestone in the treatment of C. difficile."

美國 FDA接受Optimer的fidaxomicin新藥的申報

24. January 2011 09:19 Optimer製藥公司(納斯達克:OPTR)今天宣布,美國食品和藥物管理局(FDA)已經接受申請本公司的新藥申請(NDA)的fidaxomicin用於治療艱難梭菌感染(CDI)和為減少風險時,用於治療復發的初始課程發展處。 FDA也授予本公司的要求六個月優先審核,並已指定了一個處方藥用戶收費法(PDUFA)的目標日期5302011年。此外,FDA已經通知我們,它計劃在討論保密協議滿足其抗感染藥物諮詢委員會現定於201145 在接受備案的fidaxomicin新藥證實FDA的決心是不夠完整的保密協議,以允許進行實質性審查。優先評估分類給予藥物,如獲批准,有可能提供比市場顯著改善治療,或提供一種治療在無良好的替代療法存在。優先評估手段,目標所需的時間為美國FDA審查新藥申請降低。在此基礎上分類,FDA已經指定了一個處方藥用戶收費法(PDUFA)的目標日期2011530供其審查的保密協議。 "在第三階段的臨床試驗中,fidaxomicin不僅表現出較高的臨床治愈率,但也表現出了顯著改善,減少復發,其中一個主要問題,在目前的管理課程發展處,說:"佩德羅LichtingerOptimer的總裁和首席執行官。 "該機構的接受我們的保密協議代表了一種進步,履行滿足醫療需求,並支持我們的目標是幫助病人誰患有這種疾病。" 保密協議的支持,數據從兩個最大的第三期臨床試驗比較以往對萬古黴素進行課程發展處。這兩個fidaxomicin第三期臨床研究是多中心,隨機,雙盲試驗,共收納了1,164成年患者。患者確診課程發展處收到任何fidaxomicin200毫克q12h)或Vancocin ®125毫克q6h),唯一的美國FDA批准的產品的治療課程發展處。在這兩個研究中,fidaxomicin達到主要終點的非劣效性臨床治療相比,Vancocin。重要的是,在這兩項試驗fidaxomicin統計學優於Vancocin減少復發的CDI和全球治愈率。 來源Optimer製藥公司

 

Optimer Pharmaceuticals received $68 million upfront cash from Astellas

Optimer Pharmaceuticals and Astellas Announce Collaboration to Commercialize Fidaxomicin for Clostridium difficile infection

Optimer Eligible to Receive Milestone Payments of up to $224 Million including $68 Million Upfront Cash Payment, and Double-Digit Royalties on Sales in the Territory

SAN DIEGO & STAINES, UK - February 7, 2011- Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) and Astellas Pharma Europe Ltd. ("Astellas") announced today the signing of an exclusive collaboration and license agreement to develop and commercialize fidaxomicin, an investigational antibiotic for CDI, in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (CIS). In return for an exclusive license to fidaxomicin in the territory, Astellas is obligated to pay Optimer an upfront cash payment of approximately $68 million. Optimer is also eligible to receive additional cash payments totaling up to approximately $156 million upon the achievement of certain regulatory and commercial milestones. Furthermore, Astellas is obligated to pay tiered double-digit royalty payments on net sales of fidaxomicin in the Territory. Astellas will be responsible for all future costs associated with the development, manufacturing, and commercialization of fidaxomicin in the territory including the costs of the ongoing Marketing Authorization Application (MAA) with the European Medicines Agency (EMA)."We believe the combined strengths of Astellas' world-class anti-infective business capabilities, including established relationships with payers and hospitals in Europe and certain other markets,combined with Optimer's novel therapeutic for CDI, represents the most effective way to address a serious, unmet health need," said Mr. Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd. "We look forward to bringing fidaxomicin to these markets to help patients and providers address this serious life threatening disease." "We expect the Astellas collaboration will help Optimer realize the full potential of fidaxomicin and will help position this medication in these countries as the first line of treatment, both for treating CDI and reducing recurrences," said Pedro Lichtinger, Optimer's President and CEO. "CDI poses a significant cost burden on the healthcare system and we believe, if approved, fidaxomicin will provide a cost-savings opportunity for hospitals and payers, especially when used in populations at risk of recurrence such as the elderly, patients with a prior episode, those taking concomitant antibiotics, immuno compromised patients or those with renal impairment." Fidaxomicin is an orally administered macrocyclic antibiotic with a new mechanism and narrow spectrum of action being developed for the treatment of CDI. In two Phase 3 trials for the treatment of CDI, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. Most importantly, fidaxomicin was statistically superior to vancomycin in global cure and in reducing recurrences of CDI by up to 47%. The New England Journal of Medicine has published results from the first Phase 3 trial in an article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile Infection," which appeared in the February 3, 2011 issue. Optimer has filed marketing applications in the U.S. and the EU for fidaxomicin.Optimer's exclusive financial advisor for this transaction was J.P. Morgan Securities LLC while Cooley LLP was its legal advisor. Astellas' legal advisor in the transaction was Wragge & Co LLP.

About Clostridium difficile Infection (CDI) Clostridium difficile infection, commonly referred to as "C. difficile" or "c-diff", has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S. It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment. Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. The increasing incidence of CDI, along with higher rates of both treatment failures and recurrences with current therapies have resulted in greater awareness and concern about CDI among medical professionals and public health officials. You may learn more about CDI at www.cdiinfo.org, a website of Optimer.

About Astellas Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 3,900 staff across these regions. For more information about Astellas Pharma Europe, please visit www.astellas.eu.

About Optimer Pharmaceuticals Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development, fidaxomicin and PruvelTM (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection. The FDA granted Optimer's request for a six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. Optimer has also filed a MAA with the European Medicines Agency (EMA) for fidaxomicin. PruvelTM is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.

Optimer授權Fidaxomicin (OPT-80)給Astellas 預計於美國建立百人行銷團隊!!

Optimer授權金64 潤泰富邦補

 2011/02/10 經濟日報】 國人創立、已在美國那斯達克(Nasdaq)掛牌的Optimer製藥公司,宣布將一項新型抗生素的歐洲市場授權給跨國日商藥廠,授權金2.24億美元(約新台幣64億元),創下台灣人開發新藥最高授權紀錄。Optimer公司發展有成,據了解,包括潤泰集團、富邦集團、永豐餘集團都是Optimer大股東。Optimer董事長張念慈昨(9)日表示,該公司所研發的新型抗生素Fidaxomicin,可用來對抗偽膜性結腸炎,這項感染性疾病光是在美國,每年就有300萬人被感染,而Optimer已經將這項新藥向歐盟及美國提出上市申請。Optimer公司27與日商安斯泰來(Astellas)藥廠簽約,由安斯泰來取得Fidaxomicin抗生素歐洲市場授權,Optimer獲得2.24億美元的市場授權金;藥品上市後,Optimer每年也可獲得兩位數的權利金。張念慈表示,日商安斯泰來將在第二季結束前先支付第一筆權利金6,800萬美元(約新台幣1.95億元),其餘權利金陸續今、明兩年入帳;法人推估,Optimer公司今年營收將可達到1億美元。張念慈強調,除了歐洲市場授權給安斯泰來藥廠,Optimer公司將自己經營美國市場,估計要斥資1億美元建立百人行銷團隊,明年美國市場打開後,可為Optimer創造年10億美元收入。至於Fidaxomicin抗生素的日本市場,目前也已有二、三家藥廠向Optimer公司爭取授權。成立於1998年的Optimer製藥,為張念慈和中研院院長翁啟惠在美國合作創立,設立初衷,是以翁啟惠的研究成果為基礎,要發展生技新藥。張念慈表示,Optimer公司已將Fidaxomicin的台灣市場授權給轉投資的台灣浩鼎生技,並向衛生署申請上市許可,隨著第六次江陳會兩岸簽下醫藥合作協議,未來Fidaxomicin 也有機會直接由台灣進軍大陸市場。

Fidaxomicin (also known as OPT-80 and PAR-101) is the first in a new class of narrow spectrum macrocyclic antibiotic drugs. It is non-systemic, meaning it is minimally absorbed into the bloodstream, it is bactericidal, and it has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the multiple species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of Clostridium difficile infection recurrence.It is being developed by Optimer Pharmaceuticals for treatment of Clostridium difficile infection. It is administered orally. It works by inhibiting the bacterial enzyme RNA polymerase, resulting in the death of Clostridium difficile. It is active against gram positive bacteria especially clostridia.

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