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."
Wednesday, February 9, 2011
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5月30日2011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2011年4月5日。 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2011年5月30日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Lichtinger，Optimer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fidaxomicin（200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64億 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2月7日與日商安斯泰來（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.
浩鼎(Optimer) 乳癌疫苗新藥 5億元增資(US 17.8 million)為臨床試驗
浩鼎生技 將在台上市
【2011/02/10 經濟日報】 台灣浩鼎生技董事長張念慈昨（9）日表示，為了發展乳癌新藥，已完成5億元增資，目標今年底完成二期臨床試驗，台灣浩鼎也將在台申請上市。2002年成立的台灣浩鼎生技，原本是美商Optimer製藥在台子公司，透過5億元增資，除了Optimer持股比重降到五成外，其餘參與增資的公司，還包括富邦、潤泰、永豐餘等大型集團，還有玉山金控及全球策略創投。張念慈表示，去年12月中旬起，台灣浩鼎研發的乳癌新藥OPT-822，在台灣展開第二／三期臨床試驗，預計投資4億元收取350名病患。若是今年底之前二期臨床有不錯的成果，公司不排除在台灣申請掛牌。張念慈說明，乳癌新藥OPT-822的技術來源，是中研院的研究成果，透過相同的技術來源，台灣浩鼎未來也將推出第二代乳癌新藥及醣晶片。張念慈強調，近年來新藥在國際市場授權趨勢已有改變，早期台灣不少新藥只要完成二期臨床試驗，就可與國際大藥廠談判授權。張念慈呼籲，近兩年國際大藥廠只青睬做完三期臨床試驗的新藥，以台灣現有資本市場熱中生技產業的情況來看，台灣的投資人應有足夠的資金實力，支持各生技公司將其新藥完成三期臨床試驗，如此才能創造更高的市場價值。
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