關鍵詞： 葛蘭素史克 抗生素 超級細菌 生物恐怖主義 抗生素耐藥性
2013年5月23日訊 /生物谷BIOON/ --葛蘭素史克（GSK）22日宣布,，已與美國衛(wèi)生及人類服務部（HHS）生物醫(yī)學高級研究與發(fā)展管理局（BARDA）簽署了一項高達2億美元的抗生素開發(fā)協(xié)議,，該項合作將用于支持數(shù)種潛在的新抗生素的開發(fā)，以解決耐藥性和生物恐怖主義的雙重威脅,。
由BARDA和GSK的代表組成的聯(lián)合監(jiān)督委員會,，將對試驗藥物的進展情況進行監(jiān)督，并決定是否撥款及是否添加和刪減開發(fā)項目中的化合物,。此次公-私（public-private）合作,，是華盛頓首次采取“產(chǎn)品組合方式（portfolio approach）”與制藥公司合作，資助藥物開發(fā),。這種獨特的合作,，為GSK抗菌組合產(chǎn)品開發(fā)的資金提供了靈活性，而不是僅專注于一個候選藥物,，并允許將藥物用于傳統(tǒng)研究和生物恐怖威脅,。
抗生素耐藥性問題正引發(fā)全球政府的恐慌，英格蘭首席醫(yī)療官Sally Davies爵士警告稱,，這一問題是威脅公眾健康的一枚“定時炸彈”,。最近，美國疾病控制和預防中心（CDCP）主任Thomas Frieden緊急呼吁全美醫(yī)生,、醫(yī)院負責人,、公共衛(wèi)生部門齊心協(xié)力執(zhí)行該國疾控中心的“檢測-保護”戰(zhàn)略，阻止一類“超級細菌”——抗碳青霉烯類腸桿菌屬(CRE)的傳播,。
同時,，也有人擔心恐怖分子可能會使用這些傳染性病原體（汝鼠疫、炭疽等）作為生物武器,。
抗生素耐藥性問題及所謂“超級細菌”的不斷涌現(xiàn)已持續(xù)了多年,，但制藥公司一直不愿投資于新的抗生素開發(fā)，因為回報太低,。這是由于,，患者通常只接受很短時間的抗生素治療，而且抗生素產(chǎn)品價格低,，新的抗生素往往僅用于嚴重感染,，這些問題大大降低了抗生素產(chǎn)品的銷售機會。
GSK抗菌發(fā)現(xiàn)單元負責人David Payne稱,，諸如與BARDA之間的這種公-私合作關系,，是解決這一問題方法的關鍵組成部分。
目前,，僅有少數(shù)幾個制藥公司仍在追求新抗生素的開發(fā)研究,，GSK便是其中之一，但GSK內部科學家仍然需要為其開發(fā)活動,，提出可行的商業(yè)案例,。因此，BARDA的財政支持將會是一個很大的幫助,。
此次合作所涉及的數(shù)種化合物仍處于I期測試,，這意味著假如它們在后期的臨床試驗能夠取得成功,，其獲批使用也是好幾年之后的事了。
在與政府的研究合作中,，GSK一直處于行業(yè)領先地位,，除了與BARDA之間和合作外，還與其他機構達成了其他特定制劑如疫苗和抗生素開發(fā)合作,。今年3月,，德克薩斯州A&M系統(tǒng)和GSK獲美國政府批準，在德克薩斯州設立了一個流感疫苗設施,。
同時,，GSK還與其他制藥公司、學術界,、資助機構達成了創(chuàng)造性合作及資助伙伴關系,，如歐洲最大的公-私倡議——創(chuàng)新藥物倡議（Innovative Medicines Initiative）和美國國防威脅降低局（DTRA）。（生物谷bioon.com）
英文原文：GlaxoSmithKline awarded up to $200 million by U.S. government to develop new antibiotics
- Award is first of its kind public-private partnership with Biomedical Advanced Research and Development Authority
- Funding will support development of drugs to fight antibiotic resistance and bioterrorism.
Issued: Wednesday 22 May 2013, London UK and Philadelphia, PAGlaxoSmithKline (GSK) plc and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), have agreed to a first of its kind collaboration that will support the development of several antibiotics to fight antibiotic resistance and bioterrorism.
This public-private agreement marks the first time that HHS has taken a “portfolio approach” to funding drug development with a private sector company. This unique collaboration provides flexibility to move funding around GSK’s antibacterial portfolio, rather than focusing on just one drug candidate and allow medicines to be studied for the potential treatment of both conventional and biothreat pathogens.Under the terms of the agreement, HHS will provide $40 million for the initial 18-month agreement and up to a total of $200 million if the agreement is renewed over five years.The treatment of drug resistant bacterial infections is predicted to become a global crisis due to the scarcity of new antibiotics in the pharmaceutical industry’s pipeline and a decrease in investment in research and development. Many companies have in recent years withdrawn from antibacterial R&D due to the scientific challenges and a lower return on investment, affecting the ability to treat bacterial infections and compromising our preparedness to tackle biothreat pathogens. Consequently, public-private partnership is important to help sustain effort in this area of science.
“There is an urgent need to address antibiotic resistance and new models are needed to deal with this challenging area of drug development,” said David Payne, head of GSK’s Antibacterial Discovery Performance Unit. “We strongly believe that innovative public-private partnerships such as this are integral to solving this critical healthcare issue and we are delighted to work with BARDA in a more strategic way.”
The work under this agreement will be governed by a BARDA-GSK joint oversight committee that will monitor progress, make decisions on the allocation of funds and decide on the addition or removal of drug candidates from the portfolio.GSK is an industry leader in government research collaborations and has had contracts with BARDA and other agencies for vaccines and antibiotics development. In March, GSK and the Texas A&M System and GlaxoSmithKline received U.S. government approval to establish an influenza vaccine facility in Texas.As one of the few large pharmaceutical companies still pursuing antibacterial research, GSK also has creative collaborations and funding partnerships with other companies, academia, and funding bodiessuch as the Innovative Medicines Initiative, Europe’s largest public-private initiative and the Defense Threat Reduction Agency, which is part of the U.S. Department of Defense.GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
(責任編輯：lili.zhao)
