关键词： 葛兰素史克 抗生素 超级细菌 生物恐怖主义 抗生素耐药性
2013年5月23日讯 /生物谷BIOON/ --葛兰素史克（GSK）22日宣布，已与美国卫生及人类服务部（HHS）生物医学高级研究与发展管理局（BARDA）签署了一项高达2亿美元的抗生素开发协议，该项合作将用于支持数种潜在的新抗生素的开发，以解决耐药性和生物恐怖主义的双重威胁。
由BARDA和GSK的代表组成的联合监督委员会，将对试验药物的进展情况进行监督，并决定是否拨款及是否添加和删减开发项目中的化合物。此次公-私（public-private）合作，是华盛顿首次采取“产品组合方式（portfolio approach）”与制药公司合作，资助药物开发。这种独特的合作，为GSK抗菌组合产品开发的资金提供了灵活性，而不是仅专注于一个候选药物，并允许将药物用于传统研究和生物恐怖威胁。
抗生素耐药性问题正引发全球政府的恐慌，英格兰首席医疗官Sally Davies爵士警告称，这一问题是威胁公众健康的一枚“定时炸弹”。最近，美国疾病控制和预防中心（CDCP）主任Thomas Frieden紧急呼吁全美医生、医院负责人、公共卫生部门齐心协力执行该国疾控中心的“检测-保护”战略，阻止一类“超级细菌”——抗碳青霉烯类肠杆菌属(CRE)的传播。
同时，也有人担心恐怖分子可能会使用这些传染性病原体（汝鼠疫、炭疽等）作为生物武器。
抗生素耐药性问题及所谓“超级细菌”的不断涌现已持续了多年，但制药公司一直不愿投资于新的抗生素开发，因为回报太低。这是由于，患者通常只接受很短时间的抗生素治疗，而且抗生素产品价格低，新的抗生素往往仅用于严重感染，这些问题大大降低了抗生素产品的销售机会。
GSK抗菌发现单元负责人David Payne称，诸如与BARDA之间的这种公-私合作关系，是解决这一问题方法的关键组成部分。
目前，仅有少数几个制药公司仍在追求新抗生素的开发研究，GSK便是其中之一，但GSK内部科学家仍然需要为其开发活动，提出可行的商业案例。因此，BARDA的财政支持将会是一个很大的帮助。
此次合作所涉及的数种化合物仍处于I期测试，这意味着假如它们在后期的临床试验能够取得成功，其获批使用也是好几年之后的事了。
在与政府的研究合作中，GSK一直处于行业领先地位，除了与BARDA之间和合作外，还与其他机构达成了其他特定制剂如疫苗和抗生素开发合作。今年3月，德克萨斯州A&M系统和GSK获美国政府批准，在德克萨斯州设立了一个流感疫苗设施。
同时，GSK还与其他制药公司、学术界、资助机构达成了创造性合作及资助伙伴关系，如欧洲最大的公-私倡议——创新药物倡议（Innovative Medicines Initiative）和美国国防威胁降低局（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.
(责任编辑：lili.zhao)
