抗生素研发出现重大转折？奥巴马政府拟向超级菌宣战！

抗生素研发出现重大转折？奥巴马政府拟向超级菌宣战！                                                                                  来源：生物谷 2014-09-21 10:37


2014年9月20日讯 /生物谷BIOON/ --提到抗生素，人们首先联想到的一定是青霉素！这种抗生素自从1928年问世以来，拯救了成千上万人的性命。抗生素的发展如今已经走过了近一个世纪的路程，但一直没能再有一种抗生素的"风头"盖过青霉素。这其中的一个重要原因是抗生素问世之后，患者大量使用抗生素，导致一些细菌的抗药性不断增强，使得许多抗生素再无用武之地。
而这一情况在近20年来愈演愈烈，导致生物医药公司开发抗生素的时间远远比细菌抗药性产生的时间长，造成研发成本入不敷出。而这一现状在上世纪90年代到本世纪初达到了顶峰，许多生物医药巨头纷纷放弃了抗生素研究。但是细菌抗药性并未得到根本解决。
近年来许多抗药性超级细菌的出现使得一些原本治疗形式大好的疾病控制出现问题，如超级结核杆菌的出现，使得发展中国家肺结核的控制形势趋于恶化。这也导致一些生物医药公司如罗氏等重回抗生素这一市场，不过总体而言抗生素研发领域仍然面临着诸多困难。
如今，这一问题终于受到了政府层面的注意。最近美国总统奥巴马的科技顾问委员会（PCAST）建议奥巴马政府采取措施加速新型抗生素的研究，并建议FDA为此类药物的审批设立特殊快速通道，保证其能尽快上市。一旦这一建议被奥巴马采纳，将会吸引更多的生物技术公司重返抗生素研发领域，共同对抗超级菌的威胁。
另一项建议是对现有抗生素临床研究网络进行改革，使受到严重感染的患者能够及时接受新药的治疗。此外，抗生素研究所需要的花费也是使各大生物医药公司望而却步的一个重要原因，因此，这份建议报告中还提出采取经济激励的措施提高各大生物医药公司的积极性。而奥巴马也已经根据这份建议发布了一份行政命令，其中就包括专门设立总额达2000万美元的奖金用于奖励开发对抗超级菌的抗生素药物的生物技术公司。（生物谷Bioon.com）
本文系生物谷原创编译整理，欢迎转载！转载请注明来源并附原文链接 谢谢！
详细英文报道：
Antibiotics development is about to get a needed boost with the release of new federal proposals aimed at curbing rising antibacterial-resistant infections caused by so-called superbugs.
The recommendations, put forth by the President's Council of Advisors on Science and Technology (PCAST), include ways to speed drug development of newantibiotics and make clinical trials of these drugs more efficient in light of a dried-up global pipeline. Coinciding with an executive order signed yesterday, the proposals--if adopted--could help lure companies back to the challenging field.
One proposal that would affect small biotechs and Big Pharma alike is the creation of a "robust, standing national clinical trials network for antibiotic testing" that would be able to quickly enroll patients with dangerous bacterial infections. A benefit of such a network is that it would be able to test multiple new agents from different sponsors that could be evaluated simultaneously for their safety and efficacy.
The report, drafted by an outside panel of industry and academic experts, also pushes for approval of antimicrobial agents for use in limited patient populations so that people suffering from severe infections could benefit as quickly as possible from new drugs. The advisory group also wants to establish a Special Medical Use (SMU) pathway to help the FDA deliver such limited-use drugs to the market faster.
The steep R&D costs associated with antibiotics have largely driven away the industry in recent years, but PCAST also wants to fix that. To spur more development activity in the antibiotics arena, the advisory group is proposing economic incentives with particular attention to new classes of antibiotics.
Only a few major players--including Roche ($RHHBY), Cubist Pharmaceuticals ($CBST), Basilea Pharmaceutica ($BSLN) and Otsuka--are doing late-stage work in antibiotics right now.
"While there is a pressing need for new antibiotics, economic, regulatory and scientific circumstances make their development challenging for companies and have caused many to exit the space," Cubist Pharmaceuticals said in a statement in response to the executive order and PCAST report.
President Barack Obama's executive order also included a $20 million prize to drive the development of new diagnostic tests to identify highly resistant bacterial infections.

好消息