Towards new business models for R&D for novel antibiotics

Anacor, 2009. Anacor achieves milestone from GSK for Boron-based systemic antibacterial candidate [online] (updated 12 January 2009). Available at: http://www.anacor.com/press_release_2009-1-12.php (accessed 19 January 2011).

Aronsson, B., Boscan, I.S., Cars, O., Giamarellou, H., Gyssens, I.C., Lutsar, I., Monnet, D.L., Norrby, R., Powell, M., 2009. The bacterial challenge: time to react. Final Report. European Centre for Disease Prevention & Control and the European Medicines Agency, Stockholm (Sweden). Report No.: EMEA/576176/2009. Sponsored by the ECDC, the EMA, and ReAct.

ASAQ: Hope for malaria, 2009. ASAQ: Contribution of DNDi and FACT Partners [online] (updated 2009). Available at: http://www.actwithasaq.org/en/asaq4.htm (accessed 20 October 2010).

Baltz, 2006, Marcel Faber Roundtable: is our antibiotic pipeline unproductive because of starvation, constipation or lack of inspiration?, J. Ind. Microbiol. Biotechnol., 33, 507, 10.1007/s10295-005-0077-9

Bleicher, 2003, Hit and lead generation: beyond high-throughput screening, Nat. Rev. Drug Discov., 2, 369, 10.1038/nrd1086

Business Wire, 2009. IMS Health Lowers 2009 Global Pharmaceutical Market Forecast to 2.5–3.5 Percent Growth.

Center for Drug Evaluation and Research, 2007

Center for Drug Evaluation and Research, 2010

DiMasi, 1995, Success rates for new drugs entering clinical testing in the United States, Clin. Pharmacol. Ther., 58, 1, 10.1016/0009-9236(95)90066-7

DiMasi, 2004, R&D costs and returns by therapeutic category, Drug Inf. J., 38, 211, 10.1177/009286150403800301

Evans, 2009, Portfolio analysis and R&D decision making, Nat. Rev. Drug Discov., 8, 189, 10.1038/nrd2744

European and Developing Countries Clinical Trials Partnership, 2010. EDCTP, The Netherlands [online] (updated 28 October 2010). Available at: http://www.edctp.org/ (accessed 19 January 2011).

Fernandes, 2006, Antibacterial discovery and development—the failure of success?, Nat. Biotechnol., 24, 1497, 10.1038/nbt1206-1497

GlaxoSmithKline, 2010. GSK exercises option on Anacor's novel antibiotic for the treatment of gram-negative infections [online] (updated 5 August 2010). Available at: http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10081.htm (accessed 19 January 2011).

GlaxoSmithKline, 2007. GlaxoSmithKline and Wellcome Trust announce partnership to target drug-resistant hospital infections [online] (updated 30 April). Available at: http://www.gsk.com/media/pressreleases/2007/2007_04_30_GSK1021.htm (accessed 19 January 2011).

Hamad, 2010, The antibiotics market, Nat. Rev. Drug Discov., 9, 675, 10.1038/nrd3267

Harris, G., 2010. FDA Backtracks and Returns Drug to Market. New York Times. 3 September, A11.

Jones, 2010, The antibacterial lead discovery challenge, Nat. Rev., 9, 751, 10.1038/nrd3289

Kesselheim, 2010, How Medicare could get better prices on prescription drugs, Health Affairs, 28, 832

Kesselheim, A., Outterson, K., in press. Improving antibiotic markets for long term sustainability. Yale J. Health Policy Law Ethics, 11. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1716942.

Mullin, 2004, Drug discovery: as high-throughput screening draws fire, researchers leverage science to put automation into perspective, Chem. Eng. News, 82, 23, 10.1021/cen-v082n030.p023

Newman, 2007, Natural products as sources of new drugs over the last 25 years, J. Nat. Prod., 70, 461, 10.1021/np068054v

Nwaka, 2010, Developing ANDI: a novel approach to health product R&D in Africa, PLoS Med., 7, e1000293, 10.1371/journal.pmed.1000293

Outterson, 2010, Questions about the 10×’20 initiative, Clin. Infect. Dis., 51, 751, 10.1086/655955

Outterson, 2010, Analysis of systemic antibiotics approved in the U.S. between 1980 and 2009

Powers, 2007, Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugs, Clin. Infect. Dis., 45, S153, 10.1086/519253

Purlain, T., 2010. U.S. Defense Threat Reduction Agency funding search for antibiotics on sea floor [online] (updated 21 September 2010). BioPrepWatch.com. Available at: http://www.bioprepwatch.com/news/215761-us-defense-threat-reduction-agency-funding-search-for-antibiotics-on-sea-floor (accessed 19 January 2011).

RAND Health, 2007

Simmons, 2010, Structure-based discovery of antibacterial drugs, Nat. Rev., 8, 501, 10.1038/nrmicro2349

Spellberg, 2004, Trends in antimicrobial drug development: implications for the future, Clin. Infect. Dis., 38, 1279, 10.1086/420937

Stewart, 2001, Putting a price on biotechnology, Nat. Biotechnol., 19, 813, 10.1038/nbt0901-813

Thiers, 2008, Trends in the globalization of clinical trials, Nat. Rev. Drug Discov., 7, 13, 10.1038/nrd2441

Tsouderos, T., 2010. Antibiotics caught in stalemate over clinical trials. Richmond Times-Dispatch. U.S. Government Accountability Office, 2010. New drug approval: FDA's consideration of evidence from certain clinical trials. U.S. Government Accountability Office, Washington, D.C.

Wellcome Trust, 2007. Funding: planting seeds [online] (updated 17 January 2007). Available at: http://www.wellcome.ac.uk/News/2007/News/WTX035313.htm (accessed 19 January 2011).

Wellcome Trust, 2009. New Seeding Drug Discovery award will help develop new antibiotics [online] (updated 12 January 2009). Available at: http://www.wellcome.ac.uk/News/2009/News/WTX052832.htm (accessed 19 January 2011).

Wright, 2010, Q&A: antibiotic resistance: where does it come from and what can we do about it?, BMC Biol., 8, 123, 10.1186/1741-7007-8-123

U.S. Food and Drug Administration, FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections, September 1, 2010. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm.