More bad news on new drugs

The Infectious Diseases Society of America (IDSA) has published a new report that fills in the background on last week's news below, and confirms: The landscape for new drugs against MRSA and other multi-drug resistant organisms is bleak. (The organisms, summarized in the acronym ESKAPE, are: E. faecium, MRSA, Klebsiella, Acinetobacter, Pseudomonas aeruginosa and Enterobacter.)

The report, published in the journal Clinical Infectious Diseases, is both an update of surveys of the new-drug landscape done in 2004 and 2006, and also a call to action that asks for broad federal effort to encourage pharma companies to produce new drugs.

Here are the highlights:

• Since the last iteration of the survey in 2006, only one new antimicrobial, doripenem — a very broad-spectrum injectable that is most active against the Gram-negative bacterium P. aeruginosa — has been approved.
• Only three new compounds — ceftobiprole, dalbavancin and Paratek Pharmaceutical's PTK-0796 — are in their final rounds of trials. (The report was obviously written before the latest news about ceftobiprole and dalbavancin.)
• Four of seven efforts to achieve a staph vaccine have been terminated.
  
• Though the pharma industry, through its lobbying arm PhRMA, claims "388 infectious diseases medicines and vaccines and 83 antibacterial drugs in development", that number is misleading:

Careful review of these data reveals that most are preclinical and phase 1 compounds. Also included are topical and nonabsorbable antimicrobials, which we do not consider here, and several compounds for which development has been terminated. Finally, ... many of the listed drugs are previously approved agents that are being studied for new indications.

Just to make sure no one misses the big picture, the authors emphasize:

...The number of new antibacterials that make it through the complete development process and ultimately receive FDA approval has precipitously decreased over the past 25 years. Indeed, we found a 75% decrease in systemic antibacterials approved by the FDA from 1983 through 2007, with evidence of continued decrease in approvals, even during the most recent 5-year period.

What are the answers? IDSA is candid, as in its earlier reports, that it believes incentives for drug companies are the only way to improve the situation: financial boosts, patent extensions and changes in trial requirements. Two things are critical, the group says:

• Novel intravenous and oral drugs to treat both hospitalized and community-based patients are needed, as opposed to “me too” drugs that provide minimal improvement over existing therapies.
• Priority should be given to antimicrobials with the potential to treat serious infections that are resistant to current antibacterial agents.