Drug pipeline for worst superbugs 'on life support' -U.S. report

* Only seven new drugs for infections in the works

* Companies not keeping up with pace of drug resistance

By Julie Steenhuysen

CHICAGO, April 18 (Reuters) - Only seven new drugs are indevelopment for the treatment of infections caused by anespecially nasty class of superbugs that include E. coli andCRE, the so-called "nightmare bacteria" that the U.S. Centersfor Disease Control and Prevention raised alarms about lastmonth.

The data come from the latest report by the InfectiousDiseases Society of America, or IDSA, released on Thursday,which has been tracking the rising number of bacteria thatresist even the most potent antibiotics.

"We're on the precipice of returning to the dark days beforeantibiotics enabled safer surgery, chemotherapy and the care ofpremature infants," said Dr. Helen Boucher, an infectiousdiseases expert at Tufts Medical Center in Boston and a memberof IDSA's board, whose report was published online in ClinicalInfectious Diseases.

"Simply put, the antibiotic pipeline is on life support andnovel solutions are required to resuscitate it - now," IDSAPresident Dr. David Relman said in a statement.

Boucher said health officials are losing ground becausecompanies are not developing drugs quickly enough to keep upwith the superbugs' ability to develop resistance, adding: "We're all at risk."

Almost as soon as penicillin was introduced in the 1940s,bacteria began to develop resistance to its effects, promptingresearchers to develop many new generations of antibiotics. Buttheir overuse and misuse have helped fuel the rise ofdrug-resistant superbugs.

In the past month, public health officials in the UnitedStates and Britain have sounded alarms about the growing threat.

On March 5 the CDC warned of the spread ofCarbapenem-Resistant Enterobacteriaceae (CRE), a class of whatCDC Director Thomas Frieden called "nightmare bacteria" thatkill up to half of patients who get bloodstream infections fromthem.

A week later, Sally Davies, the chief medical officer forEngland, said antibiotic resistance was a "catastrophic threat"and called for global action to fill a drug "discovery void."

'ALARMINGLY LOW'

The latest report, a follow-up to a 2009 study, is based oninterviews with drug companies, published data, informationculled from websites and other sources. It focuses on new agentsto fight gram-negative superbugs, which the group said representthe most "pressing clinical needs."

Gram-negative bacteria include E. coli, Salmonella, Shigella and other species in the class known as Enterobacteriaceaebacteria.

It suggests that companies have continued their retreat fromresearch and development of antibiotics.

"The number of antibacterial compounds in phase 2 or 3development remains alarmingly low," Boucher and colleagueswrote.

Unlike drugs for chronic diseases such as diabetes, whichare taken over many years, antibiotics are used for just a fewweeks, and efforts to control resistance have led doctors toprescribe the drugs sparingly.

For the report, Boucher and colleagues focused on new oralor intravenous antibiotics that had progressed to phase 2 orphase 3 clinical trials.

They found a total of seven drugs in development and beingtested in people with drug-resistant, gram-negative infections.

"We know not all of those drugs will make it," Boucher saidin a telephone interview.

Of the seven, one company, Polymedix, filed forChapter 7 bankruptcy this month, and AstraZeneca, whichis making two of the drugs, last month said it would invest lessmoney in developing antibiotics.

The other companies include Merck, CubistPharmaceuticals, GlaxoSmithKline and privatelyheld Achaogen Inc of South San Francisco, California.

The ISDA is pushing for new economic incentives for drugcompanies, a clarification of U.S. regulations for antibioticapproval, more funding for basic research, betterinfection-prevention efforts and better data on the spread ofdrug resistance and the use of antibiotics.