* Need to combat antibiotic resistance now “critical”
* EU to accelerate new drug approvals, ensure adequate pricing
* Plan to boost R&D collaboration via IMI initiative
* Drugmakers welcome fresh incentives for antibiotic research
By Ben Hirschler and Kate Kelland
LONDON, Nov 17 (Reuters) - Europe set out plans to boost research into the neglected area of antibiotics on Thursday by promising to accelerate approval of new drugs, while ensuring adequate prices for their makers and promoting industry-wide R&D.
Multi-drug resistant bacteria, or so-called superbugs, are a growing threat across Europe, with rates of drug resistance in one type of bacteria reaching 50 percent in the worst-hit countries, according to health officials.
But the medicine chest for new antibiotics is practically empty, following a decision by many large drugmakers to exit what has become an unprofitable area of research.
“We need to take swift and determined action if we do not want to lose antimicrobial medicines as essential treatment against bacterial infections in both humans and animals,” EU health commissioner John Dalli said, outlining the new strategy at a briefing in Brussels.
A key element of the plan rests on using the existing Innovative Medicines Initiative (IMI) — a public-private scheme jointly funded by industry and the Commission — to speed the discovery and development of novel antibiotics.
The goal is to encourage “unprecedented open sharing of knowledge” between companies at the pre-competitive research stage.
The Commission said it would also use flexibility in the current pharmaceutical legislation to give rapid approval to new antibiotics and would work with governments to make sure they enjoyed “adequate market and pricing conditions.”
Superbugs capable of evading even the most powerful antibiotics are increasing their grip in Europe and the need to combat resistance is now “critical”, according to the European Centre for Disease Prevention and Control (ECDC).
“We need to declare a war — a war against these bacteria,” the ECDC’s director Marc Sprenger told Reuters.
Sprenger said that across Europe rates of resistance to last-line antibiotics by a bacteria called Klebsiella pneumoniae had more than doubled to 15 percent by 2010 from around 7 percent five years ago.
“What’s even more worrying is that there’s a great diversity among different countries in Europe — and some countries have resistance of almost 50 percent,” he said.
K. pneumoniae is a common cause of pneumonia, urinary tract, and bloodstream infections in hospital patients. The superbug form is resistant even to a class of medicines called carbapenems, the most powerful known antibiotics, which are usually reserved by doctors as a last line of defence.
The ECDC also found a worrying increase between late 2010 and early 2011 in the incidence of bacteria with a gene known as New Delhi metallo-beta-lactamase, or NDM-1, that makes them highly resistant to almost all drugs. The NDM-1 gene is often found in bacteria like K. pneumoniae and E. coli.
With few new antibiotic drugs on the horizon, experts are increasingly worried that only a few big drug firms, such as GlaxoSmithKline and AstraZeneca, still have strong antibiotic research and development programmes.
There is little commercial incentive to invest in new drugs that may be held in reserve as last-line weapons.
Pharmaceutical companies also complain about increasingly tough barriers for market approval — necessitating extensive and costly clinical trials — as well as relatively low prices compared with returns on treatments for diseases like cancer.
GSK Chief Executive Andrew Witty, who is also current president of the European pharmaceutical association Efpia, said the Commission’s plans were a welcome step forward that could help bring more antibiotics to market.
“Unfortunately, the current commercial model doesn’t stimulate the innovation needed in this area,” he said.
“We need a fundamentally different approach and public-private collaboration, with the sharing of information and funding, provides us with a significant opportunity to reduce the hurdles in our way.”
To a large extent, antibiotic resistance is driven by the misuse and overuse of antibiotics, which encourages bacteria to develop new ways of overcoming them.
Experts say primary care doctors are partly to blame for prescribing antibiotics unnecessarily for patients who demand them. Hospitals are also guilty of overuse.
Sprenger said that the countries with the highest rates of multi-drug resistant infections, such as Greece, Cyprus, Italy, Hungary and Bulgaria, also tended to be the ones with the highest use of antibiotics.
“In general what you see is that high resistance goes hand in hand with high consumption,” he said.