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LONDON (Reuters Health) – Severe sepsis and septic shock could be associated with up to 146,000 deaths every year in the European Union and as much as 7.6 billion euros (US $6.7 billion) in patient healthcare costs, according to US drug maker Eli Lilly, which hopes to launch its breakthrough treatment Xigris, a recombinant form of Activated Protein C called drotrecogin alfa, early next year.

As regulators at the US Food and Drug Administration and the European Medicines Evaluation Agency prepare to meet later this month to decide whether to recommend approval of the potential blockbuster, the firm released statistics estimating the total social and economic burden of severe sepsis in European Union intensive care units (ICUs).

In a news release, it said a study by London-based research institute Medtap International to be presented Wednesday at the Conference of the European Society of Intensive Care Medicine (ESICM) in Geneva shows that severe sepsis is associated with deaths on a similar scale to lung cancer, breast cancer and colon cancer.

"The ICU burden associated with severe sepsis in the six countries studied–the UK, France, Germany, Italy, Spain, Netherlands–representing 83% of the EU population, showed the annual number of deaths of individuals with sepsis to be between 95,000 and 121,000, with an estimated annual ICU cost of between 4.8 billion and 6.4 billion (US $4.2 billion and $5.7 billion)," according to the statement.

"Once these figures are applied to average incidence rates in the rest of the European Union, the total death rate is estimated at between 114,000 to 146,000 per year, with a cost of between 5.8 billion and 7.6 billion (US $5.1 billion and $6.7 billion). This means that 10% to 14% of European ICU patients who develop this life-threatening condition are associated with approximately 24% to 32% of total ICU costs," the statement continued.

Professor Graham Ramsay, president-elect of ESICM said: "This study is very important because it is the first time we've had statistics which show the extent of the problem in Europe. Hopefully, this will be the first step to raising awareness of this terrible condition amongst policy-makers and the public."

Lilly said that phase lll trial results showed that patients with severe sepsis who received Xigris had a 19.4% reduction in relative risk of death compared with patients who received placebo.

"Patients are currently treated with antibiotics, with some success, for the underlying infection, but if Xigris is approved it will be the first therapy specifically indicated for the treatment of severe sepsis," Professor Jean-Francois Dhainaut, from Paris University, commented in the news release. "A combination of earlier diagnosis and a treatment breakthrough are going to be the key factors in reducing the burden of sepsis in Europe."

Analysts expect that if Xigris lives up to its promise, it could reach annual sales of more than $1 billion, helping Lilly survive the patent expiry of Prozac.