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European Commission Approves Eli Lilly and Company's Xigris for the Treatment of Severe Sepsis.

Medical/Health Writers


Novel biotech treatment becomes the first proven therapy to

reduce mortality in patients with severe sepsis in Europe

Eli Lilly and Company (NYSE:LLY) today announced that the European Commission has granted Marketing Authorisation for Xigris(TM) (drotrecogin alfa (activated)) in all 15-member states of the European Union. This novel, biotech therapy is approved for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The approval decision follows a positive opinion adopted by the European Committee for Proprietary Medicinal Products (CPMP) on Thursday, 30 May 2002. Having received this excellent news, Lilly will make Xigris available in the European Union as soon as possible.

The European Commission based its decision on the results of an international Phase III clinical trial known as PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis), which were published 8 March 2001, in The New England Journal of Medicine. Xigris reduced the relative risk of death from severe sepsis by nearly 20 percent in the trial involving 1,690 patients who had sepsis with at least one associated organ dysfunction.

"The approval of Xigris within the European Union means adult patients with severe sepsis will soon have a proven therapy to help reduce mortality from this devastating condition," said Professor Jean-Louis Vincent, Department of Intensive Care, Erasme Hospital, Brussels, Belgium. "Severe sepsis is an extremely complex and difficult-to-treat condition that can alter the function of the organs and even lead to death."

"Today's approval is a major breakthrough in the treatment of severe sepsis in Europe and brings new hope to patients with the condition and their families," said Richard Pilnik, president of European operations for Lilly. "Lilly has a long-standing commitment to producing innovative treatments to improve patient care so we are delighted to make Xigris available in Europe."

Every day 1,400 people worldwide die from severe sepsis(1), a devastating syndrome characterized by an overwhelming systemic response to infection, which can rapidly lead to organ dysfunction and ultimately death. In European Union (EU) intensive care units (ICU), severe sepsis and septic shock (severe sepsis combined with low blood pressure) could be associated with the loss of 135,000(2) lives every year and as much as EUR 7.6 billion (US$7.6 billion) in patient health costs(3). In Europe, severe sepsis is associated with deaths on a scale similar to that for lung cancer, breast cancer or colon cancer every year.(4)

Xigris received approval from the US Food and Drug Administration on 21 November 2001 for the reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II). Since the US approval, Xigris has also been approved in Puerto Rico, Israel, Australia, Argentina, Peru, Romania, Columbia, Mexico, Switzerland, India, Singapore, South Africa and now the European Union.

Xigris is a genetically engineered version of the human Activated Protein C molecule, a naturally occurring protein in the body that helps to balance many of the major forces behind sepsis, including coagulation (blood-clotting) and suppression of fibrinolysis (the body's clot-busting system). Additionally, patients with severe sepsis treated with Xigris had a more rapid decline in interleukin-6 levels, a global marker of inflammation, consistent with a reduction in the inflammatory response. The drug is administered to patients as a one-time, 96-hour infusion within an ICU setting. The precise dosage depends on the weight of the patient.

Bleeding events are common in patients with severe sepsis. In the PROWESS trial, bleeding was the most common adverse reaction associated with Xigris therapy. Serious bleeding events, including intracranial hemorrhage (0.2 percent in Xigris-treated patients and 0.1 percent in placebo-treated patients), were observed during the 28-day study period in 3.5 percent of Xigris-treated patients and 2.0 percent of placebo-treated patients. The difference in serious bleeding occurred primarily during infusion.

About Eli Lilly and Company

Lilly is a leading innovation-driven corporation and is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in the US in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

This news release contains forward-looking statements that reflect management's current beliefs about the potential for Xigris (drotrecogin alfa (activated)) for the approved indication. However, as with any pharmaceutical under development, there are significant risks and uncertainties in the process of development and regulatory review. There are no guarantees that the product will prove to be commercially successful. For additional information about the factors that affect the company's business, please see Exhibit 99 to the company's latest Form 10-Q, filed August 2002. The company undertakes no duty to update forward-looking statements.

Xigris(TM) (Drotrecogin alfa (activated)), Eli Lilly and Company, Indianapolis, Indiana

(1) Bone RC, Balk RA, Cerra FB et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies for sepsis. Chest: 1992;101: 1644-1655

(2) OECD Health Report (2000)

(3) Davies; Green; Hutton et al. Severe sepsis and septic shock: a European estimate of the cost of illness in ICUs; June 2001; Abstract presented at European Society of Intensive Care Medicine, October 2001.

(4) Davies A et al, June 2000, Severe sepsis and septic shock: a European estimate of the cost of illness in ICUs: Official manuscript.
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Comment:European Commission Approves Eli Lilly and Company's Xigris for the Treatment of Severe Sepsis.
Publication:Business Wire
Geographic Code:1USA
Date:Aug 26, 2002
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