New Drug Now Available in Europe to Treat Patients With Severe Sepsis; a Devastating Condition Associated With a Loss of Up to 135,000 Lives in European Intensive Care Units Each Year.Business Editors/Health and Medical Writers INDIANAPOLIS--(BUSINESS WIRE)--Oct. 29, 2002 Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. (NYSE NYSE See: New York Stock Exchange :LLY) announced today that Xigris(R) (drotrecogin alfa drotrecogin alfa (activated) Warning - High-alert drug! Xigris Pharmacologic class: Activated protein C (recombinant) Therapeutic class: Antisepsis drug (activated)) -- the first life-saving therapy indicated for the treatment of adult patients with severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status with multiple organ failure when added to best standard care -- is now available in many countries in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . The European launch comes less than two months after the European Commission granted Marketing Authorisation for Xigris in all 15-member states on 26 August 2002. Since the U.S. approval in November 2001, Xigris has now been approved in over 30 countries. "I have personally seen the devastation this condition can cause for patients and their families. We need all the weapons in our arsenal in order to combat this devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. condition. Now that Xigris is available in Europe, we will have that option," said Professor Jean-Louis Vincent, Head of the Department of Intensive Care at Erasme Hospital, University of Brussels The University of Brussels can refer to three universities in Brussels, Belgium:
"Lilly is once again proud to be leading the way in the production of an innovative treatment to improve patient care and help save lives. We are delighted to make Xigris available in Europe," said Richard Pilnik, President of European Operations for Lilly. The European Commission based its approval on the results of an international Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the known as PROWESS (Recombinant Human Activated Protein C Human activated protein C is a serine protease which is derived from the two chain vitamin K dependent zymogen. It is used to inhibit blood coagulation thought the selective inactivation of the cofactors Va and VLLA. Worldwide Evaluation in Severe Sepsis), which were published 8 March 2001, in The New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. . 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. Andy Durning, a 31-year-old firefighter from Glasgow, UK, received Xigris as part of a clinical trial. In response to his personal experience, Durning said, "I was having multiple organ failure. Four of the five major organs had started failing -- my heart, lungs, kidneys and liver -- and my family was told that I had a 10 percent chance of survival. Then I was put on a trial drug called Xigris and to have made it through with just a 10 percent chance of survival, I'm sure Xigris helped save my life." About Severe Sepsis Severe sepsis is a complex syndrome that affects 1.6 million people worldwide(1) and is associated with the loss of up to 135,000(2) lives in European intensive care units every year -- as many as lung cancer, breast cancer or colon cancer(3). Severe sepsis occurs when an infection (bacterial, viral, fungal or parasitic) -- often the result of surgery, burns, cancer or major injury such as those sustained in a traffic accident -- triggers a cascade of immune system responses that can lead to acute organ dysfunction and often death. About Xigris 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 coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or (blood-clotting) and suppression of fibrinolysis fibrinolysis /fi·bri·nol·y·sis/ (fi?brin-ol´i-sis) dissolution of fibrin by enzymatic action.fibrinolyt´ic fi·bri·nol·y·sis n. pl. (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 ICU intensive care unit. ICU abbr. intensive care unit ICU see intensive care unit. ICU setting. The precise dosage depends on the weight of the patient. In the EU, Xigris is approved for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. Safety and efficacy have not been established in pediatric patients with severe sepsis. In addition to the ADDRESS (Administration of Drotrecogin alfa (activated) in Early Severe Sepsis) trial investigating the use of Xigris in lower-risk patients, Lilly is undertaking trials of Xigris in children with severe sepsis, and investigating the concomitant use of low-dose heparin with Xigris. About Eli Lilly and Company Lilly, a leading innovation-driven corporation, 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 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 future studies will confirm the results reported in this press release or 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(R)(Drotrecogin alfa (activated)), Eli Lilly and Company, Indianapolis, Indiana 1. Estimated ICU restricted cases in OECD OECD: see Organization for Economic Cooperation and Development. countries, based on 1995 population data 2. Davies A et al, June 2000, Severe Sepsis and septic shock: a European estimate of the burden of disease in ICU 3. Davies A et al, June 2000, Severe Sepsis and septic shock: a European estimate of the burden of disease in ICU |
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