Lilly Stops Enrollment in Phase III Study of Recombinant Human Activated Protein C in Severe Sepsis Interim Analysis Found Study Met Criteria for Reduced Mortality INDIANAPOLIS, June 29 /PRNewswire-AsiaNet/ -- Eli Lilly and Company (NYSE: LLY) announced today that it is stopping enrollment in a Phase III clinical trial investigating the therapeutic potential of recombinant human activated protein C in the treatment of severe sepsis. An interim analysis found that the placebo-controlled trial results met the criteria for reduced mortality among recombinant human activated protein C-treated sepsis patients. Recombinant human activated protein C will be marketed as Zovant(TM) if it receives regulatory approval. The decision to stop enrollment of new patients in the PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) trial follows a favorable recommendation by an independent Data and Safety Monitoring Board (DSMB) that met on June 28, 2000, to conduct a regularly scheduled interim analysis of the study. The DSMB found positive results based on 1,520 patients in the trial with a primary endpoint of 28-day all- cause mortality. The DSMB is comprised of a small group of experts separate from Lilly that evaluates the trial based on parameters set in advance of the study. Lilly executives said they are encouraged with the interim analysis and are hopeful the results of the full evaluation of the data will support a submission to regulatory authorities for approval of Zovant. "There is a serious unmet medical need for more than 1.5 million people worldwide annually who have sepsis since there are currently no pharmacological agents approved to treat this often fatal disease," said August M. Watanabe, M.D., executive vice president, science and technology for Lilly. "We are excited about the possibility of having a treatment that may improve the chances for survival for those who are afflicted with this devastating disease." Sepsis is a disease characterized by an overwhelming systemic response to infection, which can rapidly lead to organ failure and ultimately death. Sepsis can strike anyone but can be triggered by events such as pneumonia, trauma, surgery and burns, or by conditions such as cancer and AIDS. Sepsis often occurs among hospitalized patients and, in the U.S., is the leading cause of death in non-coronary intensive care units. Each year, 700,000 new cases of sepsis are diagnosed in the U.S., killing an average of 1,400 people worldwide every day. Sepsis has a 30 to 50 percent mortality rate. Currently, treatment is limited to attempts to manage the infection and supportive therapy if the infection leads to organ failure. The estimated costs associated with the treatment of patients with sepsis range from $10 billion to $25 billion annually in the U.S. alone. Protein C is a protein in the body that appears to be severely low in sepsis patients. When protein C levels are low, it cannot be converted in sufficient quantities to the activated form, APC. As a result, coagulation and inflammation go "unchecked" resulting in serious complications. Lilly researchers believe Zovant has three important roles: preventing clot formation, breaking up clots already in existence, and reducing the inflammation that occurs in blood vessels. "More than 30 clinical trials of investigational compounds have failed to offer an effective and safe treatment," said PROWESS lead investigator Gordon Bernard, M.D., associate director of the Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center. "This positive news about recombinant human activated protein C should give clinicians hope that there may finally be a way to improve outcomes for patients with sepsis." The PROWESS trial began in July 1998 and has been conducted at clinical sites in 11 countries worldwide. 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 recombinant human activated protein C in the treatment of sepsis. 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 clinical trials will confirm the preliminary results reported in this release, or that the product will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see the company's U.S. Securities and Exchange Commission filings. SOURCE Eli Lilly and Company CONTACT: Dan Collins, 317-277-2688, or Judy K. Moore, 317-277-6265, both of Eli Lilly and Company Company News On-Call: http://www.prnewswire.com/comp/126236.html or fax, 800-758-5804, ext. 126236 Web site: http://www.lilly.com