Eli Lilly and Company and Biosite Incorporated have signed an agreement to collaborate in connection with a clinical trial employing a tailored therapy strategy for Lilly's severe sepsis drug, Xigris (drotrecogin alfa [activated]). The trial, called RESPOND (Research Evaluating Serial Protein C levels in severe sepsis patients ON Drotrecogin alfa), will investigate the use of a multipurpose biomarker, Protein C, to be used in connection with the administration of Xigris.

John C. Lechleiter, president and chief operating officer for Lilly said, "Physicians have told us they want an on-demand diagnostic that better identifies patients who might benefit from Xigris, helps monitor the patient's response, and allows tailored treatment. We hope this biomarker strategy will help maximize the value of this medicine for critically ill sepsis patients."

Under the terms of the agreement, Biosite will develop a rapid, point-of- care diagnostic capable of measuring Protein C levels. Lilly will use the Biosite test, as well as other existing FDA approved Protein C tests, to enrol patients in its upcoming Phase II-b clinical trial, which is expected to begin in the fourth quarter of 2006. Investigators also will use the tests in this novel study to help with individualized dose and duration of Xigris therapy and to evaluate patient response. The agreement also grants Biosite rights to intellectual property in the field of sepsis diagnosis, including assignment of US Patent Application No. 10/759,216 Biomarkers for Sepsis. The financial terms of the agreement were not disclosed.

"This is an important strategic development recognizing the need for diagnostic tests that can be used to both identify patients who will benefit from therapeutic treatment and monitor their status over the course of time," Kim Blickenstaff, Biosite chairman and chief executive officer said adding, "Biosite's point-of-care platform is used in more than 50 percent of US hospitals and has a growing presence in Europe, creating a significant advantage for therapeutic companies wishing to partner in this type of personalized clinical approach."

Sepsis is a common, deadly and under-diagnosed disease that claims approximately 1,400 lives worldwide each day. Severe sepsis often develops as a complication after common illnesses such as pneumonia, and bacterial infections. The leading cause of death in the non-coronary intensive care unit (ICU), severe sepsis claims the lives of more than 215,000 people in the United States every year, largely as a consequence of rapid organ failure during the most life-threatening stage of the illness -- the first 28 days.