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Lilly and Biosite to Collaborate on Clinical Trial Using Tailored Xigris Therapy
Indianapolis and San Diego (ots/PRNewswire) -
- Trial to Study Use of Biomarker to Better Define Xigris Patients and Treatment Response
Eli Lilly and Company (NYSE: LLY) and Biosite(R) Incorporated (Nasdaq: BSTE) today announced the two companies have signed an agreement to collaborate in connection with a clinical trial employing a tailored therapy strategy for Lilly's severe sepsis drug, Xigris(R) (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.
"We are very excited about this collaboration," said John C. Lechleiter, Ph.D., president and chief operating officer for Lilly. "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 enroll 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 U.S. 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," said Kim Blickenstaff, Biosite chairman and chief executive officer. "Biosite's point-of-care platform is used in more than 50 percent of U.S. 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."
About Severe Sepsis
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. Further, incidence of severe sepsis is expected to rise at a minimum annual rate of 1.5 percent. Severe sepsis will strike an estimated 934,000 people -- in America alone -- by 2010; the majority of whom will be 65 years and older.
Xigris (drotrecogin alfa [activated]) is a recombinant form of human Activated Protein C. It is administered by intravenous infusion and is available in 5 and 20 mg vials. In November 2001, the U.S. Food and Drug Administration approved Xigris 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).
Bleeding is the most common serious adverse effect associated with Xigris therapy. In PROWESS, a Phase III study, serious bleeding events were observed during the 28-day study period in 3.5 percent of Xigris-treated and 2.0 percent of placebo-treated patients. The difference in serious bleeding occurred primarily during infusion. Each patient being considered for therapy with Xigris should be carefully evaluated and anticipated benefits weighed against potential risks associated with therapy. For full safety information including contraindications and warnings, please see Xigris Prescribing Information, which can be obtained by visiting www.Xigris.com .
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and 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. Additional information about Lilly is available at www.lilly.com . F-LLY
About Biosite Incorporated
Biosite Incorporated is a leading bio-medical company commercializing proteomics discoveries for the advancement of medical diagnosis. Biosite's products contribute to improvements in medical care by aiding physicians in the diagnosis of critical diseases and health conditions.
Biosite's Triage(R) rapid diagnostics are used in more than 50 percent of U.S. hospitals and in more than 50 international markets. Information on Biosite can be found at www.biosite.com .
This press release contains forward-looking statements about Biosite's investigational Protein C biomarker for the identification, dosing and response evaluation of severe sepsis patients at high risk of death, when used in connection with treatment with Lilly's Xigris, and reflects Lilly's and Biosite's current beliefs. However, there are risks and uncertainties in the process of development and regulatory review. There are no guarantees that clinical trials for the product and device will be completed, that the product or the device will perform as expected, or that regulatory approvals will be received. For further discussion of these and other risks and uncertainties, see Lilly's and Biosite's filings with the United States Securities and Exchange Commission. Lilly and Biosite undertake no duty to update forward-looking statements.
Biosite(R) and Triage(R) are registered trademarks of Biosite Incorporated. The company's logo is a trademark of Biosite Incorporated.
Xigris(R) is a registered trademark of Eli Lilly and Company.
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