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Eli Lilly and Company

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.
About Xigris
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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
           http://www.newscom.com/cgi-bin/prnh/20060320/BIOSITELOGO )
    Web site: http://www.Xigris.com
              http://www.lilly.com
              http://www.biosite.com

Contact:

Terra Fox of Lilly, +1-317-276-5795; Investors: Nadine Padilla,
+1-858-805-2820, or Media: Susan Schotthoefer, +1-858-805-2804, both
of Biosite. Photo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20060320/BIOSITELOGO
PRN Photo Desk, photodesk@prnewswire.com

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