Biosite(R) Incorporated Announces Exclusive License for Novel Renal Injury Marker
July 13 2005 - 8:00AM
PR Newswire (US)
Biosite(R) Incorporated Announces Exclusive License for Novel Renal
Injury Marker SAN DIEGO, July 13 /PRNewswire-FirstCall/ --
Biosite(R) Incorporated (NASDAQ:BSTE) today announced it has signed
an exclusive licensing agreement with Cincinnati Children's
Hospital Medical Center and Columbia University for the use of
neutrophil gelatinase-associated lipocalin (NGAL), a biomarker that
may assist clinicians to quickly and accurately identify acute
renal failure within hours rather than days, in diagnostic,
monitoring and prognostic applications. Under the collaboration,
Biosite will make antibodies to NGAL using its proprietary antibody
development process, which combines immunization of mice and phage
display technology to generate highly diverse libraries of
Omniclonal(R) antibodies with high affinity and low
cross-reactivity. The immunoassay for NGAL will then be tested on
blood samples to assess commercialization potential. The financial
terms of the agreement were not disclosed. Acute renal failure
remains a common and critical clinical entity affecting five
percent of all hospitalized patients and 30 to 50 percent of those
in the intensive care unit. It is associated with various medical
problems, treatments, and procedures. Despite advances in medical
care, acute renal failure still carries a significant mortality
rate(i). When acute renal failure is observed in the intensive care
unit complicated with other non-renal organ dysfunction, the
associated mortality rate is 50 to 70 percent(ii). In a recent
study, published in the April 1, 2005 issue of The Lancet(iii),
concentrations of NGAL were "strikingly raised" in the urine and
serum of children with acute renal failure after cardiopulmonary
bypass. Noting that acute renal failure occurs in up to four in
every 10 patients undergoing cardiac surgery, Dr. Devarajan,
Cincinnati Children's Hospital Medical Center, Ohio, and colleagues
tested whether NGAL could act as an early biomarker for renal
injury after cardiothoracic surgery. Devarajan and his team studied
NGAL expression in blood and urine samples from 71 children
undergoing cardiopulmonary bypass using western blots and
enzyme-linked immunosorbent assay (ELISA). The current gold
standard in diagnosing renal failure (serum creatinine measurement)
leads to a diagnosis one to three days after the initial injury,
but by testing for high concentrations of NGAL, Dr. Devarajan and
colleagues at Cincinnati Children's found they could get definitive
test results within hours. "Our results indicate that NGAL is not
only a powerful immediate early biomarker for acute renal injury,
preceding any increase in serum creatinine by one to three days,
but is also a valid discriminatory marker for the entire duration
of the study," wrote the researchers. "The results from this study
appear promising, so we are looking forward to examining NGAL
further," said Gunars Valkirs, Ph.D., senior vice president Biosite
Discovery. "Acute renal failure is a common clinical disorder still
associated with a poor prognosis, and where rapid diagnosis could
play a key role in better patient outcomes." About Cincinnati
Children's Hospital Cincinnati Children's Hospital Medical Center
is a 423-bed institution devoted to bringing the world the joy of
healthier kids. Cincinnati Children's is dedicated to transforming
the way health care is delivered by providing care that is timely,
efficient, effective, family-centered, equitable and safe. It ranks
third nationally among all pediatric centers in research grants
from the National Institutes of Health. The Cincinnati Children's
vision is to be the leader in improving child health. Additional
information can be found at http://www.cincinnatichildrens.org/.
About Biosite Incorporated Biosite Incorporated is a leading
bio-medical company commercializing proteomics discoveries for the
advancement of medical diagnosis. The Company'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 approximately 50 percent of
U.S. hospitals and in over 50 international markets. Information on
Biosite can be found at http://www.biosite.com/. Except for the
historical information presented herein, matters discussed in this
press release are forward-looking statements that involve risks and
uncertainties that could cause actual results to differ materially
from any future results, performance or achievements expressed or
implied by such statements. Statements that are not historical
facts, including but not limited to statements that are preceded
by, followed by, or that include the words "will"; "believes";
"should"; "intends"; "anticipates"; "plans"; "expects";
"estimates"; or similar statements are forward-looking statements.
Forward looking statements include statements about the potential
benefits of the license agreement between Biosite, Cincinnati
Children's Hospital Medical Center, and Columbia University,
Biosite's ability to generate antibody libraries and evaluate the
diagnostic utility of the target, and the clinical utility of
measuring concentrations of NGAL for purposes of diagnosing kidney
failure or other forms of renal failure or for any other
diagnostic, monitoring or prognostic application. Risks that should
be considered include risks and uncertainties regarding the
discovery and product development process generally, risks
associated with the introduction of competitive products from
companies with greater capital and resources, uncertainties around
the proprietary nature of the targets subject to the collaboration,
uncertainties relating to clinical trials and the regulatory
approval process for any new potential product, and risks and
expenses associated with litigation, contract disputes, patent
conflicts, product recalls, manufacturing constraints, backlog,
delays or inefficiencies, shipment problems, seasonal customer
demand, the timing of significant orders, changes in reimbursement
policies, regulatory changes, competitive pressures on average
selling prices, and the other risks detailed in Biosite's most
recent Annual Report on Form 10-K, as amended, and other SEC
filings. Biosite disclaims, any intent or obligation to update
these forward-looking statements. Copies of Biosite's public
disclosure filings are available from its investor relations
department. Biosite(R), Triage(R) and New Dimensions in
Diagnosis(R) are registered trademarks of Biosite Incorporated. The
Company's logo is a trademark of Biosite Incorporated. (i) Singri
et al, Acute Renal Failure, JAMA Feb 12, 2003 - Vol 289, No. 6:
747-751 (ii) Mehta et al, Acute renal failure definitions and
classification: time for change?, J Am Soc Nephrol, 14:2178-2187,
2003 (iii) Mishra et al, Neutrophil gelatinase-associated lipocalin
(NGAL) as a biomarker for acute renal injury following cardiac
surgery, Lancet 2005; 365: 1231-1238 DATASOURCE: Biosite
Incorporated CONTACT: Nadine Padilla, VP, Corporate & Investor
Relations of Biosite Incorporated, +1-858-455-4808, ext. 3187, ; or
Amy Reyes of Cincinnati Children's Hospital Medical Center,
+1-513-636-9684, Web site: http://www.biosite.com/
http://www.cincinnatichildrens.org/ Company News On-Call:
http://www.prnewswire.com/comp/116737.html
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