Company to Initiate Additional Trial for New Submission
SAN DIEGO, May 17 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE) today said that it intends to voluntarily withdraw its
Premarket Approval (PMA) application for the Triage(R) Stroke Panel,
currently on hold with the U.S. Food and Drug Administration (FDA). As
previously disclosed by the Company, Biosite also intends to begin planning
for an additional clinical study to potentially support a new U.S.
regulatory submission for the product. The Company originally submitted the
PMA for the Triage Stroke Panel to the FDA in January 2005, and had been
preparing to submit additional information to the FDA for the pending PMA.
"Withdrawing the PMA submission will allow us the time and flexibility
to tailor a clinical trial strategy that improves the prospects for U.S.
regulatory approval and commercial success of the Triage Stroke Panel,"
said Kim Blickenstaff, chairman and chief executive officer. "We believe
that continuing with the existing PMA would have been a lengthy process
requiring the commitment of significant energy and resources, both at
Biosite and the FDA. For Biosite, these resources can now be applied more
efficiently across our entire pipeline of potential new products, including
the Triage Stroke Panel."
According to the Company, the FDA's questions primarily centered on
methodological issues in the clinical trial supporting the PMA and the
performance of the product for the proposed indication of use.
"Our initial trial was complicated by the variability in stroke care
among our trial sites," said Blickenstaff. "From a resource and knowledge
standpoint, we believe we are better prepared today to design and complete
effective clinical studies for the Triage Stroke Panel and other potential
products."
Before commencing a new clinical trial for the Triage Stroke Panel, the
Company intends to complete its analysis of data related to the Triage
Stroke Panel that were collected during the course of the PMA submission,
as well as additional information from the Company's ongoing research in
the field of stroke. After the Company has completed that process, it
intends to work with thought leaders to design a new clinical trial to
support a potential future regulatory submission to the FDA. The timing and
duration of a future clinical trial for stroke is currently being studied.
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 more than 50 percent of
U.S. hospitals and in more than 60 international markets. Information on
Biosite can be found at http://www.biosite.com.
Forward Looking Statements
This press release contains forward-looking statements about Biosite's
Triage Stroke Panel, including statements concerning potential future
clinical studies and FDA submissions related to that product, and Biosite's
ability to design and complete effective clinical trials for other products
currently in development. However, there are risks and uncertainties in the
process of development, clinical trials and regulatory review. There are no
guarantees that clinical trials for the Triage Stroke Panel or other
products currently in development by Biosite will be completed on a timely
basis or at all, that any of those products will perform as expected, or
that regulatory approvals will be received. For further discussion of these
and other risks and uncertainties that could cause Biosite's actual results
to differ materially from those expressed or implied by the forward-looking
statements in this release, see Biosite's filings with the United States
Securities and Exchange Commission, including the Company's most recent
quarterly report on Form 10-Q. Biosite undertakes no duty to update
forward-looking statements.
Biosite(R), Triage(R) and New Dimensions in Diagnosis(R) are registered
trademarks of Biosite Incorporated.
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
http://www.prnewswire.com/comp/116737.html /
CONTACT:
Nadine Padilla, VP, Corporate & Investor
Relations, +1-858-805-2820, npadilla@biosite.com, or Susan
Schotthoefer, Senior Corporate Communications Specialist,
+1-858-805-2804, sschott@biosite.com, both of Biosite
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