-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Mn7YRaDTizBWXfSV6R+L/V4wHebUtAMvmGq5F2syaf423g3O/yaXhqfhcRXnvpNH uuu9z9yYlzCmkGARxmhjNg== 0001104659-06-035715.txt : 20060517 0001104659-06-035715.hdr.sgml : 20060517 20060517161024 ACCESSION NUMBER: 0001104659-06-035715 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060517 ITEM INFORMATION: Other Events FILED AS OF DATE: 20060517 DATE AS OF CHANGE: 20060517 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOSITE INC CENTRAL INDEX KEY: 0000834306 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 330288606 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21873 FILM NUMBER: 06849286 BUSINESS ADDRESS: STREET 1: 11030 ROSELLE ST CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6194554808 MAIL ADDRESS: STREET 1: 11030 ROSELLE ST CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: BIOSITE DIAGNOSTICS INC DATE OF NAME CHANGE: 19960710 8-K 1 a06-12112_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported):  May 17, 2006

 

BIOSITE INCORPORATED

(Exact name of registrant as specified in charter)

 

Delaware

 

000-21873

 

33-0288606

(State or other
jurisdiction of
incorporation)

 

(Commission File
Number)

 

(I.R.S. Employer
Identification No.)

 

 

 

 

 

9975 Summers Ridge Road
San Diego, California

 

92121

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (858) 805-2000

 

Not Applicable.
(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o                                    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                                    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                                    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                                    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Item 8.01                               Other Events.

 

On May 17, 2006, we announced that we intend to voluntarily withdraw our Premarket Application for the Triage Stroke Panel, currently on hold with the U.S. Food and Drug Administration.  A copy of the press release announcing such withdrawal is attached to this Form 8-K as Exhibit 99.1 and is hereby incorporated by reference into this Item 8.01.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

BIOSITE INCORPORATED

 

 

 

 

 

 

Date:  May 17, 2006

By:

/s/ Kim D. Blickenstaff

 

 

 

Kim D. Blickenstaff

 

 

Chief Executive Officer and Chairman of the Board

 

3



 

INDEX TO EXHIBITS

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release of Biosite Incorporated dated May 17, 2006.

 

4


EX-99.1 2 a06-12112_1ex99d1.htm EX-99

Exhibit 99.1

 

 

Contact:  Nadine Padilla

VP, Corporate & Investor Relations

858-805-2820

npadilla@biosite.com

 

 

May 17, 2006

 

 

BIOSITE® INCORPORATED TO WITHDRAW TRIAGE® STROKE PANEL PMA

Company to initiate additional trial for new submission

 

SAN DIEGO – Biosite® Incorporated today said that it intends to voluntarily withdraw its Premarket Approval (PMA) application for the Triage® 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.”

 

-more-

 



 

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® 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 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®, Triage® and New Dimensions in Diagnosis® are registered trademarks of Biosite Incorporated.

 

2


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