Angiotech Pharmaceuticals Inc - Report of Foreign Issuer (6-K)
22 Oktober 2007 - 9:14PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of October, 2007
ANGIOTECH PHARMACEUTICALS, INC.
(Registrant's name)
1618 Station Street,
Vancouver, B.C.
Canada V6A 1B6
(604) 221-7676
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F _____ Form 40-F ___
X__
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes _____ No
__X___
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-__________.
EXHIBIT INDEX
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Exhibit Number
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Description of Document
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1.
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Material Change Report FORM 51-102F3 Dated October 19, 2007
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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, thereunto duly authorized.
ANGIOTECH PHARMACEUTICALS, INC.
Date: October 19, 2007
By: /s/
Name: K. Thomas Bailey
Title: Chief Financial Officer
Exhibit 1
FORM 51-102F3
MATERIAL CHANGE REPORT
ITEM 1:
Name and Address of Company
Angiotech Pharmaceuticals, Inc. (the Corporation)
1618 Station Street
Vancouver, BC V6A 1B6
ITEM 2:
Date of Material Change
October 9, 2007
ITEM 3:
News Release
A press release was disseminated by CNW Group on October 9, 2007.
ITEM 4:
Summary of Material Change
The Corporation announced that it intends to file Premarket Notification 510(k) documents with the U.S. Food and Drug Administration (FDA) for its innovative, anti-infective 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC).
ITEM 5.1:
Full Description of Material Change
The Corporation announced that, based on positive results from its U.S. pivotal trial, it intends to file Premarket Notification 510(k) documents with the FDA for its innovative, anti-infective 5-FU CVC. The filing is expected to be made in the fourth quarter of 2007.
The 5-FU CVC is expected to be the Corporations first product line to be completely researched, developed and commercialized using internal resources, personnel and technologies, many of which were obtained through previous acquisitions completed by the Corporation.
In July 2007, the Corporation completed enrolment of 960 patients in the clinical trial of its 5-FU CVC, which was one of the largest CVC studies ever conducted. Designed as randomized, single-blind, active controlled, two-arm, multi-center clinical study, the primary objective is to compare the Corporation 5-FU CVC to a leading anti-infective catheter with regards to preventing bacterial colonization.
Pending the receipt of all necessary regulatory approvals, the Corporation anticipates launching the commercial 5-FU CVC product line in 2008.
ITEM 5.2:
Disclosure for Restructuring Transactions
Not applicable.
ITEM 6:
Reliance on subsection 7.1(2) of National Instrument 51-102
Not applicable.
ITEM 7:
Omitted Information
No significant facts have been omitted from this report.
ITEM 8:
Executive Officer
K. Thomas Bailey
Chief Financial Officer
(604) 221-7676
ITEM 9:
Date of Report
October 19, 2007
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