FDA approves 12-month shelf life for TAXUS(R) stent system
23 Mai 2005 - 9:00AM
PR Newswire (US)
FDA approves 12-month shelf life for TAXUS(R) stent system New U.S.
shelf life is longer than any competing product VANCOUVER, May 22
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate partner, Boston
Scientific ("BSC"), today announced that the U.S. Food and Drug
Administration (FDA) has approved extending the shelf life of BSC's
TAXUS(R) Express(2)(TM) paclitaxel-eluting coronary stent system in
the United States to twelve months from the current shelf life of
nine months. The decision was based on data submitted by BSC to the
FDA that demonstrated the performance of the TAXUS system -- in
particular the drug content, drug degradation profile and
drug-release mechanism -- was maintained within FDA-approved
specifications at twelve months. The new TAXUS U.S. shelf life is
longer than any competing product, as stated by BSC. The extended
expiration date applies to all sizes of the TAXUS system for sale
in the United States. BSC said it would immediately begin updating
labels to reflect the twelve-month expiration date. The shelf life
for the TAXUS system outside the United States remains unchanged at
18 months. BSC acquired worldwide exclusive rights from Angiotech
to use paclitaxel to coat its coronary stent products and has
co-exclusive rights to other vascular and non-vascular products.
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty
pharmaceutical company pioneering the combination of pharmaceutical
compounds with medical devices and biomaterials to both create
novel solutions for poorly addressed disease states and
dramatically improve surgical outcomes. To find out more about
Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:
TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. Statements contained herein that are not
based on historical or current fact, including without limitation
statements containing the words "anticipates," "believes," "may,"
"continue," "estimate," "expects," "may" and "will" and words of
similar import, constitute "forward-looking statements" within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause the actual
results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, among others, the
following: general economic and business conditions, both
nationally and in the regions in which the Company operates;
technology changes; competition; changes in business strategy or
development plans; the ability to attract and retain qualified
personnel; existing governmental regulations and changes in, or the
failure to comply with, governmental regulations; liability and
other claims asserted against the Company; and other factors
referenced in the Company's filings with the United States
Securities and Exchange Commission or the Canadian securities
regulators. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. The
Company does not assume the obligation to update any
forward-looking statements. CONTACTS: Todd Young, Angiotech
Pharmaceuticals (Analysts & Investors) (604) 221-7676 ext 6933
Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts) (604)
221-7676 ext 6996 Eric Starkman, Starkman & Associates (Media)
(212) 252-8545 ext 12 DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Todd Young, Angiotech Pharmaceuticals (Analysts &
Investors), (604) 221-7676 ext 6933; Rui Avelar, Angiotech
Pharmaceuticals, Inc. (Analysts), (604) 221-7676 ext 6996; Eric
Starkman, Starkman & Associates (Media), (212) 252-8545 ext 12
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