Healthcare Industry News:  Central Venous Catheter 


 News Release - July 10, 2007

Angiotech completes enrolment in its Central Venous Catheter (CVC) Pivotal Study

VANCOUVER, July 10 (HSMN NewsFeed) - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced the completion of enrolment in its Central Venous Catheter (CVC) Pivotal Study, which is designed to examine the safety and efficacy of Angiotech's 5-Fluorouracil (5-FU) coated CVC in preventing bacterial catheter colonization when compared to another leading anti-infective CVC.

"The 5-FU 'anti-infective' CVC is a leading example of what we envisioned Angiotech would be able to accomplish as a fully integrated company. This is the first product that originated from our in-house drug screening and discovery efforts, progressed through our own internal clinical and regulatory development process, and will be promoted and distributed through our own marketing and sales force. In addition, since biofilm development and implant infection is a ubiquitous problem with medical devices, this technology could also provide the basis to develop drug-coated versions of other commercial products within our existing medical device portfolio," said Dr. William Hunter, President and CEO of Angiotech.

Central Venous Catheters (CVC) are usually inserted into critically ill patients for extended periods of time to administer fluids, drugs, and nutrition, as well as facilitate frequent blood draws. One of the complications associated with CVC implantation is infection, which can occur when bacteria contaminate the catheter. CVC infections that progress to bloodstream infections, or septicemia, can become life threatening.

Approximately 3.5 million CVC's are used in the U.S. annually leading to approximately 250,000 CVC-related infections and an estimated 40,000 deaths. The cost of caring for these patients is estimated to be as high as US $56,000 per infection. In addition, the Centers for Disease Control and Prevention (CDC) has raised concerns about the overuse of traditional antibiotics, which can contribute to an increase in the antibiotic resistance of bacteria.

The principle behind using 5-FU - an approved anti-cancer drug - is that the drug appears to effectively interrupt the colonization of an implanted medical device by those micro-organisms that typically gain entrance to the bloodstream via the local skin penetration of implanted catheters. This reduction in colonization by bacteria may have a net effect of reducing biofilm burden on the implanted catheters, making them less likely to serve as reservoirs for additional infection. 5-FU has also been shown to inhibit the proliferation of a number of bacterial species directly which may be a second source of efficacy in preventing catheter-based infections.

"An additional important benefit is that not only does the 5-FU coating have the potential to prevent catheter-related infections as well as traditional antiseptics and antibiotics, but since 5-FU has no clinical application as either a systemic antibiotic or a hospital antiseptic, there is little risk to the hospital or the community at-large of creating a 'super-bug' that is resistant to a useful class of antibiotic and can make infection control more complex," added Dr. Hunter.

Angiotech expects to have preliminary data results compiled in the fall, and present the final data results in early 2008 at a major scientific symposium. Pending trial results and all necessary approvals, Angiotech will prepare to launch the commercial product line in 2008.

About the CVC Pivotal Trial

The CVC trial is a randomized, single-blind, active-controlled, two-arm, multi-center clinical study. The primary objective of the study is to compare the Angiotech 5-FU coated CVC to a leading anti-infective catheter with regards to preventing bacterial colonization. The study will enrol at minimum 790 evaluable subjects at up to 25 investigative sites located in the United States.

Note on Forward Looking Statements

Statements contained in this press release that are not based on historical fact, including without limitation statements containing the words "believes," "may," "could", "plans," "will," "estimate," "continue," "anticipates," "intends," "expects" and similar expressions, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and constitute "forward-looking information" within the meaning of applicable Canadian securities laws. All such statements are made pursuant to the "safe harbor" provisions of applicable securities legislation. Forward-looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for 2007 and beyond, our strategies or future actions, our targets, our estimation of potential market size, expectations for our financial condition and the results of, or outlook for, our operations, research development and further product and drug development. Such forward-looking statements also 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 are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions, both nationally and in the regions in which we operate; technological changes that impact our existing products or our ability to develop and commercialize future products; 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; adverse results or unexpected delays in drug discovery and clinical development processes; failure to obtain patent protection for discoveries; loss of patent protection resulting from third party challenges to our patents; commercialization limitations imposed by patents owned or controlled by third parties; dependence upon, and relationships with strategic alliance partners to develop and commercialize products and services based on our work; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; the requirement for substantial funding to conduct research and development and to expand commercialization activities or consummate acquisitions; the size of the market and the potential market for our products in specific disease areas, other factors referenced in our annual information form and other filings with the applicable Canadian securities regulatory authorities or the Securities and Exchange Commission; and any other factors that may affect performance. In addition, our business is subject to certain operating risks that may cause the actual results expressed or implied by the forward-looking statements in this report to differ materially from our actual results. These operating risks include: our ability to successfully complete preclinical and clinical development of our products; the ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the ability to complete and maintain corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; the competitive environment and impact of technological change; the continued availability of capital to finance our activities; our ability to integrate into our business the operations of AMI; and, our ability to achieve the operational and other synergies and the other commercial or financial benefits expected as a result of the acquisition of AMI. Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this report to reflect future results, events or developments.

About Angiotech

Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (NASDAQ: ANPI, TSX: ANP), please visit our website at

Source: Angiotech Pharmaceuticals

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