Guidant Enrolls 300 Patients in Drug Eluting Stent Pivotal Trials and Completes Manufacturing Audit; Successful Inspection Bring
21 Septembre 2005 - 9:14PM
Business Wire
Drug Eluting Stent Milestone Results in Payment to Novartis in
Third Quarter Guidant Corporation (NYSE:GDT) today announced that
the company has enrolled more than 300 patients in its SPIRIT II
and SPIRIT III clinical trials, meeting a milestone in the
company's exclusive license agreement with Novartis Pharma AG. The
company also announced that it has successfully concluded an
inspection of its drug eluting stent manufacturing and quality
systems at its Temecula site. This inspection was conducted by
Guidant's European Notified Body, which is also reviewing the
company's submission for approval to market the XIENCE(TM) V
Everolimus Eluting Coronary Stent System in Europe. The Notified
Body found no nonconformities and will recommend certification for
Guidant. "We are pleased with our recent progress with the XIENCE V
Everolimus Eluting Coronary Stent System," said John M. Capek,
Ph.D., president, Vascular Intervention, Guidant Corporation.
"Enrollment in SPIRIT II and SPIRIT III is progressing well, and
successful completion of the audit brings us one step closer to
approval to market the XIENCE V Coronary Stent System in Europe."
SPIRIT II and SPIRIT III are large-scale pivotal clinical trials
evaluating the safety and efficacy of Guidant's drug eluting stent
system for the treatment of coronary artery disease. These
prospective, randomized, single-blind trials compare XIENCE V, an
everolimus eluting coronary stent system utilizing Guidant's cobalt
chromium MULTI-LINK VISION(R) Coronary Stent System platform,
versus the TAXUS(R) Express2(TM) Paclitaxel Eluting Coronary Stent
System. Novartis supplies everolimus to Guidant for use in drug
eluting stents and provides access to data supporting Guidant
filings with regulatory agencies. Under the terms of the agreement
with Novartis, the milestone achievement will trigger a $60 million
IPR&D charge in the third quarter of 2005, of which $40 million
will be paid to Novartis in the third quarter. An additional $20
million will be paid by December 31, 2006. Guidant Corporation
pioneers lifesaving technology, giving an opportunity for better
life today to millions of cardiac and vascular patients worldwide.
The company, driven by a strong entrepreneurial culture of 12,000
employees, develops, manufactures and markets a broad array of
products and services that enable less invasive care for some of
life's most threatening medical conditions. For more information
visit www.guidant.com. NOTE TO MEDIA: For more information about
Guidant, including its products and services, please visit the
company's newsroom at www.guidant.com/newsroom. This release
includes forward-looking statements concerning anticipated
financial results. The statements are based on assumptions about
many important factors, including trends affecting ICD and coronary
stent sales (including the introduction of drug-eluting stents);
other clinical, regulatory, competitive, and market developments;
reporting of final, audited results; and other factors identified
on Exhibit 99.1 to the company's most recent 10-Q. Actual results
may differ materially. The company does not undertake to update its
forward-looking statements.
Guidant (NYSE:GDT)
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