FDA Approves Landmark Treatment
For Coronary Artery Disease
Cordis' CYPHER™ Sirolimus-eluting Coronary Stent
Dramatically Reduces Reblockage
of Coronary Arteries
Miami, FL (April 24, 2003) – Cordis Corporation, a Johnson & Johnson company, reported today that it has received approval from the U.S. Food and Drug Administration (FDA) to market its CYPHER™ Sirolimus-eluting Coronary Stent, making it the first U.S.-approved combination drug device intended to help reduce restenosis (reblockage) of a treated coronary artery. Restenosis is one of the greatest challenges in long-term patient treatment in interventional cardiology.
"Cordis is very pleased to bring this remarkable and innovative treatment to patients, hospitals and interventional cardiologists," said Johnson & Johnson Company Group Chairman Robert Croce, who has worldwide management responsibility for Cordis Corporation. "Clinical evidence and experience with more than 50,000 patients treated to date in nearly 60 countries suggests the CYPHER™ Stent represents the beginning of a new era in interventional cardiology – an era in which the combination of drugs and devices substantially improves patient outcomes."
Jeffrey W. Moses, M.D., of Lenox Hill Hospital, New York, a principal investigator in the U.S. clinical trials for the new device, said, "The CYPHER™ Stent clinical trials set a new standard in coronary artery stent investigation. No other stent in this category has been studied so extensively in such a wide range of high-risk patients with difficult-to-treat lesions. Clinical evidence is clear that cardiologists can use this new stent with confidence."
Mr. Croce explained that the FDA approved the CYPHER™ Stent under an expedited review for use in native coronary arteries with reference diameters of 2.5 mm to 3.5 mm and lengths in 8, 13, 18, 23, 28 and 33 mm. This covers the majority of stent cases performed today.
"Our main objective is to make the CYPHER™ Stent available to all patients in need of this medical technology as quickly as possible," Mr. Croce said.
The CYPHER™ Stent was first introduced by Cordis Corporation in April 2002, and is now available throughout Europe, the Middle East, Canada, Asia-Pacific and Latin America.
Combining Drug and Device for a New Era in Interventional Treatment
Combined with the pharmaceutical agent sirolimus*, the CYPHER™ Stent is placed into a human coronary artery to prevent restenosis (reblocked arteries). Sirolimus, marketed as Rapamune® by Wyeth Pharmaceuticals, is a commercially available drug developed from a naturally occurring substance first isolated from soil samples in Easter Island in the South Pacific.
"Years of research and development involving hundreds of drugs led to our selection of sirolimus for the CYPHER™ Stent," Mr. Croce said. "Our collaboration with Wyeth resulted in this significant medical advancement in coronary care, opening the door to future drug-device therapies."
Mr. Croce added, "The clinical benefits of our CYPHER™ Stent are compelling. We are seeing solid clinical results, out to three years in our initial pilot study. These results will have an increasingly positive impact on patients."
"It's gratifying to see the impact Rapamune® (sirolimus) has had in treating patients with coronary artery disease, and its potential for an even broader application in other parts of the vasculature," said Robert R. Ruffolo, Ph.D., president, Wyeth Research. "The use of Rapamune® has had a significant impact on the field of transplantation, and now we’re seeing its potential to help the hundreds of thousands of patients who receive cardiac stents each year."
Setting a New Standard
The stent's treatment process, or mechanism of action, is controlled by a polymer coating that gradually releases the drug sirolimus into the vessel lining to prevent scar tissue growth, a frequent reaction that leads to reblockage following current treatment procedures.
"Reblockage of coronary arteries has remained a stubborn obstacle to successful long-term patient treatment," said Dr. Moses. "Currently, restenosis occurs in as many as 30 percent of patients who receive a bare metal stent.
"Our goal is to treat a blockage one time, and one time only," Dr. Moses added. "This is our patients' expectation. Now we have a treatment that can significantly reduce the incidence of re-blockage, potentially sparing tens of thousands of patients the need for repeat interventions, including bypass surgery."
The CYPHER™ Stent is the only drug-eluting coronary artery stent whose performance is supported by two large-scale, randomized, double-blind, controlled clinical trials.
"These trials, involving approximately 1,400 patients, continue to support the long-term unprecedented results for the CYPHER™ Stent," said Dr. Moses.
Data from the two-year follow-up on the pivotal European RAVEL trial and the one-year follow-up on the landmark U.S. SIRIUS trial were presented at the American College of Cardiology's 52nd Scientific Session in March. The CYPHER™ Stent data showed sustained reduction in the incidence of re-blockage by more than 90 percent as compared to a conventional bare metal stent, with a greater than 95 percent chance that patients can avoid retreatment. The outstanding results were achieved in a broad range of patients, including those with complex lesions and at high risk for reblockage.
Public and Private Coverage for Drug-eluting Stents
Recognizing the medical value of drug-eluting stents, the Centers for Medicare and Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services, moved forward in August 2002 with approval of incremental reimbursement for the new medical device, effective April 1, 2003. This new policy provides significant incremental reimbursement over and above the current bare metal stent reimbursement levels. Cordis is also actively engaged with Medicaid and private insurance payers to grant coverage and incremental reimbursement for drug-eluting stents.
A recent independent economic analysis of the SIRIUS trial performed by David J. Cohen, M.D., Harvard Clinical Research Institute, showed that the CYPHER™ Stent was cost-effective at one-year post treatment and will enable payers to recoup virtually all costs associated with the CYPHER™ Stent within 12 months. The analysis looked at actual hospital in-patient and outpatient cost data, beginning with the period of initial hospitalization and ending one-year following stent implantation.
For every 100 patients treated with the CYPHER™ Stent, there were 19 fewer revascularizations and 25 fewer hospital admissions than with the conventional stent, translating into substantial post-treatment health care savings.
Physicians or patients inquiring about information on the CYPHER™ Stent can either visit www.CYPHERUSA.com or call 1-800-781-0282.
About Cordis Corporation
For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less-invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, 5,300 Cordis employees worldwide share a strong commitment to continue the company's groundbreaking work in the fight against vascular disease.
About Johnson & Johnson
Johnson & Johnson, with approximately 110,300 employees, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical device and diagnostics markets. Johnson & Johnson has more than 200 operating companies in 54 countries around the world, selling products in more than 175 countries.
* Cordis has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released from the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune® is a trademark of Wyeth Pharmaceuticals.
NOTE TO INVESTORS:
Johnson & Johnson will conduct a conference call with financial analysts to discuss the CYPHER™ Stent approval and launch plans at 12:30 p.m. Eastern Daylight Savings Time on April 24, 2003. A simultaneous webcast of the call for interested investors and others may be accessed by visiting the Company’s Web site at www.jnj.com and clicking on the webcast icon. A replay will be available approximately two hours after the live webcast by clicking on "Webcast Archives" in the Investor Relations section of the Company's Web site.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2002. Copies of this Form 10-K are available online at www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.)
Source: Cordis Corporation |
