Guidant Licenses Everolimus From Novartis for Drug Eluting Stents.Business Editors & Health/Medical Writers
INDIANAPOLIS--(BW HealthWire)--March 27, 2002
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Agreement With Novartis Pharma AG Broadens
Guidant's Drug Eluting Stent Program
Company to Host Webcast/Conference Call Today
Novartis Pharma AG and Guidant Corporation announced today that the companies have entered into a worldwide co-exclusive license agreement granting Guidant rights to utilize the drug everolimus in drug eluting stents for the treatment of coronary and peripheral vascular diseases Peripheral Vascular Disease Definition
Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. .
Novartis will provide everolimus to Guidant, supply data to support Guidant filings with regulatory agencies, and receive milestone payments and a royalty on sales of Guidant products utilizing the drug. Pending regulatory approvals, Guidant expects to initiate clinical trials of everolimus-eluting coronary stents around the end of this year.
"Guidant is committed to leadership in the drug eluting stent market through multiple programs, and we are excited about this promising path of bringing innovative drug eluting stent therapy to physicians and patients," said Ronald W. Dollens, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Guidant Corporation. "We are enthusiastic about working with Novartis and pleased about this new relationship that strengthens and broadens our drug eluting stent program."
Everolimus is a new investigational drug in the same family as rapamycin. Rapamycin has shown early promise in clinical trials of drug eluting stents. Guidant and Novartis have independently observed positive results in animal studies evaluating the effectiveness of everolimus for the prevention of restenosis. Guidant's evaluation of the compound in pre-clinical tests utilized the company's proprietary polymer elution elution /elu·tion/ (e-loo´shun) in chemistry, separation of material by washing; the process of pulverizing substances and mixing them with water in order to separate the heavier constituents, which settle out in solution, from the technology for drug eluting stents.
Guidant's everolimus-eluting stents will leverage Guidant's market-leading position, proprietary technologies, broad patent portfolio and proven stent designs.
"We welcome this opportunity to collaborate with Guidant on medical innovations that may offer new hope to patients with heart disease," said Thomas Ebeling, CEO, Novartis Pharma AG.
Novartis has completed phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA human clinical trials evaluating the safety and efficacy of Certican(TM), an orally administered drug containing everolimus, for the prevention of organ rejection in renal and heart transplant heart transplant
Procedure to remove a diseased heart and replace it with a healthy one from a legally dead donor. The first was performed in 1967 by Christiaan Barnard. recipients.
Guidant continues to make excellent progress in drug eluting stents and is enthusiastic about the paclitaxel-coated ACHIEVE(TM) Drug Eluting Coronary Stent System. Patient enrollment in the U.S. DELIVER clinical trial was recently completed in less than four months. The DELIVER trial is designed to serve as the basis for submission for U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) approval of the ACHIEVE Stent System. Guidant expects eight-month angiographic and nine-month clinical follow-up data on the DELIVER patients to be complete by the end of this year.
The new ACHIEVE Stent System, manufactured by Cook Incorporated and to be distributed worldwide exclusively by Guidant, is expected to be available in international markets by mid-year.
Guidant will conduct a live webcast today, Wednesday, March 27, at 5:30 p.m. EST. The live webcast of Guidant's conference call will be accessible through Guidant's website at www.guidant.com/webcast or at CCBN's individual investor center at www.companyboardroom.com. The webcast will be archived on both websites for future on-demand replay.
The call will be hosted by Guidant's President and CEO Ronald W. Dollens and will focus on today's announcement as well as the company's latest cardiac rhythm management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. product developments. Also participating on the call will be John M. Capek, Ph.D., president, Vascular Intervention, and Fred McCoy, president, Cardiac Rhythm Management, Guidant.
Guidant Corporation (NYSE and PCX: GDT) pioneers lifesaving technology, giving an opportunity for better life today to 8 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 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 See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. . For more information visit www.guidant.com.
This release includes forward-looking statements concerning drug-eluting stents, including statements relating to relating to relate prep → concernant
relating to relate prep → bezüglich +gen, mit Bezug auf +acc the timing of regulatory processes and the successful commercialization of stents. The forward-looking statements are based on assumptions about many important factors, including progress in product development, the results of pre-clinical and clinical trials, regulatory approvals, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called litigation. and other factors listed on exhibit 99 to Guidant's most recent 10-K on file with the SEC. As such, they involve risks and uncertainties that could cause actual results to differ materially. The companies do not undertake to update the forward-looking statements.