Guidant Signs Definitive Agreement to Acquire Biosensors' Everolimus Eluting Stent Assets.Business Editors/Health/Medical Writers INDIANAPOLIS--(BUSINESS WIRE)--March 19, 2003 Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ) Company Updates Status of Drug Eluting Stent Program Webcast/Conference Call Scheduled for Thursday, March 20, at 11:00 AM ET Guidant Corporation (NYSE:GDT), a world leader in the treatment of cardiac and vascular disease, today announced that the company has entered into a definitive agreement to acquire certain assets of Biosensors International's everolimus eluting stent program. The agreement provides an exclusive worldwide license to Biosensors' bioabsorbable polymer formulation technology in the field of everolimus eluting stents. Guidant also obtained a nonexclusive license to utilize this technology with other drugs in drug eluting stents. Additionally, Guidant acquired the option of manufacturing and commercializing the Biosensors everolimus eluting stent that has been used in Biosensors' clinical trials. Under the terms of the agreement, Biosensors will receive an up-front cash payment of $20 million in March for the asset purchase and licensing fee, and may receive additional milestone payments over the course of clinical development and royalties on future sales of products that utilize Biosensors' technology. These milestone payments will be accounted for as in-process research and development. Guidant previously acquired an exclusive, worldwide license to the drug everolimus from Novartis Pharma AG and Novartis AG Novartis AG Swiss pharmaceutical company. It was formed through the 1996 merger of two Swiss firms: Ciba (see Ciba-Geigy) and Sandoz, a chemical company with interests in pharmaceuticals, nutrition, and agriculture. for use in drug eluting stents. "We are enthusiastic about everolimus as a compound for drug eluting stents, given our own preclinical and Biosensors' early human clinical results," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "This agreement provides intellectual property and valuable preclinical and clinical data that will complement our everolimus program. The ability to develop both non-erodible and bioabsorbable polymeric 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 technologies is an important step forward for our drug eluting stent program. "In light of the Biosensors transaction and additional insight into the FUTURE I results, the agreement will enable Guidant to potentially accelerate its path to commercialization of an everolimus eluting stent outside of the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. ," continued Mead. Preliminary results presented from the FUTURE I first-in-man clinical trial utilizing everolimus demonstrated no restenosis in 11 patients receiving the drug eluting stent at six-month angiographic follow up. Additional results from the trial will be presented by Dr. Eberhard Grube of the Herzzentrum Siegburg in Germany, principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences of the study, at the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. conference taking place March 30 - April 2 in Chicago. "The early FUTURE I clinical results were highly promising," said Dr. Grube. "The use of a bioabsorbable polymer to deliver drugs from a stent may offer unique clinical advantages. I look forward to analysis of data from the larger FUTURE II trial, which recently completed enrollment." Guidant announced an agreement in principle to enter into this transaction earlier this year. Guidant and Biosensors previously received clearance for the transaction from the Federal Trade Commission under the United States Hart-Scott-Rodino Antitrust Improvements Act The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Public Law 94-435, known commonly as the HSR Act) is a set of amendments to the antitrust laws of the United States, principally the Clayton Antitrust Act. The HSR Act was signed into law by President Gerald R. , and the agreement will take effect immediately. Guidant Provides Update on SPIRIT FIRST Study Guidant also updated the status of its everolimus eluting stent program. In addition to the first-in-man experience from FUTURE I and II now accessed via the Biosensors transaction, Guidant plans to initiate the SPIRIT FIRST trial, a dose-selection feasibility study The analysis of a problem to determine if it can be solved effectively. The operational (will it work?), economical (costs and benefits) and technical (can it be built?) aspects are part of the study. Results of the study determine whether the solution should be implemented. with Guidant's MULTI-LINK VISION(TM) Coronary Stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery stent System and everolimus, upon successful completion and analysis of its current preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. . Although analysis of three-month preclinical data of Guidant's everolimus eluting stent revealed excellent results in the majority of animals, a higher-than-expected foreign body response was observed in a small subset. Guidant conducted a thorough investigation that yielded possible root causes, and the company has initiated additional animal studies to validate the findings. "Due to our multiple stent platforms, multiple polymers, and promising early clinical and preclinical data, we remain confident in our 2005 everolimus eluting stent launch timing," commented Mead. Webcast Guidant will host a live webcast briefing Thursday, March 20, at 11:00 AM ET. Dana G. Mead, Jr., president, Vascular Intervention, will host the briefing. The webcast 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. 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 more than 11,000 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. 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 the transaction and the company's everolimus program. The statements are based on assumptions about many important factors, including clinical and regulatory developments, product development timelines and other factors identified on Exhibit 99.1 to the company's most recent 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements. System requirements To be used efficiently, all computer software needs certain hardware components or other software resources to be present on a computer system. These pre-requisites are known as (computer) system requirements and are often used as a guideline as opposed to an absolute rule. for the webcast include Internet Explorer Microsoft's Web browser, which comes with Windows starting with Windows 98. Commonly called "IE," versions for Mac and Unix are also available. Internet Explorer is the most widely used Web browser on the market. 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