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New Data on Cathflo Activase (Alteplase) in Pediatric Patients Presented at International Symposium on Endovascular Therapy SOUTH SAN FRANCISCO, CA -- January 19, 2005 -- Genentech, Inc. announced results from the Cathflo® Activase® Pediatric Study (CAPS), demonstrating that Cathflo Activase (Alteplase) can be used to restore function to central venous catheters in pediatric patients. On January 4, 2005, the U.S. Food and Drug Administration (FDA) approved Cathflo Activase, a tissue plasminogen activator (t-PA), for use in pediatric patients. The data were presented today at the International Symposium on Endovascular Therapy in Miami Beach, Florida. The label extension is for the restoration of function to central venous access devices (CVADs), as assessed by the ability to withdraw blood, in pediatric patients. The CAPS trial enrolled children between the ages of 2 weeks and 17 years. Analysis of pediatric patients in the CAPS trial as well as pediatric patients in the pivotal trials show that rates of serious adverse events were similar in the pediatric and adult populations, as were the rates of catheter function restoration. "The treatment impact of Cathflo Activase in children is consistent with what is seen in the adult population, and confirms Cathflo Activase as the standard of care for catheter clearance," said Diane Parks, senior vice president and general manager of Specialty Biotherapeutics and Managed Care at Genentech. "We believe that this study of Cathflo Activase addresses a previously unmet medical need and further demonstrates Genentech's commitment to providing innovative treatment solutions for patients. About Cathflo Activase Pediatric Study: The label extension is supported by findings from the CAPS study, a Phase IIIb open-label, single-arm trial involving 310 patients between the ages of 2 weeks and 17 years. All patients had catheter dysfunction defined as the inability to withdraw blood (at least 3 mL for patients >/= 10 kg or at least 1 mL for patients < 10 kg). The study's authors provided the FDA with data that demonstrate Cathflo Activase's acceptable safety profile in CVAD clearance and are consistent with existing data on the product's efficacy, restoring CVAD function to 83% (n=257) of patients after two doses. Rates of serious adverse events were similar to that previously observed in adult patients. In the clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis. Three cases of sepsis occurred 2 to 44 hours after treatment with Cathflo Activase. All of these patients had evidence of infection prior to administration of Cathflo Activase. About Cathflo Activase: Cathflo Activase (Alteplase) is a recombinant form of a naturally-occurring enzyme produced by the body known as tissue plasminogen activator, or t-PA. In September 2001, the FDA approved a Supplemental Biologic Licensing Application (sBLA) for Cathflo Activase for the restoration of function to CVADs as assessed by the ability to withdraw blood. Rates of serious adverse events were similar to that previously observed in adult patients. In the clinical trial, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding and venous thrombosis. Central venous access device, or CVAD, is a broad term that includes many types of catheters (thin, flexible, hollow tubes) that are inserted into and positioned within a vein in the body to deliver therapies to the bloodstream or withdraw blood for testing. It is estimated that 5 million CVADs are placed each year in the U.S., and occlusions are a frequent complication. It is estimated that up to 25% of all CVADs become occluded and that 60% of those occlusions are caused by thrombosis, the formation of a blood clot. Cathflo Activase is a thrombolytic that works by targeting fibrin (a substance that causes blood to clot), dissolving the thrombus (blood clot) and restoring function to the line. Alteplase is also marketed in different vial sizes and packaging configurations under the trade name Activase® for the treatment of acute myocardial infarction (AMI), acute ischemic stroke within three hours of symptom onset, and acute massive pulmonary embolism. The FDA first licensed Activase for the treatment of AMI in November 1987. About Genentech: Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com. SOURCE: Genentech E-mail this page to a friend or colleague! To print, use this version