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Paricalcitol Injection Receives FDA Approval for Pediatric Use

Abbott Park, Illinois, May 27, 2004 — Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved Zemplar® (paricalcitol injection) for use in children and adolescent hemodialysis patients, ages 5 to 19, with secondary hyperparathyroidism (SHPT). Zemplar initially was introduced in 1998 and currently is used to treat SHPT in the majority of adult dialysis patients in the United States.

Patients with kidney failure are unable to produce the active form of vitamin D. As a result, many dialysis patients have vitamin D deficiency and develop SHPT, a disorder that causes bone disease and can affect many organs and tissues, including the bones, red blood cells, heart, nerves and muscles.

"Because of the unique characteristics of the growing skeleton, children are particularly vulnerable to the complications of kidney failure and secondary hyperparathyroidism that can lead to bone deformities and growth retardation," said Isidro B. Salusky, M.D., a pediatric nephrologist and professor of pediatrics at the David Geffen School of Medicine at the University of California at Los Angeles, and the lead investigator for the clinical research and data collection used to support Abbott's application to the FDA seeking expanded use of Zemplar. "We need to know that the therapies available for adults are also safe for children – and now we do. This new information allows us to feel comfortable giving children the same therapy prescribed for adult patients."

Approximately 1,400 American children between the ages of 5 and 19 undergo hemodialysis, a time–consuming treatment in which blood is filtered through an artificial kidney machine to remove wastes and extra fluid from the blood.

Kidneys help keep bones healthy by metabolizing vitamin D, converting it into the active D compound that helps regulate parathyroid hormone (PTH) secretion and bone metabolism, as well as calcium and phosphorus levels. In the absence of active vitamin D, many patients with kidney failure develop SHPT, where the parathyroid glands produce excess amounts of PTH. Without proper management, SHPT can lead to weak and brittle bones, anemia, and cardiac and neurological problems. Because bones and other organs are still developing in children, and because they are typically patients for longer periods of time, complications related to SHPT can be more difficult to treat than in adults. Left untreated, SHPT can be a factor in growth retardation and lead to severe disability.

"I have witnessed the toll of kidney disease and dialysis on younger patients and their families," said Joel Melnick, M.D., global medical director, Abbott Laboratories, and a pediatric nephrologist. "One of the reasons that controlling secondary hyperparathyroidism in children is especially challenging is that their diets frequently may be high in phosphorous, the control of which is critical in dialysis patients. A third–generation D compound like Zemplar that did not cause hyperphosphatemia and hypercalcemia in clinical studies is an incredibly important asset for younger patients and can help them lead more normal lives."

"Approval of Zemplar for use in pediatric patients demonstrates Abbott's commitment to addressing the needs of the wide range of patients with kidney disease," said William Dempsey, senior vice president, Pharmaceutical Operations, Abbott Laboratories. "Abbott recently launched a worldwide research program to further study D–Receptor activation in chronic kidney disease and for a variety of related disorders."

Zemplar Pediatric Study Results
The safety and effectiveness of Zemplar were examined in a 12–week randomized, double–blind, placebo–controlled study of 29 pediatric patients, ages 5 to 19 years, with chronic renal failure on hemodialysis. Nearly all had received some form of vitamin D therapy prior to the study.

Sixty percent of patients in the Zemplar group had two consecutive 30 percent decreases in parathyroid hormone levels compared with only 21 percent of patients in the placebo group. Fewer Zemplar patients than placebo patients (23 percent compared to 31 percent) experienced elevated serum calcium levels. The overall percentage of serum calcium measurements (defined as 10.3 mg/dL or greater) was 7 percent in the Zemplar group and 7 percent in the placebo group. No subjects in either the Zemplar group or placebo group developed hypercalcemia (defined as at least one calcium value >11.2 mg/dL) during the study. Another side effect measurement used in the study was the product of serum calcium and phosphorus levels (Ca x P), measured in terms of mg2/dL2. In this study, 40 percent of Zemplar patients, compared to 14 percent of placebo patients, had at least one Ca x P > 72. The overall percentage of patients with Ca x P > 72, however, was 8 percent in the Zemplar group and 7 percent in the placebo group.

About Children and Kidney Failure
According to the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) at the National Institutes of Health (NIH), of every 100,000 children 19 and under, one or two will develop kidney failure each year. African–American teenagers are three times more likely than white teens to develop kidney failure, and boys are twice as likely as girls to develop kidney failure due to birth defects or other hereditary conditions. Because poorly functioning kidneys can leave the body's vitamin and mineral resources out of balance, the National Kidney Foundation notes that children with kidney disease are at risk for stunted growth and poor bone density.

Product Indications
Zemplar® (paricalcitol injection) is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.

Important Product Safety Considerations
As observed in Phase II and III clinical trials, adverse effects with greater than 5 percent frequency with Zemplar versus placebo, regardless of causality, were nausea (13 percent versus 8 percent), vomiting (8 percent versus 4 percent), and edema (7 percent versus 0 percent). Zemplar is contraindicated in patients with vitamin D toxicity, hypercalcemia, or hypersensitivity to product ingredients. Administration may place patients at risk for hypercalcemia, elevated Ca x P product, and metastatic calcification.

For full prescribing information on Zemplar visit www.abbottrenalcare.com.

Source: Abbott Laboratories

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