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New Drug Application Submitted for Paricalcitol Capsules

ABBOTT PARK, Ill., Aug. 2 /PRNewswire-FirstCall/ -- Abbott Laboratories today announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Zemplar® Capsules, its investigational oral therapy for earlier treatment of secondary hyperparathyroidism (SHPT). SHPT is a major complication associated with chronic kidney disease, which affects bones and vital organs. The capsule form of Zemplar would provide the potential for earlier intervention and treatment for SHPT in the more than eight million Americans with early-stage chronic kidney disease, who do not yet require dialysis or transplantation.

"Early identification and treatment of secondary hyperparathyroidism play an important role in managing chronic kidney disease. To date, physicians have had limited treatment options to manage earlier-stage patients," said Daniel W. Coyne, M.D., associate professor of medicine, Washington University School of Medicine, and lead investigator for Zemplar Capsules Phase III clinical studies. "The development of Zemplar Capsules represents an important advance for patients with this condition."

The injectable form of Zemplar, a third-generation vitamin D compound, has been available since 1998 and is the standard of care for the prevention and treatment of SHPT in the dialysis patient population. More than 200,000 Americans are being treated for end-stage renal disease (ESRD) with dialysis therapy, and more than 1.5 million patients worldwide are on dialysis. ESRD is an advanced stage of chronic kidney disease that requires some form of renal replacement therapy, including dialysis or transplantation.

More than 20 million Americans -- one in nine adults -- have chronic kidney disease, and an additional 20 million are at risk, creating what the National Institutes of Health describes as a "growing epidemic." Two major risk factors for kidney disease are diabetes and hypertension, which account for two-thirds of new cases of kidney disease each year. Minority populations bear a disproportionate burden. Research from the National Institutes of Health finds that African-Americans are six times more likely than Caucasians to develop hypertension-related kidney failure.

Additionally, according to the National Kidney Foundation, chronic kidney disease and its complications are "under-diagnosed" and "under-treated" in the U.S., resulting in lost opportunities for prevention. Current guidelines recommend the evaluation and treatment of bone disease in patients with earlier stages of kidney disease.

"The New Drug Application for Zemplar Capsules is in line with our commitment to pursue five regulatory submissions during 2004, and further showcases Abbott's robust pipeline for drug development that has the potential to address many critical health issues, including kidney disease, cancer, arthritis and HIV/AIDS," said Jeffrey M. Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, Abbott Laboratories.

About Kidney Disease

The incidence and prevalence of kidney disease have doubled in the last 10 years and are expected to continue to grow. New scientific evidence and treatment guidelines recently published by the National Kidney Foundation are changing the way doctors approach early-stage kidney disease and emphasize the importance of identification and treatment earlier in the progression of the disease.

About Secondary Hyperparathyroidism and the Role of Vitamin D

When kidneys start to fail, they gradually lose their ability to produce the active form of vitamin D. As a result, many kidney patients develop SHPT, a serious disorder that causes bone disease and can affect many organs and tissues, including red blood cells, the heart, nerves and muscles. If SHPT is not managed early it can worsen, leading to other related conditions and progression of the underlying kidney disease.

Product Indication -- Zemplar Injectable (paricalcitol injection)

Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure. Zemplar is an active form of vitamin D.

Important Product Safety Considerations -- Zemplar Injectable (paricalcitol injection)

As observed in Phase II and III clinical trials for injectable Zemplar, adverse effects with greater than 5 percent frequency with Zemplar Injectable 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 http://www.abbottrenalcare.com/.

Source: Abbott Laboratories

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