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| |  Carnitor Approved In US For End Stage Renal Disease GAITHERSBURG, MD -- December 22, 1999 -- Sigma-Tau Pharmaceuticals, Inc., the only supplier of prescription form carnitine, announced that it received approval on December 15, 1999 from the U.S. Food and Drug Administration (FDA) to market Carnitor Injection for the prevention and treatment of carnitine deficiency in patients with end stage renal disease (ESRD) who are undergoing dialysis. This indication applies only to the intravenous formulation of Carnitor and not the available oral formulations. This approval comes ten months after Sigma-Tau submitted a supplemental new drug application for Carnitor I.V. in this indication.
Approximately 350,000 Americans are currently living with ESRD, also known as chronic renal failure. "This approval truly reflects Sigma-Tau's long-standing commitment to patients who have carnitine deficiency," said Ken Mehrling, General Manager, Sigma-Tau Pharmaceuticals, Inc. "It also confirms our commitment to being the worldwide leader in carnitine and metabolic research," said Mehrling. Carnitine is a naturally-occurring substance that is crucial to the metabolic process that provides energy to the body. Carnitine deficiency is a condition that results when carnitine is not present in sufficient amounts, which disrupts the metabolic process in which cells turn nutrients into energy. ESRD patients on maintenance hemodialysis may have low plasma carnitine concentrations and an increased ratio of acylcarnitine/carnitine because of reduced intake of meat and dairy products, reduced renal synthesis, and dialytic losses. Certain clinical conditions common in hemodialysis patients such as malaise, muscle weakness, cardiomyopathy and cardiac arrhythmias may be related to abnormal carnitine metabolism. Pharmacokinetic and clinical studies with intravenous Carnitor have shown that administration of levocarnitine to ESRD patients on hemodialysis results in increased plasma levocarnitine concentrations. Sigma-Tau, who more than 10 years ago pioneered the development of the only prescription form of carnitine, maintains its leadership in the U.S. market today. In 1989, Carnitor (levocarnitine) tablets and oral solution were approved for the treatment of primary systemic carnitine deficiency. Carnitor Injection was approved in 1992 for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.
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