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Orphan Therapeutics Announces Initiation of Rolling NDA Submission for LUCASSIN(R) (terlipressin) for the Treatment of Hepatorenal Syndrome Type 1
Date:5/28/2008

HRS type 1.

(1) Sanyal 2008: Sanyal AJ, Boyer T, Garcia-Tsao G, Regenstein F,

Rossaro L, Appenrodt B, et al. A randomized, prospective,

double-blind, placebo controlled trial of terlipressin for type 1

hepatorenal syndrome. Gastroenterology. 2008;134:1360-1368.

(2) Martin-Llahi 2008: Martin-Llahi M, Pepin M-N, Guevara M, Diaz, F,

Torre A, Monescillo A, et al. Terlipressin and albumin vs albumin in

patients with cirrhosis and hepatorenal syndrome: a randomized study.

Gastroenterology. 2008;134:1352-1359

ABOUT HEPATORENAL SYNDROME (HRS)

Hepatorenal syndrome (HRS) is the progressive development of renal dysfunction in patients with late stage liver cirrhosis without any other causes of renal failure. It is likely caused by a very low blood flow through the kidneys, and two types have been described. HRS type 1 is characterized by rapid renal failure with a high mortality rate that exceeds 80% within three months. HRS type 2 represents a less aggressive form with longer survival.

The only potentially curative treatment for HRS and its underlying end- stage liver disease is liver transplantation, provided that the patient is a suitable candidate for transplantation and survives until a transplant is available. However, many patients may not receive a new liver, further supporting the need for alternate therapy options.

ABOUT LUCASSIN(R) (terlipressin)

LUCASSIN(R) (terlipressin) is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, resulting in an increase in effective arterial volume and improved renal blood flow in patients with HRS. Terlipressin is not approved by the FDA for use in the U.S. Outside the U.S., terlipressin has been available for over two decades. It has been a standard of care in Europe for esophageal variceal hemorrhage in patients with liver cirrhosis, and was recently approved in Fr
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SOURCE Orphan Therapeutics, LLC
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