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Title: Natrecor Authorized in Canada for Treatment of Acute Decompensated Heart Failure

"Natrecor Authorized in Canada for Treatment of Acute Decompensated Heart Failure"

TORONTO, CANADA -- November 14, 2007 -- Health Canada has granted a Notice of Compliance with Conditions (NOC/c) for Natrecor* (nesiritide), for the treatment of hospitalized symptomatic Acute Decompensated Heart Failure (ADHF) patients. Natrecor is the first treatment to be indicated specifically for ADHF in Canada and the first in a new drug class called human B-type natriuretic peptides. Health Canada has issued conditional marketing authorization for Natrecor under the NOC/c policy to reflect the promising nature of clinical results in patients with this serious disease. A confirmatory international trial is being conducted as a requirement under Health Canada's NOC/c policy. Natrecor is indicated for the treatment of hospitalized, symptomatic ADHF patients, who present with moderate to severe dyspnea (difficulty breathing) and signs and symptoms of persistent heart failure despite two hours of treatment with intravenous loop diuretics.[1] Congestive heart failure is a condition in which the heart is not pumping blood and oxygen to the body effectively. This causes a backup of fluid in the lungs and other parts of the body. This backup of fluids is serious and can be life-threatening. It causes swelling, shortness of breath, loss or change in appetite, weight gain and fatigue.[2] Acute decompensated congestive heart failure is the term used to describe patients with congestive heart failure whose condition has deteriorated to the point that hospitalization is often required. In Canada, congestive heart failure is a major public health problem that is associated with significant morbidity, mortality and health care costs. It affects over 350,000 people in Canada and mortality rates range from 25 to 40 per cent, one year post-diagnosis.2 Congestive heart failure plays a significant role in over 100,000 hospitalizations and almost 1.4 million hospital days in Canada, with patients at a 16 per cent risk of in-hospital mortality.[3] Natrecor, which is administered through intravenous infusion, is a recombinant form of endogenous hBNP (human B-type natriuretic peptide), a naturally occurring protein particle produced by the heart to ease its workload. Natrecor, a vasoactive agent added to diuretic therapy is the only authorized treatment for ADHF that has shown improvement in dyspnea and a reduction of elevated wedge pressures in the lungs in controlled clinical trials.[4] Reducing wedge pressure is important because elevated pressure is associated with increased heart failure symptoms, more frequent hospitalization, and increased mortality.[5] "There is a real need for new, effective treatments for ADHF," says Dr. Jonathan Howlett, Associate Professor of Medicine, Dalhousie University and Medical Director of the Queen Elizabeth Heart Function and Transplantation Program in Halifax. "The approval of nesiritide represents a welcome addition to therapies for the treatment of ADHF." In a randomized, double-blind trial including 489 patients who required hospitalization for management of dyspnea at rest due to ADHF, patients receiving Natrecor in addition to standard of care reported a greater improvement in their dyspnea at three hours than patients receiving placebo in addition to standard of care. Additionally, the pulmonary capillary wedge pressure (PCWP), right atrial pressure (RAP), CI (cardiac index) and other hemodynamic variables were monitored in 246 of the patients in this trial. There was a reduction in mean PCWP within 15 minutes of starting the Natrecor infusion, with most of the effect seen at three hours being achieved within the first 60 minutes of the infusion. A significant reduction in PCWP was sustained through 24 hours.1 "Acute decompensated congestive heart failure is a complex condition that significantly affects the lives of Canadians with the disease," says Dr. Michel White, Professor of Medicine at the Université de Montréal and Director of the Heart Failure Research Program at the Montreal Heart Institute. "We can now offer patients a new option to help manage the troubling disease symptoms of ADHF." Natrecor has been studied in over 10 clinical trials including more than 900 patients and has been used to treat over 800,000 ADHF patients around the world. The nature and incidence of adverse events (AEs) that occurred during the Natrecor clinical trial program have been well characterized and are consistent with the expected AE profile for the ADHF population. Patients in these studies had typical comorbidity such as diabetes, hypertension, renal insufficiency, arrhythmia and coronary artery disease. Therefore, Natrecor has been evaluated in patients who are highly susceptible to adverse events and in whom a high reporting rate would be expected.1 Natrecor is not recommended for patients for whom vasodilating agents are not appropriate, such as patients with significant valvular stenosis, restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent upon venous return, or for patients suspected of having low cardiac filling pressures. Natrecor should not be used as primary therapy for patients with cardiogenic shock or in patients with a systolic blood pressure less than 90 mm Hg.1 Natrecor may affect renal function in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with Natrecor may be associated with azotemia. 1 *All trademark rights used under license. REFERENCES: [1] Natrecor* Product Monograph. Ortho Biotech, 2007. [2] Heart and Stroke Foundation fact sheet: What is congestive heart failure? Accessed at: http://ww2.heartandstroke.ca/Page.asp?PageID=1975&ArticleID=5124&Src=heart&From=SubCategory (August 17, 2007). 3 Tsuyuki R., et al. Contemporary burden of illness of congestive heart failure in Canada. [Can J Cardiol, 2003:19(4)436-438.

[4] Young J., et al. Intravenous Nesiritide vs Nitroglycerin for Treatment of Decompensated Congestive Heart Failure: A Randomized Controlled Trial. JAMA, 2002: Vol 287, No 12
[5] Fonarow GC, Weber JE, Nohria A. Rapid clinical assessment of hemodynamic profiles and targeted treatment of patients with acutely decompensated heart failure. Clinical Cardiology 2004; 27(Suppl V):V-1-V-9.

SOURCE: Ortho Biotech

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