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Nile Therapeutics Announces Plans to Pursue a Post-Acute Indication in Heart Failure
Date:2/28/2011

SAN MATEO, Calif., Feb. 28, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, announced plans to pursue a new indication in the field of heart failure.  Nile plans to develop cenderitide (formerly CD-NP) as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital.  This is a novel therapeutic space for natriuretic peptides that has been termed "post-acute."

Within 90 days of admission for ADHF, approximately 40% of patients return to the hospital. Post-acute patients need sustained cardiac and renal function support to prevent a recurrence of their acute symptoms. In multiple clinical trials in both acute and chronic heart failure patients, short-term infusion of cenderitide has been shown to have positive effects on cardiovascular and renal parameters. Nile believes that the continuous and extended infusion of cenderitide through a subcutaneous pump will provide patients with sustained symptomatic relief in the outpatient setting that could contribute to a reduction in post-acute hospitalizations and persistent improvement in cardiorenal functions.

"With over 1 million admissions per year in the U.S., at a cost of over $33 billion, ADHF is one of our country's most expensive health problems," said Richard B. Brewer, Nile's Executive Chairman. "We believe that cenderitide has an opportunity to address a true unmet need in heart failure, and could help reduce the overall cost of health care."

Nile recently had a productive meeting with the United States Food and Drug Administration (FDA) on the development of cenderitide as an extended subcutaneous therapy for a post-acute indication. Nile will seek a FDA Fast-Track Approval Designation fo
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SOURCE Nile Therapeutics, Inc.
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