Nile Therapeutics Receives Fast Track Designation for Cenderitide for Post-Acute Indication

SAN MATEO, Calif., March 31, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nile's post-acute development program for cenderitide, which has the goal of reducing cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period in patients with acute decompensated heart failure.

As previously announced, Nile plans to develop cenderitide 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 indication that is being referred to as "post-acute."

"We are very pleased that the FDA has recognized cenderitide's potential to address an important unmet medical need for heart failure patients," said Joshua Kazam, Nile's Chief Executive Officer. "If our post-acute cenderitide program is successful, then we may be able to reduce the annual number of hospital visits for ADHF, potentially saving the health care system billions of dollars."

Fast Track is a designation that the FDA reserves for products that demonstrate the potential to address unmet medical needs for serious or life-threatening conditions. The Fast Track process is designed to facilitate the development and expedite the review of these products. The FDA has a number of pathways intended to meet these goals, including more frequent interactions with the FDA throughout the development process. In addition, sponsors of drugs that receive Fast Track designation can file a new drug application (NDA) on a rolling basis as data become available and have the possibility to be considered for Priority Review, which could reduce the time it takes the FDA to review the NDA from ten to six months. Fast Track designation is intended to bring valuable treatments more quickly to patients in need.

About Nile Therapeutics

Nile Therapeutics, Inc. is a biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is initially focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure, and CU-NP, a novel rationally designed natriuretic peptide. More information on Nile can be found at http://www.nilethera.com.

Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Nile's plans to develop cenderitide in the post-acute setting, the anticipated benefits of cenderitide for patients in the post-acute setting, and Nile's ability to obtain FDA approval of cenderitide in the post-acute setting, are forward-looking statements. Forward-looking statements also include statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial timelines, expected patient enrollment, anticipated benefits of cenderitide, Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile's need to raise additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission on March 14, 2011. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

SOURCE Nile Therapeutics, Inc.

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