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Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
Date:5/14/2009

pany to perform additional non-clinical or clinical studies; the potential that the FDA may impose other requirements to be completed before or after regulatory approval; the company's reliance on third parties to assist with its clinical trials, regulatory submissions, manufacturing and other important aspects of the Acetavance development program, and the risk that regulatory approval may be delayed if their performance is found to have been substandard; risks associated with FDA heightened scrutiny over the new drug approval process and the potential for accidental and intentional overdoses of acetaminophen, primarily in the outpatient setting; intense competition from existing and new products, which could diminish the commercial potential for Acetavance; the possibility that the patent rights covering Acetavance, which are limited to a specific intravenous formulation of acetaminophen and do not cover the active ingredient, may not be sufficient to preclude other formulations of intravenous acetaminophen from being developed by competitors; the potential that Cadence may require substantial additional funding in order to obtain regulatory approval of Acetavance and, if approved, to successfully launch this product candidate, and that the company may not be able to raise sufficient capital when needed, or at all; and other risks detailed in Cadence's prior press releases as well as in Cadence's periodic public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Cadence undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

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