Wednesday 6 August 2008

Cadence Pharmaceuticals Announces FDA Concurrence With Clinical Development Plan For Acetavance(TM)

�Cadence Pharmaceuticals,
Inc. (Nasdaq: CADX) announced that it has received written direction
from the U.S. Food and Drug Administration (FDA) that one post-operative
pain trial (Sinatra Study) and one febricity trial (Study 302) are sufficient
to meet the pivotal clinical trial requirements for submission of a New
Drug Application (NDA) for Acetavance, the company's intravenous
formulation of tempra for the treatment of acute pain and fever in
adults and children. As previously reported, both the Sinatra Study and
Study 302 have already been completed with prescribed outcomes. Cadence is
non required nor does it currently be after to lead up any additional clinical
trials of Acetavance for NDA submission.





Upon the pass completion of on-going clinical trials evaluating paediatric
pharmacokinetics (Study 102), adult safety (Study 351), and pediatric
refuge (Study 352), the clinical development design, consistent with the
advice received from the FDA, will be complete. The company's abdominal
laparoscopic operation trial (Study 304) is not needed for compliance of
the Acetavance NDA. The company currently anticipates submitting the NDA in
the second quarter of 2009.





"We are very pleased with the result of our communications with the
FDA," stated Ted Schroeder, President and Chief Executive Officer of
Cadence. "With this clear steering, we tin now focus on complementary the
on-going development activities and preparing to submit the Acetavance NDA."



About Acetavance(TM)





Acetavance is a proprietorship intravenous formulation of phenaphen
for the treatment of acute pain in the neck and pyrexia. Cadence acquired the undivided
rights to Acetavance in the United States and Canada from Bristol-Myers
Squibb Company (BMS), which has marketed the product as Perfalgan(R)
throughout Europe and other parts of the world beginning in 2002. In 2007,
BMS sold approximately 80 million units in Europe, where it is the market
leading injectable anodyne in price of both dollars and units sold. In
the United States, injectable analgesics to treat acute pain, particularly
in the postoperative setting, ar currently limited to opioids and a
single not steroidal anti-inflammatory drug, both of which may be
associated with significant inauspicious side-effects. In placebo-controlled
clinical trials, Acetavance has demonstrated significant hurting relief,
improved patient satisfaction, and opioid-sparing potential with a guard
profile comparable to placebo.



About Cadence Pharmaceuticals, Inc.





Cadence Pharmaceuticals is a biopharmaceutical company focused on
in-licensing, developing and commercializing proprietorship product candidates
principally for use in the infirmary setting. The company presently has two
Phase III product candidates in development, Acetavance(TM) (endovenous
acetaminophen) for the treatment of acute pain and fever, and Omigard(TM)
(omiganan pentahydrochloride 1% topical gelatin) for the prevention of
catheter-related infections. For more information some Cadence's pipeline,
visit http://www.cadencepharm.com.



Forward Looking Statements





Statements included in this press dismissal that are not a description of
historical facts are innovative statements. Forward-looking statements
include statements regarding: the FDA's concurrence with Cadence's proposition
that, presumptuous positive results, the clinical development design will be
sufficient to serve as the footing for the company's submission of an NDA for
Acetavance(TM), and that no additional clinical trials volition be required;
the rendering of results of completed clinical trials of Acetavance;
and the timeframe in which Cadence anticipates submitting an NDA for
Acetavance. The comprehension of innovative statements should not be
regarded as a representation by Cadence that whatsoever of its plans will be
achieved. Actual results may take issue materially from those set forth in this
press release due to the risks and uncertainties inherent in the company's
business enterprise, including, without limitation: the FDA english hawthorn require Cadence to
finish additional clinical, non-clinical or other requirements prior to
the submission or the approval of an NDA for Acetavance; clinical trials of
Acetavance may bring out negative or inconclusive results, or may be
inconsistent with antecedently conducted clinical trials; the outcomes of
final analyses of information from the Acetavance clinical trials may vary from
the initial analyses, and the FDA may not agree with Cadence's
rendering of such results; the clinical trial data submitted with the
NDA for Acetavance may demonstrate inadequate therapeutic efficacy, or the
prevalence or severity of adverse side effects may be greater than
hoped-for; the company may live delays in completing important
pre-commercialization fabrication development activities for Acetavance,
such as the output of batches of the product requisite to perform
stability studies, and may be required to perform additional presymptomatic
or clinical testing as a resultant role of changes to the Acetavance manufacturing
process; the company crataegus laevigata require hearty additional financing to complete
its development program for Acetavance and, if sanctioned, to successfully
launch this product prospect, and it may not be able to rear sufficient
capital when required, or at all; and other risks detailed in Cadence's prior
press releases as well as in Cadence's periodical public filings with the
Securities and Exchange Commission.





You are cautioned not to position undue reliance on these forward-looking
statements, which speak only as of the date hereof. All forward-looking
statements are qualified in their integrality by this cautionary statement and
Cadence undertakes no obligation to revise or update this press press release to
ruminate events or circumstances later on the engagement hereof. This caution is made
under the safe harbor viands of Section 21E of the Private Securities
Litigation Reform Act of 1995.



Cadence(TM), Acetavance(TM) and Omigard(TM) ar trademarks of Cadence
Pharmaceuticals, Inc. Perfalgan(R) is a trademark of Bristol-Myers Squibb
Company.




Cadence Pharmaceuticals, Inc.


http://www.cadencepharm.com




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