Cadence Pharmaceuticals Announces FDA Concurrence With Clinical Development Plan for Acetavance(TM)
Clinical Efficacy Trial Requirements Complete; Additional Trials Not Required
SAN DIEGO, July 30, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) today announced that it has received written guidance from the U.S. Food and Drug Administration (FDA) that one post-operative pain trial (Sinatra Study) and one fever 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 acetaminophen 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 positive outcomes. Cadence is not required nor does it currently plan to initiate any additional clinical trials of Acetavance for NDA submission.
Upon the completion of ongoing clinical trials evaluating pediatric pharmacokinetics (Study 102), adult safety (Study 351), and pediatric safety (Study 352), the clinical development plan, consistent with the advice received from the FDA, will be complete. The company's abdominal laparoscopic surgery trial (Study 304) is not required for submission of the Acetavance NDA. The company currently anticipates submitting the NDA in the second quarter of 2009.
"We are very pleased with the outcome of our communications with the FDA," stated Ted Schroeder, President and Chief Executive Officer of Cadence. "With this clear guidance, we can now focus on completing the ongoing development activities and preparing to submit the Acetavance NDA."
Conference Call and Webcast on July 30, 2008 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time)
Cadence management will host a conference call on July 30, 2008 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). Interested investors may participate in the conference call by dialing 877-419-6590 (domestic) or 719-325-4861 (international). To access the webcast, please visit the company's website at http://www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available on the company's website approximately two hours after the call.
Acetavance is a proprietary intravenous formulation of acetaminophen for the treatment of acute pain and fever. Cadence acquired the exclusive 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 analgesic in terms of both dollars and units sold. In the United States, injectable analgesics to treat acute pain, particularly in the post-operative setting, are currently limited to opioids and a single non- steroidal anti-inflammatory drug, both of which may be associated with significant adverse side-effects. In placebo-controlled clinical trials, Acetavance has demonstrated significant pain relief, improved patient satisfaction, and opioid-sparing potential with a safety profile comparable to placebo.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. The company currently has two Phase III product candidates in development, Acetavance(TM) (intravenous acetaminophen) for the treatment of acute pain and fever, and Omigard(TM) (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections. For more information about Cadence's pipeline, visit http://www.cadencepharm.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements. Forward-looking statements include statements regarding: the FDA's concurrence with Cadence's proposal that, assuming positive results, the clinical development plan will be sufficient to serve as the basis for the company's submission of an NDA for Acetavance(TM), and that no additional clinical trials will be required; the interpretation of results of completed clinical trials of Acetavance; and the timeframe in which Cadence anticipates submitting an NDA for Acetavance. The inclusion of forward-looking statements should not be regarded as a representation by Cadence that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the company's business, including, without limitation: the FDA may require Cadence to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of an NDA for Acetavance; clinical trials of Acetavance may produce negative or inconclusive results, or may be inconsistent with previously conducted clinical trials; the outcomes of final analyses of data from the Acetavance clinical trials may vary from the initial analyses, and the FDA may not agree with Cadence's interpretation 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 anticipated; the company may experience delays in completing important pre-commercialization manufacturing development activities for Acetavance, such as the production of batches of the product required to perform stability studies, and may be required to perform additional pre-clinical or clinical testing as a result of changes to the Acetavance manufacturing process; the company may require substantial additional funding to complete its development program for Acetavance and, if approved, to successfully launch this product candidate, and it 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.
Cadence(TM), Acetavance(TM) and Omigard(TM) are trademarks of Cadence Pharmaceuticals, Inc. Perfalgan(R) is a trademark of Bristol-Myers Squibb Company.