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Study 304 was a randomized, double-blind, multi-center study of 244patients designed to evaluate the safety and efficacy of two dosing regimensof Acetavance, 1000 mg every six hours and 650 mg every four hours, comparedto placebo over 24 hours. In addition to the 1000 mg dose administered everysix hours meeting the primary endpoint, the trial also achieved astatistically significant reduction in SPID24 for the 650mg dose administeredevery four hours (p = 0.02). Consistent with other placebo-controlledclinical trials with intravenous acetaminophen, reported safety events fromthe Acetavance and placebo treated patients were similar. The company plansto communicate the full study results in a peer-reviewed venue.
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Cadence also announced today that Study 351, a clinical trial evaluatingthe safety of repeated doses of Acetavance in adults, demonstrated a hepaticand general safety profile of Acetavance comparable to control (standard ofcare), with numerically lower proportions of subjects with elevated liverfunction tests in the two Acetavance groups compared to the standard of caregroup. Study 351 was an open-label, multi-center study of 213 hospitalizedpatients randomized to receive repeated doses of Acetavance 1000mg every sixhours, Acetavance 650mg every four hours, or standard of care for up to fivedays.
The adult clinical development program for Acetavance is now complete. Ananalysis of data from nine placebo-controlled, single and repeated dose trialsconducted in more than 1,300 adults with acute postoperative pain or feverdemonstrated that intravenous acetaminophen has a hepatic safety profilecomparable to placebo, with liver function test elevations reported as atreatment-emergent adverse event in 5.0% of subjects who received placebocompared to only 3.1% of subjects who received intravenous acetaminophen.
In addition, the company announced today that Study 102, a clinical trialto evaluate the pharmacokinetics of Acetavance in 75 pediatric patients,demonstrated the expected pharmacokinetic profile, generally comparable toadults, with an age-related reduction in clearance in newborns. Acetavancewas well-tolerated across all age groups, ranging from newborns toadolescents. Furthermore, the company announced that it has closed patientenrollment in its last required clinical trial of Acetavance, Study 352,evaluating safety in children after one to five days of repeated doses ofAcetavance up to 15 mg/kg. With the results of Study 352, which are expectedin the first quarter of 2009, the planned pediatric clinical developmentprogram for Acetavance will also be complete.
"We are pleased with the successful completion of studies 304, 351, and102," stated Ted Schroeder, President and Chief Executive Officer of Cadence."The Acetavance New Drug Application for the treatment of acute pain and feverin both adults and children remains on track for submission during the secondquarter of 2009."
Conference Call and Webcast on December 17, 2008 at 2:00 p.m. Pacific Time(5:00 p.m. Eastern Time)
Cadence management will host a conference call on December 17, 2008 at2:00 p.m. Pacific Time (5:00 p.m. Eastern Time). Interested investors mayparticipate in the conference call by dialing (877)879-6201 (domestic) or(719)325-4843 (international). To access the live webcast, please visit thecompany's website at http://www.cadencepharm.com and go to the InvestorRelations page. A replay of the webcast will be available on the company'swebsite beginning approximately two hours after the call.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused onin-licensing, developing and commercializing proprietary product candidatesprincipally for use in the hospital setting. The company currently has twoPhase III product candidates in development, Acetavance(TM) (intravenousacetaminophen) for the treatment of acute pain and fever, and Omigard(TM)(omiganan pentahydrochloride 1% topical gel) for the prevention ofcatheter-related infections. For more information about Cadence's pipeline,visit http://www.cadencepharm.com.
Forward-Looking Statements
Statements included in this press release that are not a description ofhistorical facts are forward-looking statements. Words such as "plans,""expects," "anticipates," "believes," and "will," and similar expressions, areintended to identify forward-looking statements, and are based on Cadence'scurrent beliefs and expectations. Forward-looking statements includestatements regarding: the timeframe in which Cadence anticipates filing an NDAseeking marketing authorization for Acetavance, and the timeframe in which thecompany expects to complete its analysis and announce the full results of itsclinical trials of Acetavance. The inclusion of forward-looking statementsshould not be regarded as a representation by Cadence that any of its planswill be achieved. Actual results may differ materially from those set forth inthis press release due to the risks and uncertainties inherent in thecompany's business, including, without limitation: the outcomes of finalanalyses of data from the company's clinical trials of Acetavance may producenegative or inconclusive results, may differ from the initial analyses, or maybe inconsistent with previously conducted clinical trials, and the Food andDrug Administration (FDA) may not agree with Cadence's interpretation of suchresults; the FDA may require Cadence to complete additional clinical,non-clinical or other requirements prior to the submission or the approval ofNDAs for Acetavance; data from clinical trials of Acetavance may demonstrateinadequate therapeutic efficacy, and clinical trial data, as well as reportsof adverse events from countries where intravenous acetaminophen is alreadyapproved and commercialized, may indicate that the prevalence or severity ofadverse side effects is greater than anticipated; the company may experiencedelays in completing important pre-commercialization manufacturing developmentactivities for Acetavance, and may be required to perform additional pre-clinical or clinical testing prior to submitting, or obtaining approval of, anNDA for this product candidate; the third parties on whom Cadence relies toassist with the development program for Acetavance, including clinicalinvestigators, contract laboratories, clinical research organizations andmanufacturing organizations, may not successfully carry out their contractualduties or obligations or meet expected deadlines, and the quality or accuracyof the non-clinical, clinical and manufacturing data generated by such thirdparties may be of insufficient quality to include in the company's regulatorysubmissions; Cadence may require substantial additional funding to completeits development program for Acetavance and, if approved, to successfullylaunch this product candidate, and the company may not be able to raisesufficient capital when needed, or at all, particularly in light of therecent, unprecedented volatility in the overall capital markets; and otherrisks detailed in Cadence's prior press releases as well as in the company'speriodic public filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. All forward-lookingstatements are qualified in their entirety by this cautionary statement andCadence undertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof. This caution is madeunder the safe harbor provisions of Section 21E of the Private SecuritiesLitigation Reform Act of 1995.
Cadence(TM), Acetavance(TM) and Omigard(TM) are trademarks of CadencePharmaceuticals, Inc.Contacts: William R. LaRue Anna Gralinska SVP & Chief Financial Officer Director, Investor Relations Cadence Pharmaceuticals, Inc. Cadence Pharmaceuticals, Inc. 858-436-1400 858-436-1452
SOURCE Cadence Pharmaceuticals, Inc.
