Cadence Pharmaceuticals, Inc. Reports Mixed Results for Two Trials
SAN DIEGO, Jan. 11 -- Cadence Pharmaceuticals today announced top line results of two of the company's four pivotal, Phase III clinical trials of Acetavance(TM), a formulation of acetaminophen for intravenous use. One of these clinical trials did not meet its primary endpoint of demonstrating a statistically significant reduction in patients' pain intensity levels over 48 hours compared to placebo, following abdominal gynecologic surgery. However, this same study successfully achieved several secondary endpoints, including pain relief, global patient satisfaction and time to rescue medication. Cadence also announced that its Phase III clinical trial of Acetavance in fever successfully met the primary endpoint, demonstrating a statistically significant reduction of fever over six hours compared to placebo.
Importantly, Acetavance demonstrated a safety profile in both of these clinical trials that was no different than placebo, including the evaluation of eight doses over a 48-hour period. The overall safety profile of Acetavance compares favorably with published safety data on oral acetaminophen, which is generally considered safer than a number of other pain medications currently used in the hospital setting.
"We are very pleased that the fever trial met its primary endpoint, that Acetavance was found to be safe and well-tolerated in both studies, and that there were strong positive results for several secondary endpoints in the pain trial," said James Breitmeyer, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Cadence. "We believe that our clinical trial in patients undergoing abdominal gynecologic surgery did not meet its primary endpoint because of substantially higher than predicted variability in pain intensity scores. We remain confident in the design of our ongoing Phase III clinical trial of Acetavance for the treatment of pain in adults following abdominal laparoscopic surgery, which commenced enrollment of patients in the fourth quarter of 2007. However, we will request a meeting with the United States Food and Drug Administration (FDA) to obtain the agency's advice regarding our development program for this product candidate."
"Based on the excellent safety results and the positive secondary endpoints in our abdominal gynecologic surgery clinical trial, we remain firmly committed to continuing the development of Acetavance in the United States for the treatment of acute pain and fever," said Ted Schroeder, President and Chief Executive Officer of Cadence. "Our confidence is also supported by other successful post-operative pain trials of intravenous acetaminophen and the product's strong position as the market leading injectable analgesic in Europe, where over 200 million doses have been sold since the product was launched there in 2002."
The abdominal gynecologic surgery trial, referred to as Study 301, was a Phase III, randomized, double-blind, placebo controlled, multi-center, multiple-dose study of the analgesic efficacy and safety of intravenous acetaminophen versus placebo over 48 hours for the treatment of post-operative pain following abdominal gynecologic surgery. Three hundred thirty-one hospitalized patients were enrolled in this study at 27 clinical sites in the United States.
The fever study, referred to as Study 302, was a Phase III, randomized, double-blind, placebo-controlled study of the antipyretic efficacy and safety of intravenous acetaminophen over a six-hour period. In this study, 60 adult patients at one United States clinical trial site received a single dose of Acetavance versus placebo.
Following its planned discussions with the FDA, Cadence will provide updated guidance if there is any change to the anticipated timing for submission of a New Drug Application for Acetavance, or if any additional clinical trials are required. The company also intends to disclose more detailed results of both Study 301 and Study 302 clinical trials in an appropriate medical or scientific setting after the completion of data analysis for the two studies.
Update Regarding Other Clinical Trials
Cadence expects to announce the results of a second study of Acetavance for the treatment of fever in adults, referred to as Study 303, later in the first quarter of 2008. This study is intended to assess the speed of onset of fever reduction of Acetavance compared to orally-administered acetaminophen in 81 patients at one U.S. clinical trial site.
In the fourth quarter of 2007, Cadence initiated enrollment in a Phase III clinical trial of Acetavance for the treatment of mild-to-moderate acute pain in adults following abdominal laparoscopic surgery. This randomized, double- blind, multi-center study of 240 patients, referred to as Study 304, is designed to evaluate the safety and efficacy of 24 hours of Acetavance therapy, administered as either a 1000 mg dose every six hours or as a 650 mg dose every four hours, compared to placebo. The purpose of Study 304 is to provide data on the use of Acetavance in a mild-to-moderate acute pain model, as well as information on the safety and efficacy of this product candidate at two different doses and dosing intervals. The company currently anticipates completing enrollment of this study in the second quarter of 2008.
Data from a previously completed, successful pivotal clinical trial in moderate-to-severe orthopedic pain will be submitted to FDA as part of the basis for approval of an NDA for Acetavance (Sinatra, R., et al. Anesthesiology, 2005; 102(4):822-31). Additionally, Cadence plans to initiate two multi-day safety studies of Acetavance, one study in adults and the other study in pediatric patients, in the first quarter of 2008.
Acetavance Pivotal Phase III Enrollment Status Efficacy Trials
Treatment of pain following total knee & hip replacement Completed Treatment of pain following abdominal gynecologic surgery Completed Treatment of fever in adults (vs. placebo) Completed Treatment of fever in adults (onset of action) Completed Treatment of pain following abdominal laparoscopic surgery Initiated in Fourth Quarter 2007
Other Acetavance Trials Enrollment Status
Adult pharmacokinetics Completed Adult safety Initiation in First Quarter 2008 Pediatric pharmacokinetics Actively enrolling Pediatric safety Initiation in First Quarter 2008
The company also indicated that it remains on track to complete patient enrollment in its pivotal Phase III clinical trial of Omigard(TM) (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections in the second quarter of 2008.
Conference Call and Webcast at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time
Cadence management will host a conference call on January 11, 2008, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss today's announcement. Interested investors may participate in the conference call by dialing 888-233-7853 (domestic) or 913-981-5596 (international). To access the webcast, please log on to the company's website at http://www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call and remain available on the company's website until the next quarterly financial results call.
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.
Forward-Looking Statements
Cadence cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the company's interpretation of the results of recently-completed clinical trials of Acetavance(TM); expectations for completing planned and ongoing clinical trials for both Acetavance and Omigard, and whether such additional clinical trials will be sufficient to support planned New Drug Approval (NDA) applications; the potential for filing, timing and indications for use that may be included in NDAs planned for Acetavance and Omigard; the likelihood that Cadence's clinical trials of Acetavance will be consistent with clinical trials of this product candidate conducted by Cadence's licensor or others; and Cadence's commitment to complete planned development activities for its product candidates. 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 Cadence's business, including, without limitation: the outcome of final analyses of data from recently-completed clinical trials of Acetavance may vary from the company's initial analyses, and the FDA may not agree with Cadence's interpretation of such results; additional ongoing or planned clinical trials of Acetavance conducted by the company may produce negative or inconclusive results, or may be inconsistent with clinical trials conducted by its licensors or others, and the company may decide, or the FDA may require Cadence, to conduct additional clinical trials or to modify the company's ongoing clinical trials; Cadence may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit the company's ability to obtain regulatory approval; the third parties upon whom Cadence relies to conduct its clinical trials and manufacture its product candidates may not perform as expected; Cadence's product candidates may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of Acetavance or Omigard could delay or prevent regulatory approval or commercialization, or could result in recalls or product liability claims; the market potential for pain, fever, local catheter site infections and other target markets may be less than anticipated, and the company may be unable to successfully compete in these markets; the company will need to obtain substantial additional funding to complete its product development plans and may not be able to raise sufficient capital when needed; 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.