SAN DIEGO, Aug. 30 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. , a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today announced it has completed patient enrollment in a pivotal Phase III clinical trial to evaluate its investigational product candidate, intravenous acetaminophen (IV acetaminophen), for the treatment of acute pain following gynecologic surgery. This clinical trial is part of a comprehensive Phase III clinical development program for IV acetaminophen, which includes pivotal efficacy studies for the treatment of acute pain and fever, as well as safety and pharmacokinetic studies.
“The completion of patient enrollment in this clinical trial is an important milestone for Cadence,” said Ted Schroeder, President and Chief Executive Officer of Cadence. “We believe that intravenous acetaminophen has the potential to meet a significant unmet medical need for an effective intravenous analgesic to treat acute pain and fever without the unwanted side effects associated with currently available treatments.”
Cadence’s pivotal trial of IV acetaminophen for the treatment of pain following gynecologic surgery, referred to as the IV APAP 301 Study, is a randomized, double-blind, placebo-controlled study in which a total of 331 subjects have been enrolled at 27 sites throughout the United States. Patients were treated with either IV acetaminophen or placebo in the 48-hour period following gynecologic surgery. The primary endpoint of the trial is analgesic efficacy, measured by reduction in pain intensity, compared to placebo.
“The IV APAP 301 Study is a critical element of our registration program for IV acetaminophen in the United States,” said James Breitmeyer, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Cadence. “With enrollment completed two months ahead of schedule, we are on track to announce top-line results of this study in early 2008, and we continue to make excellent progress with our other clinical trials of this product candidate.”
About the IV Acetaminophen Clinical Development Program
Cadence’s clinical development program for IV acetaminophen consists of three pivotal Phase III efficacy trials, two safety studies, and two pharmacokinetic studies, as set forth below:
Pivotal Phase III Efficacy Trials Enrollment Status -------------------------------------------------------------------------- Treatment of pain following gynecologic surgery (IV APAP 301 Study) Completed Treatment of fever in adults Ongoing Treatment of fever in adults comparing intravenous and oral administration Ongoing Other Trials Enrollment Status -------------------------------------------------------------------------- Adult pharmacokinetics (1) Completed Adult safety Initiation in Fourth Quarter 2007 Pediatric pharmacokinetics Ongoing Pediatric safety Initiation in Fourth Quarter 2007 (1) The adult pharmacokinetics trial completed enrollment in December 2006 and preliminary results were presented at the April 2007 meeting of the American Society of Regional Pain and Anesthesia.
The company anticipates completing enrollment in the two remaining, planned Phase III efficacy trials of IV acetaminophen by the end of 2007. Additionally, Cadence’s licensor for IV acetaminophen, Bristol-Myers Squibb Company, is conducting a randomized trial of IV acetaminophen for marketing purposes in Europe in patients undergoing total hip replacement surgery. Cadence expects that data from this trial may be available in 2008; however, Cadence does not plan to rely on this clinical trial as a pivotal efficacy study for its New Drug Application (NDA) submission.
Assuming successful completion of the planned clinical trials, Cadence expects to submit a 505(b)(2) NDA to the U.S. Food and Drug Administration in the second half of 2008 requesting marketing approval of IV acetaminophen for acute pain and fever in adults and children.
About IV Acetaminophen
IV acetaminophen is a proprietary, intravenous formulation of acetaminophen. In oral form, acetaminophen is the most widely used medication in history for the treatment of pain and fever in the United States. Before the development of this intravenous formulation of acetaminophen, poor stability in aqueous solutions and inadequate solubility had prevented the development of an intravenous dosage form. IV acetaminophen has been previously studied in six completed Phase III trials, and Bristol-Myers Squibb has marketed the product since mid-2002 in Europe, where over 200 million vials of the drug have been sold since launch and it is the market leader among all injectable analgesics. In the United States, opioids and ketorolac (a non steroidal anti-inflammatory drug), are the only intravenous analgesics currently available to treat acute post-operative pain and are associated with significant adverse side effects.
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 products in development, including IV acetaminophen, for the treatment of acute pain and fever, and Omigard(TM) (omiganan pentahydrochloride 1% aqueous gel) for the prevention of catheter-related infections. For more information about Cadence, 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 forward-looking statements include statements regarding: the timing for completing enrollment and disclosing results from Cadence’s clinical trials of IV acetaminophen; the potential for submitting an NDA for IV acetaminophen and the timing for any such submission; the ability of IV acetaminophen to meet a significant unmet medical need; and the market potential for IV acetaminophen. 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 release due to the risks and uncertainties inherent in Cadence’s business, including, without limitation: delays in the initiation or completion of enrollment in the company’s ongoing or planned clinical trials; the adequacy of the clinical trial design to support regulatory approvals in the stated indications or at all, and the possibility that additional clinical trials or preclinical studies may be required to support regulatory approvals; unexpected adverse side effects or inadequate therapeutic efficacy of IV acetaminophen that could delay or prevent its regulatory approval or commercialization, result in recalls or product liability claims, or diminish its market acceptance; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for IV acetaminophen; the scope and validity of patent protection for IV acetaminophen; the company’s ability to maintain patent protection for this product candidate and to commercialize it without infringing the patent rights of others; the market potential for pain, fever and other target markets, and the company’s ability to compete with new or existing products; the company’s ability to raise sufficient capital to complete its clinical development program for IV acetaminophen and to successfully launch this product candidate; and other risks detailed in Cadence’s prior press releases as well as in Cadence’s 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 news 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) and Omigard(TM) are registered trademarks of Cadence Pharmaceuticals, Inc.
Contacts: William R. LaRue SVP & Chief Financial Officer Cadence Pharmaceuticals, Inc. 858-436-1400 Anna Gralinska Director, Investor Relations Cadence Pharmaceuticals, Inc. 858-436-1452 Susan Neath Media Relations Porter Novelli Life Sciences 619-849-6007
Cadence Pharmaceuticals, Inc.
CONTACT: William R. LaRue, SVP & Chief Financial Officer, +1-858-436-1400,or Anna Gralinska, Director, Investor Relations, +1-858-436-1452, both ofCadence Pharmaceuticals, Inc.,; or Susan Neath, Media Relations of PorterNovelli Life Sciences, +1-619-849-6007, for Cadence Pharmaceuticals, Inc.
Web site: http://www.cadencepharm.com/
