SAN DIEGO, Feb. 11 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for intravenous (IV) acetaminophen.
In the Complete Response letter, the FDA only indicated that deficiencies were observed during the FDA's facility inspection of Cadence's third party manufacturer, which was completed on February 5, 2010. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval.
The Company's third party manufacturer intends to respond promptly to the observations, and Cadence plans to request a meeting with the FDA to ensure that the deficiencies have been adequately addressed to meet the requirements for NDA approval.
The FDA has also informed the Company that OFIRMEV™ has been determined to be an acceptable trade name for IV acetaminophen. The Company is very pleased with label discussions to date and continues to seek approval of OFIRMEV for the management of pain and the reduction of fever in adults and children.
"Cadence is committed to making this important new medicine available to patients and will continue to work closely with the FDA and our third party manufacturer to ensure that the observations are addressed as quickly as possible," said Ted Schroeder, President and CEO of Cadence.
About OFIRMEV (acetaminophen) Injection
OFIRMEV is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products. Cadence acquired the exclusive rights to OFIRMEV in the United States and Canada in 2006 from Bristol-Myers Squibb, which markets the product as Perfalgan® in Europe and other parts of the world. IV acetaminophen is approved in approximately 80 countries, including major markets in Europe, where the product is the market leader among all injectable analgesics. Approximately 90 million vials of IV acetaminophen were sold in Europe in 2008 representing an increase of approximately 13 percent over 2007.
The NDA for OFIRMEV includes data from two pivotal clinical trials for the treatment of acute pain in patients following orthopedic surgery and abdominal laparoscopic surgery and one pivotal clinical trial for the treatment of fever. The NDA is further supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from 1,375 patients who received IV acetaminophen in clinical trials, including 355 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to IV acetaminophen in countries outside the United States.
Conference Call and Webcast Details
Cadence management will host a conference call on Thursday, February 11, 2010 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) and interested investors may participate in the conference call by dialing (877) 303-9145 (domestic) or (760) 536-5203 (international). To access the webcast, please visit the company's website at www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call.
About Cadence Pharmaceuticals
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. For more information about Cadence, please visit www.cadencepharm.com.
Statements in this press release that are not a description of historical facts are forward-looking statements, including statements containing words such as "believes," "seeks," "anticipates," "planning," "will," and "potential," and similar expressions. For example, statements regarding the potential for obtaining approval of the NDA for OFIRMEV, the FDA's acceptance of the trade name and the potential for obtaining desirable labeling claims for this product candidate, are forward-looking statements. All such forward-looking statements are based on Cadence's current beliefs and expectations, and 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 company's reliance on its only product candidate, OFIRMEV, and the possibility that OFIRMEV may not be approved on a timely basis, or at all; the possibility that the company may not yet fully understand all of the corrective actions that will be required to resolve deficiencies identified during the inspection of the manufacturing facility for OFIRMEV, and that Cadence will experience significant delays and incur additional costs in order to fully resolve such deficiencies; the potential that further FDA scrutiny of the manufacturing site may raise additional issues that must be resolved prior to obtaining approval of the NDA, causing further delays and cost increases; intense competition from existing and new products, which could diminish the commercial potential for OFIRMEV; the possibility that the patent rights covering OFIRMEV may not be sufficient to preclude other intravenous formulations of acetaminophen from being developed by competitors; the potential for Cadence to require substantial additional funding in order to complete the necessary corrective actions at the manufacturing site for OFIRMEV, obtain regulatory approval for and commercialize this product candidate, and the risk that the company may not be able to raise sufficient capital when needed, or at all; the impact of any such financing activity on the level of Cadence's stock price; 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™ and OFIRMEV™ are trademarks of Cadence Pharmaceuticals, Inc. Perfalgan® is a registered trademark of Bristol-Myers Squibb Company.
Cadence Pharmaceuticals, Inc.
William R. LaRue, SVP and Chief Financial Officer