SCHAUMBURG, Ill., Jun 08, 2010 (BUSINESS WIRE) --APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced today it received approval from the U.S. Food and Drug Administration to market Oxaliplatin for Injection (lyophilized), 50 mg and 100 mg.
APP currently markets Oxaliplatin for Injection (lyophilized) under a previously approved ANDA for Fresenius Kabi Oncology Limited (NSE: FKONCO, BSE: 532545). APP Pharmaceuticals and Fresenius Kabi Oncology Limited are members of the Fresenius Kabi Group of companies.
Oxaliplatin for Injection is therapeutically equivalent to the reference-listed drug Eloxatin(R), which is currently marketed by the innovator sanofi-aventis. Under the terms of the previously announced settlement agreement with sanofi-aventis, which covers patents that apply to Eloxatin(R), APP Pharmaceuticals may market liquid and lyophilized Oxaliplatin products through at least June 30, 2010 and resume marketing the products on August 9, 2012.
According to IMS data, U.S. sales of Eloxatin(R) in 2009 were $993 million1. According to 2009 IMS data, combined U.S. sales of Eloxatin(R) and generic oxaliplatin were approximately $1.35 billion1.
Eloxatin(R) is approved for the adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and treatment of advanced carcinoma of the colon or rectum.
About APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008. For more information about APP Pharmaceuticals, Inc., please visit the company's Web site at www.APPpharma.com.
About Fresenius Kabi AG
Fresenius Kabi AG is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific. Fresenius Kabi's core product range includes infusion solutions, blood volume substitutes, I.V. drugs and parenteral nutrition, as well as products for enteral nutrition. Furthermore, the company provides concepts for ambulatory health care and is focused on managing and providing home therapies. With the philosophy "caring for life" and a comprehensive product portfolio, the company aims at improving the quality of life of critically and chronically ill patients all over the world. In 2009, Fresenius Kabi achieved sales of EUR 3,086 million and an operating profit of EUR 607 million. For more information visit the company's Web site at www.fresenius-kabi.com. Fresenius Kabi AG is a 100% subsidiary of Fresenius SE.
The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of our products. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. Additional relevant information concerning risks are discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Fresenius Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2009 and other documents the company has filed with the Securities and Exchange Commission.
The information contained in this news release is as of the date of this release. Fresenius Kabi Pharmaceuticals Holding, Inc. does not assume any obligation to update or revise these forward-looking statements to conform the statement to actual results, new information, developments or changes in the Company's expectations.
1 Per IMS Dataview © IMS HEALTH as of December 31, 2009
Eloxatin(R) is a registered trademark of Sanofi-aventis.
SOURCE: APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc.
Debra Lynn Ross, ABC
Director, Corporate Communications