SCHAUMBURG, Ill., Apr 01, 2010 (BUSINESS WIRE) --Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), the parent company of APP Pharmaceuticals, Inc., announced today that APP and other Fresenius Kabi companies have entered into license and settlement agreements with sanofi-aventis covering patents that apply to Eloxatin(R) (oxaliplatin injection and oxaliplatin for injection). The agreements with sanofi-aventis resolve a patent infringement lawsuit, which was pending in the United States District Court for the District of New Jersey.
In 2007, APP and Fresenius Kabi filed ANDAs seeking approval to market generic oxaliplatin products. In response to these filings, sanofi-aventis filed lawsuits against APP and Fresenius Kabi alleging that the proposed products would infringe certain patents of sanofi-aventis expiring 2017.
Under the terms of the agreements, APP and Fresenius Kabi are granted a license to market their generic versions of oxaliplatin, 50 mg/vial, 100 mg/vial and 5mg/mL, 10 mL and 20 mL vials, beginning no later than August 9, 2012.
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. According to IMS data, U.S. sales of Eloxatin(R) in 2009 were $993 million.
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 http://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 http://www.fresenius-kabi.com. Fresenius Kabi AG is a 100% subsidiary of Fresenius SE.
About Fresenius SE
Fresenius SE is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2009, group sales were approximately EUR 14.2 billion. On December 31, 2009 the Fresenius Group had 130,510 employees worldwide. For more information visit the company's Web site at http://www.fresenius.com.
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.
Eloxatin(R) is a registered trademark of sanofi-aventis.
1 2009 IMS Dataview © IMS HEALTH
SOURCE: APP Pharmaceuticals, Inc.
Debra Lynn Ross
Director, Corporate Communications
APP Pharmaceuticals, Inc.
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