APP, Fresenius Kabi and sanofi-aventis sign license and settlement agreements

Apr 2 2010

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^® (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.

“Management's Discussion and Analysis of Financial Condition and Results of Operations”

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^® 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^® in 2009 were $993 million¹.