APP's lyophilized Oxaliplatin for Injection receives FDA marketing approval

Jun 8 2010

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.

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

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®, 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®, 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^® in 2009 were $993 million. According to 2009 IMS data, combined U.S. sales of Eloxatin^® and generic oxaliplatin were approximately $1.35 billion.

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.