Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that APP Pharmaceuticals will immediately begin marketing Oxaliplatin Injection (liquid) in the U.S. The U.S. Food and Drug Administration granted approval to market Oxaliplatin Injection in two dosage strengths to Fresenius Kabi Oncology Limited (NSE: FKONCO) (BSE: 532545). APP Pharmaceuticals and Fresenius Kabi Oncology Limited are members of the Fresenius Kabi Group of companies. APP currently markets the lyophilized product, Oxaliplatin for Injection, 50 mg and 100 mg.
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Oxaliplatin 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 and Fresenius Kabi Oncology Limited 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. APP will market Oxaliplatin Injection in 5 mg/mL single dose vials, available in 10 mL and 20 mL vial sizes. APP's Oxaliplatin Injection is bar-coded, preservative-free and latex-free.
"This approval enables APP to offer its customers a choice between the lyophilized product that APP currently markets and a more convenient, ready to use liquid form," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "Adding Oxaliplatin Injection to our product offerings further expands APP's growing Oncology portfolio."
Fresenius Kabi Pharmaceuticals Holding, Inc.,