APP to launch Topotecan for Injection following FDA marketing approval

Nov 30 2010

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

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

Topotecan for Injection is therapeutically equivalent to the reference-listed drug Hycamtin®, which is currently marketed by the innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales of Hycamtin®, in 2009 were $157.1million.

Topotecan for Injection is indicated for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is also indicated for use in combination therapy with Cisplatin for stage IV-B, and for recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. APP will market Topotecan for Injection in 4 mg single dose vials; the product is bar-coded and preservative-free.

"As one of the first generic entries into the market, APP's Topotecan for Injection will help reduce the cost of cancer treatment for patients who suffer from cervical and small cell lung cancers," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "With the addition of Topotecan for Injection to our growing oncology portfolio, APP continues to demonstrate its ongoing commitment to expanding its presence in the oncology space."