APP Pharmaceuticals Receives Approval for Idarubicin HCI Injection
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 idarubicin hydrochloride injection in three dosage strengths (5mg/5mL, 10mg/10mL and 20mg/20mL). Idarubicin is therapeutically equivalent to the reference drug Idamycin PFS injection, which is marketed by the innovator Pfizer, Inc.
APP will package Idarubicin in 5mL, 10mL and 20mL dose vials and expects to launch in September 2009. APP's Idarubicin is AP-rated, bar-coded and latex-free. According to IMS data, 2008 sales of this product in the United States across all formulations and manufacturers were approximately $18.6 million1.
Idarubicin belongs to a class of drugs called anthracyclines and is the foundation of many chemotherapy regimens. It is indicated for use as a therapy in patients with acute myeloid leukemia. Idarubicin, a cytotoxic agent, works by inhibiting activities of the cancer cell necessary for life and growth, which prevents the cancer cell from reproducing and results in death of the cancer cell.
"Idarubicin is an important addition to APP's broad oncology portfolio," said Thomas H. Silberg, president and chief executive officer of APP Pharmaceuticals. "We are looking forward to launching Idarubicin within the next month and have already secured a sole source contract position with a major group purchasing organization (GPO)."
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 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 for fluid substitution, blood volume expansion, 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 patients all over the world. In 2008, Fresenius Kabi achieved sales of EUR 2,495 million and an operating profit of EUR 443 million. For more information visit the company's Web site at www.fresenius-kabi.com. Fresenius Kabi AG is a 100% subsidiary of Fresenius SE. Fresenius SE is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2008, group sales were approximately EUR 12.3 billion. For more information visit the company's Web site at 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 idarubicin hydrochloride injection. 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. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in the Fresenius Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2008 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.