APP Pharmaceuticals Receives Approval for Deferoxamine Mesylate for Injection, USP
SCHAUMBURG, Ill.--(BUSINESS WIRE)--Sep. 17, 2009-- 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 Deferoxamine Mesylate for Injection, USP, in two dosage strengths. Deferoxamine Mesylate is therapeutically equivalent to the reference-listed drug Desferal®, which is marketed by the innovator Novartis.
APP will package Deferoxamine Mesylate in single dose vials of 500 mg, 10 mL and 2 gram, 30 mL. APP's Deferoxamine Mesylate is AP-rated, bar-coded and latex-free. According to IMS data, 2008 sales of this product in the United States were approximately $11.8 million1.
Deferoxamine Mesylate is an iron chelating agent that is used for iron poisoning as well as chronic iron overload due to transfusion-dependent anemias. In the case of acute iron poisoning, Deferoxamine Mesylate is most effective when given early in the treatment of iron poisoning. Long-term treatment with Deferoxamine Mesylate has been shown to slow the accumulation of excess iron in the liver and can slow or eliminate the progression of a serious form of liver damage called liver fibrosis.
APP plans to launch Deferoxamine Mesylate in the fourth quarter of 2009, which will further expand the company’s critical care product line.
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 Deferoxamine Mesylate for Injection, USP. 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.
Desferal®, which is a registered trademark of Novartis
1 2008 IMS Data
Source: APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc.
Debra Lynn Ross
Director, Corporate Communications
Hill & Knowlton