SCHAUMBURG, Ill.--(BUSINESS WIRE)--Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that APP Pharmaceuticals will immediately begin marketing Letrozole Tablets in the U.S., after the U.S. Food and Drug Administration granted approval to market the breast cancer treatment medication 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. Letrozole is therapeutically equivalent to the reference-listed drug Femara®, which is currently marketed by the innovator Novartis Pharmaceuticals Corporation. APP will launch the product immediately.
APP will market Letrozole in 2.5 mg tablets. According to IMS data, sales of the branded product in the United States were approximately $619.4 million, with approximately 1,775,000 bottles of 30 tablets sold annually through June 2010.
“The approval of Letrozole further expands APP's Oncology product portfolio in this strategically significant market segment,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “We are delighted to be able to offer this important oral medication.”
About Letrozole Tablets, USP
Letrozole Tablets, USP is an aromatase inhibitor indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Letrozole is also indicated for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy, and as a first and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer.
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, blood volume substitutes, 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 critically and chronically ill patients all over the world. In 2010, Fresenius Kabi achieved sales of EUR 3,672 million and an operating profit of EUR 737 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 & Co. KGaA.
Fresenius Kabi Oncology Limited
Fresenius Kabi Oncology Limited is one of the leading companies in cancer research and anti-cancer products. Leveraging the global outreach through its integration with its parent company Fresenius Kabi, Fresenius Kabi Oncology Limited is benchmarking oncology excellence with world class production, state-of-the-art manufacturing, and research and development facilities. Fresenius Kabi Oncology Limited has world class expertise in the development and manufacturing of active pharmaceutical ingredients, intermediates and oral and injectable finished dosage forms.
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 products. 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, 2010 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.
1 2010 IMS Dataview © IMS HEALTH
Femara® is a trademark of Novartis Pharmaceuticals Corporation.