SCHAUMBURG, Ill.—January 23, 2012— APP Pharmaceuticals, Inc., a Fresenius Kabi Company, announced today that it has settled its litigation with The Medicines Company relating to APP’s Abbreviated New Drug Application for a generic version of the anti-clotting drug Angiomax® (bivalirudin for injection).
Under the settlement, The Medicines Company has licensed APP to begin selling APP’s generic version of Angiomax in the U.S. on May 1, 2019. Furthermore, in certain limited circumstances, The Medicines Company’s license to APP would become effective prior to May 1, 2019, and may include the right to market an authorized generic bivalirudin product supplied by The Medicines Company.
Additionally, APP entered into an agreement for the manufacture and supply of Angiomax® finished product to The Medicines Company. The agreements are subject to review by the Federal Trade Commission and the U.S. Department of Justice.
In 2007, APP filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration to manufacture and market a generic version of Angiomax®. In 2009, APP amended that filing to include Paragraph IV certifications with respect to two Medicines Company patents that were filed in 2009 and issued in 2010 and are listed in the Orange Book in connection with Angiomax®. In response to these filings, The Medicines Company filed lawsuits against APP alleging that the proposed product would infringe those patents, which expire July 27, 2028. As part of the settlement with The Medicines Company, APP admits that the two patents asserted in the lawsuits are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product. The settlement also includes APP’s agreement to dismiss its appeal of the August 2010 Federal District court decision holding that The Medicine Companies’ application for Hatch Waxman patent term extension of the Angiomax composition of matter patent was timely filed.
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.
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.
Debra Lynn Ross, ABC
Director, Corporate Communications
APP Pharmaceuticals, Inc.