APP Pharmaceuticals Announces Launch of Imipenem and Clilastatin for Injection, USP and Meropenen for Injection, USP
SCHAUMBURG, Ill. (BUSINESS WIRE)—February 8, 2012— APP Pharmaceuticals, Inc., a Fresenius Kabi Company, announced today that it will launch both Imipenem and Cilastatin for Injection, USP and Meropenem for Injection, USP in the United States. APP will begin shipping Meropenem for Injection the week of February 13, 2012 with Imipenem and Cilastatin for Injection scheduled to ship in the next three to five weeks.
Imipenem and Cilastatin for Injection is therapeutically equivalent to the reference-listed drug Primaxin IV®, which is currently marketed by the innovator Merck & Co. Meropenem for Injection is therapeutically equivalent to the reference-listed drug Merrem IV®, currently marketed by the innovator AstraZeneca Pharmaceuticals, LP.
APP’s Imipenem and Cilastatin for Injection will be available in 250 mg and 500 mg single dose vials, while Meropenem for Injection will be available in 500 mg and 1 gram single dose vials. Both products are AP-rated, preservative-free and bar-coded. According to IMS Health, in 2011 combined sales of both products in the United States were approximately $229 million1.
“The upcoming launch of these two products marks APP’s entry into the Carbapenem market,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “Adding these two products to our portfolio further strengthens our existing anti-infective line and helps solidify our continued leadership in the reliable supply of sterile generic injectables.”
About Imipenem and Cilastatin for Injection, USP
Imipenem and Cilastatin for Injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in many conditions. Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, Imipenem and Cilastatin for Injection is used in the treatment of mixed infections and as a presumptive therapy prior to the identification of causative organisms.
About Meropenem for Injection, USP
Meropenem for Injection is indicated as a single agent therapy for the treatment of skin and skin structure infections and intra-abdominal infections in adults and pediatric patients over three months, and for bacterial meningitis for pediatric patients over the age of three months.
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.