APP Pharmaceuticals Announces Approval and Launch of Gemcitabine HCI for Injection, USP in 2 Gram Dosage Form
APP first company to offer all three dosage forms
May 19, 2011
SCHAUMBURG, Ill. (BUSINESS WIRE)—May, 19, 2011—APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Gemcitabine HCI for Injection, USP, in the 2 g dosage strength. APP will launch this presentation of Gemcitabine immediately.
In January 2011, Teva Pharmaceuticals USA, Inc. received approval and APP Pharmaceuticals launched Gemcitabine HCI for Injection in the 200 mg and 1 g dosage forms as part of a commercialization, manufacture and supply agreement with Teva.
According to IMS Health data, 2010 branded product sales of all dosage strengths of Gemcitabine HCI for Injection in the United States were approximately $780 million1. Sales of the generic 2 g dosage strength accounted for $33.3 million, with 36,000 units sold from November 2010 thru March 2011.
“With the approval of the 2 g dosage, APP becomes the only generic manufacturer to offer its customers all three dosage strengths of this critically important oncology drug,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “This approval further strengthens our leading oncology portfolio.”
About Gemcitabine HCI for Injection
Gemcitabine HCI for Injection is indicated in combination with Carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy as well as in combination with Cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer. Gemcitabine HCI for Injection is also indicated in combination with Paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. It is also indicated as first-line treatment for patients with locally advanced (nonresectable stage II or stage III) or metastatic (stage IV) adenocarcinoma of the pancreas and in patients previously treated with 5-FU.
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 Gemcitabine HCI for 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, 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.
12010 IMS Dataview © IMS HEALTH
Debra Lynn Ross, ABC
Director, Corporate Communications
APP Pharmaceuticals, Inc.