APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced that it has entered into a commercialization, manufacture and supply agreement with Teva Pharmaceutical USA, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., to manufacture and market Gemcitabine HCI for Injection. Under the terms of the agreement APP has been granted a license to market Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials during the 180 day Hatch Waxman exclusivity period. APP plans to launch Gemcitabine immediately. Gemcitabine HCI for Injection is therapeutically equivalent to the reference-listed drug Gemzar(R), which is currently marketed in these dose forms by the innovator Eli Lilly and Company. According to IMS data, 2010 annual U.S. sales of Gemzar were approximately $785 million 1 in net sales, with two million units sold.
“The agreement between our two companies demonstrates APP’s willingness and versatility to enter into collaborative agreements to ensure patient access to affordable cancer treatments,” said John Ducker, President and CEO. “The addition of these two presentations of Gemcitabine HCI for Injection broadens APP’s rapidly growing oncology portfolio, and confirms our reputation as a reliable partner in this important segment.”
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.
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical USA, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s largest generic drug maker, with a global product portfolio of more than 1,250 molecules and a direct presence in approximately 60 countries. Teva’s branded businesses focus on neurology, oncology, respiratory and women’s health therapeutic areas as well as biosimilars. Teva’s leading innovative product, Copaxone(R), is the number one prescribed treatment for multiple sclerosis. Teva employs more than 40,000 people around the world and reached $13.9 billion in net sales in 2009.
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 2009, Fresenius Kabi achieved sales of EUR 3,086 million and an operating profit of EUR 607 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.