APP Pharmaceuticals Announces Approval and Launch of Topotecan for Injection
30 November 2010 - 7:01AM
Business Wire
APP Pharmaceuticals, Inc., a wholly owned subsidiary of
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ)
announced today that it has received approval from the U.S. Food
and Drug Administration (FDA) to market Topotecan for Injection,
and plans to launch immediately.
Topotecan for Injection is therapeutically equivalent to the
reference-listed drug Hycamtin®, which is currently marketed by the
innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales
of Hycamtin®, in 2009 were $157.1million 1.
Topotecan for Injection is indicated for small cell lung cancer
sensitive disease after failure of first-line chemotherapy, and is
also indicated for use in combination therapy with Cisplatin for
stage IV-B, and for recurrent, or persistent carcinoma of the
cervix not amenable to curative treatment with surgery and/or
radiation therapy. APP will market Topotecan for Injection in 4 mg
single dose vials; the product is bar-coded and
preservative-free.
“As one of the first generic entries into the market, APP's
Topotecan for Injection will help reduce the cost of cancer
treatment for patients who suffer from cervical and small cell lung
cancers,“ said John Ducker, President and Chief Executive Officer
of APP Pharmaceuticals. “With the addition of Topotecan for
Injection to our growing oncology portfolio, APP continues to
demonstrate its ongoing commitment to expanding its presence in the
oncology space.”
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 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.
Forward-Looking Statement
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. Additional
relevant information concerning risks are discussed under the
headings “Risk Factors” and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” in the Fresenius
Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending
December 31, 2009 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 Per IMS Dataview © IMS HEALTH as of December 31, 2009
Hycamtin® is a registered trademark of GlaxoSmithKline, plc.
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