APP Pharmaceuticals to Market Oxaliplatin Injection (Liquid) in the U.S.
11 6월 2010 - 2:01PM
Business Wire
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ)
announced today that APP Pharmaceuticals will immediately begin
marketing Oxaliplatin Injection (liquid) in the U.S. The U.S. Food
and Drug Administration granted approval to market Oxaliplatin
Injection in two dosage strengths to Fresenius Kabi Oncology
Limited (NSE: FKONCO) (BSE: 532545). APP Pharmaceuticals and
Fresenius Kabi Oncology Limited are members of the Fresenius Kabi
Group of companies. APP currently markets the lyophilized product,
Oxaliplatin for Injection, 50 mg and 100 mg.
Oxaliplatin Injection is therapeutically equivalent to the
reference-listed drug Eloxatin®, which is currently marketed by the
innovator sanofi-aventis. Under the terms of the previously
announced settlement agreement with sanofi-aventis, which covers
patents that apply to Eloxatin®, APP Pharmaceuticals and Fresenius
Kabi Oncology Limited may market liquid and lyophilized Oxaliplatin
products through at least June 30, 2010 and resume marketing the
products on August 9, 2012.
According to IMS data, U.S. sales of Eloxatin® in 2009 were $993
million1. According to 2009 IMS data, combined U.S. sales of
Eloxatin® and generic oxaliplatin were approximately $1.35
billion1.
Eloxatin® is approved for the adjuvant treatment of stage III
colon cancer in patients who have undergone complete resection of
the primary tumor and treatment of advanced carcinoma of the colon
or rectum. APP will market Oxaliplatin Injection in 5 mg/mL single
dose vials, available in 10 mL and 20 mL vial sizes. APP's
Oxaliplatin Injection is bar-coded, preservative-free and
latex-free.
“This approval enables APP to offer its customers a choice
between the lyophilized product that APP currently markets and a
more convenient, ready to use liquid form,” said John Ducker,
President and Chief Executive Officer of APP Pharmaceuticals.
“Adding Oxaliplatin Injection to our product offerings further
expands APP’s growing Oncology portfolio.”
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.
Fresenius Kabi Oncology Limited
Fresenius Kabi Oncology Limited is one of the leading companies
for cancer research and anti-cancer products. Leveraging the global
outreach through integration with Fresenius Kabi, Fresenius Kabi
Oncology Limited is benchmarking the oncology excellence with world
class production, state-of-the-art manufacturing and research &
development facilities. Fresenius Kabi Oncology Limited has world
class expertise for the development and manufacturing of active
pharmaceutical ingredients, intermediates and oral & injectable
finished dosage forms.
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
Eloxatin® is a registered trademark of sanofi-aventis.
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