Fresenius Kabi Enters Into Licensing and Settlement Agreements with sanofi-aventis
01 Abril 2010 - 9:39AM
Business Wire
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ),
the parent company of APP Pharmaceuticals, Inc., announced today
that APP and other Fresenius Kabi companies have entered into
license and settlement agreements with sanofi-aventis covering
patents that apply to Eloxatin® (oxaliplatin injection and
oxaliplatin for injection). The agreements with sanofi-aventis
resolve a patent infringement lawsuit, which was pending in the
United States District Court for the District of New Jersey.
In 2007, APP and Fresenius Kabi filed ANDAs seeking approval to
market generic oxaliplatin products. In response to these filings,
sanofi-aventis filed lawsuits against APP and Fresenius Kabi
alleging that the proposed products would infringe certain patents
of sanofi-aventis expiring 2017.
Under the terms of the agreements, APP and Fresenius Kabi are
granted a license to market their generic versions of oxaliplatin,
50 mg/vial, 100 mg/vial and 5mg/mL, 10 mL and 20 mL vials,
beginning no later than August 9, 2012.
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. According to IMS data, U.S. sales of Eloxatin® in 2009
were $993 million1.
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.
About Fresenius SE
Fresenius SE is a health care group with international
operations, providing products and services for dialysis, hospital
and outpatient medical care. In 2009, group sales were
approximately EUR 14.2 billion. On December 31, 2009 the Fresenius
Group had 130,510 employees worldwide. For more information visit
the company’s Web site at www.fresenius.com.
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.
Eloxatin® is a registered trademark of sanofi-aventis.
1 2009 IMS Dataview © IMS HEALTH
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