APP Pharmaceuticals to Market Anastrozole Tablets in the U.S.
29 Juni 2010 - 7:01AM
Business Wire
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ)
announced today that APP Pharmaceuticals will immediately begin
marketing Anastrozole tablets in the U.S., after the U.S. Food and
Drug Administration granted approval to market the breast cancer
treatment medication 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. Anastrozole is therapeutically equivalent to the
reference-listed drug Arimidex®, which is currently marketed by the
innovator AstraZeneca.
APP will market Anastrozole in 1 mg tablets. According to IMS
data, 2009 sales of the branded product in the United States were
approximately $916.8 million, with approximately 105 million
tablets sold annually.
“The approval of Anastrozole further expands APP's product
portfolio in the strategically important Oncology segment,” said
John Ducker, president and chief executive officer of APP
Pharmaceuticals. “We are delighted to be able to offer this
important oral medication to new customers in the retail pharmacy
channel.”
About Anastrozole
Anastrozole is approved for the adjuvant treatment of
postmenopausal women with hormone receptor-positive early breast
cancer. It is also a first-line treatment for postmenopausal women
with hormone receptor-positive or hormone receptor unknown locally
advanced or metastatic breast cancer. In addition, Anastrozole is
used in the treatment of advanced breast cancer in postmenopausal
women with disease progression following tamoxifen therapy.
Patients with estrogen receptor-negative disease and patients who
did not respond to previous tamoxifen therapy rarely responded to
Anastrozole.
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 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 2009 IMS Data
Arimidex® is a registered trademark of AstraZeneca.
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