SCHAUMBURG, Ill.–(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.”
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.
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
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
1 2009 IMS Data
Arimidex is a registered trademark of AstraZeneca.
Investor and Media Inquiries
APP Pharmaceuticals, Inc.
Debra Lynn Ross, ABC
Director, Corporate Communications
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