APP Pharmaceuticals Receives Approval for Idarubicin HCI Injection
August 10 2009 - 2:00AM
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 idarubicin hydrochloride
injection in three dosage strengths (5mg/5mL, 10mg/10mL and
20mg/20mL). Idarubicin is therapeutically equivalent to the
reference drug Idamycin PFS injection, which is marketed by the
innovator Pfizer, Inc.
APP will package Idarubicin in 5mL, 10mL and 20mL dose vials and
expects to launch in September 2009. APP's Idarubicin is AP-rated,
bar-coded and latex-free. According to IMS data, 2008 sales of this
product in the United States across all formulations and
manufacturers were approximately $18.6 million1.
Idarubicin belongs to a class of drugs called anthracyclines and
is the foundation of many chemotherapy regimens. It is indicated
for use as a therapy in patients with acute myeloid leukemia.
Idarubicin, a cytotoxic agent, works by inhibiting activities of
the cancer cell necessary for life and growth, which prevents the
cancer cell from reproducing and results in death of the cancer
cell.
“Idarubicin is an important addition to APP’s broad oncology
portfolio,” said Thomas H. Silberg, president and chief executive
officer of APP Pharmaceuticals. "We are looking forward to
launching Idarubicin within the next month and have already secured
a sole source contract position with a major group purchasing
organization (GPO).”
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 for fluid substitution, blood volume
expansion, 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 patients all over the world. In 2008, Fresenius
Kabi achieved sales of EUR 2,495 million and an operating profit of
EUR 443 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. Fresenius SE is a health care group with
international operations, providing products and services for
dialysis, hospital and outpatient medical care. In 2008, group
sales were approximately EUR 12.3 billion. 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 idarubicin hydrochloride
injection. 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. These factors include, but are not
limited to, the availability and pricing of ingredients used in the
manufacture of pharmaceutical products and the ability to
successfully manufacture products in a time-sensitive and cost
effective manner. Additional relevant information concerning risks
can be found in the Fresenius Kabi Pharmaceuticals Holding, Inc.
10-K for the fiscal year ending December 31, 2008 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.
Idamycin PFS Injection is a registered trademark of Pfizer,
Inc.
1 2008 IMS Data
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