APP Pharmaceuticals Announces Agreement with Teva Pharmaceuticals to Manufacture and Market Gemcitabine HCI for Injection
January 26 2011 - 8:00AM
Business Wire
APP Pharmaceuticals, Inc., a wholly owned subsidiary of
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ)
announced today that it has entered into a commercialization,
manufacture and supply agreement with Teva Pharmaceutical USA,
Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries
Ltd., (NASDAQ:TEVA) to manufacture and market Gemcitabine HCI for
Injection. Under the terms of the agreement APP has been granted a
license to market Gemcitabine HCI for Injection in 200 mg and 1 g
single dose vials during the 180 day Hatch Waxman exclusivity
period. APP plans to launch Gemcitabine immediately.
Gemcitabine HCI for Injection is therapeutically equivalent to
the reference-listed drug Gemzar®, which is currently marketed in
these dose forms by the innovator Eli Lilly and Company. According
to IMS data, 2010 annual U.S. sales of Gemzar were approximately
$785 million 1 in net sales, with two million units sold.
“The agreement between our two companies demonstrates APP’s
willingness and versatility to enter into collaborative agreements
to ensure patient access to affordable cancer treatments,” said
John Ducker, President and CEO. “The addition of these two
presentations of Gemcitabine HCI for Injection broadens APP’s
rapidly growing oncology portfolio, and confirms our reputation as
a reliable partner in this important segment.”
About Gemcitabine HCI for Injection
Gemcitabine HCI for Injection is indicated in combination with
Carboplatin for the treatment of patients with advanced ovarian
cancer that has relapsed at least 6 months after completion of
platinum-based therapy as well as in combination with Cisplatin for
the first-line treatment of patients with inoperable, locally
advanced (stage IIIA or IIIB), or metastatic (stage IV) non-small
cell lung cancer. Gemcitabine HCI for Injection is also indicated
in combination with Paclitaxel for the first-line treatment of
patients with metastatic breast cancer after failure of prior
anthracycline-containing adjuvant chemotherapy, unless
anthracyclines were clinically contraindicated. It is also
indicated as first-line treatment for patients with locally
advanced (nonresectable stage II or stage III) or metastatic (stage
IV) adenocarcinoma of the pancreas and in patients previously
treated with 5-FU.
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.
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical USA, Inc., a wholly owned subsidiary of Teva
Pharmaceutical Industries Ltd., (NASDAQ:TEVA) is a leading global
pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's largest generic drug
maker, with a global product portfolio of more than 1,250 molecules
and a direct presence in approximately 60 countries. Teva's branded
businesses focus on neurology, oncology, respiratory and women's
health therapeutic areas as well as biosimilars. Teva's leading
innovative product, Copaxone®, is the number one prescribed
treatment for multiple sclerosis. Teva employs more than 40,000
people around the world and reached $13.9 billion in net sales in
2009.
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
Gemzar® is a registered trademark of Eli Lilly and Company.
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