15.05.2008 10:55:00
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APP Pharmaceuticals Provides Update on Issues Related to Heparin Crisis and Actions to Ensure Uninterrupted Safe Supply
APP Pharmaceuticals, Inc. (Nasdaq: APPX) is communicating in a letter to
its customers that the company continues to work closely with the U.S.
Food and Drug Administration (FDA) to ensure that an uninterrupted and
safe supply of heparin of the highest quality is available for U.S.
patients.
APP is currently the sole supplier of therapeutic heparin vials to the
U.S. market, because drug impurities have forced the other U.S. supplier
of heparin vials to withdraw its product from the market. Heparin, a
widely used anti-coagulant, is derived from the intestines of pigs. Most
of the U.S. supply of heparin comes from China, where tainted raw
heparin material has resulted in more than 80 patient deaths in the U.S.
and hundreds of severe allergic reactions, according to the FDA.
Concerns regarding reports of severe allergic reactions resulting in
death have been linked to the contaminant, oversulfated chondroitin
sulfate, in heparin raw material.
APP has completed testing on all lots of heparin raw material dating
back to January 2006. All product has been found to be contaminant-free.
The FDA has also tested select material from APP samples and has
completed review of APP’s analytical results
confirming the purity of APP’s heparin. From
the outset in 2005 when APP received FDA approval for its heparin
supplier from China, the company instituted rigorous quality testing
procedures on its heparin raw materials which exceeded the United States
Pharmacopeia (USP) requirements. The company and its scientists are
working closely with FDA, USP and government officials to provide the
processes and methods associated with these high standards.
"Because of the steps that we have been
taking since early 2000 to ensure a safe, traceable supply chain and are
continuing to take with regard to the production of heparin, we have
been able to provide a product of the highest quality standards,”
said Patrick Soon-Shiong, M.D., chairman of APP Pharmaceuticals.
In the Company’s letter to customers, APP
details the steps that the Company has taken to assure drug purity. "With
our partner in China, we developed manufacturing standards of heparin
raw material production with the most modern equipment and trained staff
available to ensure that the material met and exceeded current USP
standards, and received FDA approval in 2005. We also established supply
chain controls to guarantee that the product is inspected at each stage
of the extraction and purification process, enabling us to certify the
quality of the finished product.”
APP has worked with the FDA to increase production and ensure the
availability of heparin for patients. Significant investments have been
made internally through the addition of new fill lines and full
packaging lines as well as additional staff, including manufacturing,
customer service, distribution and quality analytical personnel. APP
continues to manage the distribution of heparin to prevent an imbalance
of supply of this critical product needed for life-saving and
life-sustaining procedures. In addition, the Company continues its
direct shipment program to control the distribution and expedite
delivery of the products to physicians and patients in need of
therapeutic heparin.
The tainted heparin supply has resulted in skyrocketing crude heparin
prices and a tight supply of the starting material. The decrease in the
supply of raw heparin has been compounded by an increase in demand for
heparin which also serves as starting material for low-molecular weight
heparin in global markets.
In light of the dramatic increase in raw material costs, the need to
secure an uninterrupted delivery of API and the increased costs
associated with the additional required testing, as well as the hiring
of additional employees, APP has communicated to its customers the need
to adjust its heparin price. In dialysis patients this price adjustment
translates to about 6 cents per 1000 units of heparin. This increase
represents approximately 48 cents per dialysis treatment. According to
the Stanford and Fresenius Research report of May 2, 2008, the
reimbursement for managed care dialysis treatment is approximately $614,
with an average reimbursement per dialysis treatment of $325, taking
into consideration the Medicare reimbursement rate of $237 per dialysis
treatment. Thus, the impact of the total cost of heparin at its adjusted
price represents less than one half of one percent of the total cost of
the dialysis treatment.
Responding to APP’s price adjustment, Richard
Norling, President and CEO of Premier Inc., one of the largest group
purchasing organizations in the United States, stated, "We
recognize the difficulties associated with this heparin crisis. Our
primary goal is to ensure the uninterrupted supply of the highest
quality safe material for our patients. We appreciate APP’s
efforts in averting a shortage of this life sustaining product.”
Heparin is indicated for anticoagulant therapy for patients undergoing
surgery, blood transfusions, extracorporeal circulation, dialysis
procedures and other settings that require a blood-clotting inhibitor.
About APP Pharmaceuticals
APP is a specialty drug company that develops, manufactures and markets
injectable pharmaceutical products, focusing on oncology,
anti-infective, anesthetic/analgesic and critical care markets. The
company is one of the largest producers of injectables, with more than
100 generic products in more than 400 dosage formulations. APP,
headquartered in Schaumburg, Illinois, has offices in Canada and
manufacturing operations in Illinois, New York and Puerto Rico and is
traded on the Nasdaq Global Market under the symbol APPX. For more
information about APP and the products it provides, please visit www.APPpharma.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 heparin. 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 APP
Pharmaceuticals Form 10-K for the year ended December 31, 2007 filed
under the company name Abraxis BioScience, Inc. and other documents it
has filed with the Securities and Exchange Commission.
The information contained in this news release is as of the date of this
release. APP assumes no obligations to update any forward-looking
statements contained in this press release as the result of new
information or future events or developments.
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