APP Pharmaceuticals Provides Update on Issues Related to Heparin Crisis and Actions to Ensure Uninterrupted Safe Supply
15 Mai 2008 - 12:55PM
Business Wire
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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