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.
