TUCSON, Ariz., Jan. 25 /PRNewswire-FirstCall/ -- ImaRx Therapeutics, Inc. today announced that the Food and Drug Administration (FDA) has approved the company's most current lot release request for urokinase drug product. This is the first lot to be released with extended expiration dating. Urokinase, ImaRx's first commercially available FDA-approved product, is a thrombolytic or clot-dissolving agent indicated for the treatment of acute massive pulmonary embolism.
"The FDA approval of urokinase lot release brings several advantages to ImaRx," said Bradford A. Zakes, President and CEO of ImaRx. "The extended expiration dating allows us to unlock the value from our unlabeled urokinase inventory. We will also benefit from cost-savings associated with prolonged shelf-life for future urokinase supplies."
ImaRx is continuing its stability program to evaluate the potential for further expiration extensions beyond September 2009 for unlabeled vials of urokinase inventory.
In January 2008, ImaRx and Microbix Biosystems Inc. signed a letter of intent to manufacture urokinase and explore development of additional indications. Microbix is believed to be the only supplier capable of producing urokinase on a commercial scale at its production facility in Toronto. As part of the agreement, ImaRx will retain existing urokinase inventory and intends to transfer the manufacturing process and NDA to Microbix. With Microbix as its long-term supplier, ImaRx will continue to market urokinase for acute massive pulmonary embolism, while Microbix will have development rights for certain new indications.
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