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Last Updated 1/13/10
 
 
Kinlytic Development Program

 

Kinlytic™ Development Program


 Low Molecular Weight Urokinase is Microbix' first protein therapeutic drug and its first high value pipeline opportunity. Microbix’ urokinase program was considerably accelerated with the acquisition of ImaRx Therapeutics Inc. (Tucson, AZ) urokinase assets in September of 2008.  The acquisition included the inventory of Kinlytic™ (Urokinase for Injection), formerly known as Abbokinase®, the regulatory approval (NDA) in the United States and key raw materials to support manufacturing.  Microbix’ urokinase program will first focus on the transfer of the Kinlytic process to its existing urokinase manufacturing plant, then on continuing clinical development of the product to expand its approved indications. 

 Kinlytic™ (Urokinase for Injection) is indicated for the treatment of acute massive pulmonary embolism.  For complete prescribing information please follow these links (www.kinlytic.com, www.abbokinase.com ) Urokinase has been used in more than 4,000,000 patients over the past 25 years and has an exemplary safety record.  Microbix will continue to supply the existing US customer base with the existing Kinlytic inventory using the sales and marketing infrastructure acquired from ImaRx. Sales of Kinlytic are expected to make the Company cash flow positive in the near term.  This will provide funding for the installation of the Kinlytic process into the Skyway urokinase manufacturing facility and for the ongoing development of the product to expand its approved indications into Catheter Management, Oncology and Ophthalmology. 

 Microbix’ urokinase experience with years of work in the ThromboClear urokinase program ensures that the Company is ideally suited for site transfer of Kinlytic into its existing facilities.  The Skyway facility is sized and equipped to support both commercial manufacturing as well as preparation of clinical materials for new indications.  Expanded availability of urokinase from the new manufacturing site will allow rapid growth of sales from that seen recently as the product will become available to physicians who do not currently have access to the product.  

 

 

Catheter Management



Oncology and Ophthalmology


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