Finally after 15 years!A partner to return Kinlytic to the U.S. market has been identified and a definitive agreement is now being negotiated. A fully-funded program may be live by mid-2023, with disclosure on signing. Hopefully it comes together this time ImaRx Therapeutics and Microbix Biosystems Inc. Sign Letter of Intent to Manufacture and Further Develop the FDA-Approved Clot-Dissolving Drug, Abbokinase(R) Published: Jan 22, 2008 TUCSON, Ariz. and TORONTO, Jan. 22 /PRNewswire-FirstCall/ -- ImaRx Therapeutics, Inc. and Microbix Biosystems Inc. today announced that they have signed a Letter of Intent to manufacture urokinase and further explore development for additional indications. Urokinase is an FDA approved drug currently marketed under the brand name Abbokinase(R). The product has been used to treat patients in the United States for over 20 years. ImaRx intends to transfer the manufacturing process and NDA to Microbix creating a new source for urokinase. This new supply of urokinase will allow ImaRx to continue to serve its current customers beyond its existing inventory of manufactured drug product. It also provides the opportunity to expand sales to additional vascular physicians and acute care institutions and to explore clinical development of urokinase for additional vascular indications. In addition, Microbix receives the right to further develop the drug for certain new indications in catheter clearance and prophylaxis of serious catheter related complications such as blood stream infections and venous thrombi. Microbix' future targets are also expected to include opportunities in oncology and ophthalmology. Microbix is believed to be the only supplier capable of producing urokinase on a commercial scale at its production facility in Toronto. "The relationship with ImaRx provides the obvious benefits and attributes of working with an approved product," said William J. Gastle, CEO of Microbix. He went on to say, "It accelerates our timeline to commercial scale production, revenue and development of our planned indications by allowing us to leverage an approved NDA." "This truly is a win-win for both companies," said Bradford Zakes, President and CEO of ImaRx. "This agreement enables ImaRx to rejuvenate a market for which we had a limited supply of product while simultaneously providing both ImaRx and Microbix the opportunity to leverage urokinase into new, untapped indications." ImaRx will retain existing drug inventory and exclusive rights to sell the drug for the currently approved indication and will gain access to a long term drug supply through a supply agreement with Microbix. With this new supply, ImaRx will have the ability to develop urokinase for new indications other than those to be pursued by Microbix in areas such as stroke, peripheral arterial occlusion, deep vein thrombosis and myocardial infarction. Additionally, ImaRx will receive a royalty on sales of urokinase for new indications developed by Microbix. Urokinase for new indications other than those to be pursued by Microbix in areas such as stroke, peripheral arterial occlusion, deep vein thrombosis and myocardial infarction. Additionally, ImaRx will receive a royalty on sales of urokinase for new indications developed by Microbix. "Urokinase has been administered to over four million patients and has a more than 20-year history of delivering safe and predictable results. I am pleased to learn that ImaRx and Microbix intend to provide an ongoing supply of urokinase," said Barry Katzen, M.D., founder and medical director of Baptist Cardiac & Vascular Institute in Miami, Florida. "This product is a proven tool for vascular physicians, and patients will benefit as a result of its ongoing supply." In 2006, ImaRx acquired urokinase and all related assets, including an approximate four-year supply of inventory, cell lines and manufacture rights to the drug. Since October 2006, ImaRx has been selling the urokinase inventory in the U.S. market where it is approved for the treatment of patients with acute massive pulmonary embolism or blood clots in the lungs. It is estimated that approximately 700 acute care hospitals in the U.S. currently include urokinase on their pharmacy formularies. Closing of the transaction is subject to conditions to be satisfied prior to completing the manufacturing process transfer. According to the American Heart Association, each year approximately 600,000 people in the U.S. experience a blood clot that lodges in the lungs, known as a pulmonary embolism, with approximately 60,000 deaths occuring annually. A portion of these are classified as acute massive pulmonary emboli, meaning that they involve obstruction of blood flow to a lobe or multiple segments of the lungs. Over 5 million catheters or central venous access devices are placed in patients in the U.S. every year. Approximately 25% of those become occluded requiring clearance treatment or replacement. More importantly, according to a CDC report, catheter-related blood stream infections occur in approximately 200,000 to 400,000 patients causing significant morbidity and approximately 30,000 deaths annually. Cost of treatment of these infections is estimated at up to $2.3 billion per year.