Zydus Cadila and Microbix Biosystems Inc., a biotechnology company commercializing novel technologies, has entered tie-up to market the thrombolytic drug, Urokinase in the North American markets. The market size for Urokinase use in the US alone is expected to touch $400 million by 2020 between three indications like pulmonary embolism, catheter clearance and catheter prophylaxis. The same active pharmaceutical ingredient can be used in new and even larger indications in oncology and ophthalmology.

The terms of the agreement requires Zydus to provide the funding needed to re-launch the drug in the US and Canada, including an initial commitment, plus milestone based payments. Microbix will also receive a milestone payment upon reaching a certain sales target and will be guaranteed a margin plus earn a royalty fee based on sales. Zydus will receive an option on the rights to all future indications including in the areas of oncology and ophthalmology.

Urkinase, a successful thrombolytic drug, was first approved in the US in 1978 for pulmonary embolism (blockage in the arteries supplying blood to the lungs) and coronary occlusion (blockage in the vessels which carry blood to the heart). Urokinase was acquired by Microbix in 2008 which has since then stepped up efforts to re-introduce the drug in North America.

Pankaj Patel, chairman and managing director of Zydus Cadila said, “We have been investing in novel technologies, particularly in the area of biotechnology and have also been exploring partnerships to bring critical care therapies to the marketplace. Microbix' Urokinase strengthens our critical care portfolio and enhances our ability to globalize our capabilities.”

The Ontario-based, Microbix Biosystems Inc, specializes in the development of biological technologies and markets virology and biological products worldwide. The company's expertise ranges from influenza vaccine manufacturing, an animal reproduction technology for semen sexing, and to a virology products business supplying to diagnostic and pharmaceutical companies worldwide.

William J Gastle, CEO, Microbix, said, “Microbix has been the champion of Urokinase and we are committed to returning this life saving therapy to physicians and patients. We have been investing to rebuild this franchise including manufacturing infrastructure, raw materials, and technical expertise, in addition to acquiring the approved NDA's for both Canada and the US markets. With Zydus, we now have a strong commercial partner to help us realize our objective.”

“The immediate impact will include the financial support and regulatory expertise that Zydus will bring to implementing the business plan for re-launching the drug. Zydus has very experienced regulatory staff that will assist Microbix in guiding the file through the FDA and Health Canada,” Gastle added. The companies expect a definitive agreement to be signed early in 2012. The anticipated timeline for approval is late 2014.