Canadian biological technologies player, Microbix Biosystems Inc and Ahmedabad-based Zydus Cadila have signed a letter of intent (LoI) to market the Thrombolytic drug, Urokinase in the North American markets.
The terms of the agreement between both the companies 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, the company said in a statement issued on Friday.
Ontario-based, 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, the statement said.
The two companies expect a definitive agreement to be signed early in 2012, while the anticipated time-line for approval is late 2014. The estimated market size for Urokinase use in the US alone is expected to touch US $ 400 million (approx. Rs 2,116.9 crore) by 2020 between three indications namely, pulmonary embolism, catheter clearance and catheter prophylaxis. The same active pharmaceutical ingredient (API) can be used in new and even larger indications in oncology and ophthalmology.
"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 statement quoted Pankaj Patel, chairman and managing director of Zydus Cadila as saying.
Zydus Pharmaceuticals USA Inc, the group’s subsidiary in the US is among the top 3 players in the US market for 9 out of the 10 products marketed. About 51 million prescriptions are dispensed with Zydus generics in the US annually.
"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 realise our objective," said William Gastle, chief executive officer, Microbix Biosystems in the statement.
Urokinase, 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.
It was used substantially off label for dissolving large peripheral thrombi - clotting in the arteries which supply blood to the limbs in arms and legs, and until 1998 it was the standard of care for catheter clearance where it is used to re-establish flow in occluded biomedical catheters.
The drug was withdrawn from the market for 3 years from 1999 to 2002 for reasons unrelated to product performance.
Urokinase was acquired by Microbix in 2008 which has since then stepped up efforts to re-introduce the drug in North America. Over 4 million patients have been treated successfully with Urokinase, the company statement said.
Microbix Biosystems' 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.
