Ahmedabad based drug major Cadila Healthcare (Zydus Cadila) today announced the closing of a definitive agreement regarding re-launch of Kinlytic (urokinase) in North American markets with Canada based biotechnology player Microbix Biosystems Inc.
The market size for urokinase in the US is estimated to be around $ 400 million (around Rs 2213 crore).
Zydus had signed a letter of intent (LoI) with Mircrobix in January this year to market the thrombolytic drug, urokinase in North America.
Urokinase is used in clearing pulmonary embolisms and intravenous catheter blockages, and has been administered to over four million patients since it was first approved in the US in 1978. This life saving drug has been unavailable to patients since 2009 due to lack of an approved manufacturing facility. Microbix acquired all rights to urokinase in 2008 and has been working to re-introduce the drug since that time.
Under the agreement, Microbix has licensed to Zydus Cadila all its rights and expertise relating to urokinase. On the other hand, Zydus Cadila will make all further investments related to regulatory approvals, product development, manufacturing as well as marketing the drug. Zydus will be manufacturing the drug at its own biologics facility. This would help Microbix to avoid any major manufacturing scale up as well as validation costs.
On top of this, Microbix will also receive significant royalties on all sales of urokinase together with a multi-million dollar milestone payment upon Zydus' touching of $100 million (around Rs 553 crore) annual sales mark.
Commenting on the development, William J Gastle, chief executive officer of Microbix Biosystems said, "Work is underway in both companies to advance towards regulatory approval which we are targeting for late 2014."
Urokinase was the market leader among thrombolytic drugs for many years and has been an important hospital injectible. The drug has been used for a number of core indications. Pankaj Patel, chairman and managing director of Zydus Cadila said, " Microbix' Kinlytic (urokinase) strengthens our critical care portfolio and enhances our ability to globalize our capabilities."
Ontario headquartered Microbix Biosystems Inc. specialises in the development of biological technologies and markets virology and biological products worldwide. Its expertise ranges from influenza vaccine manufacturing, an animal reproduction technology for semen sexing, and a virology products business supplying to diagnostic and pharmaceutical companies across the globe.
