Zydus Cadila and Ontario, Canada-based Microbix Biosystems Inc. have entered definitive agreement regarding Kinlytic (urokinase) for which the US market is likely to reach $400 million.

Kinlytic (urokinase) is a thrombolytic biopharmaceutical and is used in clearing pulmonary embolisms and intravenous catheter blockages. It has been administered to over 4 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 Kinlytic (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 Kinlytic (urokinase).  Zydus Cadila has become responsible for all further investments, including regulatory, product development, manufacturing and marketing.  Zydus Cadila is transferring manufacturing to its own biologics facility, which permits Microbix to avoid major manufacturing scale-up and validation costs. Microbix will also receive significant royalties on all sales of Kinlytic (urokinase), plus a multi-million dollar milestone payment upon Zydus Cadila’s achievement of $100 million in annual sales.

William J. Gastle, CEO of Microbix Biosystems, said: “I am extremely proud that our many years of investment in this proven therapy are finally paying off for patients, physicians, and investors. We are very excited to be working with Zydus Cadila who has excellent manufacturing and commercial capabilities to help realize our objective.  Work is underway in both companies to advance towards regulatory approval which we are targeting for late 2014.”

In the opinion of the parties, urokinase is simply one of the most useful, safe and effective thrombolytic drugs ever used. It was the market leader for many years and physicians are looking forward to having fresh access to this important hospital injectible.  It has been used effectively for a number of core indications and showed promise for others that could not be fully explored due to the lack of a supply of drug. Microbix acquired its manufacturing facility in 2006 and the US FDA approval file originally developed by Abbott Laboratories in 2008. The Zydus Cadila partnership provides the financial and human resources to supplement Microbix’ know how and return Kinlytic (urokinase) to the market.

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’ Kinlytic (urokinase) strengthens our critical care portfolio and enhances our ability to globalize our capabilities”.

Dr. Kenneth Ouriel former chairman, Division of Surgery at the Cleveland Clinic and former SVP, International Operations, New York Presbyterian Hospital, New York, stated, “Urokinase was our workhorse agent for dissolving clots within arteries and veins until it became unavailable. Physicians felt very comfortable with its margin of safety and would welcome its long-overdue return to the marketplace”.

Microbix Biosystems Inc. specializes in the development of biological technologies and markets virology and biological products worldwide.