Microbix Biosystems Inc. Signs Agreement With Zydus Cadila to Re-Launch KINLYTIC® Urokinase in North America
Published: Aug 23, 2012
KINLYTIC® (urokinase) is a thrombolytic biopharmaceutical for which the parties expect the U.S. market will reach $400 million. KINLYTIC (urokinase) is used in clearing pulmonary embolisms and intravenous catheter blockages, and has been administered to over 4 million patients since it was first approved in the U.S. 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, Chief Executive Officer 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 U.S. 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".
About Microbix Biosystems
Microbix Biosystems Inc. specializes in the development of biological technologies and markets virology and biological products worldwide. The Company has intellectual property in large market products including the biotherapeutic drug KINLYTIC® (urokinase), a proprietary vaccine technology (VIRUSMAX®) and an animal reproduction technology (LumiSort®). Microbix supplies customers in the U.S. Europe, and Asia. Established in 1988, Microbix is headquartered in Mississauga, Ontario, Canada.
About Zydus Cadila
Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group’s operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. The group has been one of the fastest growing healthcare companies in recent years and reported 41% growth in profits for 2010-11. Revenues were in excess of US$ 1 billion. In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With over 13,500 employees worldwide, a world-class research and development centre dedicated to discovery research and eight state-of-the-art manufacturing plants, the group is dedicated to improving people’s lives.
This press release contains forward-looking statements which are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements including the risks associated with development projects, operations in Foreign jurisdictions, risks associated with engineering and construction generally, risks associated with production including control over costs, quality, quantity and timeliness of delivery of products, foreign currency and exchange rate risk, and risks of raising capital on acceptable terms or at all. These forward-looking statements represent the Companies' judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
For further information:
Visit www.microbix.com or contact: William J. Gastle, CEO, (416) 234-1624 x 230; or James
Long, CFO, (416) 234-1624 x 265.
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