TORONTO/AHMEDABAD, Jan. 6, 2012 /CNW/ - Microbix Biosystems Inc. (TSX: MBX), a
biotechnology company commercializing novel technologies and Zydus Cadila, a global
pharmaceutical company headquartered in India, today reported that they have signed a Letter of Intent
to market the Thrombolytic drug, Urokinase in the North American markets. The estimated market size
for Urokinase use in the U.S. alone is expected to touch $400 million by 2020 between three
indications: pulmonary embolism, catheter clearance and catheter prophylaxis. The same active
pharmaceutical ingredient can be used in new and even larger indications in oncology and
Urokinase, a successful thrombolytic drug, was first approved in the U.S. 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. Over 4 million patients have been treated successfully with Urokinase. Many
physicians remain loyal to Urokinase due to the drug’s superior and well-documented safety profile as
well as cost and efficacy. The drug was withdrawn from the market for 3 years from 1999 to 2002 for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.
William J. Gastle, Chief Executive Officer, Microbix Biosystems 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 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.
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”.
Zydus Pharmaceuticals USA Inc., the group’s subsidiary in the US is ranked 12th amongst the top
generic companies in the US. 51 million prescriptions are dispensed with Zydus generics in the US
annually. The company is among the top 3 players in the US market for 9 out of the 10 products
In the last two years Microbix reported that the discussions on Urokinase have been underway with
various potential industry partners. 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. 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
Gastle added, “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”. The Companies expect a definitive agreement to be signed early in 2012. The anticipated
timeline for approval is late 2014.
One of the key opinion leaders on Urokinase is Dr. Ken Ouriel former Chairman, Division of Surgery
at the Cleveland Clinic and former Senior V-P, International Operations, 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".
In October 2011 Microbix received approval for a Base Shelf Prospectus to help fund its product
development pipeline including Urokinase. The consummation of this agreement will reduce the need
for funds to be raised and, consequently, the Prospectus will be amended to reflect Zydus’ funding for
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 an FDA approved biotherapeutic drug, a proprietary vaccine technology and an
animal reproduction technology. 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.
For further information: