TORONTO/AHMEDABAD, Jan. 6, 2012 /CNW Telbec/ - 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 ophthalmology.
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 The drug was withdrawn from the market for 3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
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
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 and
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
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 Urokinase.
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
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.
SOURCE Microbix Biosystems Inc.
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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