TORONTO/AHMEDABAD, Aug. 23, 2012 /CNW/ - Microbix Biosystems Inc. (TSX:
MBX) and Zydus Cadila, global biotechnology companies headquartered in
Toronto, Canada and Ahmedabad, India, today announced the closing of a
definitive agreement regarding KINLYTIC® (urokinase).
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
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,
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
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.