TUCSON, AZ, and TORONTO, Jan. 22 /CNW/ - ImaRx Therapeutics, Inc.
(Nasdaq: IMRX) and Microbix Biosystems Inc. (TSE: MBX) today announced that
they have signed a Letter of Intent to manufacture urokinase and further
explore development for additional indications. Urokinase is an FDA approved
drug currently marketed under the brand name Abbokinase(R). The product has
been used to treat patients in the United States for over 20 years.
ImaRx intends to transfer the manufacturing process and NDA to Microbix
creating a new source for urokinase. This new supply of urokinase will allow
ImaRx to continue to serve its current customers beyond its existing inventory
of manufactured drug product. It also provides the opportunity to expand sales
to additional vascular physicians and acute care institutions and to explore
clinical development of urokinase for additional vascular indications. In
addition, Microbix receives the right to further develop the drug for certain
new indications in catheter clearance and prophylaxis of serious catheter
related complications such as blood stream infections and venous thrombi.
Microbix' future targets are also expected to include opportunities in
oncology and ophthalmology. Microbix is believed to be the only supplier
capable of producing urokinase on a commercial scale at its production
facility in Toronto.
"The relationship with ImaRx provides the obvious benefits and attributes
of working with an approved product," said William J. Gastle, CEO of Microbix.
He went on to say, "It accelerates our timeline to commercial scale
production, revenue and development of our planned indications by allowing us
to leverage an approved NDA."
"This truly is a win-win for both companies," said Bradford Zakes,
President and CEO of ImaRx. "This agreement enables ImaRx to rejuvenate a
market for which we had a limited supply of product while simultaneously
providing both ImaRx and Microbix the opportunity to leverage urokinase into
new, untapped indications."
ImaRx will retain existing drug inventory and exclusive rights to sell
the drug for the currently approved indication and will gain access to a long
term drug supply through a supply agreement with Microbix. With this new
supply, ImaRx will have the ability to develop urokinase for new indications
other than those to be pursued by Microbix in areas such as stroke, peripheral
arterial occlusion, deep vein thrombosis and myocardial infarction.
Additionally, ImaRx will receive a royalty on sales of urokinase for new
indications developed by Microbix.
"Urokinase has been administered to over four million patients and has a
more than 20-year history of delivering safe and predictable results. I am
pleased to learn that ImaRx and Microbix intend to provide an ongoing supply
of urokinase", said Barry Katzen, M.D., founder and medical director of
Baptist Cardiac & Vascular Institute in Miami, Florida. "This product is a
proven tool for vascular physicians, and patients will benefit as a result of
its ongoing supply."
In 2006, ImaRx acquired urokinase and all related assets, including an
approximate four-year supply of inventory, cell lines and manufacture rights
to the drug. Since October 2006, ImaRx has been selling the urokinase
inventory in the U.S. market where it is approved for the treatment of
patients with acute massive pulmonary embolism or blood clots in the lungs. It
is estimated that approximately 700 acute care hospitals in the U.S. currently
include urokinase on their pharmacy formularies.
Closing of the transaction is subject to conditions to be satisfied prior
to completing the manufacturing process transfer.
According to the American Heart Association, each year approximately
600,000 people in the U.S. experience a blood clot that lodges in the lungs,
known as a pulmonary embolism, with approximately 60,000 deaths occuring
annually. A portion of these are classified as acute massive pulmonary emboli,
meaning that they involve obstruction of blood flow to a lobe or multiple
segments of the lungs.
Over 5 million catheters or central venous access devices are placed in
patients in the U.S. every year. Approximately 25% of those become occluded
requiring clearance treatment or replacement. More importantly, according to a
CDC report, catheter-related blood stream infections occur in approximately
200,000 to 400,000 patients causing significant morbidity and approximately
30,000 deaths annually. Cost of treatment of these infections is estimated at
up to $2.3 billion per year.
About ImaRx Therapeutics
ImaRx Therapeutics is a biopharmaceutical company developing and
commercializing therapies for vascular disorders. The Company's research and
development efforts are focused on therapies for stroke and other vascular
disorders using its proprietary microbubble technology. ImaRx Therapeutics'
commercialization efforts are currently focused on its product, urokinase, for
the treatment of acute massive pulmonary embolism.
Microbix specializes in the development of biological technologies and
commercializing them through global partners. The Company has intellectual
property in large market biotherapeutic drugs, vaccine technologies and animal
reproduction technologies. Established in 1988, Microbix is headquartered in
Forward looking statements
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: failure of the parties to enter into a definitive
agreement; failure to finance the transfer of the manufacturing process for
urokinase to Microbix's facility; failure to develop and commercialize
urokinase on a timely basis; failure to complete due diligence to the
satisfaction of either or both parties; risks associated with the approval and
commercialization of the technologies; and risks associated with the safety
and efficacy of the stroke, peripheral arterial occlusion, deep vein
thrombosis, myocardial infarction , oncology, ophthalmology and catheter
related indications. These forward-looking statements represent the Companies'
judgment as of the date of this press release. Additional risks and
uncertainties that may impact ImaRx's results of operations can be found in
its filings with the U.S. Securities and Exchange Commission. This press
release is as of January 22, 2008 and the Companies disclaim any intent or
obligation to update these forward-looking statements.
For further information:
For further information: ImaRx Therapeutics Inc., Jennifer Marshall,
firstname.lastname@example.org, (520) 770-1259; Microbix Biosystems Inc., William J.
Gastle, CEO, (416) 234-1624 x 230; Philip Casselli, President, (416) 234-1624
x 224; The Ruth Group, Sara Ephraim, (investors) email@example.com;
Jason Rando, (media) firstname.lastname@example.org; PR POST, Robert Stephens, (416)