ImaRx Therapeutics Transitions Business Strategy
January 30 2008 - 7:00AM
PR Newswire (US)
Focuses on Commercial Product Urokinase and Evaluates Strategic
Alternatives for SonoLysis(TM) Development Program TUCSON, Ariz.
Jan. 30 /PRNewswire-FirstCall/ -- ImaRx Therapeutics, Inc.
(NASDAQ:IMRX) announced today that it will emphasize growing the
market for urokinase in contrast to its previous focus on
developing SonoLysis. The reprioritization of additional
value-creating opportunities for urokinase was made possible by the
Company's recently signed letter of intent with Microbix Biosystems
which provides for manufacture of a long term urokinase supply and
will allow the company to explore additional therapeutic
applications for the product. Urokinase, the Company's first
commercially available FDA approved product, is a thrombolytic or
clot-dissolving agent indicated for the treatment of acute massive
pulmonary embolism, or blood clots in the lungs. Following a
comprehensive review of its commercial and development programs as
well as external market conditions ImaRx's Board of Directors and
management have determined that it is in the best interests of the
Company to adjust its emphasis to focus on commercialization of
urokinase. At the same time the company will explore strategic
alternatives for continued pursuit and financing of its SonoLysis
program-the Company's clinical-stage development program utilizing
its proprietary microbubbles and ultrasound to treat ischemic
stroke. This shift of business strategy to place greater emphasis
on urokinase is expected to help the Company preserve existing
capital and focus its efforts on growing urokinase product sales
while maintaining shareholder participation in the SonoLysis
opportunity. "By focusing on broader commercial opportunities for
urokinase, we believe we can unlock shareholder value and pursue a
risk mitigated corporate strategy overall," stated Bradford A.
Zakes, President and CEO of ImaRx Therapeutics. "Currently, there
exists only one other thrombolytic product approved in the U.S. for
the treatment of acute massive pulmonary embolism. We believe the
high regulatory hurdles and safety risks of other protein derived
thrombolytics have resulted in a number of failures in this product
class in recent years. Based on the limited treatment options and
ongoing demand for urokinase in the marketplace, we believe there
exists an opportunity to significantly grow our urokinase product
sales." Until now the Company's business strategy had been focused
primarily on developing its SonoLysis program for the treatment of
ischemic stroke while monetizing its existing inventory of
urokinase. Under that strategy, the Company's cash resources would
have funded operations through the third quarter of 2008, but
continuing SonoLysis trials would have necessitated the completion
of a financing event prior to that date. In order to preserve its
existing cash resources and minimize financing risk, the Company
has commenced exploration of strategic alternatives whereby part or
all of the ongoing expenses for its SonoLysis development program
may be borne by a third party. Greg Cobb, the Company's Chief
Financial Officer stated, "By transferring our SonoLysis
development expenses to a third-party and concentrating the
company's resources on the commercialization of urokinase, we
expect to significantly reduce ImaRx's operating capital
requirements for 2008." About ImaRx Therapeutics ImaRx Therapeutics
is a biopharmaceutical company commercializing and developing
therapies for vascular disorders. The Company's commercialization
efforts are currently focused on its FDA approved product,
urokinase, for the treatment of acute massive pulmonary embolism.
The Company's research and development efforts are focused on
therapies for stroke and other vascular disorders using its
proprietary microbubble technology. About Urokinase In 2006, ImaRx
acquired urokinase and all related assets, including approximately
a four-year supply of inventory as well as cell lines and
manufacturing rights to the drug. Since October 2006, ImaRx has
been selling its urokinase inventory in the U.S. market, where it
is estimated to be listed on pharmacy formularies at approximately
700 acute care hospitals. Urokinase is a thrombolytic or
clot-dissolving agent indicated for the treatment of acute massive
pulmonary embolism, or blood clots in the lungs. The product has
been commercialized for more than 20 years and has been
administered to greater than four million patients. On January 22,
2008 the Company announced that it had entered into a letter of
intent with Microbix Biosystems for the manufacture of a long term
supply of urokinase. This agreement would allow ImaRx to explore
the development of additional indications for the drug, continue to
serve its current customers beyond its existing inventory and
expand product sales to additional vascular physicians and acute
care institutions. About SonoLysis ImaRx's SonoLysis program
involves the administration of its proprietary MRX-801 microbubbles
and ultrasound to break up blood clots and restore blood flow to
oxygen deprived tissues. The sub-micron size of MRX-801
microbubbles may allow them to penetrate a blood clot, so that when
ultrasound is applied their expansion and contraction, or
cavitation, can break the clot into very small particles. This
technology was most recently evaluated in a Phase I/II clinical
trial in combination with tPA in patients suffering from acute
ischemic stroke. According to Andrei Alexandrov, MD, Director of
the Comprehensive Stroke Research Center at the University of
Alabama, Birmingham. "Stroke remains a challenging therapeutic area
with limited treatment options. ImaRx's SonoLysis therapy
represents a novel approach to the treatment of ischemic stroke
with the potential to treat patients who are significantly
underserved today. I have treated patients with SonoLysis therapy
and believe that it remains a promising stroke treatment
alternative." Cautionary Statement For The Purpose Of The "Safe
Harbor" Provisions Of The Private Securities Litigation Reform Act
of 1995 Note: Statements made in this press release which are not
historical in nature constitute forward-looking statements for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. Such statements include but are not
limited those related to our efforts to grow the marketplace for
urokinase, our intent to reduce our operating expenses associated
with our SonoLysis development and our belief that we will allow
the Company to explore additional therapeutic applications for the
product. These statements are based on management's current
expectations and beliefs and are subject to a number of factors and
uncertainties that could cause actual results to differ materially
from those described in the forward- looking statements. Such risks
and uncertainties include but are not limited to: sales of and
demand for urokinase may decline, the FDA may not approve our
future requests for urokinase lot releases or approval of expanded
uses of urokinase beyond treatment of acute massive pulmonary
emboli, we may not be able to complete definitive documentation
with Microbix on the terms of our letter of intent, Microbix may
not be able to perfect the manufacturing process or to secure
approval from the FDA to manufacture urokinase, we may not be
effective in our marketing efforts for urokinase, and we may not
have or be able to secure sufficient capital to fund our operations
and the development and commercialization of our product
candidates. All information in this press release is as of January
30, 2008, and the Company undertakes no duty to update this
information. A more complete description of these risks can be
found in the Company's filings with the Securities and Exchange
Commission. Contacts: ImaRx Therapeutics, Inc. The Ruth Group
Jennifer Marshall Sara Ephraim (investors) VP Corporate Dev. &
Investor Relations Jason Rando (media) (520) 770-1259 DATASOURCE:
ImaRx CONTACT: Jennifer Marshall, VP Corporate Dev. & Investor
Relations of ImaRx Therapeutics, Inc., +1-520-770-1259, ; Sara
Ephraim (investors), , or Jason Rando (media), , both of The Ruth
Group for ImaRx
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