Miraculins and Alere Shift Focus of Endoglin Program from
Sub-License to Supply Agreement
WINNIPEG, MANITOBA--(Marketwired - Jan 30, 2014) - Miraculins
Inc. (TSX-VENTURE:MOM) ("Miraculins" or the "Company"), a medical
diagnostic company focused on acquiring, developing and
commercializing diagnostic and risk assessment technologies for
unmet clinical needs, announces today that Alere Inc. ("Alere") has
elected not to proceed further in the direct commercial development
of a professional diagnostic product for the biomarker Endoglin,
but instead will support Miraculins in seeking commercialization
opportunities for Endoglin by supplying key antibodies that were
developed by Alere. As part of this decision, Alere has declined to
proceed further with its Endoglin license from Miraculins and the
parties have agreed to work to enhance Miraculins' rights to
receive a secure supply of high quality, proprietary Endoglin
reagents manufactured by Alere.
Throughout the collaborative development program, Miraculins has
maintained the right to pursue complimentary commercial strategies
for the Endoglin biomarker, which have included the rights to
supply reagents for a Lab Developed Test ("LDT"). LDTs are in
vitro diagnostic tests that are developed, validated and used
for in-house pathology and diagnostic purposes. Tests can either be
marketed as a kit through the FDA's risk-based review process, or
they can be sold to the market as a testing service under LDT
definition, with the lab falling under Clinical Laboratory
Improvement Amendments (CLIA) regulation. The LDT pathway can be a
much quicker way to introduce a test to the market.
There is a growing body of scientific research, including
multiple research and clinical studies conducted by Alere,
confirming that Endoglin contributes to the pathogenesis of
preeclampsia. As the LDT route now presents the greatest potential
near-term commercialization pathway for Endoglin, Miraculins plans
to focus on advancing discussions with potential partners who have
expertise and capabilities in this space, with full support from
Alere.
"The potential for Endoglin to play a role in assessment of risk
or diagnosis of the devastating condition of preeclampsia remains
promising, and we are pleased that Alere remains committed to work
with us in developing a market for Endoglin testing by making their
proprietary GMP grade Endoglin antibodies available for
distribution," commented Christopher J. Moreau, President and CEO
of Miraculins Inc.
Currently, preeclampsia affects three million mothers worldwide
every year and is associated with premature births, infant illness
including cerebral palsy, blindness, epilepsy, deafness, lung
conditions, seizure, coma and death. There is no effective
detection method to determine the risk of developing preeclampsia
and the cause is unknown. It is estimated that preeclampsia costs
the global health care system US$3 billion per year.
About Miraculins Inc.
Miraculins is a medical diagnostic company focused on acquiring,
developing and commercializing non-invasive technologies for unmet
clinical needs. A significant number of promising diagnostic
opportunities remain un-commercialized because of the sizable gap
between the discovery stage, when research institutions are
typically involved, and the commercialization stage, when the
larger commercial enterprises become interested. Miraculins has
direct experience in bridging this gap. The Company's PreVu® POC
Test is a revolutionary new coronary artery disease risk assessment
technology that measures cholesterol levels in a patient's skin
non-invasively, painlessly and without the need for fasting. The
Company's Scout DS® system is the first non-invasive diabetes
testing system designed to provide a highly sensitive and
convenient method for measuring diabetes related biomarkers in the
skin, the accumulation of which are accelerated by abnormal blood
sugar levels and oxidative stress. Unlike current testing methods,
a Scout DS® test requires no blood draw, no fasting, and no waiting
for a lab result. The product has been used and validated in
thousands of patients around the world. The Company's preeclampsia
program is partnered with Alere Inc., one of the world's largest
diagnostic companies. For more information visit
www.miraculins.com.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release
constitute forward-looking information within the meaning of
applicable Canadian provincial securities legislation
(collectively, "forward-looking statements"). These forward-looking
statements relate to, among other things, our objectives, goals,
targets, strategies, intentions, plans, beliefs, estimates and
outlook, including, without limitation, our anticipated future
operating results, and can, in some cases, be identified by the use
of words such as "believe", "anticipate", "expect", "intend",
"plan", "will", "may" and other similar expressions. In addition,
any statements that refer to expectations, projections or other
characterizations of future events or circumstances are
forward-looking statements.
These statements reflect management's current beliefs and
are based on information currently available to management. Certain
material factors or assumptions are applied in making
forward-looking statements, and actual results may differ
materially from those expressed or implied in such statements.
Important factors that could cause actual results to differ
materially from these expectations include, among other things:
Miraculins' early stage of development, lack of product revenues
and history of operating losses, uncertainties related to clinical
trials and product development, rapid technological change,
uncertainties related to forecasts, competition, potential product
liability, additional financing requirements and access to capital,
unproven markets, supply of raw materials, income tax matters,
management of growth, partnerships for development and
commercialization of technology, effects of insurers' willingness
to pay for products, system failures, dependence on key personnel,
foreign currency risk, risks related to regulatory matters and
risks related to intellectual property and other risks detailed
from time to time in Miraculins' filings with Canadian securities
regulatory authorities, as well as Miraculins' ability to
anticipate and manage the risks associated with the foregoing.
Additional information about these factors and about the material
factors or assumptions underlying such forward-looking statements
may be found in the body of this news release. Miraculins cautions
that the foregoing list of important factors that may affect future
results is not exhaustive. When relying on Miraculins'
forward-looking statements to make decisions with respect to
Miraculins investors and others should carefully consider the
foregoing factors and other uncertainties and potential
events.
These risks and uncertainties should be considered carefully
and prospective investors should not place undue reliance on the
forward-looking statements. Although the forward-looking statements
contained in this press release are based upon what management
believes to be reasonable assumptions, Miraculins cannot provide
assurance that actual results will be consistent with these
forward-looking statements. Miraculins undertakes no obligation to
update or revise any forward-looking statement.
PreVu® and Scout DS® are
registered trademarks of Miraculins Inc. All Rights Reserved.
2014.
Miraculins Inc.Christopher J. MoreauPresident &
CEO204-477-7599204-453-1546info@miraculins.comwww.miraculins.com
Miraculins Inc. (TSXV:MOM)
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