Miraculins and Alere Shift Focus of Endoglin Program from Sub-License to Supply Agreement
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(R) 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(R) 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(R) 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.
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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(R) and Scout DS(R) are registered trademarks of Miraculins Inc. All Rights Reserved. 2014.
Contacts: Miraculins Inc. Christopher J. Moreau President & CEO 204-477-7599 204-453-1546 (FAX) firstname.lastname@example.org www.miraculins.com