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CRITICAL DIAGNOSTICS INKS EXCLUSIVE WORLDWIDE LICENSE AGREEMENT FOR NEW HEART FAILURE BIOMARKER SNEP

Company expands cardiovascular biomarker portfolio to address its growing complementary cardiac diagnostics business

SAN DIEGO, CA March 15, 2016 – Critical Diagnostics announced today that it entered into a license agreement for the exclusive worldwide rights to the use of the biomarker soluble neprilysin (sNEP) in the diagnosis and monitoring of heart failure patients. Health Sciences Research Institute Germans Trias i Pujol Foundation (IGTP) of Barcelona Spain is the licensor.

The neprilysin inhibitor Sacubitril is a key ingredient in a new heart failure drug, Entresto® marketed by Novartis (NYSE:NVS). Entresto[1] is FDA approved in the United States and EC approved in Europe. Wall Street analysts estimate sales for Entresto could reach $5-10 billion by 2020. MedPage Today called Entresto one of the top five clinical advances in cardiology in 2015.

Cardiac biomarkers allow physicians an opportunity to combine clinical observations with objectively measured sub-clinical information in making treatment decisions. In the case of heart failure, the most commonly used biomarkers are the natriuretic peptide biomarkers, BNP and NT-proBNP. However, because BNP is a substrate for neprilysin, levels of BNP will reflect the action of the drug and rise during treatment.[2] Levels of NT-proBNP, on the other hand, will reflect the effects of the drug on the heart and typically decrease during treatment.

sNEP, by contrast, is unaffected by this neprilysin substrate phenomenon, or, for that matter, other common confounding factors that typically affect natriuretic peptide biomarkers, such as age, body mass index, and renal function.

“While Entresto brings hope of longer and better life with fewer hospitalizations for millions of people with chronic heart failure,” notes James Snider, President of Critical Diagnostics, “it costs $12.50 a day, or about $4,560 a year, for the two-pill-a-day regimen, versus pennies for generics. We believe use of the biomarker sNEP can play a vital role in determining therapeutic effectiveness of Entresto, thus improving patient outcomes while helping contain potentially spiraling healthcare costs.”

Critical Diagnostics also holds exclusive worldwide rights to the heart failure biomarker ST2. ST2 is a soluble protein expressed by the heart in response to cardiac disease or injury. ST2 levels change quickly in response to changes in the patient’s condition. In an ad hoc analysis of a cohort of heart failure patients on Entresto [3], ST2 was correlated with the presence and severity of disease and underlying pathophysiology.

The Presage™ ST2 assay is CE marked and FDA cleared (indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure), has a unique CPT code, CMS (Medicare/Medicaid) reimbursement, and is in the ACC/AHA Guidelines as “not only predictive of hospitalization and death in patients with HF but also additive to natriuretic peptide levels in their prognostic value.” The ST2 test is commercially available in many countries across Europe and Asia. ST2 testing is available in a rapid test format (results in 20 minutes) with the CE Marked Aspect-PLUS™ ST2 test and companion Aspect™ Reader.

"sNEP will expand and complement our pipeline of cardiovascular tests and allows us to utilize the market channel infrastructure we have built for ST2,” states David Geliebter, CEO of Critical Diagnostics. “We estimate that the addressable market for sNEP could exceed $100 million annually by 2020."


ABOUT HEART FAILURE


Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs. As noted by Professor Eugene Braunwald, a keynote speaker at the 2015 HFA Congress, in his paper “The War Against Heart Failure,” in The Lancet, Heart failure is a global problem with an estimated prevalence of 38 million patients worldwide, and a number that is increasing with the aging of the population.

ABOUT SNEP
Neprilysin catalyzes the degradation of B-type natriuretic peptide (BNP) and participates in the breakdown of other vasoactive peptides, including bradykinin, and adrenomedullin . A membrane-bound enzyme, neprilysin can be released from the cell surface, producing a non–membrane-associated or soluble form that can be measured in blood samples. Levels of this soluble form are shown for the first time to be related to heart failure prognosis. The PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial showed that patients with heart failure treated with an angiotensin receptor/neprilysin inhibitor lived longer without being hospitalized for heart failure, than those receiving standard care with enalapril[4].

ABOUT ST2 
ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. ST2 levels change quickly in response to changes in the heart failure patient’s condition.

ABOUT CRITICAL DIAGNOSTICS

Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. Critical Diagnostics has distribution partners in 50 countries, covering two-thirds of the world’s population.

FOR MORE INFORMATION, CONTACT:
Dennis Dalangin, VP, Global Marketing and Operations
Telephone: +1 (877) 700-1250
Email: ddalangin@criticaldiagnostics.com

[1] The biomarker sNEP is not associated with Novartis or Entresto. Entresto is a trademark of Novartis.
[2] As described by Packer et al. 2015.
[3] “Plasma Biomarkers Reflecting Profibrotic Processes in Heart Failure With a Preserved Ejection Fraction: Data From the Prospective Comparison of ARNI With ARB on Management of Heart Failure With Preserved Ejection Fraction Study,” Zile MR et al, Circ Heart Fail, 2016 Jan;9.
[4] Angiotensin—Neprilysin Inhibition versus Enalapril in Heart Failure. McMurray, J.V, et al. , for the PARADIGM-HF Investigators and Committees. N Engl J Med, 2014; 371:993-1004.