Rapiscan(R) (regadenoson) is the First Selective A2A Adenosine Receptor Agonist to Receive EU Commission Licence to Aid CAD Diagnosis

LONDON, January 26, 2011 /PRNewswire/ -- Today Rapidscan Pharma Solutions (RPS) EU Ltd announced it has received marketing authorization for Rapiscan(R) (regadenoson) - a selective coronary vasodilator for use as a pharmacological stress agent in the diagnosis of coronary artery disease (CAD) - the single most common cause of death and disability in Europe[1]. Rapiscan is administered as a non-weight based bolus injection and is the first and only selective A2A adenosine receptor agonist to have a licence for use in this indication.

Diagnosis of CAD uses Myocardial Perfusion Imaging (MPI) to identify areas of poor blood flow in the heart at rest and during exercise. Patients are commonly asked to exercise on a treadmill or bicycle, however nearly half of all patients are unable to exercise adequately. Rapiscan simulates the effects of exercise by temporarily increasing blood flow through the arteries of the heart, providing an option for such patients. Unlike older agents, Rapiscan requires no dose adjustment for varying body weight[2] and its bolus dosing method is rapid (taking just 10 seconds), cutting out the need for an infusion pump and its set-up.

Founder, President and CEO of Rapidscan Pharma Solutions Dr Brent Blackburn commented, "I am extremely excited to bring Rapiscan to Europe. Rapiscan was designed to specifically address the needs of patients and healthcare professionals who conduct MPI tests. It's easier to use and better tolerated than the older agents."

Every year more than 4 million Europeans die from diseases of the heart and blood vessel[1], accounting for almost half of total mortality in Europe1. Accurate diagnosis is vital in identifying patients who are appropriate for intensive medical intervention with more than 1.5 million Europeans undergoing MPI tests annually.

Regadenoson was launched in the US in 2008 following clinical trials of over 2,000 patients with known or suspected CAD[3,4]. Today, regadenoson is currently the most widely used pharmacological stress agent in the US with more than 3 million patients having received it.

Notes to Editors:

More about regadenoson

Regadenoson is a selective A2A adenosine receptor agonist approved as a pharmacological stress agent in radionuclide MPI, in patients unable to undergo adequate exercise stress testing. Regadenoson was discovered and developed by CV Therapeutics and was approved by the FDA in April 2008 and received EU Commission License by the European Medicine Agency in September 2010.

About Rapidscan Pharma Solutions (RPS)

U.S.-based Rapidscan Pharma Solutions Inc was established in 2010 by its President and CEO Dr Brent Blackburn. In September 2010 RPS Inc licensed the rights to develop, make, and sell regadenoson from Gilead Sciences Inc for Europe, Japan, Australia, New Zealand, and Israel. Its European affiliate, RPS EU Ltd is responsible for marketing regadenoson in Europe. Dr Blackburn was previously with CV Therapeutics and was a leading member of the team that discovered and developed regadenoson in the U.S. and Europe.

References:

1. Scholte op Reimer WJM, Gitt AK, Boersma E, Simoons ML (eds.). Cardiovascular Diseases in Europe. Euro Heart Survey - 2006. Sophia Antipolis; European Society of Cardiology; 2006

2. Rapiscan Summary of Product Characteristics. Gilead Sciences; September 2010. See http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001176/human_med_001378.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125

3. Cerqueira MD, Nguyen P, Staehr P, et al, on behalf of the ADVANCE MPI Trial Investigators. Effects of age, gender, obesity and diabetes on the efficacy and safety of the selective A2A agonist Rapiscan versus adenosine: integrated ADVANCE MPI trial results. J Am Coll Cardiol 2008;1:307--?316.

4. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus Rapiscan comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol 2007;14:645-658.