February 11, 2013, London – Today Rapidscan Pharma Solutions (RPS) EU Ltd announced that they have come to agreement with Mallinckrodt Medical BV (Mallinckrodt) for the exclusive right to promote and distribute Rapiscan® (regadenoson) in France, Italy, Belgium and Spain. Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress in the diagnosis of coronary artery disease (CAD) – the single most common cause of death and disability in Europe.1

Founder, President and CEO of Rapidscan Pharma Solutions Dr Brent Blackburn commented, “We are excited to partner with Mallinckrodt in the commercialization of Rapiscan, thus doubling its market access in Europe. Mallinckrodt and RPS EU share a similar mission to bring innovative solutions to improve patient care. Mallinckrodt is an established leader in the field of nuclear medicine and cardiac imaging and is well positioned to introduce Rapiscan and its benefits to the medical community.”

Every year more than four million Europeans die from diseases of the heart and blood vessels, 1 accounting for almost half of total mortality in Europe. ¹

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. Rapiscan is administered as a non-weight based bolus injection and is the first and only selective A_2A adenosine receptor agonist to have a licence for use in this indication.² RPS EU Ltd received marketing authorization in January 2011 and launched Rapiscan in the United Kingdom and Germany later that year. Regadenoson was first launched in the US in 2008 following clinical trials of over 2,000 patients with known or suspected CAD.^1,3,4 Today, regadenoson is the most widely used pharmacological stress agent in the US with millions of patients having received it.

Notes to Editors:

More about regadenoson
Regadenoson is a selective A_2A adenosine receptor agonist approved as a pharmacological stress agent in radionuclide MPI, in adult patients unable to undergo adequate exercise stress. Regadenoson was discovered and developed by CV Therapeutics and was approved in the US by the FDA in April 2008, where it is sold by Astellas Pharma US. Gilead Sciences acquired CV Therapeutics in 2009. EU Commission Licence was granted by the European Medicine Agency in September 2010, which was transferred to RPS EU in January 2011.

About Myocardial Perfusion Imaging
Diagnosis of CAD uses Myocardial Perfusion Imaging (MPI), to identify areas of poor blood flow in the heart at rest and during exercise. MPI is a non-invasive diagnostic test where patients are commonly asked to exercise on a treadmill or bicycle. Images are created with a small amount of a radioactive substance, called a radiopharmaceutical, which shows how well blood flows to the muscle of the heart. Nearly half of all patients that require a MPI diagnostic test are unable to exercise adequately.

Rapiscan provides an option for these patients by simulating the effects of exercise by temporarily increasing blood flow through the arteries of the heart and increasing heart rate. Unlike older agents, Rapiscan requires no dose adjustment for varying body weight and is administered as a 10 second injection,²which eliminates the need for an infusion pump and it’s set-up. Beyond the practical benefits, Rapiscan selectively stimulates the A_2A adenosine receptors responsible for the increase in blood flow, but not other adenosine receptors believed to cause undesirable effects that have been associated with the existing pharmacological stress agents.^2,5

About Rapidscan Pharma Solutions (RPS EU Ltd)
Its President and CEO Dr Brent Blackburn and his co-founders Dan Spiegelman and Louis G Lange, MD, PhD, established U.S.-based Rapidscan Pharma Solutions (RPS) Inc in 2010. RPS Inc licenced from Gilead Sciences Inc the rights to develop, make, and sell regadenoson in all countries of the world except for the United States, Canada and Mexico. Its European affiliate, RPS EU Ltd received marketing authorization for Rapiscan in January 2011 and in collaboration with GE Healthcare, launched Rapiscan in the United Kingdom and Germany later in 2011. 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.

About Mallinckrodt Medical BV
Mallinckrodt Medical BV engages in the manufacture and distribution of products for nuclear medicine procedures. Mallinckrodt Medical B.V. is based in Petten, the Netherlands, and operates as a subsidiary of Covidien plc as part of Mallinckrodt, the Pharmaceuticals business of Covidien.

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. Rapidscan Pharma Solutions EU Ltd. 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.
5. a. Buhr C, Gössl, M, Erbel R, Eggebrecth H “Regadenoson in the detection of coronary artery disease” Vasc Health Risk Manag. 2008;4(2):337-40. b. Ghimire G, Hage FG, Heo J, Iskandrian AE. “regadenoson: A focusd update” J Nucl Cardiol. 2012 Dec 11. [Epub ahead of print]

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