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 A2A 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 A2A 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 A2A 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.
- 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
- Rapiscan Summary of Product Characteristics. Rapidscan Pharma Solutions EU Ltd. See
- 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.
- 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
- 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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