Rapidscan Pharma Solutions EU Ltd Selects GE Healthcare to Promote and Distribute Rapiscan(R) (regadenoson) in the United Kingdom and Germany
By Ge Healthcare And Rapidscan Pharma Solutions, PRNEWednesday, May 11, 2011
LONDON, May 12, 2011 - Today Rapidscan Pharma Solutions (RPS) EU Ltd reports that they have come
to agreement with GE Healthcare to promote and distribute Rapiscan(R)
(regadenoson) in the United Kingdom and Germany. Rapiscan is a selective
coronary vasodilator for use as a pharmacological stress agent for
radionuclide myocardial perfusion imaging 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)
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. 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.
Unfortunately, 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
weight2 and its bolus dosing method is rapid (taking just 10 seconds),
cutting out 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.(2,3)
Founder, President and CEO of Rapidscan Pharma Solutions Dr Brent
Blackburn commented, "I am pleased to be able to partner with GE Healthcare.
We share a common objective - each striving to improve patient healthcare by
the timely and accurate diagnosis of disease with products with improved
tolerability and that are easier to use. Rapiscan was designed to
specifically address the needs of patients and healthcare professionals who
conduct MPI tests and GE Healthcare is uniquely situated as a leader in the
field of cardiac imaging and molecular diagnostics to efficiently introduce
Rapiscan to the UK and German healthcare communities."
Stephen Lightfoot, Global MI-SPECT Segment Leader, Medical Diagnostics,
GE
Healthcare said "The opportunity to launch Rapiscan with Rapidscan Pharma
Solutions EU leverages the expertise and unique capabilities of both
organizations - to bring an important product used for the diagnosis of
coronary artery disease to the UK and German marketplace."
Every year more than 4 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.
Regadenoson was launched in the US in 2008 following clinical trials of
over 2,000 patients with known or suspected CAD.(1,4,5) Today, regadenoson is
currently the most widely used pharmacological stress agent in the US with
several 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 adult patients unable to
undergo adequate exercise stress. Regadenoson was discovered and developed by
CV Therapeutics and was approved 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.
About Rapidscan Pharma Solutions (RPS)
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 has licenced the rights to
develop, make, and sell regadenoson from Gilead Sciences Inc for Europe,
Latin America, Japan, Australia, New Zealand, and Israel. Its European
affiliate, RPS EU Ltd received marketing authorization for Rapiscan in
January 2011 in the European Union. 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 GE Healthcare
GE Healthcare provides transformational medical technologies and services
that are shaping a new age of patient care. Our broad expertise in medical
imaging and information technologies, medical diagnostics, patient monitoring
systems, drug discovery, biopharmaceutical manufacturing technologies,
performance improvement and performance solutions services help our customers
to deliver better care to more people around the world at a lower cost. In
addition, we partner with healthcare leaders, striving to leverage the global
policy change necessary to implement a successful shift to sustainable
healthcare systems.
Our "healthymagination" vision for the future invites the world to join
us on our journey as we continuously develop innovations focused on reducing
costs, increasing access and improving quality and efficiency around the
world. Headquartered in the United Kingdom, GE Healthcare is a $17 billion
unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs
more than 46,000 people committed to serving healthcare professionals and
their patients in more than 100 countries. For more information about GE
Healthcare, visit our website at www.gehealthcare.com.
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. March 2011. See
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. 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.
4. 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.
5. 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.
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Prescribing information is available upon request.
For further media enquiries please contact: Nicola Kent, Packer Forbes Communications, +44(0)20-7036-8550, nicola at packerforbes.com; Aleisia Gibson, GE Healthcare, Medical Diagnostics, +1-609-865-4004, Aleisia.gibson at ge.com; All other enquiries: Brent Blackburn, PhD, President & CEO, Rapidscan Pharma Solutions Inc, +1-650-776-1198, brent.blackburn at rapidscanpharma.com
Tags: Ge Healthcare And Rapidscan Pharma Solutions, Germany, London, May 12, United Kingdom