GE Healthcare Collaborates With Manipal Health Systems to Conduct Clinical Studies of Medical Diagnostic Products in India

GE Healthcare Collaborates With Manipal Health Systems to Conduct Clinical Studies of Medical Diagnostic Products in India

June 29, 2006

Company's First Integrated Development Center (IDC) Opens in Bangalore as Part of Strategic Development of its Global Clinical Studies Program

    BANGALORE, India, June 29 /PRNewswire/ -- GE
Healthcare, a division of the General Electric Company
(NYSE: GE) today announced the opening of its first
Integrated Development Center (IDC) at Manipal Hospital in
Bangalore, India. 

    The IDC in Bangalore is expected to conduct around
1,000 scans annually as part of the planned clinical trials
and will be part of a series of global multi-country
clinical studies in the United States, the European Union
and several other countries. Over time, GE Healthcare will
create more IDCs in key strategic locations globally. 

    Information obtained from this site will be combined
with data from other centres globally and contribute
towards the development of new contrast and molecular
imaging agents or new indications for existing agents. 

    The first studies will focus on Visipaque(TM)
(iodixanol) an isosmolar contrast agent that was launched
globally by GE Healthcare in 1996. Visipaque has been used
in millions of X-ray and computer tomography procedures to
date. Contrast agents are used during medical diagnostic
procedures to provide image enhancement of tissues and
organs. Future studies will be extended to cover the
company's entire diagnostic imaging portfolio. 

    Under the terms of the collaboration, physicians at
Manipal Hospital will act as study investigators and
provide clinical and imaging services and administration in
the hospital. 

    The IDC in Bangalore will play a crucial role in GE
Healthcare's ongoing global clinical research program and
support its vision of "Early Health" by helping
to bring new diagnostic imaging agents to market and
working to address serious unmet medical needs in oncology,
neurology and cardiology. 

    Together, the collaboration between GE Healthcare and
Manipal Hospital will benefit local patients in a number of
ways. Particularly, the investment in imaging infrastructure
will increase access to the most advanced medical diagnostic
technology available. 

    Manipal Hospital will conduct clinical research trials
using a wide range of GE Healthcare's innovative diagnostic
imaging technologies including its LightSpeed VCT, Discovery
STe 16 slice PET/CT scanner, Dual Head Gamma Camera with CT
(SPECT/CT) and TwinSpeed High Definition Magnetic Resonance
(HDMR) imaging system. 

    Dan Peters, President and CEO of Medical Diagnostics at
GE Healthcare said, "The clinical studies in India are
a key part of our global strategy. We want to use our
unique abilities in biology and engineering to develop
novel imaging agents that will provide groundbreaking
molecular diagnostic options for physicians and their
patients. The research efforts of GE Healthcare's Medical
Diagnostics R&D team are currently focused on
functional and molecular imaging agents that help doctors
evaluate the physiology of disease and make treatment
decisions earlier with confidence." 

    Mr. V. Raja, President, GE Healthcare India, said:
"We are extremely pleased to collaborate with Manipal
Hospital which is one of India's most respected
institutions. GE Healthcare and Manipal Hospital are both
driven by a desire to change the future of healthcare by
helping patients experience "Early Health," which
focuses on early diagnosis rather than late disease.
Together, we will be able to create one of the most
advanced Integrated Development Centers in the world. We
will also be tapping into the resources of the GE Global
Research Centre here in Bangalore, as well the expertise of
our global Medical Diagnostics team." 

    Peters added, "This collaboration highlights our
commitment to supporting the development of the Indian
healthcare system. India is a great home for these clinical
studies due to its rich R&D capability, highly skilled
medical professionals and sophisticated medical
infrastructure." 

    Dr. Ranjan Pai, Chief Executive Officer, Manipal
Education and Medical Group, said, "GE Healthcare has
been our partner for a number of years and we are excited
to team up with them again to drive such an important
program forward." 

    The unique combination of a super speciality healthcare
institution -- Manipal Hospital -- with pharmaceutical
development resources and imaging equipment support -- GE
Healthcare -- and scientific expertise -- GE Global
Research Centre -- in one locality creates the excellent
opportunity for successfully carrying out complex trials
more efficiently and effectively, and thereby helping bring
new diagnostic pharmaceuticals to market sooner. 

    About GE Healthcare

    GE Healthcare provides transformational medical
technologies and services that are shaping a new age of
patient care. Our expertise in medical imaging and
information technologies, medical diagnostics, patient
monitoring systems, performance improvement, drug
discovery, and biopharmaceutical manufacturing technologies
is helping clinicians around the world re-imagine new ways
to predict, diagnose, inform and treat disease, so their
patients can live their lives to the fullest. 

    GE Healthcare's broad range of products and services
enable healthcare providers to better diagnose and treat
cancer, heart disease, neurological diseases, and other
conditions earlier. Our vision for the future is to enable
a new "early health" model of care focused on
earlier diagnosis, pre-symptomatic disease detection and
disease prevention. 

    Headquartered in the United Kingdom, GE Healthcare is a
US$15 billion Unit of General Electric Company (NYSE: GE).
Worldwide, GE Healthcare employs More than 43,000 people
committed to serving healthcare professionals and Their
patients in more than 100 countries. For more information
about GE Healthcare, visit our website at
http://www.gehealthcare.com. 

    About Manipal Health Systems

    Bangalore based Manipal Health Systems is the pinnacle
of the dreams of the inimitable Dr. T M A Pai, a Gandhian
and philanthropist, who served the country with a mission
to provide quality education and medical facilities at
affordable prices. He laid foundation of India's first
private medical college in 1953 at Manipal, and in a span
of 50 years, his pioneering effort has emerged as Manipal
Education and Medical Group (MEMG) which comprises over 57
institutions today. Manipal Health Systems is the
healthcare division of this pioneering institution. 

    The over 5000 bed Manipal Health Systems is by far the
largest (in terms of bed strength and single ownership),
deepest (in terms of rural reach) and most integrated (from
rural welfare and corporate clinics to tertiary care
hospitals) Hospital Management Group in Asia. Two of the
health systems with hubs at Mangalore and Manipal serve
entire west coast of India from Goa to Kerala while the
flagship Bangalore health system serves patients from 20
countries across the globe. 

    Manipal Health Systems has three tertiary care hospital
located at the hubs, 9 secondary care hospitals, 19 Primary
Healthcare Centres, 7 rural welfare centres, Complimentary
Clinics at Bangalore International Airport and Mangalore
domestic airport and over 55 Community Development
projects. Manipal Health Systems treated 1.5 million
patients as Out Patients and 0.4 mn as In Patients in
2005-06. 

    About Visipaque(TM):

    X-ray/CT product for diagnosis of a wide range of
diseases including coronary heart disease and to aid in
stent placement. The only contrast media available for
intravascular use that is isosmolar (has the same
osmolality as blood) at all iodine concentrations. It is
also formulated with the important electrolytes sodium and
calcium at physiological levels, to maintain electrolyte
balance. 

    In the United States: Visipaque is not for Intrathecal
Use. All non-ionic, iodinated contrast media currently
available inhibit blood coagulation in vitro less than
ionic contrast media. Clotting has been reported when blood
remains in contact with syringes containing non-ionic
contrast media. Caution must be exercised in patients with
severely impaired renal function, combined renal and
hepatic disease, combined renal and cardiac disease, severe
thyrotoxlcosis myelomatosis, or anuria, particularly when
large doses are administered. (See Precautions). 

    Prescribing Information(1) Visipaque(TM) iodixanol

    Please refer to full national Summary of Product
Characteristics (SPC) before prescribing. 

    Presentation

    An isotonic, aqueous solution containing iodixanol, a
non-ionic, dimeric contrast medium, available in three
strengths containing either 150 mg, 270 mg or 320 mg iodine
per ml. 

    Indications

    X-ray contrast medium for use in adults in
cardioangiography, cerebral angiography, peripheral
arteriography, abdominal angiography, urography,
venography, CT enhancement, studies of the upper
gastrointestinal tract, arthrography, hysterosalpinography
(HSG) and endoscopic retrograde cholangiopancreatography
(ERCP). Lumbar, thoracic and cervical myelography in
adults. In children for cardioangiography, urography, CT
enhancement and studies of the upper gastrointestinal
tract. 

    Dosage and Administration

    Adults and children: Dosage for intravascular and oral
use varies depending on the type of examination, age,
weight, cardiac output, general condition of patient and
the technique used (see SPC and package leaflet). 

    Contra-Indications

    Manifest thyrotoxicosis. History of serious
hypersensitivity reaction to Visipaque. 

    Precautions, Warnings, etc.

    A positive history of allergy, asthma, or reaction to
iodinated contrast media indicates need for special
caution. Premedication with corticosteroids or H1 and H2
antagonists should be considered in these cases. Although
the risk of serious reactions with Visipaque is regarded as
low, iodinated contrast media may provoke serious,
hypersensitivity reactions. Therefore the necessary drugs
and equipment must be available for immediate treatment.
Patients should be observed for at least 30 minutes
following administration of contrast medium, however
delayed reactions may occur. Non-ionic contrast media have
less effect on the coagulation system in vitro, compared to
ionic contrast media. When performing vascular
catheterisation procedures one should pay meticulous
attention to the angiographic technique and flush the
catheter frequently (e.g. with heparinised saline) so as to
minimise the risk of procedure-related thrombosis and
embolism. Ensure adequate hydration before and after
examination especially in patients with renal dysfunction,
diabetes mellitus, paraproteinemias, the elderly, children
and infants. Special care should also be taken in patients
with hyperthyroidism, serious cardiac disease, pulmonary
hypertension, patients predisposed to seizures (acute
cerebral pathology, tumours, epilepsy, alcoholics and drug
addicts), and patients with myasthenia gravis or
phaeochromocytoma. Particular care is required in patients
with severe disturbance of both renal and hepatic function
as they may have significantly delayed contrast medium
clearance. All iodinated contrast media may interfere with
laboratory tests for thyroid function, bilirubin, proteins,
or inorganic substances (e.g. iron, copper, calcium, and
phosphate). In diabetic patients metformin should be
stopped when contrast media are used. The timing of this
should be amended based upon serum creatine/renal function
levels. (refer to SPC) An increased risk of delayed
reactions (flu like or skin reactions) has been associated
with patients treated with interleukin-2 up to two weeks
previously. The safety of Visipaque in pregnancy has not
been established. The degree of excretion into human milk
is not known. Breast feeding should be discontinued prior
to administration and not recommenced until at least 24
hours after administration. 

    Side Effects

    Usually mild to moderate, and transient in nature, they
include discomfort, general sensation of warmth or cold,
pain at the injection site or distally. Serious reactions
are only seen on very rare occasions. Nausea, vomiting, and
abdominal discomfort are rare. Hypersensitivity reactions
occur occasionally with symptoms such as rash, urticaria
and pruritus (immediate or delayed). Severe reactions such
as bronchospasm, angioedema, dyspnoea and fatal anaphylaxis
are very rare. Neurological reactions, headache, dizziness,
seizures, and transient motor or sensory disturbance (e.g.
taste or smell alteration) are very rare. Also reported
very rarely; vagal reactions, cardiac arrhythmia,
hypertension and `iodide mumps'. Arterial spasm may follow
injection. A minor transient rise in creatinine is common.
Renal failure is very rare. Post phlebographic phlebitis or
thrombosis is very rare. Gastrointestinal disturbances
including diarrhoea, nausea/vomiting and abdominal pain and
systemic hypersensitivity reactions occur occasionally
(<1:10, >1:100). 

    Overdose

    In the event of accidental overdosing, renal function
should be monitored for at least 3 days in addition to
supportive measures. Haemodialysis should be considered if
needed. 

    Marketing Authorisation Number

    Visipaque 150 mg I/ml - 60.635, 270mg I/ml - 60.636,
320mg I/ml - 60.637; 
Visipaque USP 150 mg I/ml - 62.916; Visipaque USP 270 mg
I/ml - 62.917; Visipaque USP 320 mg I/ml - 62.918. 

    Marketing Authorisation Holder

    Amersham Health AS, Nycoveien 1-2, Postboks 4220
Nydalen, N-0401 Oslo, Norway. 

    Further information on request from: Amersham Health,
The Grove Centre, White Lion Road, Amersham, Bucks HP7 9LL.


    Date of preparation: October 2004.

    (1) Indications and approvals may vary in different
countries. Consult 
        your local package insert for details. Further
information available 
        on request. 

    For more information, please contact:
     Sebastien Duchamp
     Communications Director
     GE Healthcare International
     Tel:   [phone]

SOURCE  GE Healthcare