OUR FOCUS IS CONTRAST AGENTS

FOR CLINICAL IMAGING

Iohexol Injections

Carlos Costa
November 2014

Confidential
Confidential
iMAX Diagnostic
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Imaging 2014

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History

Subsidiary of Hovione
Founded in 1959
Global facilities (4 facilities in 4 countries)
Pharmaceutical drug substance development and
manufacturing
iMAX Founded in Ireland, November 2011
Sole focus on generic clinical contrast agents
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iMAX - Iohexol Injection

Iodinated Contrast Agents

iMAX Diagnostic Imaging Iohexol Dossier

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Iodinated Contrast Agents What they are?

Iodine contrast agents (like Iohexol) are used in classic
X-ray techniques or computed tomography.

Contrast agents are necessary to create an artificial

contrast between the organ or tissue to be diagnosed on
the one hand, and vascular or surrounding anatomic
structures on the other. Most X-ray contrast media
contain chemical elements of high atomic number such
as iodine. They attenuate X-rays, thereby enhancing
contrast with organ structures.

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Iodinated Contrast Agents Who uses them and for what?

Applications

Users

Computer tomography

Radiologist

Angiography

Interventional

Urography

cardiologist

Interventional
techniques
(Angioplasty)
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Iodinated Contrast Agents Key Players

Player

Products

GE Healthcare

Omnipaque (Iohexol)

Bracco

Iopamiron/Isovue

Bayer Schering

(Iopamidol)

Covidien

Ultravist (Iopromide)

Guerbet

Optiray (Ioversol)

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Zenetix (Iobitridol)
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What we do

Develop and manufacture generic contrast

agents for X-ray, CT, and MRI
Seek local licensees and distribution partners
for set territories
Drug Substance Offering
Iohexol
Iopamidol
Iodixanol

Drug Product Development Pipeline

Gadopentetate dimeglumine
Macrocyclic MRI agent

Drug Product Offering

Iohexol 300mgI/ml
Iohexol 350mgI/ml
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From Plant to Patient

Raw Materials
Chemical Engineering
Post Processing

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Drug Product
Manufacturing
Packaging
Distribution

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Patient Prep
Drug Administration

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iMAX Iohexol Injection

Iodinated Contrast Agents

iMAX Diagnostic Imaging Iohexol Dossier

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iMAX Diagnostic Imaging Iohexol Dossier - Offering

iMAX Diagnostic Imaging has developed a dossier for a generic of GE
Healthcare Omnipaque (Iohexol). The API is produced by Hovione and the
formulation is done at a leading contractor in EU.
20ml

50ml

100ml

500ml

300mg/ml
Iohexol
350mg/ml

Documentation:
- Dossier in EU CDT format
- CPP (on request)
Regulatory Status in EU:
- Approved in EU by the INFARMED (Portuguese Health Authority)

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Thank you!

Carlos Costa
Director of Supply Chain
Phone: +351 91 907 1636
+353 87 232 0011
ccosta@imaxdiagnostic.com
www.imaxdiagnostic.com

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